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目的:建立盐酸尼卡地平葡萄糖注射液的细菌内毒素检查方法。方法:根据2005年版《中国药典》(二部)附录细菌内毒素检查法进行试验。结果:当水为溶剂时,样品对细菌内毒素检查法有干扰作用;改用稀释剂Ⅰ作为溶剂,干扰预试验和干扰试验结果表明,样品在4倍以上稀释浓度时可排除干扰。结论:盐酸尼卡地平葡萄糖注射液按限值L=0.5EU.mL-1进行细菌内毒素检查是可行的,可以用细菌内毒素检查法取代热原检查法检测盐酸尼卡地平葡萄糖注射液。
Objective: To establish a bacterial endotoxin test for nicardipine hydrochloride injection. Methods: According to the 2005 edition of “Chinese Pharmacopoeia” (two) appendix bacterial endotoxin test method for testing. Results: When water was used as the solvent, the sample had an interfering effect on bacterial endotoxin test; instead, diluent I was used as the solvent, which interfered with the pre-test and the interference test. The results showed that the interference of the sample could be eliminated when the concentration was more than 4 times. CONCLUSION: Bacterial endotoxin test is feasible for nicardipine hydrochloride injection according to the limit of L = 0.5EU.mL-1. Bacterial endotoxin test can replace nicardipine hydrochloride injection in place of pyrogen test.