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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 method for the detection of bacterial endotoxin in Shenqi Fuzheng Injection by anti-enriched liquid reconstitution limulus reagent. Methods: The anti-enriched liquid reconstituted limulus reagent was used to inhibit or enhance the different batches of Shenqi Fuzheng injection. The test was conducted to determine the endotoxin test method of Shenqi Fuzheng injection. RESULTS: Anti-enrichment and reconstitution of stilbene reagents could eliminate the interference of Bifidobacterium Fuzheng injection (2-fold dilution) on bacterial endotoxins. Conclusion: It is feasible to perform Bacterial endotoxin test on Shenqi Fuzheng Injection with 0.25 EU·ml-1 limulus reagent with resuscitation solution.