氟马西尼原料药中细菌内毒素检查

Method of Bacterial Endotoxins Test in Flumazenil Bulk Drug

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.