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US 4,904,643 AGranted
Thymus derivative active after oral administration, methods of preparation and pharmaceutical compositions
AssigneeEllem Industria Farmaceutica S.p.A.
InventorsBrunetto Brunetti, Marco Prada
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Abstract
Thymolymphotropin, a thymus derivative able to stimulate the differentiation and the function of T-lymphycytes, is active after oral administration and can be prepared through a process of partial acid lysis of mammal thymuses. Pharmaceutical compositions containing thymolymphotropin are utilized in the treatment of primary and secondary immunodeficiencies.
Claims16
A process for preparing a thymus derivative including the following steps:
- (a) subjecting thymus tissue to a first treatment with an inorganic acid at about room temperature for 18 to 24 hours;
- (b) increasing the temperature of the product under process to values ranging from 40.degree. to 48.degree. C. and maintaining said temperature for about 70-80 hours;
- (c) subsequently increasing the temperature of the product to values ranging from 50.degree. to 55.degree. C. and maintaining said temperature for 70 to 80 hours;
- (d) raising the pH of the obtained solution to values ranging from 4.3 to 4.8 and maintaining the solution at 75.degree. to 85.degree. C. for 30 minutes;
- (e) filtering the solution to produce a first filtrate;
- (f) adjusting the pH of said first filtrate to values ranging from 6.2 to 6.8;
- (g) filtering said first filtrate to produce a second filtrate;
- (h) adjusting the pH of said second filtrate to values ranging from 9.2 to 9.7;
- (i) filtering said second filtrate to produce a third filtrate;
- (j) adjusting the pH of said third filtrate to values ranging from 6.6 to 6.8;
- (k) removing high molecular weight proteins from said third filtrate to produce a fourth filtrate having a protein content consisting essentially of proteins with a molecular weight of less than 10,000 daltons;
- and
- (l) removing salts from said fourth filtrate.
10 more elements
Dependencies are inferred from the claim text.