The drug has anti-inflammatory and antimicrobial properties

 

(57) Abstract:

The invention relates to the field of medicine. The drug has anti-inflammatory and antimicrobial properties, in its composition contains Shilajit, mass fraction which is 3-15%, ascorbic acid, excipients and fillers, in the following ratio of components, g: mummy 0.01 to 0.3, ascorbic acid 0,004-0,015, talc 0,00597, starch 0,051, calcium stearate 0,0303, sugar and 0.2. The drug provides greater therapeutic activity. 1 C.p. f-crystals, 3 tables.

The invention relates to medicine, namely pharmacology, in particular to drugs on the basis of the mummy.

Drug use Shilajit began long ago. The study of its properties, identifying its medicinal qualities continues. Currently Shilajit as a drug used in the form of a powder, melt the paste or solution.

In Oriental medicine, Shilajit is used in the form of pills of various shapes, mixing mummy with rose water, crystalline sugar, gum Arabic (A. W. Shakirov. The secret of the ancient balm mumie-Asil. Tashkent: Medicine, 1983)

Known multi-component drug, which is widely used for the composition of saffron, gypsum, seed meconopsis, leaves and flowers of adata vasica, grass zmeegolovnika, honey and mummy. (Mummy - mysterious ancient medicine. Alma-ATA, 1990, S. 10-11).

Also known tablet dosage form "Shilajit drugs" (mummy), containing extract of shiladjit (Hygienic certificate of conformity N ROSS IN. PR.F from 02.02.98,)

The disadvantages of this drug is inadequate therapeutic efficacy.

Object of the invention is a drug that has anti-inflammatory and antimicrobial properties, which have great therapeutic activity.

This result is achieved in that the preparation comprises mummy, mass fraction which is 3-15%, ascorbic acid, excipients and fillers, with the following ratio of components, g:

Mumie - 0,01-0,3

Ascorbic acid - 0,004-0,015

Excipients - 0,02-0,06

Filler - Rest

As auxiliary substances the product contains talc, starch (100%), calcium stearate, and as filler - sugar.

Optimal specified number of components obtained experimentally.

Mummy composition of the ins B32P-617, B1and other, essential oils, bee venom. It is biologically natural combination of chemical elements, oxides, amino acids cause a bactericidal and a therapeutic effect, affecting the metabolic processes in the body.

Mumie in the specified interval behaves as bioactive natural stimulant and provides a drug composition a synergistic effect. Quantitative introduction mummy in the composition optimally, as less than 0.01 g, the effect is insufficient for the manifestation of it as anti-inflammatory and antimicrobial agent, and more than 0.3 g impractical, because the dose is not accompanied by the increase of therapeutic action.

Therapeutic effect of the drug is enhanced by the introduction of ascorbic acid in the form of supplements. In amount less than 0.004 g, the effect is not observed, and more than 0.015 g, apply irrational, since excess ascorbic acid is excreted from the body.

As auxiliary components, ensuring the reliability of the time raspadaemosti and baled used talc, starch (100%) and to improve the flowability of the granules and increase the strength of the pressing - calcium stearate. As the filler used is about drug mummy, sugar, ascorbic acid, calcium stearate is crushed in a mill to form a powder, sift and introduced into the granulator. There also add a pre-prepared with 10% starch paste and damp granulation. The received raw granules are dried at a temperature of 40-50oC for 4-6 hours. The dried granulate is placed in a mixer and add outrivals mixture of talc + calcium stearate) and stirred. The resulting mixture is subjected to pelletizing.

To obtain the proposed drug components must meet the requirements of the relevant Pharmacopoeia (FS) and temporary Pharmacopoeia (VFS), the state standards (GOST). Components for preparation of the drug were taken in the ratios shown in table. 1.

An experimental study of the properties of the obtained preparation was conducted in accordance with "guidance on experimental (preclinical) study of non-steroidal anti-inflammatory pharmacological substances".

Experimental study of anti-inflammatory activity was carried out on outbred rats weighing 130-200 g outbred mice 20-26 g of both sexes. Mummy and the second paste (pill) in doses from 50 to 500 mg/kg, single and multiple times depending on the nature of the inflammatory process in the experiment.

Determination of anti-inflammatory activity was carried out on a model of acute inflammatory edema caused subplanetary introduction to the hind leg of the rat 0.1 ml of 2% aqueous solution of formalin. Measuring volume of the foot was performed after 2, 4, 8 and 24 hours at the time of maximum development of edema. Experimental rats were injected intragastrically once the proposed drug substance in doses of 100, 200 and 500 mg/kg 1 hour prior to the introduction of phlogogenic agent. Antiphlogistics activity of the preparations was estimated at a maximum of inflammatory edema in control (1, 2, 7).

As the main indicators of the intensity of the inflammatory response and anti-inflammatory effect of study drug used indicator of growth paws (% by source) and % inhibition of inflammation by the formula

,

whereto- the volume of swollen paws in the control minus the initial volume of the same foot to edema,about- the volume of swollen paws in the experience minus the initial volume before swelling.

In table. 2 shows the effect of the drug on the growth of the paws of rats with formalin edema.

Antimicrobial activity of the drug or broth, Hottinger, in experiments with mushrooms environment Saburo). Confidence interval microbiological tests 095 (GFH, vol. 1, S. 199). Activity against bacteria studied in strains presented in table. 3.

Thus, the proposed drug has a specific anti-inflammatory and antimicrobial activity (drug at various concentrations from 0.5 to 10% active against gram-positive and gram-negative bacteria and fungi dermatophytes). Selected excipients and used in the pharmaceutical factors correlate with processes tabletting mummy with the manifestation of therapeutic activity.

1. The drug is anti-inflammatory and antimicrobial actions, including Shilajit, an excipient and a filler, characterized in that it further comprises ascorbic acid, and as excipients contains talc, starch and calcium stearate, and as filler - sugar, in the following ratio of components, g:

Mumie - 0,01 - 0,3

Ascorbic acid - 0,004 - 0,015

Talc - 0,00597

Starch - 0,051

Calcium stearate - 0,0303

Sugar - 0,2

2. The drug under item 1, characterized in that it is made in the

 

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