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目的应用凝胶法和动态浊度法检查丹红注射液中的细菌内毒素含量。方法按《中国药典》2010年版方法,确定丹红注射液细菌内毒素限值,分别进行凝胶法和动态浊度法细菌内毒素检查的干扰试验。结果凝胶法结果表明,本品稀释40倍后对试验无干扰作用;动态浊度法结果表明,本品在稀释40倍时外加内毒素回收率在50%～200%之间。结论凝胶法和动态浊度法可用于丹红注射液中的细菌内毒素检查。
Objective To detect bacterial endotoxin content in Danhong injection by gel method and dynamic turbidity method. Methods According to the Chinese Pharmacopoeia 2010 edition, the limit of bacterial endotoxin of Danhong injection was determined, and the interference test of bacterial endotoxin test by gel method and dynamic turbidity method were carried out respectively. Results The results of gel method showed that the product had no interference with the test after 40-fold dilution. The results of dynamic turbidity method showed that the recovery of endotoxin was between 50% and 200% when the product was diluted by 40 times. Conclusion Gel method and dynamic turbidity method can be used for bacterial endotoxin test in Danhong injection.