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Preparation method of heparin sodium injection

A technology of heparin sodium and injection, applied in blood diseases, pharmaceutical formulations, extracellular fluid diseases, etc., can solve problems such as spontaneous bleeding, local irritation and bleeding

Inactive Publication Date: 2017-05-10
青岛冠龙生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The heparin sodium injection of routine production has the following defects: 1. The high concentration of heparin sodium injection can easily cause spontaneous bleeding
2. The pH value of the injection is quite different from the pH value in the blood, and it is not an isotonic solution that may cause local irritation and bleeding, etc.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] (1) Take each component according to the stated dosage: every 2000 ml of the injection contains: 0.11 million units of heparin sodium, 18.4 g of sodium chloride, 2.6 ml of phenol and 2150 ml of water for injection;

[0016] (2) The above-mentioned components are dissolved until uniform, and the pH value is adjusted to 6.9 with 1mol / L hydrochloric acid solution and 1mol / L sodium hydroxide solution;

[0017] (3) The prepared solution is filtered, potted, subpackaged and sterilized to obtain the product.

[0018] The pH value of the obtained heparin sodium injection was 7.1; the osmotic pressure was 301 mosmol / kg.

Embodiment 2

[0020] (1) Take each component according to the stated dosage: every 2000 ml of the injection contains: 0.11 million units of heparin sodium, 18.5 g of sodium chloride, 2.8 ml of phenol and 2150 ml of water for injection;

[0021] (2) Dissolve the above-mentioned components until uniform, and adjust the pH value to 7.0 with 1mol / L hydrochloric acid solution and 1mol / L sodium hydroxide solution;

[0022] (3) The prepared solution is filtered, potted, subpackaged and sterilized to obtain the product.

[0023] The pH value of the obtained heparin sodium injection was 7.2; the osmotic pressure was 304 mosmol / kg.

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PUM

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Abstract

The invention discloses a preparation method of a heparin sodium injection with the specification of 2ml:1000U. Each 2000ml of the heparin sodium injection contains 0.0011 billion of heparin sodium, 18g-19g of sodium chloride, 2ml-3ml of phenol and 2150ml of injection water. The pH value and osmotic pressure of the heparin sodium injection are similar to human blood, so that the phenomenon that a blood vessel is locally blocked due to blood coagulation is avoided, the adverse reactions of bleeding and the like of tube sealing injections are reduced, and the stability and the safety are remarkably improved.

Description

technical field [0001] The invention relates to the field of chemical pharmaceutical technology, in particular to a method for preparing an injection, in particular to a method for preparing a heparin sodium injection. Background technique [0002] Heparin sodium is mainly found in mammalian tissues. Heparin sodium for commercial use is mainly sodium salt extracted from the intestinal mucosa of pigs. Heparin sodium is an acidic mucopolysaccharide, and it is the drug of choice for rapid anticoagulation. Heparin sodium can combine with some lysine residues of antithrombin, so that antithrombin cannot play its role and achieve anticoagulant effect. It is widely used clinically in the treatment of deep proximal venous thrombosis, pulmonary embolism, acute arterial occlusion or myocardial infarction: it can also be used in surgical prevention of thrombosis. Another important clinical application of heparin sodium is to maintain smooth extracorporeal circulation of blood during...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/727A61K47/10A61K47/02A61P7/02
CPCA61K31/727A61K9/0019A61K9/08A61K47/02A61K47/10
Inventor 刘乃山张明芳陈娥功
Owner 青岛冠龙生物制药有限公司