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目的:建立盐酸布比卡因注射液细菌内毒素检查方法。方法:参照《中国药典》2005年版(二部)附录收栽的细菌内毒素检查法及其原则进行实验,用不同厂家的鲎试剂对两种规格盐酸布比卡因注射液进行干扰试验。结果:当盐酸布比卡因注射液稀释浓度为0.625 mg·ml~(-1)时可消除对鲎试剂与细菌内毒素凝集反应的干扰。结论:盐酸布比卡因注射液可用细菌内毒素检查法进行安全性质量检查。
Objective: To establish a bacterial endotoxin test for bupivacaine hydrochloride injection. Methods: According to the method of bacterial endotoxin test and its principle, the Chinese Pharmacopoeia 2005 edition (2) appendix was used to carry out experiments, and the interference test of two kinds of bupivacaine hydrochloride injection with different manufacturers’ s reagent was carried out. Results: When the concentration of bupivacaine hydrochloride injection was 0.625 mg · ml -1, the interference of limulus agents with bacterial endotoxin agglutination was eliminated. Conclusion: Bupivacaine hydrochloride injection can be used bacterial endotoxin test for safety and quality inspection.