Drug – bio-affecting and body treating compositions – Extract – body fluid – or cellular material of undetermined... – Digestive system
Patent
1997-03-17
1999-09-07
Smith, Lynette R. F.
Drug, bio-affecting and body treating compositions
Extract, body fluid, or cellular material of undetermined...
Digestive system
424550, 424937, A61K 3537, A61K 3538, A01N 6300, A01N 6500
Patent
active
059484420
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
The invention relates to the preparation "ENTEROGENIN--pulvis and ampules", the method for its isolation on an industrial scale production of the pharmaceutical forms and investigation of the pharmacological effects of the preparation. The active component of "ENTEROGENIN--pulvis and ampules" is a bioactive substance isolated from intestinal mucosa. Data have been reported about substances present in the intestinal mucosa that inhibit cell proliferation (1,2,3). There are no reports in the literature concerning isolation of substances that exert stimulating effect on morphogenesis. We have patented a method for isolation of biostimulating substance from intestinal mucosa of warm-blooded animals (4,5). This method has certain disadvantages--complex technologic process which renders relatively expensive the production of the substance, and incompleteness of the method to the stage of producing final pharmacologically tested forms.
SUMMARY OF THE INVENTION
This invention has as its objects to: 1) refine the said method for isolation of the bioactive component of the preparation "ENTEROGENIN--pulvis and ampules"; 2) develop pharmaceutical forms of the preparation "ENTEROGENIN--pulvis and ampules"; 3) Test the pharmacological action of the preparation "ENTEROGENIN--pulvis and ampules" in the veterinary and zootechnical practice after experimental investigation of the effects of the bioactive component.
BRIEF DESCRIPTION OF THE FIGURE
FIG. 1 is a flowchart describing the isolation of stimulating enterogenin.
DETAILED DESCRIPTION OF THE INVENTION
The first object is accomplished by method for isolation of a stimulator of biosynthetic processes from pig intestinal mucosa. Principally, the production scheme comprises the following steps: 1) isolation of a specific cellular mass from animal intestinal mucosa which is discarded as a waste product in the casing cleaning shops of meat packing plants; 2) obtaining an alcoholic acid extract after settling the high molecular weight polymers; at this stage any contamination associated with the initial biomass is prevented; 3) ion-exchange fractionation in batch procedures; 4) ultrafiltration of the eluent obtained from the fractionation. The technological scheme is described in Example 1.1. Compared with the method described in Patent BG 49927 MPK A61K37/02 the improvements are as follows: the reagents are used in smaller amounts; some of the stages of the basic technologic scheme are changed and their number reduced; the parameters of the ultrafiltration are changed and further specified. As a result, two instead of one bioactive nucleopeptides named by us "stimulating enterocytogenins", have been isolated.
The second object is achieved by preparation of two pharmaceutical forms: 1) packets of enterosolvent granules "ENTEROGENIN pulvis" for peroral administration; 2) vials of "ENTEROGENIN ampules" containing the purified bioactive preparation in a depot form. Stored at a temperature of 2 to 6.degree. C. the pharmaceutical forms can preserve their action for three years. The analysis of the above mentioned pharmaceutical forms has been officially approved by the Laboratory for Veterinary Preparation Control with the National Office of Veterinary Medicine (6). The analysis comprises the reactions for chemical and biological identification of the biologically active nucleopeptides in "ENTEROGENIN". Additionally, an analysis of the vehicle components of the pharmaceutical forms are given.
The third object is achieved by laboratory and clinical experiments and introductions in veterinary practice. The bioactive nucleopeptides contained in "Enterogenin--pulvis and ampules" act at a molecular level; the proliferative cycle of the physiologically regenerating intestinal mucosa cells is shortened which results in an increase of the resorptive surface of small intestines; in non-proliferating cells they stimulate the synthesis of specific proteins: actomyosin in the striated muscles, detoxicating proteins in the liver, immunogenic proteins in t
REFERENCES:
Skraastad O, Reichelt KI, Virchows Arch B, 56, 1989, 393-396.
Skraastad O, Reichelt KI, J Gastroent 23, 1986, 801-807.
Triffnov B, et al., Regulatory Peptides, 51, 1994, 111-119.
Triffonov B, et al, J Gastrointest Motil 4, 1992, 193-199.
Popov, et al, 1986, "The Effect of a Stimulatory Enterocytogenin . . . " Folia Media, pp. 28-31.
Trifonov, et al, 1994, "Biological Effects of a Novel Peptide . . . " Regulatory Peptide 51:111-119.
Boshev Nikola Atanassov
Petrov Metodi Stefanov
Roussev Jeorge Konstantinov
Trifonov Borislav Borisov
Christo Alexandrov Alexandrov
Nelson Brett
Smith Lynette R. F.
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