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目的:建立榄香烯注射液的细菌内毒素检查法。方法:按2010年版《中国药典》细菌内毒素检查法相关规定进行试验。结果:该注射液在1.09 mg·ml~(-1)浓度下对细菌内毒素检查无干扰作用。结论:所建立的榄香烯注射液的细菌内毒素检查方法具有可行性,其内毒素限值可定为0.46 EU·mg~(-1)。
Objective: To establish the bacterial endotoxin test of elemene injection. Methods: According to the 2010 edition of “Chinese Pharmacopoeia” bacterial endotoxin test method for the relevant provisions of the test. Results: The injection of 1.09 mg · ml -1 concentration of bacterial endotoxin test without interference. Conclusion: The established method of bacterial endotoxin test for elemene injection is feasible and its limit of endotoxin can be set as 0.46 EU · mg -1.