摘要
目的:确立用鲎试剂(TAL)法检测泛影葡胺注射液中的内毒素。方法:参照《美国药典》23版及《中国药典》1995年版二部收载的细菌内毒素检查方法的要求进行试验。结果:用标示值灵敏度为0.5EU·ml^(-1)的鲎试剂检查泛影葡胺注射中的细菌内毒素是有效的。结论:0.5EU·ml^(-1)鲎试剂可以用于泛影葡胺注射液中的内毒素检测。鲎试剂(TAL)法可替代泛影葡胺注射液热原检查项目中的家兔(RT)法。
Objective: To establish tachypleus amebocyte lysate(TAL) to determine the bacterial endotoxin in meglumine diatrizoate injection. Methods: The test was conducted according to the request of bacterial endotoxin inspecting method included in 'American Pharmacopeia' ed 23 and part II in China pharmacopeia, 1995. Results: It was effective that bacterial endotoxin in meglumine diatrizoate injection can be tested by TAL with accuracy of 0.5 EU·ml-1. Conclusions: 0.5 EU·ml-1 of TAL can not only be used to test bacterial endotoxin in meglumine diatrizoate injection, and it may also replaces rabit test.
出处
《中国药师》
CAS
2000年第1期40-40,共1页
China Pharmacist
关键词
泛影葡胺
注射液
细菌内毒素
鲎试剂
Meglumine diatrizoate injection
Tachypleus amebocyte lysate
Bacterial endotoxin
