| 摘要 |
1. A stable lyophilized formulation comprising recombinant human activated protein C; a bulking agent selected from the group consisting of mannitol, trehalose, raffinose, and sucrose, and mixtures thereof; and a buffer system such that on reconstitution the resulting formulation has a pH between 5.5 and 6.3. 2. The formulation of Claim 1, wherein comprising dis-(1-9)-inactivated protein C and dis-(1-10)-inactivated protein C in an amount less than 10% of total formulation weight. 3. The formulation of Claim 1, wherein comprising dis-(1-9)-inactivated protein C and dis-(1-10)-inactivated protein C in an amount less than 5% of total formulation weight. 4. The formulation of Claim 1,2 or 3, wherein the pH of the solution is between 5.9 to 6.1. 5. The formulation of Claim 4, wherein the buffer system is sodium citrate. 6. The formulation of any one of Claims 1-5, wherein further comprises a pharmaceutically acceptable salt. 7. A lyophilized formulation comprising recombinant human activated protein C, salt and excipient selected from the group consisting of mannitol, trehalose, raffinose, and sucrose, wherein the weight ratio is about 1 part activated protein C, between about 7 to 8 parts salt, and between about 5 to 7 parts excipient. 8. The formulation of Claim 7, wherein the weight to weight ratio is about 1 part activated protein C, about 7.6 parts salt and about 6 parts excipient. 9. The formulation of any one of Claims 6-8, wherein the salt is NaCl, and the excipient is sucrose. 10. The formulation of any one of Claims 6-9, wherein on reconstitution the resulting formulation comprises 5 mg/mL recombinant human activated protein C, 30 mg/mL sucrose, and 38 mg/mL NaCl. 11. Use the formulation of any one of Claims 1-10, as a medicament in the treatment of disease states involving intravascular coagulation. 12. Use the formulation of any one of Claims 1-10, as a medicament in the treatment of thrombotic stroke. 13. A unit dosage form comprising a unit dosage receptacle containing the formulation of any one of Claims 1-10.
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