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目的:制备长春西汀自微乳化给药系统,并对其体外释药及初步稳定性进行了评价。方法:通过溶解度实验、相分离实验以及三元相图的研究筛选了长春西汀自微乳化处方;并对制剂进行了粒径分布、溶出度及初步稳定性的考察。结果:长春西汀自微乳处方组成:Solutol HS 15(A)为表面活性剂;Transcutol P(B)为辅助表面活性剂;Ethyl Oleate(C)为油相。所得处方的自微乳化时间<1 min,粒径<100 nm。体外释放实验表明自微乳化制剂受溶出介质pH值影响小,在不同pH值非依赖型介质中均能快速完全释放药物。结论:所制备的长春西汀自微乳化制剂能够显著提高难溶性药物的溶解度,为体内研究提供实验依据。
OBJECTIVE: To prepare vinpocetine self-microemulsifying drug delivery system and evaluate its in vitro drug release and initial stability. Methods: The self-microemulsifying prescription of vinpocetine was screened through the solubility experiment, the phase separation experiment and the ternary phase diagram. The particle size distribution, dissolution and initial stability of the formulation were investigated. Results: Vinpocetine self-microemulsifying formulation consisted of Solutol HS 15 (A) as a surfactant, Transcutol P (B) as a co-surfactant, and Ethyl Oleate (C) as an oil phase. The resulting self-microemulsification time <1 min, particle size <100 nm. In vitro release experiments show that the self-microemulsifying medium is less affected by the pH of the dissolution medium and can rapidly and completely release the drug in different pH-independent mediums. CONCLUSION: The self-microemulsifying preparation of vinpocetine can significantly improve the solubility of insoluble drugs and provide experimental evidence for in vivo study.