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目的建立注射用腺苷钴胺的细菌内毒素检查方法。方法根据《中国药典)2010年版二部收载的细菌内毒素检查法的要求,用两个不同厂家鲎试剂对3批注射用腺苷钴胺进行干扰试验和细菌内毒素检查。结果注射用腺苷钴胺浓度低于或等于0.125mg·m L-1时不干扰细菌内毒素检查。结论用细菌内毒素检查法来控制注射用腺苷钴胺的质量是可行的,此方法灵敏可靠,经济,方便。
Objective To establish a bacterial endotoxin test method for adenosine diphosphate injection. Methods According to the requirements of bacterial endotoxin test contained in the 2010 edition of “Chinese Pharmacopoeia” (2010 edition), interference test and bacterial endotoxin test were performed on three batches of adenosine cobalamin for injection using two different manufacturers. Results Concentrations less than or equal to 0.125 mg · m L-1 for adenosine diphosphate did not interfere with the bacterial endotoxin test. Conclusion Bacterial endotoxin test to control the quality of injection of adenosine cobalamin is feasible, this method is sensitive, economical, convenient.