应用细菌内毒素检查法对注射用穿琥宁进行热源质检测

The application bacterium endotoxin is examined the law to Potassium Dehydroandrographolide Succinate For Injection Carry on warmhearted testings survey feasible quality research

通过对临床常用的注射用穿琥宁进行细菌内毒素的可行性、干扰试验,结果表明,该制剂用输液溶解后能在1:4以上稀释浓度,用灵敏度为0.25EU/ml 以上的鲎试剂对注射用穿琥宁进行细菌内毒素检查,符合药典要求。

Carry on feasible quality of bacterium endotoxin by means of puting on to Potassi- um Dehydroandrographolide Succinate For Injection clinical in common use、Jam is tested,Result makes knnown,That preparation use perfusion afterwards being dissolved 1:4 desaturation con- centration,Tachypleus Amebocyte Lysate (TAL)that in the way of the response act as over the 0. 25EU/ml is to Potassium Dehydroandrographolide Succinate For Injectione carried on the bacteri- um endotoxin check,Accord with the pharmacopoeia demand.