The drug is in the form of tablets based on an extract of motherwort

 

The invention relates to medicine, in particular to the drug based on an extract of motherwort, intended for the treatment of functional disorders of the Central nervous system. Suggested remedy in the form of tablets based on an extract of motherwort, including as auxiliary substances, sugar, starch, calcium stearate. The tool further comprises polyvinylpyrrolidone and microcrystalline cellulose, Aerosil, and motherwort extract used in the form of dry powder in the following ratio, wt. %: dry extract of motherwort 7-14, microcrystalline cellulose 15-23, starch 14-20, polyvinylpyrrolidone 2-4, Aerosil 5-10, calcium stearate 0.5 to 1, sugar - the rest is up to 100. A simple and accessible form of the medicinal product in the form of tablets has increased strength at the same time quick raspadaemosti in water, stability during storage. table 2.

The present invention relates to medicine, in particular to the drug based on an extract of motherwort, intended for the treatment of functional disorders of the Central nervous system.

Currently, motherwort is one of the most common 64146).

For the manufacture of a medicinal product is used or chopped raw or briquettes, which must be pre-infuse in hot boiled water, which is extremely inconvenient for use. In addition, the biological activity of such tincture low.

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

The disadvantages of alcohol-water extraction is the fact that ethanol can cause changes in the severity of the effect of the active substance, and also the response of the patient. (M. D. Mashkovsky. Medicinal product. M, 2001).

For oral administration of the drug, especially during a long course of treatment, are most suitable solid form. The tablet is one of the most comfortable and technologically advanced species perform solid dosage forms of chemotherapeutic drugs, because the factory produced by long time retains the properties of the drug (qualitative and quantitative composition, the dosage in connection with a sufficient shape stability), it is also convenient in the performance and storage.

The closest to the claimed invention are tablets on the basis of the former is calcium stearate or magnesium stearate (U.S. Pat. RF 2145230). For the manufacture of tablets using liquid extract of motherwort, thickened in the evaporation apparatus to the dry matter content of not less than 50%, which was introduced excipients. The mass was heated, dried and granulated. The obtained granulate outrival and alloy preformed.

Osnovnym the disadvantage of this drug is its low mechanical strength during production, which entails a large loss of raw materials, unsatisfactory (less than 75% within 45 min) release of the active agent.

Motherwort, like most substances of plant origin, has no ability to direct pelletizing. Therefore, to create stable for quite a long time, meet pharmacopoeial requirements of the dosage form, it is necessary to introduce auxiliary substances in quantities defined pharmaceutical and therapeutic usefulness.

There is little dosage forms as tablets, which takes into account the need to ensure their easy swallowing patients, despite the variety of existing known dosage forms of pharmaceuticals for taking them inside.

The authors put a lot of, who have difficulty swallowing medications. For these purposes, suitable drugs that dissolve inside the mouth.

However, they are almost a little because of such defects as: - complex stages of production - limited in the application of the active constituents of substances, especially extracts of medicinal plants, the difficulty of treatment with these drugs because of their lack of hardness associated with the rapid disintegration and dissolution in the oral cavity.

The purpose of this invention is to obtain a simple and accessible form of the medicinal product in the form of tablets, increase the strength of the tablets at the same time quick raspadaemosti in the water, increasing stability during storage. To eliminate the above disadvantages of the proposed solid dosage form consisting of an extract of motherwort, which masks the taste of the medicine and prevents the release of medication in the mouth, but releases the drug after ingestion.

This goal is achieved through the use of the drug in the form of tablets based on an extract of motherwort, including as auxiliary substances, sugar, starch, calcium stearate, and optionally containing polyvinylpyrrolidone, microqr the wearing components, wt.% Dry extract of motherwort - 7-14 microcrystalline Cellulose - 15-23 Starch - 14-20 Polyvinylpyrrolidone - 2-4 Aerosil - 5-10 calcium stearate and 0.5-1
Sugar - the Rest is up to 100
As a diluent in tablets are most often used starch as the most accessible stuff. But it is known that a high starch content (30 wt%) causes a sharp decrease in strength tablets and, more importantly, reducing their raspadaemosti (Ant I. A. Technology of drugs. M., 1971, S. 602).

The authors managed by using as solvent a mixture of starch and cellulose to maintain the hardness of the tablets in the manufacture. Use as binders polyvinylpyrrolidone in combination with the proposed diluent also helped to achieve this goal.

The technical result obtained by implementing the present invention is the achievement of the required quality, in particular a satisfactory strength, stability during storage, the desired rate of release, regardless of the activity of the gastric and intestinal juices and intestinal motility.

For all formulations of the drug used following the General method of manufacture.

An example implementation of the invention.

Mixture about the rum polyvinylpyrolidone, mix to a uniform distribution of moisture, granularit on the device for producing granules through a sieve with the hole diameter of 2 mm and dried to a residual moisture content of 1-2%. After dry granulation to crushed to granules add calcium stearate, and the mixture tabletirujut. The obtained tablets with an average weight of 0.2 g satisfy the requirements of the pharmaceutical agent. The results are presented in table. 1.

Studies have shown that the proposed tool provides stability and uniformity of the release of motherwort when storing not less than 2 years. The number of motherwort, released from the tablet (prototype), after 5 h is 57.5of 12.5%, while the same indicator for the claimed composition is 53.76,0%.

The quality indicators derived drugs are summarized in table. 2.

Get tablets motherwort mass of 0.2 g containing extract of motherwort 0,014, the Content of the target additives per tablet corresponds to the claimed amounts. The manufacture of the tablets meet the requirements of the monograph; do not crumble, have a solid smooth edges, smooth surface throughout crocomo composition pharmaceutical composition of getting of pills is not accompanied by the accumulation of tablet mass on the equipment, also, hardly any loss of the active substance and the change in the mass ratio of components in the finished tablets in relation to settlement. Properties of tablets are stored during the whole shelf life (up to 2 years).


Claims

The drug is in the form of tablets based on an extract of motherwort, including as auxiliary substances, sugar, starch, calcium stearate, wherein the tool further comprises polyvinylpyrrolidone and microcrystalline cellulose, Aerosil, and motherwort extract used in the form of dry powder in the following ratio, wt. %:
Dry extract of motherwort - 7-14
Microcrystalline cellulose - 15-23
Starch - 14-20
Polyvinylpyrrolidone - 2-4
Aerosil - 5-10
Calcium stearate and 0.5-1
Sugar - the Rest is up to 100 RUB

 

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