摘要
目的:本文研究了重组人干扰素α2b 脂质体包封率的测定方法,为干扰素α2b 脂质体的研究和质量控制提供方法。方法:薄膜分散法制备重组人干扰素α2b 脂质体,应用双抗体夹心酶联免疫法(ELISA)测定其药物含量,考察了方法的回收率、板内及板间精密度和专属性,应用超速离心法分离脂质体中的游离药物,ELISA 法测定游离药量,从而测定脂质体药物包封率。结果:ELISA 法测定重组人干扰素α2b 的板内精密度的 RSD<9.4%(n=5),板间精密度 RSD<18.5%(n=3);超速离心(60000 r·min^(-1),2h,4℃)可将脂质体中的游离药物与脂质体完全分离,3批重组人干扰素α2b 脂质体药物包封率测定结果分别为30.3%,32.0%和29.4%。结论:超速离心-ELISA 测定法可用于重组人干扰素α2b 脂质体包封率的测定。
Objective： To prepare recombinant human interferon α- 2b（ rhlFN α- 2b）liposomes and develop a method to determinate entrapment efficiency for controlling and inspecting its qualities. Methods：The interferon α -2b liposomes were prepared by film dispersion method and the activities of interferon α -2b were determined by the enzyme linked immunoassay（ELISA）. The recovery and viability within plate and between plates were determined. Free and liposomal rhIFN α 2b were separated by ultracentrifugation which was performed for 2 h at 60000 r · min^ - 1 and a temperature of 4 ℃. The supernatant （ containing free rhIFN α - 2b） was collected and then assayed, and the total amount of rhlFN α -2b in liposomes preparation was determined by ELISA. The trapping efficiency was calculated. Results：The within -plate relative standard deviation values was no more than 9.4% （n =5 ）. The entrapment efficiencies of three batches of interferon α -2b liposomes were respectively 30. 3% ,32.0%,29.4%. Conclusions： Ultracentrifugation - ELISA method is fit to determinate the entrapment efficiency of interteron α- 2b liposomes.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2007年第3期311-314,共4页
Chinese Journal of Pharmaceutical Analysis
