Total (galenic) phytopreparations. Technological processes of manufacturing phytopreparations on the example of motherwort tincture Acquaintance with the technological process of manufacturing phytopreparations

  • Date: 08.03.2020

Completed by: Bitenskaya Vera

Checked by: Gubina Irina

Petrovna

    Introduction

    Extracts

    Liquid extracts

    Tinctures

    Thick extracts and dry extracts

    Water extraction technology using concentrate extracts

    Extracts included in complex preparations

    Leaders in the production of extracts

    conclusions

    Literature

1. Introduction

Extracts are one of the oldest dosage forms of official medicine..

After the discovery of a method for producing alcohol, the ancient Roman physician Galen was the first to introduce into medicine the use of alcohol extracts from plants - galenic preparations. The result of the further development of this type of extraction of biologically active substances from plant material was alcohol extracts. In our time, these ancient medicinal categories have not lost their relevance, they are constantly developing and, as a result, in many states they have a pharmacopoeial status.

All types of extracts are called extracts, while a clear distinction is made according to the consistency of the extract obtained: liquid, thick (soft) and solid (dry). At the same time, liquid forms are classified as liquid extracts and tinctures, the method of obtaining which differs in the ratio of raw materials and extractants (tinctures) taken for extraction or in the ratio of raw materials and finished products (extracts). In liquid extracts, as a rule, one part by weight or volume is equivalent to one part by weight of the original dried drug. Extracts can be standardized and quantified (discrete). Standardized extracts are extracts that are standardized within the therapeutic activity of a particular active substance or component. Quantitatively determined extracts are those extracts, the standardization of which is carried out within certain limits of any marker components of the extract. Determination of extracts by their production process and properties is allowed. Since extracts can be considered both substances for the preparation of other finished medicinal products, and as medicinal products for various applications, all those requirements are set for them that are specific for a certain type of finished medicinal product.

There are 2 phytopreparation leaders on the Ukrainian market: Bionorica AG and Natur Produkt vega. The plant materials used by these companies are grown in specially designated areas. This approach makes it possible to guarantee the quantitative and qualitative composition of the initial product used and the effect of the finished medicinal product. The phytoniring concept (phyto - plant, engi - technology development) - organically combines a rational approach to herbal medicine and modern scientific and technical achievements of the pharmaceutical industry, the knowledge that mankind has accumulated for centuries, and the highest production requirements.

2. EXTRACTS Extracta

Definition Extracts are concentrated liquid medicinal products (liquid extracts and tinctures), soft (thick extracts) or hard (dry extracts) consistency, obtained from dried medicinal plant materials or animal material, which are usually dried.

Various types of extracts are known. Standardized extracts are extracts in which the content of components with known therapeutic activity is regulated within acceptable values. Standardization is achieved by mixing the extracts with an inert material or other series of extract. Quantified extracts - extracts in which the content of components is regulated within certain limits. Their standardization is carried out by mixing different series of extracts.

Other extracts are characterized by their production process (the state of the medicinal plant material or animal material that is extracted, solvent, extraction conditions) and by their properties. Manufacturing Extracts are prepared by appropriate methods using ethanol or other suitable solvent. Different batches of medicinal plant material or animal material can be ground before extraction. In some cases, the material that is extracted may be amenable to pretreatment, for example, enzyme inactivation, grinding or defatting. After extraction, unnecessary materials are removed if necessary. Medicinal plant raw materials, animal materials and organic solvents used in the manufacture of extracts must meet the requirements of the relevant articles of the Pharmacopoeia. For thick and dry extracts in which organic solvents are removed by evaporation, distilled or recirculated solvents may be used, provided that the distillation processes are controlled and the solvent is checked against standards before reuse or mixing with another proposed material. The water used for the extraction must be of suitable quality. Suitable water can be considered water that meets the requirements for "Purified water" in bulk ", with the exception of the test for bacterial endotoxins given in the article" Purified water ".

Drinking water can be used if it meets the requirements of a specific regulatory and technical document that ensures the proper quality of water for the production of a specific extract. Extraction with a specific solvent results in typical ratios of the characteristic components in the material that is extracted; during the production of standardized or quantified extracts, purification procedures can practically lead to an increase in these ratios relative to the expected level; such extracts are referred to as "purified".

Dosage forms of industrial production.

Lecture number 15.

Lecture plan:

  1. Phytopreparations.
  2. Extracts. Characterization, receipt, storage.
  3. The most purified phytopreparations (novogalenic preparations).
  4. Tablets. Dragee. Capsules. Aerosol medicines.
  5. Modern dosage forms. Prolonged dosage forms.

Extracts obtained from medicinal plant raw materials are referred to drugs, combined in accordance with the source of their production in the group of phytopreparations. Depending on its properties, a distinction is made between preparations from fresh plants and preparations from dried plant materials. Phytopreparations are manufactured at pharmaceutical enterprises. The vast majority of phytopreparations are obtained from medicinal plant materials. Medicinal herbal raw materials are the most valuable source of a huge number of highly effective drugs.

Tinctures occupy a prominent place in the catalog of official galenic preparations.

Tinctures are called liquid alcohol, alcohol-water and alcohol-ether extracts of pharmacologically active substances from medicinal plant materials, obtained without heating and removing the extractant.

In the manufacture of tinctures, three methods are used:

◘ maceration;

◘ percolation;

◘ dissolving extracts.

Maceration- the main method of making tinctures (soaking method). The crushed raw materials with the extractant are placed in a sealed vessel and infused at a temperature of 15 - 20 0 С, stirring from time to time. Insist within 7 days, if there are no other agreed terms. Then the hood is drained, the residue is wrung out, washed with a small amount of the extractant, squeezed out again, the compressed hood is added to the drained hood, after which the combined hood is brought to the required volume with the extractant.

Percolation- applicable to small quantities of raw materials (this is a filtering method). The crushed raw material is moistened in a separate closed vessel with a sufficient amount of extractant, adding until the raw material is completely wetted. Leave for 4 hours, after which the swollen material is tightly placed in a percolator and with an open tempering valve such an amount is added so that its layer (mirror) above the surface is - 30 - 40 mm. The liquid pouring out of the tap is poured back into the percolator, the tap is closed, and left for 24 hours. Then the percolator is percolated by lowering in 1 hour a volume of liquid corresponding to 1/48 of the used volume of the percolator until the desired amount of tincture is obtained.

If the tinctures prepared by the maceration and percolation methods are cloudy and contain suspended particles, then before filtration they are clarified by settling in sedimentation tanks for several days at a temperature not higher than 8 0 C, after which the tincture is drained.

Dissolution- this method is used in the production of certain tinctures by dissolving the corresponding dry or thick extracts in ethanol of the required concentration. The dissolving operation takes little time and only needs a mixing tank with a lid. The resulting solutions are filtered.

The manual contains brief information about plant raw materials, cell culture of medicinal plants, data on the chemical structure and properties of active substances of phytochemicals, theoretical foundations of the process of extracting plant raw materials and other technological processes in the production of phytopreparations. Data on the methods of isolation and purification of various medicinal substances from plants (physical and chemical technology), instrumentation of technological processes for the production of tinctures, extracts, novogalenic preparations and individual compounds are presented. Examples of complex processing of medicinal raw materials are given. The textbook is intended for postgraduate professional education of pharmacists, for students of pharmaceutical universities, pharmaceutical faculties of medical universities, chemical and technological universities studying the chemistry and technology of phytopreparations, as well as for specialists of chemical and pharmaceutical plants, firms, pharmaceutical factories, production laboratories and workers in scientific research technological laboratories engaged in the development of technology for phytochemicals.

Characteristics of biologically active substances.
Biologically active substances (BAS) include compounds that actively affect the human body and are used as medicinal substances. Medicines - dosed drugs in a specific dosage form. Depending on the generality of TP, the raw materials used and (in some cases) the effect on the body, 8 groups of drugs are distinguished: chemical drugs, chemical pharmaceuticals, phytochemicals, antibiotics, vitamins, endocrine drugs, immunological drugs, radioactive isotopes.

Chemical preparations are individual chemical compounds produced by enterprises of the chemical industry for various sectors of the national economy and used in medical practice as drugs (for example, sodium bromide, potassium bromide, sodium bicarbonate, sodium thiosulfate).
Chemical-pharmaceutical preparations - chemical substances produced by enterprises of the chemical-pharmaceutical industry, as a rule, on the basis of multi-stage fine organic synthesis. This group of drugs includes anti-tuberculosis (ftivazid, isoniazid, etc.), local anesthetic (novocaine, trimecaine, etc.).


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The essence of the invention: Usage: methods of obtaining phytopreparations with high physiological activity. The essence of the invention: the raw material is crushed, the extraction mixture is prepared by dissolving inorganic salts in the steam condensate and the raw material is combined with the mixture in a ratio of 1: 6.5. The resulting slurry is heated and processed under pressure. At the same time, the processing is first carried out at a lower temperature, and then at a higher one, more than 130oС. Evaporation is carried out to 35 - 45% of the dry matter residue in the extract at a temperature below 100 ° C. 1 ill.

