RU2589507C1 - Agent based on dry motherwort extract and method for production thereof - Google Patents

Abstract

FIELD: medicine; pharmaceuticals.

SUBSTANCE: present invention relates to pharmaceutical industry, namely to herbal agent possessing sedative action. Sedative agent on the basis of the powdered motherwort dry extract is made in the form of pills and contains microcrystalline cellulose, lactose monohydrate, polyvinylpyrrolidone, calcium or magnesium stearate, talc, sodium carboxy-methyl starch (primogel), that are taken in certain proportions, the pills have a coating. Method of preparing the said agent: a mixer is loaded with dry motherwort extract, microcrystalline cellulose, lactose monohydrate, which are mixed for 5 minutes and granulated with 10 % aqueous solution of polyvinyl pyrrolidone, this is followed by wet granulation, drying, powdering the mixture with primogel, calcium or magnesium stearate and talc, then dry granulation, tabletting and coating obtained pill cores.

EFFECT: above pills are characterised by disintegration within 12-14 minutes, increased flowability of up to 6 g/s and strength that is higher than 90 N.

7 cl, 5 ex

Description

The invention relates to the pharmaceutical industry and medicine, as well as to the food industry, in particular to herbal products, in particular to preparations based on extracts of medicinal plants, where the active ingredient is a biologically active plant component - dry motherwort extract in the form of a powder.

Currently, motherwort is one of the most common medicinal plants, used both independently (US Pat. RF 2145230), and in various collections (US Pat. RF 2137496, 2164146). The tool can be registered and made in the form of a medicinal product, as well as a biologically active food supplement (BAA).

Motherwort extract is recommended for sale to the population as an additional source of flavonoids for people with impaired functional state of the nervous and cardiovascular system Motherwort has a calming effect, normalizes heart rate, increases heart rate, shows antispasmodic and hypotensive properties. Motherwort helps relieve nervous tension with increased nervous excitability, neurosis, the initial stages of hypertension. Helps with insomnia, facilitates the onset of sleep, improves the quality and duration of sleep.

Known drugs based on liquid or thick extracts of motherwort or combinations thereof in the form of tinctures, balms, elixirs, syrups, suspensions, drops for oral administration.

Known dosage forms or dietary supplements in the form of collections of crushed medicinal plants, powders.

A known composition of dietary supplements with a sedative effect, containing motherwort, hops, oats, hawthorn, lemon balm or mint, coriander, clover (RU 2138280 C1, 09/27/1999).

Motherwort as a sedative is used in the form of infusion, tincture, extract (Mashkovsky M.D. Medicines. - 15th ed. Revised., Revised and supplemented. - M .: RIA "New Wave", 2007, p. 88 ) Motherwort is also part of numerous collections and complex sedative preparations (RF patents 2019185, 2223778, 2278684, 2281111, 2295968, 2298413).

For the manufacture of a medicine, either crushed raw materials or briquettes are used, which must first be infused in hot boiled water, which is extremely inconvenient for use. In addition, the biological activity of such a tincture is low.

Known tincture containing crushed motherwort in 70% alcohol, and motherwort extract containing cut grass of motherwort and also ethyl alcohol.

The disadvantages of alcohol-water extracts is that ethanol can cause changes in the severity of the effect of the active substance, as well as the patient’s reaction to it (MD Mashkovsky. Medicines. M., 2001).

For administration inside the drug, especially with a long course of treatment, solid forms are most suitable. The tablet is one of the most convenient and technologically advanced types of solid dosage forms. The dosage form in the form of tablets has several advantages over liquid dosage forms, namely: small volume, the possibility of accurate dosing in mass production, ease of use, storage and transportation.

Motherwort, like most substances of plant origin, does not have the ability to direct tableting. Therefore, to create stable for a sufficiently long time, satisfying the pharmacopoeial requirements of the dosage form and technical conditions (TU) for dietary supplements, it is necessary to introduce excipients in amounts determined by pharmaceutical and therapeutic expediency.

Known methods for the preparation of tablet forms using thick and liquid extracts of medicinal plants for granulation of the tablet mass.

