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目的建立注射用维生素B6的细菌内毒素检查方法。方法根据中国药典2010年版二部附录细菌内毒素检查法,采用2个不同厂家的鲎试剂对注射用维生素B6进行研究。结果注射用维生素B6细菌内毒素检查限值为0.30 EU.mg 1,其最大不干扰浓度为0.208 mg.mL 1,用灵敏度为0.06 EU.mL 1或更高灵敏度的鲎试剂可进行检验。结论细菌内毒素检查法可用于注射用维生素B6中内毒素的检查。
Objective To establish a bacterial endotoxin test for vitamin B6 for injection. Methods According to the Chinese Pharmacopoeia 2010 edition two appendix bacterial endotoxin test method, using two different manufacturers of 鲎 reagent injection of vitamin B6 research. Results The limit of detection of vitamin B6 bacterial endotoxin for injection was 0.30 EU.mg 1, the maximum non-interfering concentration was 0.208 mg.mL 1 and the test was carried out with a reagent with a sensitivity of 0.06 EU.mL 1 or higher sensitivity. Conclusion Bacterial endotoxin test can be used for the detection of endotoxin in vitamin B6 for injection.