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目的:确立注射用吡柔比星细菌内毒素检查方法。方法:参照中国药典2000年版二部细菌内毒素检查法要求进行试验。结果:该药在0.5mg·ml-1浓度下不干扰内毒素试验。结论:该药采用内毒素检查法代替热原检查法,方法可行。
Objective: To establish a method for detecting bacterial endotoxin of pirarubicin for injection. Methods: According to the Chinese Pharmacopoeia 2000 edition two bacterial endotoxin test requirements of the test. Results: The drug did not interfere with the endotoxin test at a concentration of 0.5 mg · ml-1. Conclusion: The method of endotoxin test instead of pyrogen test, the method is feasible.