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目的:建立克林霉素磷酸酯氯化钠注射液细茵内毒素检查的方法。方法:按照《中国药典》2005年版收载的细菌内毒素检查法的要求进行干扰试验。结果:克林霉素磷酸酯氯化钠注射液经1:6稀释后,对细菌内毒素检查法无干扰。结论:克林霉素磷酸酯氯化钠注射液可用细菌内毒素检查法代替热原检查法,且结果一致。
Objective: To establish a method for detecting endotoxin in clindamycin phosphate sodium chloride injection. Methods: In accordance with the “Chinese Pharmacopoeia” 2005 edition contained in the bacterial endotoxin test requirements interference test. Results: Clindamycin phosphate sodium chloride injection diluted 1: 6, no interference on bacterial endotoxin test. Conclusion: Clindamycin phosphate sodium chloride injection bacterial endotoxin test instead of pyrogen test, and the results are consistent.