Rectal tool

 

(57) Abstract:

The invention relates to medicine and pharmaceutical industry and for the creation of new drugs used for the treatment of acute and chronic prostatitis. The inventive rectal medicine as biologically active substances contains liquid purified extract of the prostate gland of cattle and the filler in the following ratio, wt.%: liquid purified extract prostate cattle to 46.0 and 47.0, filler - the rest. The invention provides enhanced Arsenal of drugs. 1 C.p. f-crystals, 2 tab.

The invention relates to medicine and pharmaceutical industry and for the creation of new drugs used for the treatment of acute and chronic prostatitis.

Known rectal tool used in proctology for the treatment of diseases of the anorectal region, rectum and prostate, containing as the active ingredient plant extract of alfalfa and a filler, in the following ratio of components, wt.%:

gelatin (18-20), glycerin (33-35), boric acid (1,1-1,16), alfalfa extract (5-6), ikenye pumpkin seeds and lipophilic basis in the ratio of 1:1

The objective of the invention is to expand the Arsenal of drugs with local action for the treatment of prostatitis.

The essence of the invention lies in the fact that rectal medicine as biologically active substances contains liquid purified extract of the prostate gland of cattle (cattle) and the filler in the following ratio, wt.%:

liquid purified extract of the prostate gland of cattle-46,0-47,8; filler - rest.

The filler used gelatin, glycerin, sodium carbonate-bicarbonate buffer.

Liquid purified extract of the prostate gland of cattle, not containing high-molecular cellular debris, is an intermediate product in the production of dry injectable "Prostatilen" without the final stage of freeze drying. It contains 5 mg/ml water-soluble low molecular weight peptides in the Alp activity is not below 20 %. The composition of the drug promotes increased circulation and improved outflow of secretions from the prostate gland for the correction of violations that accompany any changes in circulation and trophic prostate cancer.

The filler contains substances that are permitted by the State Pharmacopoeia of the USSR. The use of sodium carbonate-bicarbonate buffer in the preparation of filler was allowed to stabilize physico-chemical properties of suppositories within 1 year of storage.

Use in the manufacture offer rectal means of sterile source components guarantees high microbiological purity: 0-20 bacteria and fungi per 1 g rectal means when a valid 1103aerobic bacteria and 1102yeast and moulds in 1 g suppository in the absence Enterobakteriaceae, Pseudomonas aeruginosa, Staphylococcus aureus (GF X1, V. 2, S. 193 - 200 and Change N 1 category 4 to GF xi. 2 from 28.12.95).

We offer rectal means obtained as follows. Sterile filler is heated and mixed under aseptic conditions with pre-warmed sterile liquid purified extract of the prostate gland of cattle with constant stirring. The resulting mixture is poured into a special pre-cooled sterile form. Completed forms are cooled, then dismantled in aseptic conditions. Ready suppositories check according to the requirements of the State more precise biologically active substance, while the melting of the suppository within the body for 10 min at 37oC leads to rapid absorption of the tool in the mucous membrane of the rectum.

Example 1. Under aseptic conditions in a heat resistant glass flask, mixed with 42 ml of sterile sodium carbonate-bicarbonate buffer and is 98.7 g of gelatin. The mixture was kept to swell for 30 minutes at a temperature of 20oC. the Swollen gelatin was placed in a water bath at a temperature of 60oC and dissolve it with constant stirring. To a solution of gelatin in a water bath at a temperature of 60oC add with constant stirring and 39.9 ml of glycerol, pre-heated to the same temperature. The resulting mixture was poured in a measuring bottle, cover with a cotton-gauze tube and sterilized. Cooled to 50oC filler is mixed with the sterile liquid purified extract of the prostate gland of cattle in the ratio of 1.1:1.0 with constant stirring. The resulting mixture is poured into a special chilled sterile form. Pre-forms are washed with detergent, rinsed with water, treated with 3% hydrogen peroxide for 45 min, rinsed again with distilled water, dried, sterilized the conditions. Ready suppositories check on compliance with the requirements of the State. Pharmacopoeia and packaged in foil or blister.

Example 2. Under aseptic conditions in a heat resistant glass flask are mixed and 39.9 ml of sterile sodium carbonate-bicarbonate buffer and 96.6 g of gelatin. The mixture was kept to swell for 30 min at temperature 20oC. the Swollen gelatin was placed in a water bath at a temperature of 60oC and dissolve it with constant stirring. To a solution of gelatin in a water bath at a temperature of 60oC add with constant stirring 42 ml of glycerol, pre-heated to the same temperature. The resulting mixture was poured in a measuring bottle, cover with a cotton-gauze tube and sterilized. Cooled to 50oC filler is mixed with the sterile liquid purified extract of the prostate gland of cattle, preheated to a temperature of 37oC, in a ratio of 1.1: 1.0 with constant stirring and poured into sterile form.

Further operations are performed analogously to example 1.

We offer rectal tool contains 5 mg of low molecular weight peptides on 1 suppository melts at 37oC for 10 min, the pH is, Chislennye physico-chemical properties within 1 year if the conditions for storage and transport.

A comprehensive examination and treatment of 115 patients with chronic chlamydial prostatitis etiology, located on outpatient treatment in the outpatient Department of a hospital N 18, Ufa in 1997 - 1998

For clinical examination and treatment of individual patients older than 18 years with a verified diagnosis of urogenital chlamydia trachomatis from clinical symptoms of chronic prostatitis, which is not less than 3 months before treatment was not carried out the treatment with drugs that have effects similar to levamisole, azithromycin, prostatilen.

Clinical studies before and after treatment included a digital rectal examination of the prostate in order to clarify the dimensions of the cancer, its consistency, intensity median groove, the degree of pain, microscopic examination of the secret of the prostate gland, ultrasound examination of the prostate gland (PI), seminal vesicles and bladder with determination of residual urine, uroflowmetry. All patients were determined by the initial (before treatment) and final (after treatment) antibody titers to chlamydia.

All patients were divided into 3 groups:

1 (control 0) group patients received basic therapy without drugs prostate is h per day for 10 days on the background of basic therapy.

group 3 patients (40 pax) received prostatilen in the form of rectal suppositories, representing a mixture of liquid extract from the tissue of the prostate gland of cattle and filler, and 10 mg per day (2 candles) on the background of basic therapy.

The results of clinical trials are presented in table. 1, 2.

As can be seen from table 1, in the initial examination complained of pain p. 1, 2, 3, 4 - 88,69 % the sick. After the treatment had minimal number of complaints (2,5%) on pain of various etiologies from patients in group 3 who suppository liquid purified extract of the prostate gland of cattle.

Was studied by changing the size, texture, surface conditions, and median grooves mud in CP patients chlamydial nature. The increasing size of the mud was detected in 48,7 % of patients. Normalization of the size mud after treatment occurred in all groups of patients. As can be seen from the table. 2, the lowest percentage of residual after treatment in group 3 (2,5%) treated with liquid extract of cattle in the form of suppositories in addition to the basic therapy. Thus from table 1, 2 shows that the use of suppositories leads to a more pronounced positive dynamics of clinics is about to say, what we offer rectal means containing liquid purified extract of the prostate gland of cattle, can be used in the treatment of patients with chronic prostatitis.

1. Rectal treatment for prostatitis various etiologies, containing biologically active substance and a filler, characterized in that the biologically active substances it contains purified liquid extract of the prostate gland of cattle in the following ratio, wt.%:

Liquid purified extract of the prostate gland of cattle - 46,0 - 47,8

Filler - Rest

2. Means under item 1, characterized in that the filler it contains gelatin, glycerin and sodium carbonate-bicarbonate buffer.

 

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