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目的考察维生素B6注射液细菌内毒素检查方法。方法用不同厂家的鲎试剂对不同批号的维生素B6注射液分别进行干扰试验,确定维生素B6注射液细菌内毒素检查方法。结果维生素B6注射液的最大不干扰浓度为0.2mg·mL-1。结论维生素B6注射液采用凝胶法进行细菌内毒素检查满足中国药典2010年版要求。
Objective To investigate the bacterial endotoxin test of vitamin B6 injection. Methods Different manufacturers of 鲎 reagent for different batches of vitamin B6 injection were interference test to determine the vitamin B6 injection bacterial endotoxin test method. Results The maximum non-interfering concentration of vitamin B6 injection was 0.2 mg · mL-1. Conclusion Vitamin B6 gel method for bacterial endotoxin test to meet the requirements of the Chinese Pharmacopoeia 2010 edition.