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目的:建立盐酸格拉司琼注射液的细菌内毒素检查法。方法:按《中国药典》2000年版细菌内毒素检查法及其应用指导原则进行实验。结果:将盐酸格拉司琼注射液稀释到浓度为0.02mg·ml-1时,无干扰因素。结论:建立盐酸格拉司琼注射液细菌内毒素检查法具有可行性,其细菌内毒素限值可定为应小于25EU·mg-1。
Objective: To establish a bacterial endotoxin test for granisetron hydrochloride injection. Methods: According to the Chinese Pharmacopoeia 2000 edition bacterial endotoxin test method and its application guidelines for experiments. Results: Granisetron hydrochloride injection diluted to a concentration of 0.02mg · ml-1, no interference factors. Conclusion: It is feasible to establish the bacterial endotoxin test for granisetron hydrochloride injection. The bacterial endotoxin limit should be less than 25EU · mg-1.