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Heparin Series
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Heparin Sodium
Date【2018-06-01 17:58】 All:【】次

 

Description

 

Name:Heparin Sodiun

Product Code:HS

Grade:Ch.P/EP/USP/BP/EP6/Crude

 

Intioduction

 

Heparin,a natural anticoagulant,is a kind of sulphated glycosaminoglycans.The moldcule is a chain structure consisting orepeated hexose or octose units,its main disaccharide units is trithionicacid disaccharide.Heparin persents in warious mammalian tissues including liver,lung,heart,spleen,kidney,thymus,intestinal mucosa,muscle and blood.Thus heparin can be extracted from healthy porcine intestinal mucosa and lung or healthy bovine lung,all stages of production and procurement must be conducted under the supervision of Quality Management System.The production technology is validated by the virus inactivated production process,so the harmful contaminants can be removed.

 

It is composed of polymers of altemating derivatives of α-D-glucosamine(N-sulfated,O-sulfated,orN-acetylated) and uronicacid(α-L-induronic acid or β-D-glucuronic acid) joined by glycosidic linkages.Some of these components have the property of prolonging the clotting time of blood.

 

Heparin in animal tissues bound with proteins resulted in glucoprotein complex which is a in vivo present form.So the peparation process inculding two steps:glucoprotein extracting and dissociation,heaprin isolation and purfifcation.There are sulfonic acid and carboxyl group in heparin and show highly acidic,chemical reaction between this polyanion with cation resulted in salt.The cation includs metallic cation such as Ca2+/Na+/K+,organic base pyridinium compound such as hexadecylpyridinium cholride (CPC),brucine/basicdye-azure A,cationic surface active agent (hexadecyl trimethylammonium bromide)such as catin exchanger and electropositive protein such as protamine ect.N-sulfonic acid in heparin structure is closely related with its anticoagulant activily,thus the activity will decreased after this chemical structuer was destroyed.The strucure is sensitive to acid hydrolysis and stable under basic condition.The dissociated hydroxyl of heparin is easy to be esterized,sulfonation will lead to activity decreasing while acetyization has no such effects.

 

Heparin sodium is a white or off-white color powder,odorless,hygroscopir,freely soluble in water and insoluble in orgenic solvent such as ethanol,acetone,dioxane and so on .Optical rodation and characteristic absorption peak at 185-220mm,infrared characteristic absorption peak ta 890cm-1,940cm-1,absorption value at 1210-1150cm-1 was used to determine rapidly.

 

Qualification

 

SFDA-GMP Certificate:ShanDong l0415

CEP certificate:R1-CEP 2003-197-Rev02

Germany Hamburg BSG

GMP certificate:WEL/020409/GMP-YAN

FDA DMF registration number:18355

Registration Certificate of India:(IP/BP/USP standard)BD-544

MF registration Certificate of Japan:(EP standard)222MF10193

Registration Certificate of Russia:016111/01

Registration Certificate of Korea:20100211-124-G-17-01

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