A kind of high-purity nadroparin calcium

A high-purity nadroparin calcium technology, applied in the field of heparin drugs, can solve the problems of less impurities, low quality standard of low-molecular-weight heparin calcium, high anti-Xa factor/anti-IIa factor titer ratio, and achieve the effect of reducing the burden
CN104804110BActive Publication Date: 2017-04-12SHENZHEN SCIPROGEN BIO PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
SHENZHEN SCIPROGEN BIO PHARMA
Publication Date
2017-04-12

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Abstract

The invention relates to the technical field of heparin medicines, in particular to high-purity nadroparin calcium. The high-purity nadroparin calcium is prepared by the steps of sodium removal, splitting, restoration-calcium-conversion, ultraviolet light irradiation, extraction-ultra-filtration, alcohol precipitation-pulping and centrifugation-drying; strong acid cation exchange resin is added into a heparin sodium solution to enable the heparin sodium solution to reach a certain pH range as well as to remove about 1 / 3 sodium ions from the heparin sodium solution through ion exchange and filtration so as to reduce the load of calcium-conversion in the late period; calcium oxide is used to replace the sodium hydroxide for neutralizing the reaction liquid to reduce the intake amount of the sodium ions in the reaction liquid; sodium borohydride and excessive calcium chloride are both added into the reaction liquid and are stirred for a proper duration for achieving a better calcium-conversion effect; the primary feed liquid is irradiated by the ultraviolet light, so that the vast majority of N-NO foreign matters are removed to enable the content of the N-NO to meet the most strict EP (European pharmacopoeia) demand.
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Description

technical field

[0001] The invention relates to the technical field of heparin drugs, in particular to nadroparin calcium with high purity and narrow molecular weight distribution range. Background technique

[0002] Heparin is a sulfated glycosaminoglycan compound extracted from mammalian tissues (such as small intestinal mucosa, lung, liver). It is extremely complex and cannot be synthesized artificially for a long time, and currently only heparin derived from pig small intestinal mucosa can be used for clinical treatment.

[0003] Heparin series drugs are mainly used for the prevention and treatment of deep vein thrombosis, hemodialysis anticoagulation, anticoagulation after surgery, etc., and are also used for the prevention and treatment of acute coronary syndrome and ischemic cerebral thrombosis. In addition, they are also widely used in obstetrics and gynecology. Department of Medicine, Pediatrics, Respiratory Medicine, Oncology and Burns, etc.

[0004] In the mid-1...

Claims

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