氟马西尼原料药中细菌内毒素检查  

Method of Bacterial Endotoxins Test in Flumazenil Bulk Drug

作　　者：杨雅婷 吕晓君 张菊 徐小玲 何开勇 沈佳特 YANG Yating;LYU Xiaojun;ZHANG Ju;XU Xiaoling;HE Kaiyong;SHEN Jiate(Hubei Institute for Drug Control,Wuhan 430075,China;Hubei Engineering Research Center for Drug Quality Control,Wuhan 430075,China)

机构地区：[1]湖北省药品监督检验研究院,武汉430075 [2]湖北省药品质量检测与控制工程技术研究中心,武汉430075

出　　处：《医药导报》2024年第9期1470-1476,共7页Herald of Medicine

摘　　要：目的 建立氟马西尼原料药中细菌内毒素的检查方法。方法 依照2020年版《中华人民共和国药典(四部)》通则1143细菌内毒素检查法,用二甲亚砜(DMSO)溶解氟马西尼,再用细菌内毒素检查用水(BET水)稀释,用凝胶法和动态浊度法进行干扰实验和内毒素回收实验。结果 氟马西尼原料药加入DMSO溶解,制成浓度为10 mg·mL^(-1)的溶液,再用BET水稀释100倍及以上时对细菌内毒素检查法无干扰作用。结论 所建立的细菌内毒素检查方法可用于氟马西尼原料药的细菌内毒素检查,控制其产品质量。Objective To establish a method for bacterial endotoxin test of flumazenil bulk drug.Methods According to the bacterial endotoxin test(BET)method in general rule 1143 in the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ),flumazenil was dissolved with dimethyl sulfoxide(DMSO)and diluted with BET water.The gel-clot method and kinetic turbidimetric assay were used to carry out the interference test and endotoxin recovery test.Results Flumazenil was dissolved with DMSO to 10 mg·mL^(-1),and then diluted 100 times or more by BET water,which has no interference effects on the bacterial endotoxin test.Conclusion The BET method established in this study can be used to control the quality of flumazenil by performing bacterial endotoxin tests.

关 键 词：氟马西尼 细菌内毒素 干扰实验 

分 类 号：R971[医药卫生—药品] R927.1[医药卫生—药学]