摘要
目的:建立抗增液复溶鲎试剂检测参芪扶正注射液中细菌内毒素的检查法。方法:通过抗增液复溶鲎试剂对不同批号的参芪扶正注射液分别进行抑制或增强试验,考察确立参芪扶正注射液内毒素检查法。结果:用抗增液复溶鲎试剂可以消除参芪扶正注射液(2倍稀释)对细菌内毒素检查干扰。结论:用抗增液复溶灵敏度0.25EU·ml-1的鲎试剂对参芪扶正注射液进行细菌内毒素检查是可行的。
Objective: To establish a bacterial endotoxins test for Shengqifuzheng injection by TAL. Method: TAL was reconstituted with Antienhancement liquid. Inhibition or enhancement test was conducted for Shengqi Fuzheng injection of different group sign by TAL to establish the endotoxins examination. Result: When the limulus lysate' s sensitivity(λ)was 0. 25 EU·ml-1, the maximum valid dilution was 1: 2, the interference between the sample and the relative TAL could be eliminated. And the result of bacterial endotoxins test is the same as that of pyrogen test in healthy mature rabbits. Conclusion: The result was reliable,the bacterial endotoxins test for Shengqifuzheng injection by TAL reconstituted with antienhancement liquid was feasible.
出处
《中国药师》
CAS
2005年第1期73-74,共2页
China Pharmacist
