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目的:研究丹参酮ⅡA自微乳化释药系统(TanⅡA-SMEDDS)的处方工艺,探求其最佳处方配比。方法:通过溶解度实验、处方配伍实验和三元相图的绘制,以自乳化时间、色泽和粒径大小为指标,筛选油相、表面活性剂、助表面活性剂的最佳搭配和处方配比;并对含药SMEDDS的粒径和载药量进行了测定;绘制了TanⅡA-SMEDDS制剂的溶出曲线。结果:处方选用IPM为油相(35%),Cremophor RH40/TW80(1∶1)为表面活性剂(40%),PEG400为助表面活性剂(25%)。含药微乳的粒径为(61.5±2.7)nm,自乳化时间35 s,载药量为1.948 mg.g-1。体外溶出结果表明10 min内药物的体外溶出可达80%。结论:所制备的TanⅡ-SMEDDS达到了设计要求,为开发TanⅡ新制剂提供了依据。
OBJECTIVE: To study the prescription of TanⅡA-SMEDDS and explore the optimal formula of Tanshinone ⅡA. Methods: Based on the solubility test, the prescription compatibility experiment and the ternary phase diagram, the optimal combination of the oil phase, the surfactant and the cosurfactant and the prescription ratio were screened by the self-emulsifying time, color and particle size . The particle size and drug loading of SMEDDS were measured. The dissolution profile of TanⅡA-SMEDDS preparation was drawn. RESULTS: IPM was used as the oil phase (35%), Cremophor RH40 / TW80 (1: 1) as the surfactant and PEG400 as the co-surfactant (25%). The particle size of the drug-containing microemulsion was (61.5 ± 2.7) nm, the self-emulsifying time was 35 s and the drug loading was 1.948 mg.g-1. In vitro dissolution results show that the drug dissolution in vitro within 10 min up to 80%. Conclusion: The prepared Tan Ⅱ-SMEDDS meets the design requirements and provides the basis for the development of Tan Ⅱ new formulation.