  • 3. By patent number and publication year
  • 2,000,000 ... 2099999 (1994-1997)
  • 2100000 ... 2199999 (1997-2003)

Patent number: 2060683 Patent class (s): A23K1 / 00, A23K1 / 14, A23K1 / 175 Application number: 93046243/15 Application filing date: 09/30/1993 Publication date: 05/27/1996 Applicant (s): Limited Liability Partnership Nauchno - implementation enterprise "APT - Ecology" Author (s): PI Lavin; A.P. Moroz Patent holder (s): Limited Liability Partnership Research and Development Enterprise "APT - Ecology" Description of the invention: The invention relates to methods of obtaining phytopreparations from plant raw materials and can be used to obtain phytopreparations with high physiological activity.

A known method of manufacturing phytopreparations, providing for grinding raw materials, preparing an extraction mixture and obtaining an extract (AS USSR N 1375226, class A 23 K 1/00, 1984).

The disadvantage of the prototype is the complexity of the technology for obtaining a phytopreparation. The technical result of the invention is to simplify the method of obtaining phytopreparations of increased physiological activity.

The invention is illustrated by a drawing.

The device for the manufacture of phytopreparations contains interconnected shredder 1 of plant raw materials, a container 2 for preparing an extraction mixture, a hopper 3 for placing in it crushed plant materials, a screw 4 for feeding raw materials into a weighing doser 5, a mixer 6 for obtaining a suspension, block 7 of the first stage extraction "cold extraction", batching unit 8 inorganic salts, storage tank 11 for steam condensate, reaction boilers 12 for high-temperature pulp treatment, cooler 13, settling centrifuge 14, raffinate collector 15, capacity 16 of the extract accumulator, unit 17 for dosing the extract, separator 18 , a storage tank 19 of the clarified extract, a vacuum evaporator 20, a steam cooler 21, a container 22 for accumulating a concentrated extract, while the chopper 1 of plant raw materials is connected to the hopper 3 for placing in it crushed vegetable raw materials, located above the screw 4 for feeding raw materials into the weighing dispenser 5 associated with mixer 6 for obtaining a suspension associated with the inlet of the unit 7 of the first stage of extraction and with the tank 2 for preparing the extraction mixture associated with the dosing unit 8 of inorganic salts and with the storage tank 11 for steam condensate, the outlet of the extractor-disperser 7 is connected with the inlet of the storage tank 9 for pulp, the output of which is connected to the input of the metering pump 10, the output of which is connected to the inputs of each of the reaction boilers 12 for pulp processing, the outputs of which are connected to the inputs of the cooler 13, the output of which is connected to the input of the cooling centrifuge 14 connected to the raffinate collector 15 and the storage tank 16 extract connected to the extract dosing unit 17 connected to the inlet of the separator 18, the outlet of which is connected to the inlet of the accumulator 19 of the clarified extract, the outlet of which is connected to the inlet of the vacuum evaporator 20, one of the outlets of which is connected to the inlet of the container 22 for accumulating the concentrated extract, and the second outlet of the vacuum evaporator 20 is connected to the inlet o cooler 21 steam associated with the storage tank 11 steam condensate.

The connection of the structural elements is carried out by means of pipelines with valves and actuators. The ratio of plant raw materials to the extraction mixture 1: 6.5 is selected to ensure the possibility of pulp formation. With a decrease in this ratio, the suspension does not possess the properties of a pulp (it is low-flow), and with an increase in the ratio, the pulp stratifies into an extract and a solid phase, and this does not contribute to the processing of the pulp in an extractor-disperser. The method is implemented as follows.

Take vegetable raw materials, for example, willow leaves, oak leaves, alfalfa grass (alfalfa hay), clover grass (clover hay), etc., grind it in a chopper 1 to a linear size of 5-8 mm. At the same time, an extracting mixture is prepared in tank 2, and salts are added from the dispenser 8. The crushed raw materials are loaded into the hopper 3, from which the raw material is fed by the screw 4 to the weighing dispenser 5. The raw material of a given mass is fed into the mixer 6 by the weighing dispenser 5, and from the tank 2 an extraction mixture is added to provide a ratio of 1: 6.5. The resulting suspension is fed through the shut-off equipment to the unit 7 of the first stage of extraction, where "cold" extraction takes place. The resulting extract is poured into a storage tank 9, from where it is transferred to a storage tank 16, and the raw plant biomass is again poured with an extractant in the amount required to create a hydromodule 1: 6.5.

Then the pulp is transferred to the storage tank 9 of the pulp. From the storage tank 9 of the pulp, the pulp is pumped into the reaction boilers 12 using the dosing pump 10. In the reaction boilers 12, the pulp is processed at a temperature of 130-155 ° C and a pressure of 4.5x105-6.5x105 Pa for 30-35 minutes and is supplied under pressure to cooler 13. After cooling in cooler 13 to 50-55 ° C, the slurry is fed in a fixed flow to a settling centrifuge 14, where it is separated into extract and raffinate, the raffinate enters the raffinate collector 15, and the extract enters the extract storage tank 16, where it is combined with the originally obtained extract ... The extract from the storage tank 16 by means of the extract dosing unit 17 enters the separator 18, where the extract is clarified, the ballast substances (substances that worsen the physiological activity of phytopreparations, mineral dust particles) are separated from the extract.

After separation of the extract, the clarified extract is pumped into a storage tank 19, from which it is fed to a vacuum evaporator 20, where water is extracted from the extract until the dry residue content in the extract is 35-45%. The concentrated extract enters the storage tank 22 for its further packaging.

Steam, which is a waste product from the vacuum evaporator 20, through the steam cooler 21, where it condenses in the form of steam condensate, is sent to the storage tank 11 of the steam condensate, from which it is subsequently sent to the vessel 2 for preparing the extraction mixture.

The invention increases the physiological activity of the phytopreparation, the yield of the phytopreparation per unit of raw material, and also simplifies the technology of its preparation, because in the process of processing technology, energy consumption is reduced. The formula of the invention: A method for producing phytopreparations, including grinding plant raw materials, preparing an extraction mixture, combining crushed plant raw materials with it in a steam condensate, processing the pulp by heating it, separating the solid fraction from the cooled pulp, purifying the extract from ballast substances and microparticles, evaporating the extract under vacuum characterized in that the crushed plant material at the first stage of extraction is soaked in a cold extraction mixture with inorganic salts dissolved in it in a ratio of 1: 6.5 and kept for 20-60 minutes, the solid fraction of the pulp is separated, and the extract is processed by heating to 130-155 ° C with a pressure holding of 4.5 · 105 6.5 · 105 Pa for 30 to 35 minutes, evaporation of the extract under vacuum is carried out to 35–45% of the dry matter content in the extract at a temperature of not more than 100 ° C.

Phytopreparations in modern rational pharmacotherapy

Herbal medicine is a branch of medicine that deals with the treatment of medicinal plants or their parts, as well as preparations based on them. The term comes from the Greek word phytos (plant). The pharmacological action of phytopreparations has been proven either by special clinical studies, or as a result of the analysis of the accumulated experience of medical use, and it has been proven by strictly medical methods. Such drugs are standardized either by the main active ingredient, or by the substance that predominates in the given drug.

Phytotherapeutic medicines do not include preparations from medicinal plants made for homeopathy, anthroposophic medicine, spagyrica, as well as non-standardized mixtures of plant and synthetic bioactive substances or natural bioactive substances isolated in pure form.

Yesterday and today of medicinal plants

The knowledge of the healing power of plants has been around for thousands of years and has been influenced over the centuries by various, today sometimes absurd, theories of disease and disease classifications. However, without many plant bioactive substances from the rich treasury of herbal medicine, it is still impossible today to imagine an arsenal of strictly scientifically oriented academic medicine. What is at least quinine extracted from the bark of the cinchona tree, which for a long time served as the main remedy for the treatment of malaria.

In many cases, it was possible to isolate individual active ingredients from medicinal plants. This became a prerequisite for the development of the synthesis of bioactive substances and their standardized analogues. Thanks to this, medicine has gained a great advantage in the production of highly effective and potent medicines due to a more accurate dosage of substances than in the preparation of extracts and other preparations from medicinal plant materials. At the same time, this led to the release of medicinal substances beyond the limits of herbal medicine itself.

The dose of the drug is optimal only when it contains a strictly defined amount of the bioactive substance. This allows you to accurately predict the effect of the drug.

A striking example is cardiac glycosides, which were originally obtained from digitalis. Their therapeutic spectrum is extremely narrow, and therefore, in order to avoid the development of serious side effects, a very precise dosage is required.

Previously, doctors used infusions or extracts from foxglove, but there was always a risk of overdose up to poisoning, since the concentration of bioactive substances - cardiac glycosides - from plant to plant and, therefore, from drug to drug varied within fairly significant limits.

