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目的:建立盐酸左布比卡因及其注射剂细菌内毒素的检查方法。方法:按2010年版《中国药典》(二部)附录细菌内毒素检查法的要求,通过干扰试验确定样品最大不干扰质量浓度,并进行方法学验证。结果:样品的质量浓度为1.56 mg/ml(λ=0.25EU/ml)时对鲎试剂与细菌内毒素之间的凝集反应无干扰;样品的细菌内毒素限值确定为0.08 EU/mg。结论:所建立的方法可用于盐酸左布比卡因及其注射剂的细菌内毒素检查。
Objective: To establish a method for the detection of bacterial endotoxin of levobupivacaine hydrochloride and its injection. Methods: According to the requirements of bacterial endotoxin test in the appendix of “Chinese Pharmacopoeia” (Part 2) of 2010 edition, the maximum undisturbed mass concentration of sample was determined by interference test and the methodological verification was carried out. Results: The agglutination reaction between limulus reagent and bacterial endotoxin did not interfere with the sample concentration of 1.56 mg / ml (λ = 0.25EU / ml); the bacterial endotoxin limit of the sample was determined to be 0.08 EU / mg. Conclusion: The established method can be used for bacterial endotoxin test of levobupivacaine hydrochloride and its injection.