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目的探索复方利多卡因西甲硅油乳剂的制备工艺和含量测定。方法复方利多卡因西甲硅油乳剂采用新工艺生产,其主要成分利多卡因含量用反相高效液相色谱法测定。结果复方利多卡因西甲硅油乳剂在高速搅拌下混合,超级净化台上分装,室温6个月内质量稳定;利多卡因质量浓度在50~200 mg.L-1内与其峰面积(A)之间线性良好(r=0.999 9),加样回收率在99.1%,RSD为0.37%。结论本制备工艺配制的复方利多卡因西甲硅油乳剂质量稳定;所建方法可用于复方利多卡因西甲硅油乳剂的质量控制。
Objective To explore the preparation process and determination of compound lidocaine simethicone emulsion. Methods The compound lidocaine simethicone emulsion was produced by a new process. The main component, lidocaine, was determined by reversed-phase high performance liquid chromatography. Results Compound lidocaine simethicone emulsion was mixed under high speed agitation. The supernatant was placed on a super clean bench and the quality was stable within 6 months at room temperature. The concentration of lidocaine in the range of 50 ~ 200 mg.L- (R = 0.999 9). The recovery rate was 99.1% and the RSD was 0.37%. Conclusion The preparation process of compound lidocaine simethicone emulsion stability and quality; the method can be used for the quality control of compound lidocaine simethicone emulsion.