Other examples of natural bioactive substances that did not become herbal remedies, but whose isolation and use contributed to the progress of therapy, are cocaine from coca leaves, atropine from belladonna, ergotamine from ergot, and reserpine from rauwolfia roots.

Cocaine was the first local anesthetic. Atropine is used to this day as an antidote for some poisoning and in intensive care, as well as in ophthalmology. Many migraine medications contain ergotamine alkaloids.

The famous Aspirin also originates from a medicinal plant. The very name of the active ingredient indicates its plant origin. Salicylic acid was first extracted from willow bark (lat. Salix), and then in laboratories they received acetylsalicylic acid from it.

In modern herbal medicine, plants with low toxicity and good tolerance are mainly used. However, some of them come across those that, if handled incorrectly or too long-term use, can cause significant side effects. For example, the herb Artemisia absinthium L. contains active narcotic derivatives that can cause disorders of the central nervous system and general mental disorders. With the use of drugs from ginseng, side effects such as heart failure, a decrease in the effectiveness of antidiabetic drugs were observed. Regarding herbal remedies, even now we must remember the old, but still valid teaching of Paracelsus: "All plants contain poison and there is nothing without poison, only the dose depends on whether the poison becomes poison or not."

Phytopreparations are characterized by the fact that the complex of substances contained in the medicinal plant is completely transferred into them. In this sense, bioactive substances isolated from medicinal plants under laboratory conditions, as well as individual substances synthesized according to their sample, in the strict sense do not belong to phytopreparations.

Plant secret

The search for the "principle of action" of a medicinal plant led to a scientific controversy that has not been resolved to this day. Phytochemistry tries to identify the effective ingredients contained in a medicinal plant, divide them into monosubstances, and among them find an active ingredient that is active against a particular disease. However, other scientists doubt that the effect of the medicinal plant as a whole is limited only by the action of a few of the substances it contains, each separately.

It is known that some medicinal plants, the therapeutic benefits of which have been documented by clinical experience and confirmed by scientific research, have not yet identified the main bioactive substances (Table 1). An example is St. John's wort with its proven antidepressant effect.

Classical herbal medicine today is based on the fact that medicinal plants in most cases contain several bioactive ingredients, which are called effectors. They contain additional substances called co-effectors (associated bioactive substances) that increase the bioavailability of the effectors for the body. At the same time, the action of effectors and co-effectors is influenced by the individual characteristics of the patient, for example, the general condition, the so-called. constitution, as well as the type and severity of the disease. There are extreme cases when a plant contains ingredients that, depending on the characteristics of a particular patient, act completely differently and can even cause opposite reactions. A similar effect can be observed in the well-researched medicinal plant - ginseng root. The contained ginsenoside Rg1 increases blood pressure and stimulates the central nervous system, while ginsenoside Rb1 reduces blood pressure and calms the nervous system. The body's response to this or that ingredient depends on the initial state of the patient. Thus, herbal medicine is a phenomenon that is attributed to classical naturotherapy: it does not act in one direction, but is more aimed at restoring the balance of body systems. That is why many herbal remedies have a reputation for normalizing, leading to equilibrium.

Therefore, manufacturers of phytopharmaceuticals strive to produce preparations in which as many of the ingredients originally found in the plant would be preserved, and in their "natural", balanced ratio. Many phytopharmaceuticals are standardized, qualitatively and quantitatively assessed by the content of the so-called basic substances or those substances that are considered effective. It can also be the substances prevailing in the given medicinal product. Such preparations are usually made on the basis of expensive and complex extraction, the purpose of which is to achieve a higher content of bioactive substances in the preparation.

Methods for the production of phytopreparations are varied. In this case, either the whole plant (lat.planta herba), flowers (floes), leaves (folium), roots (radices), fruits (fructus), seeds (semina), bark (cortices), rhizomes (rhizomata) are used. Juice is made from fresh raw materials, alcohol, oil, alcohol-water and water extracts. Dry or specially dried parts are turned into powder, sometimes pressed into tablets or crushed for further preparation of collections. Extracts or extracts in most cases contain different ingredients in different concentrations depending on the solvent used. So, some substances dissolve in alcohol, and others in water. Changing the dosage form, solvent or extractant significantly affects the biological activity of drugs. So, the oil extract from the herb of the creeper has a wound-healing effect, because contains a significant amount of carotenoids, and the water extract (infusion) has a hypotensive effect due to the presence of flavonoids. A decoction and tincture of calamus rhizomes are used as bitterness (a means that stimulates the work of the glands of the digestive tract). And the powder of the rhizomes of this plant suppresses the secretion of gastric juice.

The same applies to the method of preparation of the medicinal product. Decoctions (Decoctum) do not contain the same substances as hot or cold infusions (Infusum), cold extracts. Therefore, the technical and regulatory documentation contains precise instructions for the manufacture and quality control of phytopharmaceuticals. If we are talking about medicines for home preparation, then there are specific prescriptions for consumers that must be followed.

In addition, oils and extracts for ointments, baths, inhalations and other means for external use are obtained from medicinal plants. In such preparations, the line between a drug and a means of prevention and hygiene is blurred.

Unfortunately, herbal preparations are often of varying quality. It depends on the initial state of plant raw materials, the thoroughness of preparation and processing of semi-finished products, as well as compliance with the concentration parameters. Only the high quality of phytopreparations can provide them with the necessary properties and action in standard therapy.

The use of phytopreparations in medical practice

In the previous hundred years, the principles of choosing the therapeutic options of the doctor who provide assistance to the patient have repeatedly changed. The first decades of the 20th century were marked by epoch-making advances in medicine and, above all, in pharmacotherapy. Spoiled by success, medicine tried not to remember the risks and side effects of drugs. They were understated or only mentioned in passing, for example, on the package insert of a medicinal product. Medical practice received, to the detriment of an integrated approach to examining a patient and communicating between a doctor and a patient, a kind of "chemical-technological bias".

And now, general practitioners and family doctors continue to prefer drug therapy. For example, private general practitioners and therapists in Germany prescribe about 2/3 of all medicines used in the country, of which the bulk is intended for patients over 60 years of age. At the same time, the treatment of chronic diseases in old and senile age only in rare cases requires the use of drugs with a quick and strong effect. Just phytopreparations for the most part do not have such an effect. Therefore, they are often prescribed by doctors, and their long-term effect and wide therapeutic spectrum, combined with relative safety, play a decisive role in this.

The use of drugs, as a rule, is based on the accumulated medical experience, and not on documented data from clinical trials, which does not meet the modern requirements of evidence-based medicine.

The results of toxicological, pharmacological and clinical studies in the following sequence are used as scientific evidence of the effectiveness of a drug: controlled studies, uncontrolled studies, observations on use and summary reports on individual reports. It would seem that with such requirements, the tradition of use and the accumulated medical experience play rather a subordinate role in assessing the therapeutic efficacy of a drug, and phytopreparations still need to be studied, their effectiveness should be investigated using controlled clinical trials. Such studies are difficult to conduct due to the pronounced placebo effect and the mild and relatively slow onset of the effect.

In Germany, the Allensbach Institute for Demoscopy operates, which systematically conducts surveys about the opinion of the country's population about medicinal products of natural origin. In 1997, 2,697 representatively selected respondents, aged 16 to 90, were interviewed. Prescribing natural medicines by a doctor was considered very important by 27% of the respondents, 48% - important and only 15% - not very important. This shows how much importance the population of Germany attaches to phytopreparations. When asked whether the respondent considered these drugs to be effective, 8% answered “no”, 43% - “I don’t know,” while 49% were confident in the effectiveness of herbal remedies. At the same time, the majority of respondents believed that phytopreparations should act in the body differently from synthetic drugs.

The risk of treatment with medicinal plants was assessed by 80% of respondents as small, while 90% of respondents assessed this risk when using synthetic drugs from medium to high. Moreover, in these assessments there was no difference between the adherents of herbal medicine and its opponents.

The patient, not knowing whether he is taking a synthetic or herbal preparation, can transfer the unwanted side effects of synthetic drugs to herbal remedies. Therefore, the so-called observations on the use of drugs are much more informative. Such studies were carried out for the majority of commonly used herbal remedies. For example, a similar study involving 10,815 patients with senile dementia who were treated with ginkgo biloba showed that only 183 people (1.69%) indicated spontaneous side effects, while in the comparison group (2141 patient), in which patients received a synthetic nootropic drug for the same disease, 116 patients (5.42%) reported side effects (Burkard and Lehrl, 1991).

Even more pronounced differences were found in the pharmacotherapy of patients with depression. Tricyclic antidepressants, which have been used for more than 30 years, caused unwanted side effects at the very beginning of treatment (dry mouth, poor accommodation, weakness) in 20-50% of all patients. With the use of new synthetic antidepressants, the proportion of side effects decreased and amounted to 20%, which is still very high (Linden et al., 1992). And recently introduced into therapeutic practice herbal antidepressant based on St. John's wort extract showed the lowest frequency of side effects, which is 10 times lower than those mentioned (Woelk et al., 1993). These two examples can be considered as evidence that both the accumulated medical experience and the patient's expectations for better tolerance of herbal medicines can be scientifically proven for individual drugs.

