目的:建立鸦胆子油自微乳溶出度的测定方法。方法:采用气相色谱法测定鸦胆子油中油酸的含量,以确定鸦胆子油自微乳化制剂溶出度测定的最佳条件。色谱条件为DB—FFAP毛细管柱(0.25mm×30m,0.25μm),进样口温度220℃,检测器温度220℃,柱温205℃,进样量1μL。以0.1mol·L^-1HCl为溶出介质,硬胶囊壳为载体,转篮法测定鸦胆子油自微乳化给药系统的体外溶出度。结果:鸦胆子油自微乳累积溶出度在15min达90%。结论:该测定方法准确可靠,可用于鸦胆子油自微乳的质量控制。
Objective: To establish determination method of in virto release of Brucea javanica oil self- microemulsion. Method: The content of oleic acid from B. javanica oil was determined by GC method, to determine optimum conditions of dissolution determination of B. javanica oil self-microemulsion. Chromatographic conditions were: DB-FFAP capillary column (0.25 mm × 30 m, 0.25 μm) , column temperature of 205 ℃ , temperture of inlet and detector were 220 ℃, sample volume 1 μL. 0. 1 mol · L^-1 HC1 as dissolution medium, hard capsule shell as a carrier, in vitro release of B. javanica oil self-microemulsion drug delivery system was determined by rotating basket method. Result: Cumulative dissolution of B. javanica oil self-microemulsion was 90% in 15 min. Conclusion: This determination method was accurate and reliable, and it could be used for quality control of B. javanica oil self-microemulsion.