BG60664B1 - Antiulcerous composition - Google Patents

Abstract

The device is intended for prophylaxis and treatment of ulcerative disease as well as inflammatory and erosive processes in the digestive tract. It has a high therapeutic effect, a complex effect, and side effects on its prolonged administration. It is a bovine serum, preferably in the form of a lyophilisate obtained from pooled calf blood of calves up to 10-12 months of age, containing 5.5-8.5 g% total protein of pH 7-8.5. The formulation is suitable for self-administration either as a pharmaceutical form or as a curative food. A declaration of license readiness according to Art.

Description

TECHNICAL FIELD

The invention is an anti-ulcer agent which relates to the pharmaceutical and food industries, and in particular to the manufacture of preparations and foodstuffs for the prevention and treatment of peptic ulcer disease and of inflammatory and erosive processes in the digestive tract.

BACKGROUND OF THE INVENTION Anti-ulcer agents are known / 1 /:

I. Antisecretory agents (inhibiting hydrochloric acid secretion):

1 (H) antagonists (selectively inhibiting the H-methoxyanate 2 E hydrochloric acid secretion):

+ * +

2 / Inhibitors of Η, K-ATPase (inhibiting proton pump of apical membrane of wall cells);

3 / Anticholinergic agents (reducing the basal secretion of hydrochloric acid);

II. Anti-cyanide compounds - alkali salts that neutralize part of hydrochloric acid;

III. Protectors:

I (Sucralfate / with antipepsin, barrier and pro-prostaglandaine effect);

2 / Bismuth preparations / with antipeptin, mucigenic and anticampilobacterial effect /;

3 / Lrostaglanainergic agents (inhibiting aenylate cyclase and gastrin release, stimulating mucus production and local microcirculation);

4 / Antioxiaants / with anti-freezing and membrane-protecting and microcirculatory effect /;

5 / Thiol compounds, Somatostatin, epidermal growth factor, etc.

Characteristic of known preparations, which have come into practice or are still in the experimental phase, is their unilateral effect on a limited range of processes that condition and accompany ulcer. Therefore, in clinical practice combined treatment is applied - with preparations with different mechanisms of action, with appropriate diets and regimen.

The search for effective prophylactic and therapeutic agents that have complex effects, high therapeutic effect and no side effects with prolonged intake is continued.

SUMMARY OF THE INVENTION

In order to solve the problems related to the prophylactic and curative action of the preparations, as well as the problems related to the production, provision of environmentally friendly technologies, maximum utilization of waste products, a means for the prevention and treatment of peptic ulcer containing as an active ingredient is offered. calf serum derived from slaughtered calf blood up to 10-12 months of age containing 5.5-8.5 g% total protein, pH 7-8.5, alone or together with suitable pharmaceutically acceptable components for oral administration farm pharmaceutical form or form for administration as a medicament.

For both self-administration and the manufacture of pharmaceuticals and medicines, the serum is preferably in the form of lyophilisate. Serum obtained from the pool of slaughtered blood from previously tested and selected healthy animals is passed through an antibacterial filter and then tested for sterility against viruses, aerobic and optional anaerobic microorganisms, mycoplasmas and yeast fungi.

EXAMPLES FOR THE IMPLEMENTATION OF THE INVENTION

Example 1. Composition of the product for one vine: 3 g of lyophilisate from calf serum, containing a total protein of 5.5 or 8.5 g. with pH - 7.

Example 2. Composition of the vine product: 3 g of lyophilisate from calf serum, as in example 1. 5,000 1) 1 vitamin A. 0, 3 g of vitamin E, 0,5 g of methionine. 0.1 g cysteine.

Pharmacological study of the drug.

A. Tests were performed on 129 white male rats, foam VIzgag with an average body weight of 235.5 +/- 15.8 g. Animals were pasted into the fusion groups: control - 46 rats treated with saline. 1 group-24 rats fed with free agent solution according to Example 1, group II-19 rats fed with compound with the composition according to example 2, group III-19 rats fed with free solution of the amino acids cysteine and methionine and vitamins A and Well, in vines as in Example 2, and Group IV, 21 rats> watered with Ranitiline solution / 2apµcass / ClOax /. III and IV are recalculated from Examples 1 and 2 for the experimental animals and applied in a volume of 1 ml distilled ox.

The rats were lunched once with a probe for 8 days, then left in cages without shavings for 24 hours with water ace! NIP.

The next day, the animals were stretched for 24 hours on operating tables to obtain gastric stress ulcers. During starvation and stress, the test animals were replenished once with the test agents. After 24 hours of stress, the animals are anesthetized with Nembutal, the abdominal cavity is opened, the stomachs are reparated and cut along the large curvature. The ulcers were counted as a sex magnifier and fused to be recorded in 10% formalin solution for histological examination. The results are presented in Table 1.

Tabliaia ι

Groups number of animals per group number survived- led number of animals without ulcers common number ulcers ANIMALS with ulcers degree on statement index on Pauls Control 46 41 1 244 87,0 5.95 5.18

And a group 24 24 3 76 87.5 3.17 • 2.78 Group 11 19 19 5 41 73,7 2.16 1.59 Group III 19 19 1 93 94.7 4.89 4.63 Group IV 21 17 3 100 00,7 5.88 3.92

The examples provided do not exhaust the form of administration of the agent and do not limit the scope of the invention.

For the purposes of the invention, any commercial product of beef serum from animals up to 10-12 months of age may be used, for example, serum used as a culture medium for cell cultures.

The agent can be administered alone as an aqueous solution of lyophilisate in a preferred dose of 3 g per administration.

It can be administered in solid, semi-solid or liquid oral dosage form containing excipients, flavors, flavoring agents, biologically active additives such as vitamins, amino acids and the like. It can be administered as a therapeutic or prophylactic in the form of a food product which contains, in addition to the preferred dose agent, appropriate excipients, nutrients, flavors, flavoring agents, vitamins, carbohydrates, amino acids and the like.

Claims (1)

PATENT CLAIMS An agent for the prophylaxis and treatment of ulcerative disease comprising as an active ingredient a bovine serum, preferably in the form of a lyophilisate obtained from a calf carcass to a C0-C month of age, containing 5.5 - 8.5 g total protein, pH 7-8.5. alone or together with suitable pharmaceutically acceptable ingredients for peroral pharmaceutical form or curative food.