So, phytopreparations have a special kind of therapeutic advantage, based on the trust that the majority of the population in various countries has in herbal medicines. The general therapeutic effect is formed with any drug therapy from pharmacodynamic and psychodynamic components. The former is often overrated, while the latter is often underestimated. And this is especially true for most herbal remedies, which, on the one hand, is due to the special trust of patients, and on the other hand, is associated with typical areas of application of phytopreparations. With mild health disorders, which play a dominant role in daily medical practice, the psychodynamic effect of drugs can be 40-90%, i.e. the main part of the therapeutic effect (Table 2).

However, the psychodynamic effect correlated with the indications is specific not only for herbal medicine. Perhaps due to the declining proportion of specific side effects in double-blind controlled trials, new synthetic psychopharmacological agents, in particular antidepressants, now face the same challenge in proving efficacy as phytopharmaceuticals once did (Kirsch and Sapirstein, 1998 ; Montgomery, 1999a and b; Schutz, 1999). This raises the question of how generally it is advisable to prescribe high-risk drugs such as benzodiazepines, for example, for sleep disturbances, which are relieved by placebo in 80% of cases, and when with a safe valerian drug can you achieve almost the same effect?

The desire of many patients to be treated with medicinal plants is in most cases based on the emotional perception that a "natural product" is milder and less risky than a "chemical" drug. Patients may underestimate the severity of possible adverse reactions. For example, so-called "forte" (potent) preparations, including traditional plant preparations containing cardiac glycosides from Atropa belladonna and Colchicum, do not meet the safety criteria for herbal preparations. Therefore, with appropriate indications, it is better to prefer the appointment of pure substances of these drugs (cardiac glycosides, atropine, colchicine). On the other hand, trust in a drug is the best prerequisite for its successful use, especially in chronic diseases in the elderly. In such cases, it is not rational or medical wrong to explain to the patient the academic arguments for and against the use of these drugs. Once a doctor has made a decision to prescribe a drug, it is much more advisable to build patient confidence by responding positively to the drug in question. While the basic knowledge about synthetic drugs is mainly related to their chemical structure, which is of little interest to the patient, at the heart of each phytopreparation is a very specific medicinal plant. Its portrayal and history of use can serve as a great backdrop for conversation.

A significant part of the patients for whom phytotherapeutic drugs are recommended are patients with mild symptoms of diseases and with such symptoms that can be interpreted in two ways or ascribed to the manifestations of various disorders, an unambiguous scientifically based diagnosis of which is difficult to make. In addition, a large proportion are patients with chronic diseases and symptoms that cannot be left without drug control, patients in whose treatment the effect is achieved, not least due to the psychodynamic response. Herbal medicine is relevant for patients with chronic diseases, when phytopreparations play the role of accompanying therapy; for elderly patients, when phytopreparations are used for a very long time and a mild therapeutic effect and safety are required.

The use of phytopreparations by groups of diseases (in descending order)

  • - respiratory tract diseases
  • - diseases of the central nervous system
  • - diseases of the gastrointestinal tract, liver and gallbladder
  • --cardiovascular diseases
  • --dermatological diseases
  • --nonspecific increase in immunity
  • --gynecological diseases
  • - means for internal use in rheumatic diseases

phytopreparation extract medicine

Table 1

Examples of pharmacologically investigated herbal medicines, the therapeutic efficacy of which has been confirmed by controlled studies and well-documented medical reports on clinical observations

Preparations or extracts of medicinal plants

Bioactive substance

pharmachologic effect

Application area

Ginkgo biloba

Bilobalide, ginkgolides, flavone ester

Neuroprotective, antioxidant, hemorheological

Symptomatic treatment of organic brain disorders

St. John's wort

Presumably hypericin and hyperforin

Local anti-inflammatory, astringent, antiseptic, antidepressant

Mild to moderate depressive episodes

Chamomile flowers

Presumably hamazulene, bisabolol, lipophilic flavones

Anti-inflammatory, antispasmodic

Inflammatory diseases of the skin, respiratory tract, gastrointestinal tract

Alliin and alliinase

Lowering lipid, inhibiting platelet aggregation, fibrinolytic, antibacterial, lowering blood pressure

Prevention of atherosclerosis

Mottled thistle

Silymarin, silibinin

Antihepatotoxic. At the cellular level, it enhances the formation of ribosomes and protein synthesis

Toxic and chronic liver inflammation

Horse chestnut seeds

Aescin (triterpenesaponin)

Antiexudative; prevention of edema.

Symptoms of chronic venous insufficiency

Senna leaves

Sennosides

Antiabsorptive

Constipation, bowel movement before diagnostic measures

Hawthorn leaves and flowers

Presumably glycosylflavones, proanthocyanidin

Cardioprotective

Functional heart failure corresponding to the second stage according to NYHA

table 2

Proportion of people who recovered from the psychodynamic placebo effect in mild to moderate disease (according to Gauler and Weihrauch, 1997)

Features of the preparation of infusions from medicinal plant raw materials containing essential oils. Features of the preparation of aqueous extracts from medicinal plant raw materials containing saponins. Features of the preparation of aqueous extracts from medicinal plant raw materials containing tannins. Features of the preparation of aqueous extracts from medicinal plant raw materials containing ...


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GBOU SPO "PENZA BASIC MEDICAL COLLEGE" OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

COURSE WORK

Topic: "Preparation of liquid and solid phytopreparations in a pharmacy."

Prepared by: E. Barbashova, student of group 12F-1 of the Pharmacy department, Supervisor: V.A. Grossman

Penza 2015

Introduction ………………………………………………………… .................... 3

1. Phyto-crops ………………………………………………………………… .. 4

2. Infusions and decoctions…. ………………………………………………………… .7

    1. Features of preparation of infusions from medicinal plant raw materials containing essential oils ………………………………………………………………………… 12
    2. Features of preparation of aqueous extracts from medicinal plant raw materials containing saponins …………………………………………………………………… ..13
    3. Features of the preparation of aqueous extracts from medicinal plant raw materials containing tannins ………………………………………………………… 14
    4. Features of preparation of aqueous extracts from medicinal plant raw materials containing antroglycosides …………………………………………………………… 15
    5. Peculiarities of preparation of aqueous extracts from medicinal plant raw materials containing phenologlycosides ………………………………………………………………………………………………………………………… 16
    6. Features of preparation of aqueous extracts from medicinal plant raw materials containing cardiac glycosides ……………………………………………………… 16

2.7. Peculiarities of preparation of aqueous extracts from medicinal plant raw materials containing cardiac alkaloids …… ... ………. ………………………………………………………………………………………………………………………….

  1. Mucus ………………………………………………………………………… ..17

Conclusion ……………………………………………………………………… ..21

References ……………………………………………………………… 25

Introduction.

A medicine is a complex physicochemical system, which is a combination of medicinal substances and pharmaceutical factors (dosage form, technology, etc.), designed to ensure, when taken, the maximum therapeutic effect with a minimum dosage and side effects.

The science that studies the theoretical foundations and practical methods of preparing medicines is called drug manufacturing technology, or pharmaceutical technology.
Drug manufacturing technology is one of the main and most complex pharmaceutical disciplines. To deeply understand and correctly assess the features of technological processes in relation to the production of drugs, knowledge of general and other pharmaceutical disciplines is required - physics, chemistry, pharmaceutical chemistry, pharmacognosy, analytical chemistry, biochemistry, biopharmacy, pharmacokinetics, etc.

Phytopreparations time-tested means that traditional medicine is successfully used to improve the health and prevention of human diseases.

Since ancient times, people have used herbal healing as the only and most effective way of national health improvement. Nowadays, herbs have been replaced by phytopreparations.

Phytopreparations - intermediate products and complexes of plant origin. Natural herbal remedies figure prominently in modern pharmacotherapy. Phytopreparations contain chemically pure substances isolated from plants, purified complexes of natural substances, infusions, decoctions, tinctures, extracts. Pure substances of plant origin, which contain phytopreparations, in their characteristics fully correspond to synthetic remedies. At the same time, complex phytopreparations have the potential of being natural. Natural substances, which contain phytopreparations, are close to the human body, which also gives rise to the peculiarities, which must be taken into account in the process of their experimental and clinical research.

The role of phytopreparations at different stages of health improvement of a person is different. Complex phytopreparations at different stages of a person's recovery, carry a different role. In the initial stages, they are able to prevent further development of the disease or mitigate its manifestations. At the height of the disease, phytopreparations act as means of additional therapy to enhance efficiency, reduce side effects, and correct impaired functions. In the process of recovery, herbal remedies are used along with synthetic remedies. To the extent of recovery, phytopreparations are gradually replacing the latter.

