显色基质法检测乳酸环丙沙星氯化钠注射液的细菌内毒素

摘要

Objective To compare bacterial endotoxin test of Ciprofloxacin Lactate and Sodium Chloride Injection by chromogenic substrate limulus amebocytelysate method and sol-gel method. Methods Sample dilution method was used to study of chromogenic substrate limulus reagent on different batches of Ciprofloxacin Lactate and Sodium Chloride Injection, compared with interfering test of sol-gel limulus reagent sample. Results The standard curve correlation co-efficient of chromogenic substrate limulus amebocytelysate was above 0.98. Ciprofloxacin Lactate and Sodium Chloride Injection was not interfere with the concentration of 0.5 mg/mL, which was obviously higher than that of gel colt method (0.125 mg/mL). Conclusion Compared with sol-gel method, chromogenic substrate method has the characteristic of sen-sitive, rapid, quantitative and good repeatability, can be used for content determination on endotoxin of Ciprofloxacin Lactate and Sodium Chloride Injection.%目的：比较显色基质法与凝胶法检测乳酸环丙沙星氯化钠注射液的细菌内毒素的效果。方法采用样品稀释法研究显色基质鲎试剂对不同批号乳酸环丙沙星氯化钠注射液的干扰,并与凝胶法鲎试剂对样品的干扰试验比较。结果显色基质法标准曲线的线性相关系数≥0.98,乳酸环丙沙星氯化钠注射液在0.5 mg/mL浓度时无干扰作用,明显高于凝胶法无干扰浓度(0.125 mg/mL)。结论与凝胶法比较,显色基质法有灵敏、快速、能定量、重复性好的特点,可用于乳酸环丙沙星氯化钠注射液内毒素含量的测定。