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目的:研究盐酸多巴酚丁胺注射液细菌内毒素检查法的可行性。方法:采用鲎试剂法根据《中国药典》2005年版(二部)附录细菌内毒素检查法进行样品预干扰试验和正式干扰试验,确定样品的试验浓度及内毒素限值。结果:将样品浓度稀释到0.8mg·mL-1时,不干扰细菌内毒素试验,其细菌内毒素限值定为1.2EU·mg-1。结论:采用鲎试剂法检查盐酸多巴酚丁胺注射液中的细菌内毒素是可行的。
Objective: To study the feasibility of bacterial endotoxin test in dobutamine hydrochloride injection. Methods: The sample pre-interference test and formal interference test were conducted according to the appendix of Bacterial Endotoxin Test of Chinese Pharmacopoeia (2005 Edition) (Ⅱ) by using 鲎 reagent method to determine the test concentration and endotoxin limit of the sample. Results: When the sample concentration was diluted to 0.8mg · mL-1, the bacterial endotoxin test was not disturbed, and the bacterial endotoxin limit was 1.2EU · mg-1. CONCLUSION: It is feasible to examine the bacterial endotoxin in dobutamine hydrochloride injection by using the 鲎 reagent method.