It is important to understand that ineffective plants do not exist in nature. Phytopreparations created in order to properly use one or another plant remedy, for the healing of the body. The properties of medicinal herbs are well researched. It is very difficult to correctly combine the desired properties with various herbs. Phytopreparations can combine medicines from several plants. This is so because phytopreparations are created by medical specialists with the necessary professional knowledge.

Phytopreparations different groups of action should be expanded in the range of modern specialists in pharmacology. This is due to a number of factors of the modern intense rhythm of life, especially the inhabitants of industrial megalopolises, and unfavorable ecological conditions of the environment. It is no coincidence that phytopreparations are preferred. This is due to a number of positive properties that phytopreparations have. Phytopreparations have low toxicity with a sufficiently high efficiency, a wide range of therapeutic action, a complex organoprotective and harmonizing effect on the patient's body, a minimum of side effects, and relatively cheap compared to synthetic drugs. Phytopreparations, if taken in time, can restore daily biorhythms, reduce the development of somatic pathology caused by psychogenic factors, improve the quality of life, mitigate the negative impact on the human body of stressful situations, as well as unfavorable environmental and industrial factors under conditions of maladjustment.

1. Phyto-gatherings.

Phyto-picks are mixtures of several types of crushed, less often whole, medicinal plant materials, sometimes with the addition of salts, essential oils used as medicines.

The raw materials used for the preparation of the fees must comply with the requirements of the regulatory and technical documentation in the form of a pharmacopoeial or temporary pharmacopoeial monograph. The raw materials included in the collection must be crushed in accordance with the intended purpose. When using the collection, for the preparation of infusions and decoctions, the raw materials included in the collection are crushed separately.

Fees are one of the oldest, if not the most ancient dosage form. They are mentioned in the first papyri. Gathering was well spread at that time: it was used as a drink, was used for smoking, burned in order to obtain fragrant fumes, etc. As a semi-finished product for a medicine made by the patient himself at home, fees later gave way to more rational and convenient medicines.

Fees are used for the preparation of infusions and decoctions, rinses, as well as for baths.

The disadvantage of most collections (underdosed) is the need to dose them to patients at home, most often with a spoon, which leads to significant dosage fluctuations.

The phyto-collection components are mixed on sheets of parchment paper until a uniform mixture is obtained. In this case, mixing begins with components included in smaller quantities, gradually moving to large ones.

Through observations, it was found that for an adult (25-60 years old) the optimal single dose of the collection is 1.5 g, and the average daily dose is within 5.0 g. For children, the dose for taking the drug collection is determined primarily by age and body weight.

General collection technology.

In order to more completely extract the active substances contained in the medicinal plant raw materials included in the collection, the latter in most cases is preliminarily crushed. The raw materials included in the collection are crushed separately. Leaves, grasses and bark are cut with scissors or knives, root and grass cutters (leathery leaves are first cut and then turned into a coarse powder in a mortar).

Roots and rhizomes, depending on their shape, size and hardness, are cut or crushed in mortars. Various mills can also be used to grind them.

Fruits and seeds are passed through rollers, runners or disc mills. In a pharmacy where there is no such equipment, they can be crushed (crushed and ground) in a large porcelain or metal mortar.

Flowers and small inflorescences are consumed in a non-crushed, whole form, since the flower shell does not interfere with the extraction of active substances (exceptions are linden flowers, consisting of dense plant tissue).

Plant raw material is a fairly difficult-to-grind object due to the presence of water in plants. In order to facilitate grinding, the raw material is dried to a residual moisture content of no more than 5-7%, which significantly increases its fragility.

The degree of grinding depends on the purpose of the collection. So, parts of plants that are part of teas or collections, which are used to prepare infusions or decoctions for ingestion or for gargling, are crushed in accordance with the characteristics of plant raw materials, and those included in the collections for baths and emollient collections for poultices must be crushed into pieces no more than 2mm in size.

The required degree of grinding is achieved by using sieves. At all degrees of grinding, the dust is sifted through a sieve with a hole size of 0.2 mm.

An essential rule when grinding medicinal plant materials is the need to grind the taken amount of raw materials without residue. This is due to the fact that different plant tissues (even of the same organ, such as a leaf) contain different amounts of active substances and have different mechanical properties. In case of improper grinding, material with an underestimated content of active ingredients can be obtained.

A significant difficulty in preparing the collections is the need for uniform mixing of the constituent parts, since pieces of different plant materials have different shapes, weights and sizes and therefore have a pronounced tendency to delamination.

Mixing the fees, prepared in small quantities, is carried out by hand on a sheet of paper. Shredded vegetable raw materials, which are part of the collection in significant quantities, are mixed in large enameled cups (mortars) using a celluloid plate or spatula.

With stirring, the materials that make up the collection in the largest amount are weighed first. They are scattered evenly on paper or poured into a cup, after which they are sprinkled with the remaining parts of the collection and mixed by pouring. You should not grind the raw materials, as a very fine powder and a large amount of dust are obtained.

If the fees include essential oils, then they are introduced in an alcohol solution by spraying the mixed mass. If the collection includes salts, then they are first dissolved in a minimum amount of water, and then the collection is also introduced by spraying. In this case, the humidified waste should then be dried at a temperature not exceeding 60 °. After removal of the solvent, the introduced substances in the form of small crystals are quite firmly held in the folds of leaves and flowers, between the hairs that often cover the surface of leaves, flowers and stems, in the cracks of the root pieces, which prevents the collection from stratification. This cannot be achieved by mixing dry salts with the collections.

Packing, storage and dispensing fees.

Fees are packed and dispensed in cardboard boxes lined with parchment from the inside, or in double paper bags of 50, 100, 150 200 g. and applications. Store the fees in a cool, dry, dark place.

2. Infusions and decoctions.

Infusions and decoctions, as defined by the State Pharmacopoeia, are aqueous extracts from medicinal plant materials or aqueous solutions of concentrate extracts specially designed for these purposes.

As a rule, infusions and decoctions are prepared in such a way that from 10 parts by weight of plant material, 100 parts by volume of the finished extract are obtained.
Infusions and decoctions are prepared depending on the histological structure of the raw material.

Infusions are prepared from raw materials with a loose histological structure.

The crushed medicinal plant raw materials are infused in a boiling water bath for 15 minutes, and then cooled at room temperature for 45 minutes.

Decoctions are prepared from raw materials with a rough histological structure (bark, roots, rhizomes, leathery leaves).

Crushed medicinal plant materials are infused in a boiling water bath for 30 minutes, and then cooled at room temperature for 10 minutes.

In terms of their physicochemical nature, water extracts are combined systems with a liquid dispersion medium. They combine true solutions, solutions of macromolecular compounds, colloidal solutions, and tyk are polydisperse systems in which suspensions (starch) and diluted emulsions (essential oils) are presented.

Along with the active substances during the extraction process, a significant amount of related substances (proteins, gums, starch, peptides, pigments) pass into infusions and decoctions, which actively affect the therapeutic effect of the active substances.

According to the instructions of the GF, infusions and decoctions from materials containing alkaloids should be prepared in water, to which citric or tartaric acid is added in an amount equal to the alkaloids content in a given sample of the starting material.

For the preparation of decoctions and infusions, special equipment should be used. In the conditions of pharmacies, these are infundir devices of various designs AI-3, AI-3000, AI-8000, etc. At home, this is an improvised infundirny apparatus consisting of a boiling water bath and an infusion vessel placed on it. It is most rational to carry out the infusion of a water extract in a ceramic, porcelain dish, a heat-resistant glass or enamel dish; the extraction processes in stainless steel vessels are much worse. The use of dishes made of aluminum, copper and other metals without an appropriate protective coating is unacceptable, since the interaction of biologically active substances of plants with these metals can be observed.

Purified water should be used as an extractant when obtaining infusions and decoctions. In the conditions of pharmacies and phyto-production, water purification can be carried out using installations for distillation, ion exchange or reverse osmosis. At home, it is also necessary to purify the water as much as possible. This is due to the fact that drinking water contains impurities of iron, heavy metals, oxidants, which, during infusion, react with the active substances of the plant, which, in turn, leads to a decrease in the therapeutic activity of the extracts, and in some cases, to the appearance unwanted side effects.

For the preparation of decoctions and infusionsThe crushed raw materials are placed in an infusion or infusion vessel preheated for 15 minutes in a boiling water bath and poured with a calculated amount of purified water at room temperature. The infusion time of the extract in a boiling water bath for infusions is 15 minutes, for decoctions - 30 minutes. Then the hood is removed from the water bath and cooled at room temperature, thereby continuing the process of extracting the active ingredients. For infusions, this time is 45 minutes, for decoctions - 10 minutes. In the case of preparing aqueous extracts with a volume of more than 1000 ml, the infusion time in a boiling water bath and at room temperature should be increased by 10-20 minutes, depending on the volume.

