Application recombinant streptokinase for preparing medicine to treat high viscosity blood disease

A technology of hyperviscosity and streptokinase, which is applied in the application field of recombinant streptokinase in the preparation of drugs for the treatment of hyperviscosity, can solve the problems of unsatisfactory curative effect, slow onset of effect, no special drug treatment, etc., and achieve remarkable curative effect , fast onset and short medication cycle

Inactive Publication Date: 2007-01-31
SHANGHAI FOSUN PHARMA (GROUP) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, for the treatment of hyperviscosity at home and abroad, no matter whether it is traditional Chinese medicine or western medicine, there is no special medicine f

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Example 1: Preparation of recombinant streptokinase (r-SK)

[0017] Recombinant streptokinase was prepared according to the method disclosed in the example of Chinese patent 94112106.2, and the pure product was obtained and then lyophilized in aliquots. The powder injection specifications were 500,000 IU / bottle and 100,000 IU / bottle for use.

Embodiment 2

[0018] Example 2: Recombinant streptokinase (r-SK) maximum toxicity test

[0019] Pharmaceutical preparation: Take 12 bottles of samples (500,000 IU / 5mg / bottle), add 5ml of saline (100,000 IU / 1mg / ml) to each bottle, and the concentration is 0.1%.

[0020] Animals: Female guinea pigs (391.2±22.7g) and males (340.9±33.7g) half each, 10 in groups.

[0021] Dosage: Each guinea pig is administered at a dose of 50,000 IU / 100g, a human body weight is 60Kg, and the clinical dosage is 500,000 IU, which is equivalent to more than 50 times the clinical drug dose. The injection volume is 0.5ml / 100g. ) Or femoral (female) intravenous injection slowly.

[0022] Test results: Observation for two weeks, no deaths, normal activities, and the dose limit is greater than 5mg / kg (equivalent to 500,000 IU / kg).

[0023] Group

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Dose

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Observation time (days)

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Embodiment 3

[0026] Example 3: Acute toxicity test of recombinant streptokinase (r-SK) in mice

[0027] Kunming mice 19.2±0.8g, 20 mice. Half of the male and half, fasted for 4 hours before administration. The acute toxicity LD50 could not be determined by the preliminary test, so the limit test was done. Each mouse had IV r-SK (concentration 1.2mg / ml). Each mouse is injected with 0.2ml / 10g. Observed for one week, there was no abnormal phenomenon in each mouse, none of the mice died, and the dose limit was greater than 24 mg / kg. (Equivalent to 2.4 million IU / kg)

[0028] Group

[0029] Remark: 24mg / kg is equivalent to 2.4 million IU / kg. After 7 days of observation, the mice were sacrificed and dissected, and the main organs were not abnormal.

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Abstract

An application of the recombinant staphylokinase in preparing the medicines for treating high-viscosity blood with high curative effect and safety is disclosed.

Description

Technical field [0001] The invention relates to the use of recombinant streptokinase, in particular to the application of recombinant streptokinase in the preparation of drugs for treating hyperviscosity. Background technique [0002] As early as 1933, Tillett and Garner accidentally discovered when studying group C β-hemolytic streptococcus that the filtrate of the bacteria can dissolve fibrin clots in human plasma, thus establishing streptolinase (SK) for clinical treatment The possibility of thrombotic diseases [Sherry S. Thrombolytic therapy in acute myocardial infarction a perspective [J]. Drugs, 1987, 33 (Suppl 3): 1-12.]. Since then, a series of basic and clinical studies have confirmed that SK is a polypeptide composed of 414 amino acids with a relative molecular weight of 45,000 to 47,000, which is a highly effective thrombolytic drug. Its mechanism of action is to first combine with plasminogen in the blood to form a biologically active compound, and then activate the u...

Claims

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Application Information

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IPC IPC(8): A61K38/48A61P7/02A61P7/00
Inventor 王漪张向荣
Owner SHANGHAI FOSUN PHARMA (GROUP) CO LTD
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