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目的:建立新鱼腥草素钠注射液的细菌内毒素检查法。方法:根据《中国药典》2000年版二部收载的细菌内毒素检查法的要求进行实验。结果:将新鱼腥草素钠注射液稀释30倍,用标示灵敏度为0.5 EU·ml-1的鲎试剂进行细菌内毒素检查是有效的。结论:鲎试剂可用于新鱼腥草素钠注射液的细菌内毒素检查。
Objective: To establish a bacterial endotoxin test for the new sodium houttuyfonate injection. Methods: According to the requirements of the bacterial endotoxin test method contained in the 2000 edition of the Chinese Pharmacopoeia. RESULTS: New Houttuyfonate Sodium Injection was diluted 30-fold and bacterial endotoxin testing was validated using a titration reagent with a sensitivity of 0.5 EU · ml-1. Conclusion: 鲎 reagent can be used for new sodium houttuyfonate injection bacterial endotoxin test.