Factors influencing the extraction process:

  • Medicinal product standard
  • Grinding of medicinal plant raw materials
  • The ratio of the amount of raw materials and extractor
  • Physicochemical composition of raw materials
  • Extraction mode (temperature and infusion time)
  • Extractor pH and its nature
  • Influence of enzymes and microorganisms
  • Concentration difference

The ratio of raw materials and extractant.

According to the requirements of the State Fund XI , if the doctor did not indicate the concentration of the water extract in the prescription, then infusions and decoctions are prepared from the raw materials of the general list in a ratio of 1:10.

From poisonous and potent raw materials (thermopsis herb, belladonna leaves, foxglove leaves), water extracts are prepared in a ratio of 1: 400.

Exceptions - in a 1:30 ratio, prepare:

  • Ergot horns;
  • Lily of the valley herb;
  • The root of the source;
  • Spring adonis;
  • Rhizomes with valerian roots.

Shredding of medicinal plant raw materials.

Grinding of medicinal plant materials is one of the main factors affecting the extraction process. According to the law of diffusion, the larger the surface area in contact between water and raw materials, the more substances are extracted.

It must be remembered that too fine grinding results in the extraction of a large amount of ballast substances and reduces diffusion, especially if the raw material is rich in mucous substances and starch.

Leaves and grasses up to 7 mm

Leathery leaves of bearberry, lingonberry and eucalyptus up to 3 mm

Stems, roots, rhizomes and bark from 5 to 7 mm

Fruits and seeds up to 0.5mm

Small flower baskets are not crushed, as well as mint, lemon balm and sage leaves.

Water absorption coefficient of medicinal plant raw materials.

During infusion, medicinal plant materials absorb large amounts of water. Water is also lost due to dish wetting and evaporation. For the preparation of infusions and decoctions of water, you should take more than it is prescribed in the recipe, taking into account the coefficient of water absorption.

The water absorption coefficient shows how many milliliters of water are retained by 1 gram of raw material after it has been infused and squeezed out.

If the water absorption coefficient is not indicated in the table, then the conventionally accepted ones are used:

Roots 1.5

Barks, herbs, flowers 1.0

Seeds 3.0

Table. Water absorption coefficients for various types of medicinal plant materials

WATER ABSORPTION COEFFICIENTS OF MEDICINAL VEGETABLE RAW MATERIALS

name of raw materials

Coefficient, ml / g

Oak bark

Viburnum bark

Buckthorn bark

Calamus roots

The roots of istode

Licorice roots

Serpentine rhizomes

Rhizomes with burnet roots

Potentilla rhizomes

Lingonberry leaves

Nettle leaves

Mother-and-stepmother leaves

Mint leaves

Plantain leaves

Senna leaves

Bearberry leaves

Sage leaves

Rowan fruit

Dog-rose fruit

Adonis herb

Hypericum herb

Lily of the valley herb

Wormwood herb

Motherwort herb

Creeper herb

Horsetail herb

Streak grass

Linden flowers

Chamomile flowers

Hop cones

Algorithm for preparing water extracts.

  1. Calculate the amount of raw materials and water.
  2. Heat the inflatable jacket in a boiling water bath for at least 15 minutes.
  3. Grind the medicinal product, sift it out of dust and weigh the required amount.
  4. Measure the required amount of water taking into account the water absorption coefficient.
  5. Pour the raw materials into an infuser, add water, mix, close with a lid.
  6. Notice the start time of the infusion.
  7. After insisting and cooling, strain the contents of the infund through a double layer of gauze and a washed cotton swab.

If there is little dry matter, then filter it into a graduated cylinder. If there are a lot of dry substances, then they are filtered into a stand. If necessary, the volume is adjusted with water to the volume prescribed in the recipe through the squeezed raw material.

Disadvantages of Extemporal Aqueous Extracts from Raw Materials:

· Instability during storage, as the extractant is water, and medicinal plant raw materials contain microorganisms and enzymes.

· The dosage form is obtained non-standard in any case.

· Requires special manufacturing techniques - grinding, equipment, etc.

· The sick leave is delayed.

· Inconvenience of use.

2.1. Features of the preparation of infusions from medicinal plant raw materials containing essential oils.

  • Anise fruit
  • Fennel fruit
  • Rosemary shoots
  • Eucalyptus leaves
  • Thyme herb
  • Melissa herb
  • Oregano herb
  • Pine buds
  • Calamus rhizomes
  • Chamomile flowers
  • Sage leaves
  • Mint leaves
  • Rhizomes with valerian roots
  • Rhizomes with elecampane roots

From medicinal plant raw materials containing essential oils, regardless of the histological structure, only infusions are prepared.

During infusion and cooling, the lid is not opened, since essential oils are distilled with water vapor.

2.2. Features of the preparation of aqueous extracts from medicinal plant raw materials containing saponins.

  • Ginseng root
  • Violet herb
  • Horsetail herb
  • Liquorice root
  • Rhizomes with cyanosis roots
  • Leuzea rhizomes with roots

Saponins are well extracted from medicinal plant raw materials in an alkaline medium, poorly in a neutral medium, and are not extracted in an acidic medium.

Note: if the recipe contains an MP containing saponins. NaHCO 3, then it is placed in an infundirka along with the medicinal product, before infusion, to create an alkaline reaction of the medium.

If NaHCO 3 is not registered, then it should be taken independently at the rate of 1.0 NaHCO 3 for 10.0 raw materials.

Example:

Rp: Decocti radicis Glicerisa 200ml

Sirupi sacchari 20.0

M. D. S : ¼ glasses in the morning and in the evening.

A prescription has been issued for a complex liquid underdosed dosage form for internal use - a mixture, an infusion of water extraction.

According to the order of the Ministry of Healthcare of the Russian Federation No. 308, it should be prepared using a mass-volume method.

According to the requirements of the State Fund XI , the concentration of water extraction is not specified, should be prepared from a ratio of 1:10

Licorice root contains saponins and is a raw material with a rough histological structure, so a decoction should be prepared.

Saponins are well extracted in an alkaline environment, so for cooking you should take NaHCO 3 calculation 1.0 for 10.0 raw materials. NaHCO 3 should be added to the infundir.

The broth should be infused for 30 minutes and cooled for 10 minutes at room temperature.

The sugar syrup should be added immediately to the dispensing bottle.

To issue the main label with a green signal color and the inscription "internal". Additional labels: “Keep out of the reach of children”, “Store in a cool, dark place” and “Shake before use”.

Working recipe:

Licorice roots, crushed and sifted from dust 20.0

Purified water 200ml + (20.0 x 1.7) = 234ml

Sodium bicarbonate 2.0

Sugar syrup 20.0

Total V = 220ml

Preparation: Prepared the workplace. Heated the inflatable jacket in a water bath for at least 15 minutes.

She crushed the licorice roots, sifted them out of dust, weighed 20.0 and poured them onto the capsule.

I measured out 234 ml of water with a graduated cylinder. She poured licorice roots from the capsule into an infuser and filled it with water. Weighed 2.0 on a hand scale NaHCO 3, added to the infundirka. She closed the lid and noticed the infusion time. She insisted for 30 minutes, then removed the infuser from the water bath and cooled it for 10 minutes at room temperature.

The broth was filtered through a double layer of gauze and a cotton swab washed with cleaned water into a measuring cylinder. I squeezed the raw material and, if necessary, brought the volume with water to 200 ml through the squeezed raw material. The broth was poured into a bottle for vacation. I measured out 20 ml of sugar syrup and poured it into a bottle. Corked, shaken, issued for vacation. From memory, I filled in the PPK.

2.3. Features of the preparation of aqueous extracts from medicinal plant raw materials containing tannins.

  • Oak bark
  • Blueberry fruit
  • Cherry fruits
  • Serpentine rhizomes
  • Burnet rhizomes
  • Potentilla rhizomes
  • Butane leaves

Raw materials with a rough histological structure, therefore, only decoctions are prepared from it.

Tannins dissolve well in hot water, and when cooled, they precipitate and remain on the filter during filtration, therefore, the broth from raw materials containing tannins is filtered immediately after infusion without cooling.

2.4. Features of the preparation of aqueous extracts from medicinal plant raw materials containing antroglycosides.

  • Rhubarb root
  • Joster fruit
  • Buckthorn bark
  • Senna leaves

Antroglycosides of rhubarb in a small concentration have a fixing effect and irritate the nerve endings of the mucous membrane of the small intestine, enhances peristalsis and has a laxative effect.

Infusions and decoctions from rhubarb root have the opposite therapeutic effect. From rhubarb, you should prepare the water extract that is prescribed in the recipe.

Infusions and decoctions are filtered hot without refrigeration.

Joster fruits have a rough histological structure, and decoctions are prepared from them. Insist for 30 minutes, then filter without cooling.

A decoction is prepared from the buckthorn bark. Insist for 30 minutes, then filter without cooling. The broth can be used only after a year of storage or after heat treatment of the bark so that the broth does not induce vomiting.

A decoction is prepared from senna leaves. Insist 30 minutes. In addition to antroglycosides, senna leaves contain a large amount of ballast resinous substances, which, when released into the gastrointestinal tract, cause intestinal colic and abdominal pain.

