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Method for producing thrombolytic preparation
| Details |
Inventors: Suyama, Tadakazu;
Assignee: The Green Cross Corporation (Osako, JP)
Primary Examiner: Shapiro; Lionel M.
Assistant Examiner:
Attorney, Agent or Firm: Cushman, Darby & Cushman
A method for producing a thrombolytic preparation characterized in that among treatment conditions in the urokinase production pH is maintained within the neutral or weakly alkaline range throughout each treatment step to produce a thrombolytic preparation containing urokinase having a molecular weight of 54,000.+-.10,000 as major ingredient. |
|
DETAILED DESCRIPTION What is claimed is: 1.
In a method for producing a thrombolytic preparation from a fresh urine or a crude urokinase solution which consists essentially of (1) adsorbing urokinase on a selected adsorbent, (2) eluting and recovering the absorbed urokinase, (3) heat-treating the recovered urokinase solution at a temperature of 50.
degree.
to 70.
degree.
C.
for 8 to 12 hours, and (4) subjecting the heat-treated solution to dialysis, the improvement comprising carrying out the heat-treatment step at pH 6 to 8 and carrying out the dialysis step at pH 5.
5 to 12 to recover urokinase having a molecular weight of 54,000.
+-.
10,000.
2.
A method for producing a thrombolytic preparation according to claim 1, comprising adding a heat-stabilizer for urokinase selected from the group consisting of glycine, lysine, arginine, sucrose, mannitol, sodium chloride and gelatin to the aqueous solution containing urokinase.
3.
A method according to claim 2 wherein the stabilizer is selected from the group consisting of arginine, sucrose, mannitol, sodium chloride and gelatin.
Description:
This invention relates to a method for producing a thrombolytic preparation containing as major constituent urokinase having a molecular weight of 54,000.
+-.
10,000.
Urokinase is an enzyme existing in minute amounts in human urine and has a function of activating plasminogen contained in serum to form plasmin having fibrinolytic activity.
Being an effective activator for the fibrinolytic system, urokinase is isolated from human urine or tissue cultures of kidney and purified to be clinically used widely in treatment of various thrombosis, cancers in combination with carcinostatic agents, and other diseases.
Thus, urokinase has become very useful in the pharmaceutical field.
The present inventors conducted studies to promote more efficient utilization of urokinase in its therapeutic use.
The urokinase preparations currently in use as pharmaceuticals are mixtures of different molecular weights.
Two types of urokinase have been known, the one having a molecular weight of about 33,000
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