中国临床药学杂志

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。

AIM To explore preparation and determination of compound hydrochloride lidocaine and simethicone emulsion.METHODS The new technology was used for making compound hydrochloride lidocaine and simethicone emulsion.Hydrochloride lidocaine was determined with RP-HPLC.RESULTS The quality of the preparation that mixed by stirring in high-speed and packaging in super-purification was stable in room temperature for six months.There was a good linear relationship within the concentration range of 50-200 mg·L1 of hydrochloride lidocaine(r=0.999 9),respectively.The RSD was 0.37%.The recovery rate was 99.1%.CONCLUSION The quality of this emulsion is stable by preparating in above-mentioned technology.The method may be used for quality control of the preparation.