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目的:建立注射用盐酸头孢替安的细菌内毒素检查方法。方法:采用《中国药典》2010年版二部附录收载的细菌内毒素检查法。对注射用盐酸头孢替安进行凝胶法干扰试验。结果:注射用盐酸头孢替安稀释至浓度5.0 mg·ml~(-1),并调节pH为7.2时对细菌内毒素检查法无干扰作用。结论:使用细菌内毒素检查法检查注射用盐酸头孢替安中的细菌内毒素是可行的,可用细菌内毒素检查法代替家兔热原检查法。
Objective: To establish a bacterial endotoxin test for cefotiam hydrochloride for injection. Methods: Bacterial endotoxin test was carried in the appendix of “2010 edition of Chinese Pharmacopoeia”. Cefotiam Hydrochloride injection for gel interference test. Results: Cefotiam hydrochloride was diluted to a concentration of 5.0 mg · ml -1 and adjusted to pH 7.2 without interfering with bacterial endotoxin test. CONCLUSIONS: It is feasible to use bacterial endotoxin test to examine bacterial endotoxin in cefotiam hydrochloride for injection. Bacterial endotoxin test can replace bacterial pyrogen test in rabbits.