Abstract：OBJECTIVE To investigate the quality status and problems of chondroitin sulfate injections and select the critical quality control items concerning the efficacy and safety to study in order to improve the quality standards. METHODS The statutory methods were adopted to test the samples. Many testing methods were established or improved on the basis of domestic and international standards and literature review and field research,including enzymatic HPLC,multiangle laser light scatter (MALLS),reverse phase chromatography,size exclusion chromatography, etc. RESULTS The national evaluation test in 2016 showed that all 41 batches of the samples met the requirements of current specifications. Exploratory studies showed that the assay results of the samples from some companies were obviously above the upper limit. The injection standard lacked control of molecular weight and molecular weight distribution. The disaccharide composition analysis suggested that in some bulk drug there was the risk of other origins of chondroitin sulfate sodium incorporation into the API. The study on the anticoagulatory effect of chondroitin sulfate sodium showed that chondroitin sulfate sodium from different origins had the action of anticoagulation. Chondroitin sulfate sodium from shark source had the most potensive anticoagulation effect. CONCLUSION Some items in the quality specification of chondroitin sulfate sodium injections are infeasible,including assay and molecular weight and molecular weight distribution need to be improved.
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