注射用赖氨匹林细菌内毒素检查法的研究  

Validation of bacterial endotoxin test in lysine acetylsalicylate for injection

作　　者：凌真 

机构地区：[1]扬州市药品检验所,扬州225009

出　　处：《天津药学》2013年第3期1-3,共3页Tianjin Pharmacy

摘　　要：目的:研究注射用赖氨匹林的细菌内毒素检查方法。方法:用不同厂家生产的鲎试剂对注射用赖氨匹林进行细菌内毒素检查法干扰试验。结果:注射用赖氨匹林在稀释至3.12 mg/ml时,对灵敏度为0.25 Eu/ml的鲎试剂无干扰作用。结论:注射用赖氨匹林可以用细菌内毒素检查法取代热原检查法。Objective：To study the bacterial endotoxin test in lysine acetylsalicylate for Injection. Method：The interferences of lysine acetylsalicylate for injection were investigated with TAL from various manufactures. Results ： When diluted to 3.12 mg/ml, lysine acetylsalicylate for injection did not interfere with the endotoxin test with TAL （0.25 Eu/ml）. Conclusion：It is feasible for lysine acetylsalicylate for injection that bacterial endotoxin test can take the place of pyrogen test.

关 键 词：注射用赖氨匹林 细菌内毒素检查 鲎试剂 

分 类 号：R284[医药卫生—中药学]