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目的:建立盐酸多巴胺注射液中细菌内毒素检查的鲎试剂法。方法:根据《中国药典》2005年版二部细菌内毒素检查法,采用2个不同厂家生产的鲎试剂对盐酸多巴胺注射液通过调节pH值及稀释倍数等方法进行干扰试验和细菌内毒素检查。结果:盐酸多巴胺注射液pH值调至7.0、稀释至600倍即最大不干扰浓度为0.0167mg·mL-1时,对鲎试剂与细菌内毒素的凝集反应无干扰作用。6批样品中细菌内毒素限值为15 EU·mg-1。结论:采用鲎试剂法控制盐酸多巴胺注射液的细菌内毒素是可行的。
Objective: To establish a method of bacterial endotoxin test in dopamine hydrochloride injection. Methods: According to the bacterial endotoxin test in the 2005 edition of Chinese Pharmacopoeia, interference test and bacterial endotoxin test were carried out on the dopamine hydrochloride injection by adjusting the pH value and dilution factor by using the 鲎 reagent produced by two different manufacturers. Results: The pH value of dopamine hydrochloride injection was adjusted to 7.0 and diluted to 600 times, ie, the maximum non-interfering concentration was 0.0167 mg · mL-1, there was no interference effect between limulus agents and bacterial endotoxin agglutination. The bacterial endotoxin limit of 6 batches of samples was 15 EU · mg-1. Conclusion: It is feasible to control the bacterial endotoxin in Dopamine Hydrochloride Injection by 鲎 reagent method.