Compound hemostatic originated from venom

A hemostatic drug and snake venom technology, applied in the field of enzyme preparations, can solve problems such as glomerular damage, adverse immune response, and limited dosage, and achieve remarkable drug effects

Active Publication Date: 2006-08-02
PENGLAI NUOKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In fact, as a large-molecular-weight protein drug, it is easy to cause adverse immune responses to the human body, such as: fever response, production of antibodies, formation of immune complexes with large molecular weight, and certain damage to glomeruli, thus limiting its use dose

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Example 1 coagulation factor X activator (FXA) in vitro coagulation test

[0041] The method for measuring the activity of similar products was used for the in vitro coagulation test. The specific test method was as follows: take 0.2ml of human-citrate anticoagulant plasma, put it into a test tube with a diameter of 1cm, put it in a water bath at 37°C for 3 minutes, and add it to preheat at 37°C Mix 0.2ml of the sample solution immediately, start at 40 seconds, check the plasma coagulation situation, record the initial coagulation time, measure 3 tubes at the same time, the error of the initial coagulation time of the three tubes should be less than 20 seconds. If the initial coagulation time is less than 40 seconds, dilute the test solution appropriately, and record the concentration of the test solution coagulated within 60 ± 20 seconds. The amount of enzyme coagulated, defined as one unit. Calculate the potency and record the test results.

[0042]

[0...

Embodiment 2

[0046] Example 2 Class thrombin (batroxobin) and coagulation factor X activator synergistic in vitro coagulation test

[0047] Use the thrombin-like enzyme (batroxobin) with a concentration of 500u / ml and the coagulation factor X activator with a concentration of 500u / ml to prepare the test solution according to the required ratio in the table below to ensure that the theoretical value of the final solution is: 500u / ml. Positive control 1 was 1 unit of thrombin-like enzyme (batroxobin), positive control 2 was 1 unit of coagulation factor X activator, and negative control was normal saline.

[0048]

Embodiment 3

[0049] Embodiment 3 thrombin (batroxobin) and blood coagulation factor X activator alone and synergistic in vivo hemostasis test

[0050] In accordance with the clinical research guidelines, the in vivo coagulation test adopts the mouse tail docking method. Combined with the clinical dosage of thrombin-like enzyme (batroxobin) we choose: 20~0.1 unit / 60kg This range selects four points respectively for thrombin-like enzyme (batroxobin) and blood coagulation factor X activator as the blood coagulation in mice In the test, the dosage of the mice was adjusted accordingly according to the human dosage, and the dosage adjusted according to the relevant ratio was 8-0.04u / kg.

[0051] The specific method is as follows: get coagulation factor X activator and thrombin-like enzyme (batroxobin) respectively to configure solutions with appropriate concentrations as the test solution.

[0052] Take healthy mice, divide them into 7 groups at random, 5 in each group, inject 0.5ml into the ta...

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PUM

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Abstract

The compound hemostatic originated from venom features the main active components comprising batoxobin and blood coagulation factor X activator in the purity higher than 97 5 and weight ratio of 1-1000. The compound hemostatic has ensured curative effect, lowered proteinase consumption and thus reduced negative immune response probability.

Description

Technical field: [0001] The present invention relates to an enzyme preparation, specifically provides a compound hemostatic drug derived from snake venom, the contained active ingredients are snake venom-like thrombin (batroxobin) and blood coagulation factor X activator (FXA), especially for the The separation and purification process of FXA in the drug and the formulation of the compound preparation were optimized. Background technique: [0002] In 1934, Macfarlane et al. found that Viper venom had a very significant blood coagulation effect. When it was diluted 1000 times, it could also coagulate the blood of hemophiliacs in 17 seconds (see The Lancet, Drs. Macfarlane & Barnett: Haemostatic Possibilities of Snake- venom, Nov, 3, 1934, 985-987). It was used as a hemostatic agent for external use in some early foreign regions (see The Lancet, Clinical and Laboratory Notes, Feb. 22, 1936, 428). At that time, the whole poison without separation and purification was used, suc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/58A61K38/57A61P7/04A61K35/583
Inventor 薛百忠薛雁王宏英徐梅苏珊沈文彧
Owner PENGLAI NUOKANG PHARMA CO LTD
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