丙泊酚中/长链脂肪乳注射液包封率分析方法的建立

Establishment of a method for the determination of propofol entrapment efficiency in a medium and long chain of fat emulsion injection

目的 :建立丙泊酚中/长链脂肪乳注射液包封率的分析方法。方法 :利用超滤法分离微乳和游离药物,采用Agilent的XDB-C_(18)作为色谱分离柱、乙腈-水(7∶3)为流动相、检测波长275 nm、柱温25℃、流速1.0 ml/min和进样量5μl进行色谱分析。结果 :本方法重复性考察的RSD为1.14%。日间精密度考察RSD为1.25%。结论 :所建立的包封率定量方法,简便、快速、重复性好,可作为工艺筛选过程中灵敏、高效、有区分力的监测方法。

Objective： To establish a method for the determination of propofol entrapment efficiency in a medium and long chain of fat emulsion injection. Methods： The microemulsion and free propofol were separated by ultrafiltration and the high performance liquid chromatography was carried out on an Agilent XDB-C18 column using acetonitrile-water （7：3） as a mobile phase at flow rate of 1.0 ml/min, column temperature 25 ℃ and detective wave length of 275 nm. Results： The RSD for repeatability and inter-day precision was 1.14% and 1.25%. Conclusion： This method is simple, steady and reliable and can be used for the determination ofpropofol entrapment efficiency in a fat emulsion.