注射用三磷酸胞苷二钠细菌内毒素检查法的研究  

Study on Bacterial Endotoxin Test of Cytidine Disodium Triphosphate for Injection

作　　者：苑艳飞 刘广文 张德奎 王海燕 YUAN Yan-fei;LIU Guang-wen;ZHANG De-kui;WANG Hai-yan(Tai’an Institute of Food and Drug Inspection and Testing(Tai’an Fiber Inspection Institute),Tai’an 271000,China)

机构地区：[1]泰安市食品药品检验检测研究院(泰安市纤维检验所),山东泰安271000

出　　处：《食品与药品》2024年第2期162-165,共4页Food and Drug

基　　金：2022年山东省药品风险监测项目。

摘　　要：目的建立注射用三磷酸胞苷二钠细菌内毒素检查方法。方法按《中国药典》2020年版四部通则1143细菌内毒素检查法,从严确定注射用三磷酸胞苷二钠的限值,用凝胶法进行方法学验证和细菌内毒素检查。结果两个厂家的4批供试品在0.2 mg/ml浓度下对两个厂家的鲎试剂不存在干扰,细菌内毒素的限值设定为2.5 EU/mg,4批注射用三磷酸胞苷二钠细菌内毒素的检查结果均符合规定。结论本研究建立的细菌内毒素检查方法可用于替代家兔热原检查法,满足对注射用三磷酸胞苷二钠的质量控制要求。Objective To establish a method for bacterial endotoxin test of Cytidine Disodium Triphosphate for Injection.Methods The bacterial endotoxin limit of Cytidine Disodium Triphosphate for Injection was strictly determined according to General Rule 1143 Bacterial Endotoxin Test Method listed in the Fourth Part of Chinese Pharmacopoeia(2020 Edition),and the methodology validation and bacterial endotoxin test were performed by the gel method.Results Four batches of test articles from two manufacturers at the concentration of 0.2 mg/ml did not interfere with the limulus test reagents from two manufacturers.The limit value of bacterial endotoxin was set as 2.5 EU/mg.The results of bacterial endotoxin test for four batches of Cytidine Disodium Triphosphate for Injection met the requirements.Conclusion The bacterial endotoxin test method established in this study can be used to substitute the rabbit pyrogen test and meet the quality control requirements of Cytidine Disodium Triphosphate for Injection.

关 键 词：注射用三磷酸胞苷二钠 细菌内毒素 凝胶法 干扰试验 

分 类 号：R927.12[医药卫生—药学]