抗增液复溶鲎试剂检查参麦注射液的细菌内毒素  

The Bacterial Endotoxins Test for Shenmai Injection by TAL Reconstituted with Antienhancement Solution

作　　者：李庆德[1] 陈晓锋[1] 李文玮[2] 

机构地区：[1]广东省韶关市粤北人民医院药剂科,广东韶关512026 [2]广东省佛山市中医院药剂科,广东佛山528000

出　　处：《中国药业》2005年第7期36-37,共2页China Pharmaceuticals

摘　　要：目的:建立抗增液复溶鲎试剂检测参麦注射液中细菌内毒素的方法。方法:对不同批号的参麦注射液分别进行抑制或增强试验,考察确立其内毒素检查法。结果:用抗增液复溶鲎试剂可以消除参麦注射液(40倍稀释)对细菌内毒素检查的干扰。结论:用抗增液复溶灵敏度0.25EU/mL的鲎试剂对参麦注射液进行细菌内毒素检查是可行的。Objective:To study the bacterial endotoxins test for Shenmai injection by TAL reconstituted with antienhancement solution. Methods:TAL was reconstitute d with antienhancement solution.Inhibition or enhancement test was conducted for Shenmai injection with different batch number by TAL to establish the endotoxin s examination.Results:When the limulus lysate's sensitivity(λ) is 0.25 EU/mL,th e maximum valid dilution is 1 ∶40,the interference between the sample and the r elative TAL is eliminable.And the result of bacteria lendotoxins test is the sam e as that of pyrogen test with healthy mature rabbits.Conclusion:The result is r eliable,the bacterial endotoxins test for Shenmai injection by TAL reconstituted with antienhancement solution is feasible.

关 键 词：参麦注射液 抑制或增强试验 鲎试剂 抗增液 

分 类 号：R927.12[医药卫生—药学]