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目的:建立黄体酮注射液细菌内毒素检查的方法,探讨油剂的细菌内毒素检查方法。方法:将黄体酮注射液与水混合振荡,将内毒素从注射用油萃取到水中进行测定。考察水萃取液的干扰及水油振荡萃取步骤中内毒素的绝对回收率。结果:黄体酮注射液与水振荡后,水萃取液对内毒素检查无干扰。振荡萃取步骤中外加20、10、5 EU·mL-1浓度的内毒素回收率在78.5%~117.4%之间,符合药典要求。结论:黄体酮注射液作为油剂,经水萃取后采用动态浊度法和凝胶法进行细菌内毒素检查均可行。
Objective: To establish a method for the bacterial endotoxin test of progesterone injection and to explore the bacterial endotoxin test method. Methods: Progesterone injection was mixed with water and the endotoxin was extracted from water for injection. The interference of aqueous extracts and the absolute recovery of endotoxin in the water-oil oscillation extraction step were investigated. RESULTS: After the progesterone injection and water were shaken, the aqueous extract had no interference with the endotoxin test. The recoveries of endotoxin in the extraction step of 20,10,5 EU · mL-1 in the extraction step ranged from 78.5% to 117.4%, which met the pharmacopoeial requirements. Conclusion: Progesterone injection can be used as the oil agent, and the dynamic turbidity and gel method for bacterial endotoxin test are feasible after water extraction.