甘精胰岛素原料药细菌内毒素检查方法学研究  

Bacterial Endotoxin Test Methodology of Insulin Glargine Active Pharmaceutical Ingredients

作　　者：张红梅[1,2] 方芳 李祥胜 许雷鸣 ZHANG Hongmei;FANG Fang;LI Xiangsheng;XU Leiming(Anhui University of Chinese Medicine,Hefei,Anhui,China 230012;Anhui Institute for Food and Drug Control,Hefei,Anhui,China 230051)

机构地区：[1]安徽中医药大学,安徽合肥230012 [2]安徽省食品药品检验研究院,安徽合肥230051

出　　处：《中国药业》2022年第20期72-74,共3页China Pharmaceuticals

基　　金：安徽省药品监督管理局科技创新项目[AHYJ-KJ-202004]。

摘　　要：目的建立甘精胰岛素原料药的细菌内毒素检查方法。方法以0.01 mol/L盐酸溶液溶解样品,细菌内毒素检查用水稀释,用2个不同厂家的鲎试剂,按2020年版《中国药典(四部)》通则1143项下凝胶法进行细菌内毒素干扰试验。结果样品的细菌内毒素检查限值为10 EU/mg,在此条件下,样品细菌内毒素检查的最大不干扰质量浓度为0.4 mg/mL,2个不同厂家的鲎试剂均可对样品进行细菌内毒素检查。结论所建立的方法可用于甘精胰岛素原料药的细菌内毒素检查。Objective To establish a bacterial endotoxin test(BET)method for insulin glargine active pharmaceutical ingredients(API).Methods The samples were dissolved with 0.01 mol/L hydrochloric acid solution,and were diluted with water for BET.According to the gel method in general rule 1143 of the Chinese Pharmacopoeia(2020 Edition,VolumeⅣ),the bacterial endotoxin interference test was carried out with tachypleus amebocyte lysate(TAL)from two different manufacturers.Results The BET limit of the sample was 10 EU/mg.Under this condition,the maximum noninterference mass concentration of the sample for the BET was 0.4 mg/mL.TAL from two different manufacturers could be used for the BET of samples.Conclusion The established method can be used for the BET of insulin glargine.

关 键 词：甘精胰岛素 原料药 细菌内毒素检查 干扰试验 盐酸溶液 

分 类 号：R927.1[医药卫生—药学]