Known tablets based on motherwort extract containing, as excipients, milk sugar or glucose, starch, talc, calcium stearate or magnesium stearate (US Pat. RF 2145230). For the manufacture of tablets using liquid motherwort extract, thickened in an evaporator to a solids content of at least 50%, into which auxiliary substances were introduced. The mass was heated, dried and granulated. The resulting granulate was dusted and tableted.

The main disadvantage of the known drug is its low mechanical strength in production, which entails large losses of raw materials, unsatisfactory (less than 75% for 45 minutes) release of the active principle, and the bitter taste of the drug is also a disadvantage.

The closest in value and combination of essential features to the claimed invention is a drug in the form of tablets (RU 2207116) based on motherwort extract - 7-14 wt. % and auxiliary substances: microcrystalline cellulose - 15-23 wt. %, starch - 14-20 wt. %, polyvinylpyrrolidone - 2-4 wt. %, calcium stearate - 0.5-1 wt. % and the rest of sugar up to 100 wt. % Motherwort extract is used as a dry powder.

The disadvantage of this composition and the production method is the use of alcohol and sugar and unsatisfactory (less than 75% for 30 minutes) release of the active principle, as well as the bitter taste.

The closest analogue (prototype) to our proposed group of solutions is a drug in the form of tablets (RU 2012124704 A), the composition according to option 2.

The following technical solutions are patented: composition of tablets, method for producing tablets, composition of shells and methods for producing coatings.

Option 2

wt. %:

Dry plant extract or mixtures thereof in 1-25 powder form MCC 101 20-60 Lactose Monohydrate 20-70 Polyvinylpyrrolidone 0,1-10 Aerosil 0.1-5 Calcium stearate 0.1-1 or magnesium Talc 0.1-3

Composition with the active substance - motherwort extract:

Example 2

Composition per 1 tablet, wt. %:

Motherwort extract dry 7.0 MCC 101 38.9 Lactose Monohydrate fifty Aerosil 0.6 Talc 2.0 Calcium stearate 0.5 Polyvinylpyrrolidone 1,0

The proposed method consists of the following stages: dry motherwort extract powder, MCC 101, lactose monohydrate, aerosil are loaded into the mixer, mixed for 5 minutes and moistened with 10% aqueous solution of polyvinylpyrrolidone s / m, mixed for 5 minutes, wet granulation is carried out (2 × sieve 2 mm), drying, dry granulation (sieve 1 × 1 mm), dusting and tableting.

When conducting analyzes, it was found that the disadvantage of this composition and the method of obtaining, in case of execution with motherwort extract, is the mismatch of the obtained tablets with the disintegration rate. Disintegration of tablets p / o - more than 30 minutes (normal: not more than 30 minutes).

Since the composition No. 2 in option 2 does not correspond in terms of disintegration, additional work was carried out and the optimal composition and method for producing tablets of motherwort extract p / o were eliminated, eliminating this drawback. This composition is claimed as an invention in the proposed application.

The objective of the invention is to develop a tool where the active ingredient is a biologically active plant component - dry motherwort extract in the form of a dry powder in pharmaceutically acceptable proportions with improved disintegration and release of the active principle.

Another objective of the invention is the development of tools where the active ingredient is a biologically active plant component - dry motherwort extract in the form of a dry powder in pharmaceutically acceptable proportions; simplification of the method, manufacturability of production; the exclusion of the use of alcohol in production; the ability to reproduce the drug in the form of a biologically active additive or in the form of a medicinal product in the form of: coated tablets. Another objective is to improve the taste.

The tasks are solved in that a biologically active plant component is used as the active ingredient — dry motherwort extract in the form of a powder in pharmaceutically acceptable proportions. The experimentally selected composition and method of obtaining funds in the form of tablets. To improve the palatability, the compositions of the shells were selected taking into account the disintegration rate and the release of the active principle.

Dosage form and dietary supplements in the form of tablets has several advantages over liquid dosage forms and dietary supplements, namely: small volume, the possibility of accurate dosing in mass production, ease of use, storage and transportation.

