Heparin sodium injection and preparation method thereof

Abstract

The invention discloses a heparin sodium injection. The injection is prepared from the following components in parts by weight: 25-300 parts of heparin sodium, 80-100 parts of sodium chloride and the balance of injection water, wherein the pH of the injection is regulated to 5.8-6.8 with sodium hydroxide or hydrochloric acid. The invention further discloses a preparation method of the injection. The injection is formed by combining heparin sodium, sodium chloride, injection water, nitrogen and a packaging bottle, wherein the nitrogen is saturated, and the injection is packaged by an ampoule bottle or a tube-type bottle. The heparin sodium injection is simple in formula; compared with the prior art, the heparin sodium injection, in the range of dosage portion and pH value, has the advantages of impurity amount reduction and high product quality, is simple in preparation process and stable in quality, and is suitable for industrial large-scale production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations and relates to an injection, in particular to a preparation method capable of increasing the stability of heparin sodium injection. Background technique [0002] Heparin sodium is the sodium salt of aminodextran sulfate extracted from the intestinal mucosa of pigs or cattle. It is a mucopolysaccharide substance and belongs to an anticoagulant drug. It can be taken up by vascular endothelial cells after entering the human body. It is commonly used clinically Prevention and treatment of thrombosis or embolism diseases (such as myocardial infarction, thrombophlebitis, pulmonary embolism, etc.); disseminated intravascular coagulation (DIC) caused by various reasons; also used in hemodialysis, extracorporeal circulation, catheterization, microvascular surgery Anticoagulant treatment of certain blood specimens or instruments during operations such as Heparin sodium is easily hydroly...

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Problems solved by technology

Heparin sodium is easily hydrolyzed under acidic conditions, and it is easy to oxidize with oxidants in the production process to inactivate and affect stability (see: Zuo Yong, Pan Xunhai. Research on factors affecting the stability of heparin sodium[J]. Journal of Sichuan Institute of Technology , 2009, 22 (6): 67-69), and then in the preparation process of heparin sodium injection, the requirements for environmental conditions and process parameters are very strict. Adverse effects, such as the degradation of heparin sodium, the reduction of drug efficacy, and the enhancement of toxic and side effects often occur

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