Heparin is a natural anticoagulant and antithrombotic glycosaminoglycan drug,which has been widely used in clinical practice as an anticoagulant to prevent and treat arterial and venous thrombosis due to its relative ease of use,safety,and low cost.The anticoagulant properties result from the ability of the polysaccharide to enhance the rate of inactivation of blood coagulation pro-teinases by their natural protein inhibitors,the most important of which is antithrombin.It is a heterogeneous,linear,highly sulfated,anionic glycosaminoglycan with a broad distribution in relative molecular weight and charge density.Heparin can be divided into unfractionated heparin(UFH),low-molecular-weight heparin(LMWH),and ultralow-molecular-weight heparin(ULMWH)by molecular weight,which is administered systematically,and all of them have been developed by several manufacturers and have advantages in terms of pharmacokinetics and convenience of administration.The biological characteristics and biological activities of heparin with different molecular weights vary.The control of heparin potency is an important part of quality control.Biological assay is capable of comprehensively reflecting all variable effects and monitor conformational changes that are difficult to anticipate and detect during production,which cannot be achieved by chemical assay.At present,there are five main methods for estimating the potency of heparin in pharmacopoeias of various countries:1.the blood method(rabbit,pig,or sheep);2.the moving average method;3.the plasma recalcification method;4.the activated partial thromboplastin time(APTT)method;5.the chromogenic substrate method.The application of these methods in the biological potency estimation of heparin has developed well and widely used.This article reviewed and summarized the study and research progress of biological assay of heparin,discussed the advantages and disadvantages of these methods,and proposed prospects for the future development of heparin biological assay.
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