Also, the advantages of using tablets, in comparison with other dosage forms of drugs and dietary supplements:

- To use them in tablets is much easier than making decoctions of medicinal plants or diluting alcohol tincture.

- The possibility of use for those people who are contraindicated in the use of alcohol-containing solution.

- Ease of use in places (outside the home), where there is no way to pour drops into a glass, make an infusion.

The technical result is the development of a composition and method for producing a medicine or dietary supplement in the form of tablets based on a biologically active plant component — dry motherwort extract in the form of a powder with improved disintegration and release of the active principle, with sufficient mechanical strength, hardness, and also with good stability through the qualitative and quantitative selection of excipients.

In improving the technologies of the existing pharmaceutical production, as in the development of the dosage form and dietary supplements, an important role is played by excipients, the choice of which should be justified after evaluating their physicochemical and technological characteristics, studying their effect on the effectiveness, safety and stability of drugs

The choice of excipients is the most important task for a technologist working in a modern pharmaceutical production, the correct solution of which helps not only to create a safe and effective drug, but also to increase the economic efficiency of production and reduce the cost of equipment and personnel. The correct choice of excipient allows you to give the tablet the necessary hardness, improve mechanical stability, achieve the desired solubility, a given release time. For this purpose, traditional auxiliary products, such as microcrystalline cellulose, lactose monohydrate, aerosil, Primogel (or another brand of disintegrant based on sodium carboxymethyl starch), magnesium and calcium stearates, the ratio of which in the tablet mass can vary depending on specific characteristics of the active substance to obtain a tablet dosage form of appropriate quality. Microcrystalline cellulose (MCC) is one of the highly pressed materials. This is a unique substance that combines binder, sliding and loosening properties with sufficient fluidity and high compressibility, which is explained by the presence of hydrogen bonds between particles formed during plastic deformation during tableting.

Also the technical result is the composition and method of producing the shell in order to improve the taste of the product, taking into account the rate of disintegration and release of the active principle. The application of membranes has the following goals: to give the tablets a beautiful appearance, increase their mechanical strength, hide unpleasant taste, smell, protect from environmental influences (light, moisture, oxygen), localize or prolong the action of the drug, protect the mucous membranes of the esophagus and stomach from the destructive effect of a drug substance.

Also, the technical result is the development of shell compositions without the use of dyes in order to reduce production costs and to preserve the taste of the shells (dyes have an unpleasant aftertaste and have small carcinogenic properties). During storage and when exposed to light, shells with dyes tend to fade, i.e. the color of the drug changes.

Also the technical result is the exclusion from the composition of the drug alcohol, which is a fire hazardous substance, thus achieving safe working conditions.

Also, the technical result is the manufacture of funds in the form of tablets, which improves the ease of use, storage and transportation.

The technical result of the proposed invention is achieved in the composition and method of obtaining funds in the form of tablets based on a biologically active plant component - dry motherwort extract in the form of a powder in the following ratio of components, wt. %:

Dry motherwort extract in powder form 7.0 Microcrystalline cellulose 35.5 (MCC) Lactose Monohydrate 50,0 Polyvinylpyrrolidone 1,0 Sodium carboxymethyl starch (Primogel) 4.0 Calcium stearate or magnesium 0.5 Talc 2.0

The proposed method consists of the following stages: dry motherwort extract, MCC, lactose monohydrate are loaded into the mixer and mixed for 5 minutes, granulated with a 10% aqueous solution of polyvinylpyrrolidone, wet granulation is carried out, drying, dusting of the mass with primogel, calcium or magnesium stearate and talc, is carried out dry granulation, the tabletting step and the resulting tablet cores are coated.

In this composition, microcrystalline cellulose (MCC) and lactose monohydrate in the indicated proportions are selected as a filler. Excipients affect the rate of release, the speed and completeness of absorption of the drug substance, as well as its stability, so their choice in each case is scientifically justified. We experimentally established the optimal ratio of MCC and lactose monohydrate, which led to an increase in the flowability of the tablet mass to 6.0 g / s and a strength of more than 90 N.

