黄体酮注射液细菌内毒素检查的方法比较研究  

Comparative study on bacterial endotoxin test in progesterone injection

作　　者：刘骅[1] 许雷鸣[1] 

机构地区：[1]安徽省食品药品检验所,合肥230051

出　　处：《药物分析杂志》2014年第6期1113-1119,共7页Chinese Journal of Pharmaceutical Analysis

基　　金：安徽省食品药品监督管理系统科研项目(0004)

摘　　要：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 set up the bacterial endotoxin test for progesterone injection and study what should be done to confirm the method is suitable for the determination of bacterial endotoxins in oily solutions. Methods： Since the progesterone injection is an oily solution,the oily injection was shaken with water.The endotoxins were then extracted in the aqueous phase from the oil-based solutions without interference（inhibition/enhancement）of the product and the recovery of the endotoxins added into the oily-injection was determined. Results： The validation test demonstrated that the endotoxins in oily injection passed over into the aqueous phase was not influenced（inhibited/enhanced）by extraction with water.For oily injection with concentrations of 20,10,5 EU·mL^-1 of endotoxin,78.5%-117.4% of the endotoxin was recovered after extraction,which met the requirements of the Pharmacopoeia. Conclusion： The kinetic turbidimetric limulus test and the gel-clot test were suitable for detecting bacterial endotoxins in progesterone injection.

关 键 词：黄体酮 注射用油 细菌内毒素 动态浊度法 凝胶法 方法比较 

分 类 号：R917[医药卫生—药物分析学]