Quality evaluation and specification research of heparin / 中国药学杂志

ABSTRACT

OBJECTIVE: To understand the quality status and problems of domestic heparin products and evaluate the suitability of statutory standard and test methods. 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 ion chromatography, capillary electrophoresis, mutiangle laser light scatter (MALLS), reverse phase chromatography, size exclusion chromatography, micro-chromogenic substrate methods, etc. RESULTS: The national evaluation test in two consecutive years of 2009 and 2010 showed that the majority of the samples complied with the 2005 edition of Chinese Pharmacopoeia. But this standard lacked control of impurities, and the limits of some items were not suitable. A few samples contained heparin-like impurities; phenol was added as preservatives arbitrarily. The assay method of anti-factor X a and anti-factor II a activity had high specificity, which was better to control the potency of heparin. Ethanol residues in the raw material of some samples exceeded the standard limit. The control of nucleic acid and protein was good. The determination of polarimetry and osmolality reflected some problems. Through this study, the quality specification of heparin in the 2010 edition of Ch. P had been improved a lot. CONCLUSION: Domestic heparin products have better quality at present. The quality specification of the raw material and injection of heparin in the 2010 edition of Chinese Pharmacopoeia is relatively perfect and close to European Pharmacopoeia and the United States Pharmacopoeia. Our capability of quality test of heparin has been substantially improved. Consequently, we have taken part in several international collaborative studies and won international voice in the quality control of heparin products.