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目的:建立刺五加注射液的细菌内毒素(ETX)检查法。方法:根据中国药典1995 年版二部收载的细菌内毒素检查法的要求进行实验。结果:将刺五加注射液经7 倍稀释后可排除干扰因素,用标示灵敏度为0-5 EU·ml-1 的鲎试剂检测细菌内毒素是有效的。结论:刺五加注射液的热原检查可用细菌内毒素法。
Objective: To establish the bacterial endotoxin (ETX) test for Acanthopanax Injection. METHODS: Experiments were performed according to the requirements of the bacterial endotoxin test method contained in the Chinese Pharmacopoeia 1995 edition. RESULTS: The interference factor was eliminated after 7-fold dilution of Acanthopanax Injection, and the detection of bacterial endotoxin was effective using a limulus reagent with a sensitivity of 0-5 EU ml-1. Conclusion: The pyrogen test of Acanthopanax injection can use bacterial endotoxin method.