添加表面活性剂检测西罗莫司原料药细菌内毒素的含量  

Determination of Bacterial Endotoxin Content in Sirolimus API by Adding Surfactant

作　　者：温耀明[1] 范建辉[1] 吴文清 邹昕[1] 邱观荣[1] 李平[1] 肖丽华[1] Wen Yaoming;Fan Jianhui;Wu Wenqing;Zou Xin;Qiu Guanrong;Li Ping;Xiao Lihua(Fujian Institute of Microbiology,Fuzhou 350007,China;Fujian Kerui Pharmaceutical Co.,Ltd.,Fuzhou 350313,China)

机构地区：[1]福建省微生物研究所,福州350007 [2]福建科瑞药业有限公司,福州350313

出　　处：《中国药事》2022年第3期301-305,共5页Chinese Pharmaceutical Affairs

基　　金：福州市科技计划项目(编号2020-GX-21)。

摘　　要：目的:采用添加表面活性剂建立难溶性西罗莫司原料药细菌内毒素的检测方法。方法:以0.1%(W/V)聚山梨酯-80溶解西罗莫司原料药,用细菌内毒素检查用水(BET水)稀释后进行凝胶法细菌内毒素检查的方法学研究。结果:西罗莫司原料药用0.1%(W/V)聚山梨酯-80溶解并用BET水稀释至0.4 mg·mL^(-1)浓度及以下时对鲎试剂凝集反应无干扰作用。结论:通过添加聚山梨酯-80的凝胶法可检测西罗莫司原料药细菌内毒素的含量,操作简便。Objective:To establish a method for the test of bacterial endotoxin in insoluble sirolimus API by adding surfactant.Methods:The methodological study on bacterial endotoxin test by gel-clot method was carried out with 0.1%(W/V)polysorbate-80 dissolving sirolimus API and bacterial endotoxin test water(BET water)diluting sirolimus API.Results:When sirolimus API was dissolved with 0.1%(W/V)polysorbate-80 and diluted with BET water to the concentration of 0.4 mg·mL^(-1)or less,it had no interference effect on the agglutination reaction of tachypleus amebocyte lysate.Conclusion:By adding polysorbate-80,the content of bacterial endotoxin in sirolimus API can be detected by gel-clot method,and it is easy to operate.

关 键 词：西罗莫司原料药 细菌内毒素 聚山梨酯-80 表面活性剂 凝胶法 

分 类 号：R917[医药卫生—药物分析学]