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Medicinal composition containing fiber eliminating enzyme

A technology for defibrase and composition, which is applied in the field of pharmaceutical compositions containing defibrase, can solve the problems of increased production cost, troublesome production, and difficulty in determining the actual titer, and achieves the effect of avoiding contact and ensuring curative effect

Inactive Publication Date: 2003-11-19
江苏浦金药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In actual use, considering the decline of defibrase titer, when preparing preparations, it is often fed according to 130-200% of the labeled amount, but on the one hand, this brings about an increase in actual production costs, and on the other hand, due to the decline in titer Uncertain range makes it difficult to determine the actual potency, which affects the product qualification rate and brings great trouble to production

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0008] Embodiment 1: Defibrase freeze-dried powder injection (1)

[0009] Defibrase 100 units

[0010] 20 people serum albumin injection 20ml

[0011] Mannitol 10g

[0012] Dextran 20 30g

[0013] Add water for injection to 1000ml

[0014] Among them, defibrase is a proteolytic enzyme extracted from the venom of Agkistrodon halys (ussriensis Emelianor) or Agkistrodon acutus (Guenther) in Changbai Mountains. The molecular weight of its main component is 36000 (±5000), which meets the National Drug Standards (WS 1 -XG-031-2000).

[0015] The above preparation solution was aseptically divided into 1000 vials, freeze-dried, capped and packaged.

Embodiment 2

[0016] Embodiment 2: Defibrase freeze-dried powder injection (2)

[0017] Defibrase 50 units

[0018] Human Albumin 2.5g

[0019] Mannitol 10g

[0020] Dextran 20 30g

[0021] Add water for injection to 1000ml

[0022] The above preparation solution was aseptically divided into 1000 vials, freeze-dried, capped and packaged.

Embodiment 3

[0023] Embodiment 3: Defibrase freeze-dried powder injection (3)

[0024] Defibrase 5000 units

[0025] 20% Human Serum Albumin Injection 50ml

[0026] Dextran 20 30g

[0027] Water for injection to 1000ml

[0028] The above preparation solution was aseptically divided into 1000 vials, freeze-dried, capped and packaged.

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PUM

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Abstract

A composite medicine containing norfibrase features that a human hemoalbumen a protecting agen is added to form a water film surrounding the norfibrase protein molecule to prevent it from being contacted with solvent (water), that is, from being adsorbed to lower its medical value.

Description

technical field [0001] The present invention relates to a pharmaceutical composition containing defibrase. Background technique [0002] Defibrase is used as a drug for the treatment of cerebral infarction, thromboangiitis obliterans, femoral artery embolism, pulmonary embolism and other diseases, each injection is 5-10 units, the dosage form is freeze-dried powder injection, and the preparation specification is 5-10 units / piece . At the same time, defibrase injection is also used clinically. Recent studies have found that when defibrase is used in small doses (that is, when it is less than 1 unit each time), it has obvious hemostatic effect (Chinese patent CN 1308965A). 1 unit / piece. [0003] Regardless of the dosage form and specification of the defibrase preparation, its concentration is extremely low (calculated by weight, the concentration of its medicinal solution or preparation solution is all less than 0.001%). After defibrase is highly diluted, the potency will ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/43A61K47/42A61P9/10A61P9/14A61P11/00
Inventor 欧阳强朱虹王光凤李树宽杨志坚
Owner 江苏浦金药业有限公司
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