Microcrystalline cellulose (MCC) - purified, partially depolymerized alpha-cellulose obtained by treating wood pulp with mineral acids, is used as a binder and filler in tablet formulations. You can use any brand of MCC, but it is preferable to use the MCC brand 101. MCC 101 has smaller particles and when using wet granulation is sufficient. Other brands of MCC are obtained by granulation, they represent the form of pellets, the disadvantage is the cost. The use of these brands of MCC will lead to a rise in the cost of funds.

Lactose monohydrate has high stability, low hygroscopicity, relatively low cost and various functional properties; it is used as a binder and filler in tablet formulations.

As a binder, it contains polyvinylpyrrolidone.

Polyvinylpyrrolidone (PVP) is a synthetic polymer-gamma-vinyl lactam N-aminobutyric acid. By changing the synthesis conditions, it is possible to obtain vinylpyrrolidone polymers with different molecular weights: low molecular weight (molecular weight 6-10 KD or 6000-10000), medium molecular weight (25-40 kD) and high molecular weight (40-60 kD). PVP has the ability to form complexes with different substances. PVP preparations are powders readily soluble in water and 95 ° alcohol. The drugs are indifferent to the body, are not broken down by enzymes, excreted unchanged by the kidneys. In the pharmaceutical industry, PVP can be used to prolong the action of drugs and, as a binder, in the manufacture of tablets. When introduced into drug mixtures, the latter are easily tabletted without the addition of an inert filler, resulting in a decrease in the weight and volume of the tablets. It is possible to use PVP with any molecular weight, but it is preferable to use medium molecular weight polyvinylpyrrolidone. The use of other brands of polyvinylpyrrolidone can lead to higher cost of funds.

The use of excipients such as calcium stearate, magnesium stearate, talc or a combination thereof as a sliding creates a thin film on the surface of such a dosage form as a tablet, which gives it a sliding effect and facilitates ingestion of the tablet when taken orally, in addition, such auxiliary substances increase flowability of the tablet mass.

Sodium carboxymethyl starch - primogel was chosen as a disintegrant. It is a modified starch, a simple starch ether, a water-soluble anionic polymer compound. It is odorless, non-toxic. It is a white or yellow powder, without taste and smell, easily absorbs moisture. Soluble in water with the formation of colloidal solutions, stable. Soluble in alcohol, ether, chloroform and other organic solvents. The product is stable in aqueous solution.

To ensure an acceptable disintegration of the tablets, Primogel (sodium carboxymethyl starch) was used in the amount of 4%, here it plays the role of a super disintegrant. Primogel neutralizes the negative effect of magnesium or calcium stearate on the strength and disintegration of tablets. The difference between the compositions of the proposed tablet cores from the prototype are:

1. The exception from the composition of Aerosil and replacing it with Primogel, which allowed to reduce the disintegration of the tablets. The disintegration of tablets of the claimed composition is from 12 to 14 minutes (the norm is not more than 30 minutes), the disintegration of tablets made according to the composition D1 (RU 2012124704) is more than 30 minutes. Primogel also neutralizes the negative effects of magnesium or calcium stearate on the strength and disintegration of tablets.

2. Different ratios of microcrystalline cellulose and lactose monohydrate - 35.5 / 50.0 (in the proposed application) and 38.9 / 50.0 (in D1 - RU 2012124704), which increased the flow rate - 17-19 g / s ( in the proposed application) and 11-13 g / s (in D1 - RU 2012124704). The optimal ratio of MCC and lactose monohydrate led to an increase in the flowability of the tablet mass to 6.0 g / s and a strength of more than 90 N.

The manufacturing methods of the tablet cores also have differences.

The proposed method consists of the following stages: dry motherwort extract, MCC, lactose monohydrate are loaded into the mixer and mixed for 5 minutes, granulated with 10% aqueous solution of polyvinylpyrrolidone, wet granulation is carried out, drying, dusting of the mass with primogel, calcium or magnesium stearate and talc, dry granulation is carried out , the tabletting step and the resulting tablet cores are coated.