Resins dissolve well in hot water. When the decoction is cooled, the resin precipitates and can be filtered. Therefore, a decoction is prepared, which is cooled completely.

2.5. Features of the preparation of aqueous extracts from medicinal plant raw materials containing phenologlycosides.

  • Bearberry leaves
  • Lingonberry leaves

Bearberry and lingonberry have leathery leaves covered with a whiskey bloom, which prevents the extraction of the action of substances through the surface of the leaf blade. Therefore, the raw material is crushed finer than other leaves 1-3mm, since the extraction proceeds through the break of the leaf.

Raw materials with a rough histological structure contain a large amount of tannins on the surface of which phenol glycosides are adsorbed.

Only decoctions are prepared from this raw material. Insist for 30 minutes and filter without refrigeration to preserve the active ingredients.

Note: together with the bearberry broth, hexamethylenetetramine is often prescribed, which, when dissolved in a hot broth, dissolves into formaldehyde and ammonia. Urotropin should be dissolved in a completely cooled broth, and the resulting solution should not be filtered.

2.6. Features of the preparation of aqueous extracts from medicinal plant raw materials containing cardiac glycosides.

  • Lily of the valley herb
  • Foxglove leaves
  • Spring adonis herb

When making infusions from raw materials containing cardiac glycosides, it is necessary to strictly observe the temperature-time regime, since when overheated, cardiac glycosides decompose into aglycone and a sugar part with a loss of pharmacological properties. For the manufacture of infusions, you can use only standard medicinal plant raw materials or raw materials with an overestimated VALOR, in this case, the raw materials are taken less, and its amount is calculated by the formula:

x - the amount of raw materials with an overestimated content of active substances that must be taken;

a - the amount of standard raw materials per recipe;

b - VALOR standard raw materials;

c - VALOR of non-standard raw materials.

Digitalis cardiac glycosides (digitoxin) are accumulated in the heart muscle and have a prolonged effect. To avoid overdose of digitoxin and cardiac arrest, the patient's prescription is withdrawn, and a signature is written out instead.

2.7. Features of the preparation of aqueous extracts from medicinal plant raw materials containing cardiac alkaloids.

  • Thermopsis herb
  • Belladonna herb
  • Henbane grass
  • Dope herb
  • Ephedra shoots
  • Ergot horns, etc.

The extraction process is influenced by the pH of the extractor. Alkaloids in raw materials can be contained in the form of salts and in the form of bases. Salt alkaloids are soluble in water, but base alkaloids are not. To dissolve them, the extractor must be acidified. Acidification is carried out by adding 0.83% hydrochloric acid (HCl) solution. Acids are taken by weight as much as pure alkaloids are contained in the taken amount of medicinal plant materials.

When making aqueous extracts from ergot, hydrochloric acid is taken in a fourfold amount in relation to the mass of alkaloids contained in the sample of raw material taken. The infusion should not be carried out in metal informer.

An exception:

a) The herb of thermopsis does not need acidification of the extractant, since the alkaloids are in it in the form of salts (Prof. Muravyov).

b) Ergot horns are insisted in a water bath for 30 minutes and cooled artificially, since they are thermolabile.

3. Slime

A separate technological group of water extracts is made up of the so-called mucus, a kind of infusion of plant materials rich in water-soluble high-molecular substances known as plant mucus.

Mucus is a thick, viscous liquid that is obtained as a result of dissolution or swelling in water of various mucous substances, such as arabic and apricot gum, marshmallow roots, as well as substances contained in flax seeds. Mucus covers the skin and mucous membranes with a thin layer and thereby protects them from irritating effects of various factors, including irritation by certain chemical compounds. In this regard, mucus is usually used as an additional ingredient in liquid dosage forms, which include medicinal substances that have an irritating effect.

Plant mucus is characterized by the ability to form aqueous solutions with a very high viscosity. The latter circumstance makes it difficult to extract mucus from plant materials and forces these extracts to be prepared from small amounts of starting materials by prolonged and vigorous shaking, most often with water heated to almost boiling.

Aqueous extracts from raw materials containing mucous substances are prepared at room temperature:

Cold infusion method (marshmallow root mucus)

Shaking method with hot water (mucus of flax seeds)

In terms of consistency, mucus are thick viscous liquids that are hygroscopic sols. They are incompatible with alcohols, acids, alkalis, tannins and some other substances.

Water-soluble medicinal substances are dissolved in the prepared mucus. Water-insoluble medicinal substances are administered in the form of suspensions with ready-made mucus. Liquid drugs are administered according to an algorithm.

All mucus are natural high molecular weight compounds that are used in medicine as swelling, emollient, enveloping agents in the form of mixtures and enemas. Some mucus are used as emulsifiers (mucus starch, salep). There are two mucus in the recipe of pharmacies - the mucus of the marshmallow root and the mucus of the flax seeds. They are prepared extemporaneously.

Mucus must be issued with an additional label "keep in a cool place", as it quickly undergoes microbial spoilage and the label "shake up before use", since the system is polydisperse.

Flax seed slime.

In flax seeds, mucus is contained only in the thin-walled cells of the shiny seed skin and is easily extracted with water. Flaxseed mucus is prepared from whole seeds.

Flax seeds contain 6% mucus and 35% fatty oil. The mucus is located in the epidermis of the seed coat, and it is removed very quickly. Fatty oils are ballast substances, they can go rancid and give the dosage form an unpleasant unpleasant taste and smell. To prevent this from happening, you can not use crushed seeds so that the fatty oils are not extracted.

The mucus is prepared at 1:30, unless otherwise indicated. When calculating water, Kp, Kv is not used, since the raw material does not absorb water.

The mucus is obtained by shaking the seeds with hot water (at least 95 ° C), while the bottle must be of a much larger volume, well sealed, and so that the water does not cool down for a long time, the bottle is wrapped in a towel. Shake by hand for 15 minutes. After shaking, the mucus is filtered through two layers of gauze into a bottle for dispensing.

The seeds are poured into a voluminous bottle with a cork, poured over with boiling water and shaken in the hand or on a vibrating apparatus for 15 minutes. The resulting mucus is filtered through a small piece of canvas. It turns out 30 parts of a thick, transparent, colorless mucus, which should not be brought to a given weight by adding water.
Sometimes it is recommended to rinse the seeds with a little cold water before preparing the mucus. To avoid indeterminate loss of mucus, this completely unnecessary and useless operation should never be done.

This mucus should not be prepared in insufficiently voluminous flasks, which do not milking the possibility of intensive mixing of the liquid while shaking.

Some foreign pharmacopoeias prescribe to prepare this mucus using a thirty-minute infusion at room temperature. However, the use of boiling water is more expedient, since it makes it possible to obtain a relatively sterile preparation. Flaxseed mucus is not microbiologically resistant and cannot stand long-term storage.

Marshmallow root mucus.

Marshmallow roots contain 35% mucus and 37% starch (ballast).

Peculiarities:

1. Prepared by cold infusion at room temperature.

2. Infusion time at room temperature - 30 minutes with constant stirring in a regular glass stand.

3. Water extraction after infusion is filtered without squeezing, since during squeezing starch and scraps of plant cells will pass into the extract, its viscosity increases, the infusion becomes cloudy, an environment is created for the development of microorganisms.

4. When calculating water and raw materials, the consumption coefficient (Kp) is used. The consumption coefficient shows how many times you need to increase the amount of raw materials and the extractor in order to obtain the prescribed volume of mucus of the required concentration. Cr was bred empirically.

When making an infusion from the roots of marshmallow, you should use the consumption coefficient (Cr) by which the prescribed amount of raw materials and extractant is multiplied. The consumption coefficient is a tabular value and depends on the ratio of raw materials and extractant.

Table. Consumption coefficients used in the preparation of infusion from marshmallow root

P / p No.

Amount ratio
and purified water

Consumable
coefficient

1.0-100 ml

1,05

2.0-100 ml

3.0-100 ml

1.15

4.0-100 ml

5.0-100 ml

Rp: Infusi radices Altheae ex 5,0-120ml

Natrii hydrocarbonatis 1.0

Elixiri pectoralis 5 ml

MDS: Take 1 tablespoon 3 times a day.

The prescription contains a liquid dosage form for internal use, a mixture based on an aqueous extract.

According to the order of the Ministry of Healthcare of the Russian Federation No. 308, it should be prepared using a mass-volume method.

An infusion is prepared from the marshmallow root by the method of cold infusion. The marshmallow root contains starch and, when heated, forms a paste.

To get the required volume and concentration of mucus, water and raw materials for cooking, you should take more. Their number must be calculated taking into account the consumption coefficient of 5% - 1.3.

The infusion must be filtered through a double layer of gauze without squeezing.

Sodium bicarbonate should be dissolved in the finished aqueous extract without agitation.

Cmax 10% Cf = 1.0 - 125 X = 0.8%

X - 100

Consequently, the volume occupied by dry matter is not taken into account.

