注射用奥扎格雷钠细菌内毒素检查方法研究  

On Bacterial Endotoxin Test for Ozagrel Sodium for Injection

作　　者：王晓雯 于德志 方选 扆雪涛 朱爱民 

机构地区：[1]山东省青岛市食品药品检验研究院,青岛266071

出　　处：《中国药事》2017年第4期403-406,共4页Chinese Pharmaceutical Affairs

摘　　要：目的:探讨注射用奥扎格雷钠细菌内毒素检查方法替代家兔热原检查法的可行性。方法:采用2个不同厂家的鲎试剂,用凝胶法进行干扰预试验及干扰试验;用灵敏度为0.5EU·mL^(-1)鲎试剂和0.8mg·mL^(-1)的奥扎格雷钠溶液进行细菌内毒素检查。结果:注射用奥扎格雷钠稀释到0.8mg·mL^(-1)时,对鲎试剂与内毒素的凝集反应无干扰作用;样品的细菌内毒素限值确定为0.625EU·mL^(-1)。结论:注射用奥扎格雷钠可用细菌内毒素检查法替代原有的家兔热原检查法。Objective： To investigate the feasibility of replacing pyrogen test with bacterial endotoxin test for ozagrel sodium for injection. Methods： Gelation method was adopted for pre-trial interference experiment and interference experiment with tachypleus amebocyte lysatein from two different manufacturers. Tachypleus amebocyte lysatein with a 0.5EU·mL^-1 sensitivity and 0.8mg·mL^-1 solution of ozagre sodium were used in the bacterial endotoxin test. Results： There was no interference in the agglutination reaction between tachypleus amebocyte lysatein and endotoxin when 0.8mg·mL^-1 solution of ozagre sodium was utilized. The most suitable limit for bacterial endotoxin in preparation for ozagrel sodium for injection was 0.625EU·mL^-1. Conclusion： Bacterial endotoxin test can be used for ozagrel sodium for injection to replace pyrogen test.

关 键 词：注射用奥扎格雷钠 细菌内毒素检查法 凝胶法 

分 类 号：R92[医药卫生—药学]