The method according to D1 consists of the following stages: dry motherwort extract powder, MCC 101, lactose monohydrate, aerosil are loaded into the mixer, mixed for 5 minutes and moistened with 10% aqueous solution of polyvinylpyrrolidone s / m, mixed for 5 minutes, wet granulation is carried out (sieve 2 × 2 mm), drying, dry granulation (1 × 1 mm sieve), dusted, tableted. A variant of the coating obtained tablets nuclei. Coating compositions and methods of application also have differences. In the claimed tool developed compositions of the shells without the use of dyes in order to reduce production costs and in order to preserve the taste of the shells (dyes have an unpleasant aftertaste and have small carcinogenic properties). During storage and when exposed to light, shells with dyes tend to fade, i.e. the color of the drug changes, which in turn leads to a reduction in the shelf life of the drug.

The advantage of the claimed compositions of the shells and coating technologies is the saving of raw materials, time spent on the stages of coating, as well as improving the quality of the shells and lengthening the shelf life of the drug. The option of coating with a film coating in the claimed tool. When coating the coating, Opadry mixes from Colorcon (USA), or Colicut film formers from BASF (Germany), or Oydragit from Rem-pharma (Germany), as well as coatings based on cellulose derivatives, which dissolve the active compound, were used substances in the stomach. A 15% aqueous suspension was prepared based on any film former. Coating of the tablets was carried out at a temperature of 40-42 ° C. Got a very good film coating. Since dyes were not introduced into the film-forming mixtures, the tablets turned out to be of a pleasant white color. The weight of the motherwort extract tablets is 14 mg, film-coated - 0.208 g. The quantitative content of flavanoids in terms of rutin is 0.134 g (norm is not less than 0.06 g). Disintegration of the tablets is from 12 to 14 minutes (the norm is not more than 30 minutes).

Sugar coating option in the claimed tool:

Example 5

The weight of the motherwort extract tablets with a sugar coating is 0.38 g. Brief technology for coating the core tablets with a sugar coating:

1. Application of an insulating layer from a solution of PVP n / m and gelatin.

2. Application of unpainted suspension (sugar syrup, magnesium hydroxycarbonate, PVP solution, titanium dioxide)

3. Gloss of tablets (wax and talc).

The composition and technology make it possible to obtain a shiny, even, stable coating with a pleasant sweet taste. Since the colorants were not added to the coating, the tablets turned out to be shiny white.

In the prototype D1, the compositions and methods for producing coatings are different.

Sugar coating option:

Composition per 1 tablet shell:

Sugar (sucrose) 0.1359036 Polyvinylpyrrolidone n / m 0.0024074 Magnesium hydroxycarbonate 0,0351438 Titanium dioxide 0,0034654 Talc 0,000225

Silicon Colloidal Dioxide

(aerosil) 0,0024524 Tropeolin "0" 0,0000672 Beeswax 0.0000902 Edible gelatin 0,0002400 Sheath Weight: 0.18 g

Brief technology of coating the core tablets with a sugar coating:

1. Application of an insulating layer from a solution of PVP and gelatin.

2. Application of unpainted suspension (sugar syrup, magnesium hydroxycarbonate, PVP solution, titanium dioxide).

3. Application of a colored suspension (sugar syrup, magnesium hydroxycarbonate, a solution of PVP, titanium dioxide, tropeolin "0").

4. Gloss of tablets.

Film coating option.

For coating used Opadry II Yellow 12%. aqueous suspension. Coating of the tablets was carried out at a temperature of 40-42 ° C. A very good film coating was obtained, but the disintegration of the p / o tablets was more than 30 minutes (normal: not more than 30 minutes).

Example 1. One of the options means is proposed in the following ratio of components, in wt. %:

Dry motherwort extract in the form of

powder 7.0 Microcrystalline cellulose 35.5 (MCC) Lactose Monohydrate 50,0 Polyvinylpyrrolidone 1,0 Sodium carboxymethyl starch (Primogel) 4.0 Calcium stearate 0.5 Talc 2.0

The resulting tablets have a good appearance, strength 12-13 kgf / cm ² , abrasion - less than 0.17%.

