SAR107375E注射液细菌内毒素检查方法学验证及热原检查研究  

Verification of the method for bacterial endotoxin test of SAR107375E injection and its pyrogen test research

作　　者：栗景蕊[1] 曹春然[1] 孙圆媛[1] 胡宇驰[1] 

机构地区：[1]北京市药品检验所中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《中国新药杂志》2017年第24期2989-2994,共6页Chinese Journal of New Drugs

摘　　要：目的:对SAR107375E注射液细菌内毒素检查的可行性进行验证,建立合理的安全性检查方法。方法:将SAR107375E注射液进行细菌内毒素凝胶法检查,并通过干扰实验考察细菌内毒素凝胶法检查的适用性。在不适宜采用凝胶检查法的情况下,考虑建立家兔法进行热原检查。结果:SAR107375E注射液不适宜用细菌内毒素检查法进行质量控制,建立家兔热原检查法。结论:拟采用热原检查法对SAR107375E注射液进行质量控制。Objective：To verify the feasibility of bacterial endotoxin test for SAR107375E injection, and to establish a reasonable safety test method for the drug. Methods： SAR107375E injection were tested by bacterial endotoxin method（gel method）, and the rationality was investigated by interference test. If it is not suitable for tested by bacterial endotoxin method（gel method） , then establish the rabbit method for pyrogen test. Results：As SAR107375E injection＇s quality, it is not suitable for controlled by bacterial endotoxin method（ gel method） , it is necessary to establish a rabbit method for the pyrogen test. Conclusion： The quality of SAR107375E injection should be controlled by pyrogen test.

关 键 词：SAR107375E注射液 细菌内毒素检查 热原检查 

分 类 号：R973.2[医药卫生—药品]