Stabilized liquid preparation of the protease which activates blood coagulation factor VII, or of its proenzyme

1. A stabilized liquid preparation comprising:

a. a protease or its proenzyme, wherein the protese or its proenzyme activates blood coagulation factor VII;

b. at least one compound selected from the group consisting of ornithine, diaminopimelic acid, agmatine, creatine, guanidinoacetic acid, acetylornithine, citrulline, argininosuccinic acid, tranexamic acid, and ε-aminocaproic acid or their salts and derivatives; and

c. wherein said preparation has a pH between 2.0 and 8.0.

2. The stabilized liquid preparation of claim 1 , which additionally comprises at least one ionic detergent.

3. The stabilized liquid preparation of claim 1 , which additionally comprises at least one nonionic detergent.

4. The stabilized liquid preparation of claim 2 , wherein the ionic detergent is present in an amount ranging from 0.001 to 0.5 percent by weight of the liquid preparation.

5. The stabilized liquid preparation of claim 3 , wherein the nonionic detergent is present in an amount ranging from 0.001 to 0.5 percent by weight of the liquid preparation.

6. The stabilized liquid preparation of claim 1 , wherein the pH is between 2.5 and 6.8.

7. The stabilized liquid preparation of claim 1 , wherein the pH is between 3.5 and 6.8.

8. The stabilized liquid preparation of claim 1 , wherein the liquid preparation additionally comprises:

a. at least one detergent;

b. at least one sugar;

c. at least one amino acid; and optionally.

9. The stabilized liquid preparation of claim 8 , wherein the detergent is at least one ionic detergent.

10. The stabilized liquid preparation of claim 8 , wherein the detergent is at least one nonionic detergent.

11. The stabilized liquid preparation of claim 8 , wherein the detergent is present in an amount from 0.001 to 0.5 percent by weight of the liquid preparation.

12. The stabilized liquid preparation of claim 8 , wherein the at least one sugar is selected from the group consisting of glucose, arabinose, and mannose.

13. The stabilized liquid preparation of claim 8 , wherein the at least one amino acid is selected from the group consisting of arginine, lysine, and glycine.

14. The stabilized liquid preparation of claim 1 , wherein the ionic strength of the liquid preparation is adjusted to greater than 10 mSi by addition of a salt.

15. The stabilized liquid preparation of claim 8 , wherein the ionic strength of the liquid preparation is adjusted to greater than 10 mSi by addition of a salt.

16. The stabilized liquid preparation of claim 1 , wherein the protease or its proenzyme is in lyophilized form.

17. The stabilized liquid preparation of claim 8 , wherein the protease or its proenzyme is in lyophilized form.

18. The stabilized liquid preparation of claim 1 , wherein the protease or its proenzyme is present in an amount greater than 0.5 mg/ml.

19. The stabilized liquid preparation of claim 8 , wherein the protease or its proenzyme is present in an amount greater than 0.5 mg/ml.

20. A pharmaceutical composition comprising the stabilized liquid preparation of claim 1 .

21. A diagnostic reagent comprising the stabilized liquid preparation of claim 10 .

22. A method of treating thromboembolic disorders by administering to a mammal, the pharmaceutical composition according to claim 20 .

23. A method of treating complications associated with leg vein thrombosis, myocardial infarction, or stroke by administering to a mammal, the pharmaceutical composition according to claim 20 .

24. A method of treating disorders caused by fibrin-containing thrombi by administering to a mammal the pharmaceutical composition according to claim 20 .

25. The stabilized liquid preparation of claim 8 , wherein the liquid preparation additionally comprises at least one complex with a calcium ion.