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目的:建立注射用穿琥宁的细菌内毒素检查方法。方法:按《中国药典》2000年版(二部)附录的细菌内毒素检查方法及指导原则进行实验。结果:注射用穿琥宁40倍稀释液对鲎试剂无干扰作用。结论:注射用穿琥宁的细菌内毒素检查法取代家兔热原检查法,灵敏度高,操作简便,重现性好。
Objective: To establish a bacterial endotoxin test method for the injection of Chuanhuning. METHODS: Experiments were performed according to the bacterial endotoxin test method and the guidelines in the appendix of the 2000 edition of the Chinese Pharmacopoeia (Part 2). RESULTS: The 40-fold dilution of Chuanhuning injection did not interfere with limulus reagent. Conclusion: The method of bacterial endotoxin test for the injection of Chuanhuning injection replaces the rabbit pyrogen test method. It has high sensitivity, easy operation and good reproducibility.