The breast elixir should be added by double crushing to the ready-made mixture. Because as a result of changing the solvent, a suspension is formed.

To issue the main label with a green signal color and the inscription “internal” for the vacation. And additional labels:“Keep out of the reach of children”, “Store in a cool, dark place” and “Shake before use”.

Shelf life according to the order of the Ministry of Healthcare of the Russian Federation No. 214 - 2 days.

Working recipe:

Marshmallow roots, crushed and screened from dust 5.0 x 1.2 = 6.0

Purified water 120ml x 1.2 = 144ml

Sodium bicarbonate 1.0

Breast elixir 5ml

Total V = 125ml

Prepared the workplace. On a hand scale, I weighed 6.5 marshmallow roots and poured them into a stand. I measured out 156 ml of peeled oxen with a measuring cylinder, poured it into a stand.

Insisted at room temperature for 30 minutes with constant stirring.

The mucus was filtered through a double layer of gauze into a measuring cylinder. The raw material was not squeezed out.

If necessary, the volume was brought up to 125 ml through the raw material. Poured the mucus into the stand.

On a hand scale, I weighed 1.0 sodium bicarbonate and poured it into a stand and dissolved. Strain through a double layer of gauze into a bottle for dispensing.

I poured about 5 ml of mucus into a small holder and mixed it into 5 ml of breast elixir. The resulting suspension was added with shaking into a bottle for dispensing.

The bottle was sealed, checked for leaks, the solution was clean. Has issued labels for vacation. From memory, I filled in the PPK.

Conclusion.

The increasing popularity of herbal medicine is due to many reasons. Herbal medicines usually work weaker than synthetic ones, they have fewer side effects. The possibilities of herbal medicine are very great: after all, almost every plant has a wide range of medicinal properties (it has an analgesic,cardiotonic, anti-inflammatory, expectorant, diaphoretic, improving appetite and digestion, laxative and astringent, hemostatic and reducing the process of blood coagulation, bactericidal, and other actions).

Medicinal plants, while producing fewer side effects than synthetic drugs, are less likely to cause allergic reactions. Some fees can, if necessary, be taken for years without fear of causing harm to the patient, which is especially important in chronic diseases. In patients who have been on a strict diet for a long time and at the same time taking medicinal plant preparations, vitamin deficiencies do not occur, since the collection contains a complex of natural vitamins in an optimal combination for the body.

As a result of the use of medicinal plants, the metabolism and the content of cholesterol in the blood are normalized, the excretion of toxic metabolites from the body is increased, which slows down the development of atherosclerosis and related complications.

Infusions and decoctions are aqueous extracts from medicinal plant materials. Usually they are prescribed internally, sometimes externally as lotions, rinses, baths, etc. In terms of physicochemical properties, aqueous extracts are combinations of true colloidal solutions, as well as solutions of high-molecular compounds extracted from plant materials. The use of water extracts for various diseases has been practiced since ancient times. Claudius Galen (about 1800 years ago), who did not share the opinion of Hippocrates about the existence of ready-made medications in nature, argued that, along with medicinal substances, there are plants in plants that can have a harmful effect on the body. Already in those days, doctors strove to obtain a more convenient form of the drug through the simplest processing of plant material.

Despite the presence of synthetic phytochemicals in the arsenal of pharmacies, such ancient dosage forms as infusions and decoctions are still used. To a large extent, the popularity of aqueous extracts is due to the rather high therapeutic efficiency, reasonable price, relatively fast technology for obtaining aqueous extracts, which does not require complex equipment, and is available to any pharmacy. The most significant disadvantage of these dosage forms is their storage instability. In aqueous extracts, the phenomena of chemical transformation of substances are possible - hydrolysis, oxidation or reduction. In addition, during storage, infusions and decoctions are susceptible to microbial spoilage (due to mold and yeast). The active ingredients of some plants have not yet been established.

For some plants, the optimal technological methods for the isolation of pure active substances have not been developed. In most cases, the therapeutic effect of water extracts does not depend on one active substance, but on their whole complex. Despite the apparent simplicity of the preparation of infusions and decoctions, the extraction process proceeding in this case is very complex. Substances extracted from plant materials are enclosed in cells, through the membranes of which the solvent (water) must first penetrate, and then return back to the resulting solution. The extraction process includes stages such as diffusion and osmosis, leaching, desorption. When extracting plant medicinal raw materials, dry material rich in hydrophilic substances (proteins, fiber, tannins) swells in contact with water. In this case, water first flushes out soluble and insoluble substances from the outer cells (mainly destroyed), and then, under the action of capillary forces, it penetrates into the intercellular space, from there - through the pores of the walls and partly directly through the walls into the cells. Inside the cells, the liquid interacts with the substances located there, forming true solutions. A concentrated solution is formed inside the cells, which creates a significant osmotic pressure, causing osmotic diffusion between the contents of the cells and the surrounding fluid with a lower osmotic pressure. Osmosis processes proceed spontaneously until the osmotic pressure outside and inside the cells becomes equal. In this case, molecular and convective diffusion occurs. Molecular diffusion is caused by the chaotic movement of molecules and depends on the stock of kinetic energy of the particles. Its speed depends on the temperature (directly proportional), the size of the surface separating the substances, the thickness of the layer through which diffusion passes. The longer the diffusion, the more matter passes from one medium to another. Convective diffusion is the transfer of matter as a result of actions that cause the movement of a liquid (shaking, temperature changes, mixing). This type of diffusion is much faster. Using this theory of extraction, in most cases it is possible to ensure the maximum transfer of active substances from plant raw materials to the extract in a fairly short time. For example, in order to speed up the extraction process in the manufacture of hoods, frequent stirring of the liquid is required. To facilitate the penetration of water into the thickness of the material having a cellular structure, the raw material is crushed. In addition, grinding is carried out to increase the contact surface of water with material particles.

To increase the rate of diffusion exchange, and, consequently, extraction, the process is carried out at an elevated temperature. This physical factor, as a rule, increases the solubility of substances.

The potential of herbal medicine is very great: after all, almost every plant has a wide range of medicinal properties. In cases where treatment is impossible without synthetic drugs, the use of herbal preparations in combination with chemotherapeutic agents contributes to an easier course of the disease and avoids complications. In the presence of chronic diseases, annual phytoprophylaxis reduces the frequency and severity of exacerbations, and for some patients it provides long-term remission. Skillfully compiled fees can, if necessary, be taken for a long time without fear of harming the child's body.

Aqueous extracts are used for the treatment of indolent, chronic diseases and are not used for first aid.

Bibliography.

1. State Pharmacopoeia. 11th edition, 2nd edition. Ministry of Health of the USSR 1990 Publisher: M. Medicine.

2. Azhgikhin I.S. Drug Technology - 2nd ed., Rev. and add. - M .: Medicine, 1980.

3. Order of the Ministry of Health of the Russian Federation No. 308 dated October 21, 1997 “On approval of instructions for the manufacture of liquid dosage forms in pharmacies”.

4. Russian pharmacies. No. 1- 2, 2004

5. Manufacturing technology of dosage forms / ed. E.F. Stepanova. "Medicine for You" series. Rostov n / a: "Phoenix", 2002

6. Pharmaceutical technology / ed. Prof. IN AND. Pogorelova. Textbook. A handbook for farm students. Schools and colleges. Rostov n / a: Phoenix, 2002.

7. Muravyov I.A. Technology of dosage forms. Textbook. - M .: Medicine, 1988.

8. Order of the Ministry of Healthcare of the Russian Federation No. 214 of July 16, 1997 “On quality control of medicines manufactured in pharmacies”.

9. Pharmaceutical technology. A guide to laboratory exercises. V.A. Bykov, N.B. Demina, S.A. Katkov, M.N. Anurova. 2010 r.

10. Kondratyeva T.S. Technology of dosage forms. M .: Medicine, 1991.

11. Pharmaceutical technology. Technology of dosage forms. I.I. Krasnyuk, G.V. Mikhailova. 2011 r.

12. FZRF No. 86-FZ dated 22.06.98. "About medicines".

13. Pharmaceutical technology. V.A. Grossman. 2012 r.

14. Pharmaceutical technology / ed. Prof. IN AND. Pogorelova. Study guide for students of the farm. schools and colleges. Rostov n / a: Phoenix, 2002.

15. Pronchenko G.E., Herbal Medicines: A Handbook: A Handbook for Universities (edited by A.P. Arzamastsev, I.A. Samylina)

GEOTAR-Media, 2002

16. http://www.fito.nnov.ru/technology/technology02.phtml

17.http: // stydend. ru / 2013/01/27 / nastoi - i - otvary - slizistye - izvlecheniya. html

18.http: // studentmedic. ru / referats. php? view = 1952

19.http: // vmede. org / sait /? id = Farm _ texnologiya _ bzg _ ls _ gavrilov _2010

20.http: // www. medkurs. ru / pharmacy / technology 86 / section 2290/11546. html

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