Hemocoagulase freeze-dried powder injection and preparation method thereof

A technology of freeze-dried powder injection and thrombin, which is applied in the field of biological product preparations, can solve the problems of high price of high-purity snake venom, difficult to determine the actual potency, affecting the qualified rate of products, etc., so as to reduce the dosage of snake venom, reduce allergic reactions or other Toxic and side effects, stable potency

Inactive Publication Date: 2010-06-30
PEKING UNIV FOUNDER GRP CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The freeze-dried powder injection of the present invention solves the following problems in the prior art: 1. Solve the problem that the potency of the current snake venom thrombin preparation and storage process obviously drops, so that when the preparation is fed, it can be fed normally or slightly higher than Normal feeding (110-130%) does not need to be fed by 150-200% like the existing technology; 2, because the price of high-purity snake venom is very expensive, the freeze-dried powder injection of the present invention solves the problem of existing preparations because the initial feeding is too high The problem of high cost; 3. It solves the problem that the actual potency of the existing preparations is difficult to determine due to the uncertain range of potency loss, which affects the qualified rate of the product and brings great trouble to production; 4. Solve the problem that The cost of albumin contained in the lyoprotectant formula in the existing preparations is high, and there is the possibility of being infected by pathogens, such as human immunodeficiency virus (HIV) and hepatitis B virus (HBV), which can induce immunity in some people possible response

Method used

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  • Hemocoagulase freeze-dried powder injection and preparation method thereof
  • Hemocoagulase freeze-dried powder injection and preparation method thereof
  • Hemocoagulase freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0118] formula:

[0119] Bothrops atrox snake venom thrombin 1000KU

[0120] Gelatin 6g

[0121] Dextran-20 24g

[0122] Sorbitol 36g

[0123] Preparation method:

[0124] 1. Weigh the prescribed amount of gelatin and add 400ml of water, heat and stir to dissolve completely;

[0125] 2. Weigh the prescribed amount of dextran and sorbitol, add to the above solution, stir to dissolve completely, and adjust the pH value to 6.8 with sodium hydroxide solution or hydrochloric acid solution;

[0126] 3. After heating and boiling, add an appropriate amount of activated carbon and keep it for adsorption for 30 minutes. After decarburization, filter it with a 0.22μM filter membrane, let it cool to room temperature, and add water for injection to make up to 600ml;

[0127] 4. Add prescribed amount of snake venom thrombin by sterile filtration, mix evenly, quantitatively fill 0.6ml / cartridge solution, a total of 1000 bottles, put the half-pressed rubber stopper into a freeze drying m...

Embodiment 2

[0131] formula:

[0132] Agkistrodon halys snake venom thrombin 1000KU

[0133] Gelatin 6g

[0134] Dextran-20 24g

[0135] Sorbitol 36g

[0136] Preparation method:

[0137] 1. Weigh the prescribed amount of gelatin and add 400ml of water, heat and stir to dissolve completely;

[0138] 2. Weigh the prescribed amount of dextran and sorbitol, add to the above solution, stir to dissolve completely, and adjust the pH value to 6.8 with sodium hydroxide solution or hydrochloric acid solution;

[0139] 3. After heating and boiling, add an appropriate amount of activated carbon and keep it for adsorption for 30 minutes. After decarburization, filter it with a 0.22μM filter membrane, let it cool to room temperature, and add water for injection to make up to 600ml;

[0140] 4. Add prescribed amount of snake venom thrombin by sterile filtration, mix evenly, quantitatively fill 0.6ml / cartridge solution, a total of 1000 bottles, put the half-pressed rubber stopper into a freeze dryin...

Embodiment 3

[0144] formula:

[0145] Bothrops atrox snake venom thrombin 10000KU

[0146] Gelatin 6g

[0147] Dextran-20 24g

[0148] Sorbitol 36g

[0149] Preparation method:

[0150] 1. Weigh the prescribed amount of gelatin and add 400ml of water, heat and stir to dissolve completely;

[0151] 2. Weigh the prescribed amount of dextran and sorbitol, add to the above solution, stir to dissolve completely, and adjust the pH value to 6.8 with sodium hydroxide solution or hydrochloric acid solution;

[0152] 3. After heating and boiling, add an appropriate amount of activated carbon and keep it for adsorption for 30 minutes. After decarburization, filter it with a 0.22μM filter membrane, let it cool to room temperature, and add water for injection to make up to 600ml;

[0153] 4. Add prescribed amount of snake venom thrombin by sterile filtration, mix evenly, quantitatively fill 0.6ml / cartridge solution, a total of 1000 bottles, put the half-pressed rubber stopper into a freeze drying ...

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Abstract

The invention provides a hemocoagulase freeze-dried powder injection and a preparation method thereof, and belongs to the field of biological products and preparations. The hemocoagulase freeze-dried powder injection takes hemocoagulase as an active ingredient, and a freeze-dried protective agent consists of gelatin, dextran-20, and sorbierite. The hemocoagulase freeze-dried powder injection can be used as a haemostatic and the like.

Description

technical field [0001] The invention relates to a snake venom thrombin freeze-dried powder injection and a preparation method thereof, belonging to the field of biological product preparations. Background technique [0002] Thrombin uses fibrin I as a substrate, and quickly transfers to the injured part of the blood vessel to form a fibrin clot, preventing blood from flowing out from the injured part. The blood coagulation process is roughly divided into three stages, namely the activation of coagulation factor X; the activation of prothrombin; and the transformation of fibrinogen into fibrin. The effect that can make fibrinogen into fibrin is called thrombin-like effect; the effect that can be exerted by activating coagulation factor X and prothrombin is called thrombin-like effect. Snake venom is rich in proteases, among which a class of serine proteases is closely related to toxicological effects such as blood coagulation disorders caused by snake bites, and belongs to t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/48A61K47/42A61P7/04
Inventor 郭欲晓张立红易崇勤李洋
Owner PEKING UNIV FOUNDER GRP CO LTD
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