双氯芬酸钠盐酸利多卡因注射液细菌内毒素检查法的研究

Study on the Bacterial Endotoxin Test for Compound Diclofenas Sodium and Lidocaine Hydrochloride In-jection

目的 :建立双氯芬酸钠盐酸利多卡因注射液 (CDL)的细菌内毒素检查方法。方法 :确定CDL的细菌内毒素限值 ,进行干扰试验 ,并测定其最大非干扰浓度。结果 :CDL对细菌内毒素反应有抑制作用 ,通过稀释的方法可排除干扰 ,最大非干扰浓度为其300倍稀释液。结论

OBJECTIVE:To establish a bacterial endotoxin test for compound diclofenac sodium and lidocaine hydrochloˉride injection(CDL).METHODS:The limitation of endotoxin in CDL was determined and a interference test was performed to determine the maximum non-interference concentration.RESULTS:CDL could interfere the detection of bacterial endotoxin,which could be overcome through300-fold dilution of the preparation.CONCLUSION:The bacterial endotixin test can be used to replace the detection of pyrogen in CDL.