Process for preparing bioabsorbable sheet preparation holding thrombin
View Patent ↗A process for preparing a bioabsorbable sheet preparation holding thrombin is provided. A process for preparing a bioabsorbable sheet preparation holding thrombin which comprises immersing a bioabsorbable sheet consisting of polyglycolic acid in a thrombin solution containing thrombin as an active ingredient, glycerol as a softening agent, Tween 80 as a permeating agent, and optionally histidine and trehalose as a stabilizing agent followed by drying to hold thrombin on said bioabsorbable sheet, and a bioabsorbable sheet preparation holding thrombin prepared by said process.
1. A bioabsorbable sheet preparation, comprising:
1,000 to 2,000 Units/mL of thrombin,
30 to 40 mg/mL of trehalose,
0.01 to 1% of at least one detergent, and
2.4 to 180 mM of histidine.
2. The preparation of claim 1 , which further comprises sucrose.
3. The preparation of claim 1 , which further comprises mannitol.
4. The preparation of claim 1 , which further comprises sorbitol.
5. The preparation of claim 1 , which further comprises erythritol.
6. The preparation of claim 1 , which further comprises arginine.
7. The preparation of claim 1 , further comprising lysine.
8. The preparation of claim 1 , further comprising glutamic acid.
9. The preparation of claim 1 , further comprising glycine.
10. The preparation of claim 1 , further comprising aspartic acid.
11. The preparation of claim 1 , further comprising glycerol.
12. A process for preparing the bioabsorbable sheet preparation holding thrombin of claim 1 , which comprises:
(1) preparing a solution comprising a detergent, trehalose, histidine, glycerol and thrombin;
(2) adding dropwise the solution of (1) to a bioabsorbable sheet or immersing a bioabsorbable sheet in the solution of (1); and
(3) drying the bioabsorbable sheet of (2).
13. The process of claim 12 , wherein glycerol is at 1 to 2%.