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Medicine composition for improving stability of human urine kininogenase

A technology of urinary kallikrein and its composition, which is applied in the field of pharmaceutical compositions for improving the stability of the biological activity of biochemical drug human urinary kallikrein, and can solve problems such as easy inactivation

Active Publication Date: 2007-05-30
GUANGDONG TECHPOOL BIO-PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The technical problem to be solved in the present invention is to overcome the problem that human urinary kininogenase freeze-dried powder is easily inactivated when it is made into an aqueous solution, and improve its stability.

Method used

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  • Medicine composition for improving stability of human urine kininogenase

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～5

[0014] The quantities listed in the table below were weighed for each stabilizer raw material. The unit of weight is milligrams.

[0015] Preparation method: Weigh each medicinal stabilizer according to the species and weight listed in the table, add water for injection to dissolve respectively, adjust the pH value to 6-7 after mixing, then add water for injection to 5000 ml, filter aseptically through filter membrane, and divide Packed in 1,000 ampoules, sealed and sterilized by moist heat.

Embodiment 6

[0016] Embodiment 6 solution stability experiment

[0017] Take one 0.5pNAU human urinary kininogenase freeze-dried powder injection, add one 5 ml of stabilizer solution prepared by the method of Examples 1 to 5 to dissolve, inject in 100 ml of 0.9% sodium chloride solution and shake well, 20 Place it at ℃, observe the appearance change at 1, 6, 12, 24, 36, and 48 hours, and take samples to determine the pH value and residual activity. The results are shown in Tables 1-5.

[0018] Take another 0.5pNAU human urinary kininogenase freeze-dried powder injection, dissolve it in 5ml of 0.9% sodium chloride solution, then inject it into 100ml of 0.9% sodium chloride solution, shake well, place it at 20°C, and place it in 1, 6, 12, 24, 36, and 48 hours were observed for appearance changes, samples were taken to determine the pH value, and residual activity was used as a control. The results are shown in Table 6.

[0019] Table 1 human urinary kallikrein plus embodiment 1 stabilizer i...

Embodiment 7

[0032] Embodiment 7 solution stability experiment

[0033] Take one 0.5pNAU human urinary kininogenase freeze-dried powder injection, add one 5 ml stabilizer solution prepared according to the method of Examples 1 to 5 to dissolve, pour into 100 ml of 5% glucose isotonic solution and shake well, at 20°C After standing, observe the appearance change at 1, 6, 12, 24, 36, and 48 hours, and take samples to determine the pH value and residual activity. The results are shown in Tables 7-11.

[0034] Take another 0.5pNAU freeze-dried powder injection of human urinary kininogenase, dissolve it in 5ml 5% glucose solution, then inject it into 100ml 5% glucose solution, shake well, place it at 20°C, and store it at 1, 6, 12, 24 , 36 and 48 hours to observe the appearance change, take samples to determine the pH value, and the residual activity as a control, the results are shown in Table 12.

[0035] Table 7 human urinary kallikrein plus embodiment 1 stabilizer after the stability test ...

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Abstract

A pharmaceutical composition for improving biological activity stability of human urinary kallikrein is disclosed. The composition chooses one or combination of the following ingredients: mannitol, dextran intradex, hydrolyzed gelatin and sodium citrate to prepare liquid. In clinical practice, it is used for dissolving freeze dried human urinary kallikrein, then being dissolved to large volume liquid. It can delay evidently the decreasing of the human urinary kallikrein activity.

Description

technical field [0001] The invention relates to a pharmaceutical composition, especially a pharmaceutical composition for improving the biological activity stability of biochemical drug human urinary kallikreinogenase. Background technique [0002] Human Urinary Kallidinogenase (Human Urinary Kallidinogenase) is a protease extracted and refined from human urine, which has the functions of dilating blood vessels and preventing thrombosis. The applicant's previous patent application "02116783.4 Application of Human Urinary Kallikrein in the Preparation of Drugs for Treating and Preventing Cerebral Infarction" discloses its medical use. Human urinary kininogenase is usually prepared as a freeze-dried powder injection. In clinical application, it is first dissolved with a small amount of isotonic solution, and then diluted in large liquids such as sodium chloride solution and glucose solution for intravenous infusion. Since human urinary kininogenase is a kind of proteolytic en...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/49A61K9/08A61K47/36A61K47/42A61K47/10A61K47/12A61P7/02
Inventor 傅和亮谢永立苗丕渠王晓岩
Owner GUANGDONG TECHPOOL BIO-PHARMA CO LTD
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