Claims for Patent: 4,347,243

Summary for Patent: 4,347,243

Title:	Acid soluble, pepsin resistant platelet aggregating material
Abstract:	Acid soluble, pepsin resistant, platelet aggregating material isolated from equine arterial tissue by extraction with dilute aqueous acid, method of isolation and use to control bleeding.
Inventor(s):	Schneider; Morris D. (Knoxville, TN)
Assignee:	Research Corporation (New York, NY)
Application Number:	06/292,200
Patent Claims:	1. A method of preparing a hemostatic agent comprising the steps of: (a) extracting cleansed, homogenized equine arterial tissue with dilute aqueous acid at from about 0.degree. C. to 5.degree. C., (b) dialyzing the extract against dilute acid, (c) subjecting the retentate to proteolysis with pepsin, and (d) precipitating the hemostatic agent by the addition of a water soluble salt to the resulting mixture. 2. The method of claim 1 wherein the arterial tissue is burro aortic tissue. 3. The method of claim 1 wherein the arterial tissue is horse aortic tissue. 4. The method of claim 1 wherein the acid is acetic acid for both extraction and dialysis. 5. The method of claim 2 wherein the acid is acetic acid for both extraction and dialysis. 6. The method of claim 3 wherein the acid is acetic acid for both extraction and dialysis. 7. An acid soluble, pepsin resistant, non-dialyzable, proteinaceous hemostatic agent isolated from equine arterial tissue characterized by the ability to enhance platelet aggregating activity in mammalian blood, stable for extended periods of time at temperatures as low as -85.degree. C., losing its platelet aggregating activity when exposed to collagenase at 37.degree. C. or when heated at 100.degree. C. for fifteen minutes; containing the following average number of amino acid residues per 1,000 total amino acid residues: which on SDS-PAGE electrophoresis products bands characteristic of the following molecular weights: 322,000 300,000 250,000 220,000 163,000 132,000 116,000 100,000 61,500 51,500 45,000 36,000 8. A hemostatic agent of claim 7 in a pharmaceutically acceptable carrier. 9. A hemostatic agent of claim 7 in an externally administerable pharmaceutical carrier. 10. A hemostatic agent of claim 7 in a balanced salt solution. 11. A hemostatic agent of claim 7 in water. 12. A method of stimulating platelet aggregation in mammalian plasma or whole blood which comprises contacting said plasma or whole blood with an amount which is effective to stimulate platelet aggregation of an acid soluble, pepsin resistant, non-dialyzable, proteinaceous hemostatic agent isolated from equine arterial tissue characterized by the ability to enhance platelet aggregating activity in mammalian blood, stable for extended periods of time at temperatures as low as -85.degree. C., losing its platelet aggregating activity when exposed to collagenase at 37.degree. C. or when heated at 100.degree. C. for fifteen minutes; containing the following average number of amino acid residues per 1,000 total amino acid residues: which on SDS-PAGE electrophoresis produces bands characteristic of the following molecular weights: 322,000 300,000 250,000 220,000 163,000 132,000 116,000 100,000 61,500 51,500 45,000 36,000 13. A method as in claim 12 wherein the hemostatic agent is in a pharmaceutically acceptable carrier. 14. A method of controlling external bleeding from a wound or incision comprising contacting said wound or incision of an amount which is effective to control bleeding of an acid soluble, pepsin resistant, non-dialyzable, proteinaceous hemostatic agent isolated from equine arterial tissue characterized by the ability to enhance platelet aggregating activity in mammalian blood, stable for extended periods of time at temperatures as low as -85.degree. C., losing its platelet aggregating activity when exposed to collagenase at 37.degree. C. or when heated at 100.degree. C. for fifteen minutes; containing the following average number of amino acid residues per 1,000 total amino acid residues: which on SDS-PAGE electrophoresis produces bands characteristic of the following molecular weights: 322,000 300,000 250,000 220,000 163,000 132,000 116,000 100,000 61,500 51,500 45,000 36,000 15. A method of detecting abnormal platelet function comprising contacting platelets in plasma or whole blood under test with an acid soluble, pepsin resistant, non-dialyzable, proteinaceous hemostatic agent isolated from equine arterial tissue characterized by the ability to enhance platelet aggregating activity in mammalian blood, stable for extended periods of time at temperatures as low as -85.degree. C., losing its platelet aggregating activity when exposed to collagenase at 37.degree. C. or when heated at 100.degree. C. for fifteen minutes; containing the following average number of amino acid residues per 1,000 total amino acid residues: which on SDS-PAGE electrophoresis produces bands characteristic of the following molecular weights: 322,000 300,000 250,000 220,000 163,000 132,000 116,000 100,000 61,500 51,500 45,000 36,000 and comparing the aggregation response of said platelets to the response of normal platelets.

Details for Patent 4,347,243

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		1999-08-31