Example 2. One of the options is proposed tools in the following ratio of components, in wt. %:

Dry motherwort extract in the form of powder 7.0 Microcrystalline cellulose 35.5 (MCC) Lactose Monohydrate 50,0 Polyvinylpyrrolidone 1,0 Sodium carboxymethyl starch (Primogel) 4.0 Magnesium stearate 0.5 Talc 2.0

The resulting tablets have a good appearance, strength 12-14 kgf / cm ² , abrasion - less than 0.18%.

Example 3. One of the options is proposed in the following ratio of components, in wt. %:

Dry motherwort extract in powder form 7.0 Microcrystalline cellulose 35.5 (MCC 101) Lactose Monohydrate 50,0 Polyvinylpyrrolidone s / m 1,0 Sodium carboxymethyl starch (Primogel) 4.0 Calcium or Magnesium Stearate 0.5 Talc 2.0

The resulting tablets have a good appearance, strength 11.5-12 kgf / cm ² , abrasion - less than 0.17%.

The tablets obtained in example 1, 2 and 3 were coated. (Examples of shells are discussed below). The shell allows you to hide the bitter taste of the active substance - motherwort extract.

Film Coating Option

Example 4

When coating the coating, Opadry mixes from Colorcon (USA), or Colicut film formers from BASF (Germany), or Oydragit from Rem-pharma (Germany), as well as coatings based on cellulose derivatives, which dissolve the active compound, were used substances in the stomach. A 15% aqueous suspension was prepared based on any film former. Coating of the tablets was carried out at a temperature of 40-42 ° C. Got a very good film coating. Since dyestuffs were not added to the film-forming mixtures, the tablets turned out to be of a pleasant white color. The weight of the motherwort extract tablets was 14 mg, film-coated - 0.208 g. The quantitative content of phlovanoids in terms of rutin was 0.134 g (norm no less than 0.06 g). Disintegration of the tablets is from 12 to 14 minutes (the norm is not more than 30 minutes).

Sugar coating option:

Example 5

The weight of the tablets Motherwort Extract with sugar coating 0.38 g

Brief technology of coating the core tablets with a sugar coating:

4. Application of an insulating layer from a solution of PVP n / m and gelatin.

5. Application of unpainted suspension (sugar syrup, magnesium hydroxycarbonate, PVP solution, titanium dioxide)

6. Gloss of tablets (wax and talc).

The composition and technology make it possible to obtain a shiny, even, stable coating with a pleasant sweet taste. Since the colorants were not added to the coating composition, the tablets turned out to be shiny white. The weight of one tablet p / o is 380 mg, the diameter of the core tablet is 8 mm, the radius of curvature is 0.75 D. The disintegration of the tablets is from 15 to 18 minutes (normal no more 30 minutes).

Both coatings are possible. Coating the product with a sugar coating allows you to get a taste of sweet shiny white tablets. Coating the agent with a film coating makes it possible to obtain opaque white tablets without taste, which is preferable for patients with diabetes mellitus.

The composition and method of producing coated motherwort tablets are described by the above examples, but are not limited to.

The inventive tool provides the specified pharmacological effect, meets the requirements of the State Pharmacopoeia XI ed. And TU, is stable during storage and has a shelf life of at least two years. It can be produced as a dietary supplement or as a medicine.

The therapeutic effect of the drug was tested on 30 volunteers aged 30 to 60 years who took drugs based on motherwort, valerian and hawthorn. Patients had complaints of headaches, heartaches after nervous tension, irritability, restlessness, and insomnia.

The tests were carried out as follows:

15 people took motherwort tablets only, the other group - motherwort tablets, coated (sugar or film). A post-treatment survey gave the following results.

1 group noted:

- unpleasant taste of the drug; a desire to either drink or seize something to remove this aftertaste;

- the convenience of tablets is that they can be carried with you and taken even on the road;

- the effectiveness of this tool is good, begins to act within five minutes;

- tablets are easily dosed, depending on the state of the body, age, various quantities can be used;

General impression: the desire to improve the taste of the drug.

