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目的:探讨采用鲎试剂法检测盐酸多沙普仑注射液中细菌内毒素的可行性。方法:依照《中国药典》2010年版二部中细菌内毒素检查法,用两个厂家的鲎试剂对3批盐酸多沙普仑注射液进行干扰试验和细菌内毒素检查。结果:浓度为5.0mg·ml~(-1)的供试品溶液对鲎试剂与细菌内毒素之间的凝集反应有抑制,而稀释2.5 mg·ml~(-1)时干扰作用消失。结论:鲎试剂法可用于盐酸多沙普仑注射液中细菌内毒素的检测。
Objective: To investigate the feasibility of detecting the bacterial endotoxin in Doxorubicin Hydrochloride Injection by using 鲎 reagent method. Methods: According to the bacterial endotoxin test in the second edition of Chinese Pharmacopoeia (2010 edition), three batches of Doxyprogesterone Hydrochloride Injection were used for interference test and bacterial endotoxin test by using the two manufacturers’ reagent. Results: The test solution with the concentration of 5.0 mg · ml -1 inhibited the agglutination reaction between the limulus reagent and the bacterial endotoxin, and the interference disappeared when diluted with 2.5 mg · ml -1. Conclusion: 鲎 reagent method can be used for the detection of bacterial endotoxin in doxapram hydrochloride hydrochloride injection.