Group 2 noted:

- improving the taste of the drug. Film-coated - tasteless; sugar-coated - pleasant sweet taste.

- the convenience of tablets;

- physiologically mild sedative effect;

- the effect is very soft, you can hardly notice that the tablet began to act;

- pleasant appearance of the drug;

- facilitating swallowing of the drug.

General impression :: milder sedative effect, pleasant appearance and taste of the drug.

REFERENCES

1. Mashkovsky M.D. Medicines, 15th ed., New Wave, 2005

2. "Synthetic and biological polymers in pharmacy." M., 1990

3. Research I.O. OAO Tatkhimpharmpreparaty.

4. Paid FIPS database on the Internet.

5. Azhgikhin I.S. Technology of drugs / M .: Medicine, 1975.

6. RU 2145230 C1, 10.02.2000.

7. PULATOV TP et al. Obtaining dry preparations from motherwort five-lobed. Abstracts of the All-Union Conference 06/29/01/07/1989. - L., 1989, p. 137.

8. KISILEVA T.L. Motherwort. - M .: Medical assistance, 1993, No. 3, p. 50-52.

9. The State Pharmacopoeia of the USSR. Vol. 1, 2. Ministry of Health of the USSR - 11th ed.

10. O.I. Belova, V.V. Karchevskaya, N.A. Kulakov et al. Technology of dosage forms in 2 volumes. Textbook for high schools. T. 1.

11. Alyushin M.T., Artemyev A.I., Trakman Yu.G. Synthetic polymers in domestic pharmaceutical practice. M .: "Medicine". - 1974. - 152 p.

12. Golikov S.N., Guryanov G.A., Kozlov V.K. Ways and methods of prolonging the action of drugs (state of the issue and prospects) // Pharmacology and Toxicology, 1989. No. 2. - S. 5-15.

13. Yasinitsky B.G. Corrigents of smell and taste in the production of drugs / B.G. Yasinitsky, E.B. Dolberg, T.V. Medvedev. M .: UBNTIMedprom, 1987 .-- 27 p.

Claims (7)

1. A sedative based on dry motherwort extract, made in the form of tablets, including microcrystalline cellulose, lactose monohydrate, polyvinylpyrrolidone, calcium or magnesium stearate, talcum powder, characterized in that the active substance is motherwort extract in the form of dry powder and the product additionally contains sodium carboxymethyl starch (Primogel), while the tablets are coated in the following ratio of core components, wt. %:
Dry motherwort extract powder form 7.0 Microcrystalline cellulose 35.5 (MCC) Lactose Monohydrate 50,0 Polyvinylpyrrolidone 1,0 Sodium carboxymethyl starch (Primogel) 4.0 Calcium stearate or magnesium 0.5 Talc 2.0 2. The tool according to p. 1, characterized in that the used MCC brand 101. 3. The tool according to claim 1, characterized in that the molecular weight polyvinylpyrrolidone is used. 4. The tool according to p. 1, characterized in that it is coated with any pharmaceutically acceptable coating, including sugar coating or film. 5. The tool according to p. 4, characterized in that it is coated with a sugar coating of the following composition, wt. %:
Sucrose 75.5 Povidone (polyvinylpyrrolidone 1.34 low molecular weight) Magnesium carbonate basic 19.56 Titanium dioxide 1.93 Talc 0.125 Silicon Colloidal Dioxide (aerosil) 1,362 Beeswax 0,050 Gelatin 0.133 6. The tool according to p. 4, characterized in that it is coated with a 12-15% aqueous suspension of Opadry or a film former Kollikut or Oydragit, as well as coatings based on cellulose derivatives, providing dissolution of the active substance in the stomach. 7. The method of preparation of the agent according to claim 1, characterized in that dry motherwort extract, MCC, lactose monohydrate are loaded into the mixer and mixed for 5 minutes, granulated with a 10% aqueous solution of polyvinylpyrrolidone, wet granulation, drying, dusting of the mass with primogel, stearate are carried out calcium or magnesium and talcum powder, carry out dry granulation, the stage of tabletting and the resulting tablet cores are coated.