反相微乳制备的影响因素考察及处方优化

目的:考察油相、乳化剂和药物对反相微乳形成的影响。方法:采用伪三元相图法,考察乳化剂为司盘-80/吐温-80,模型药为胸腺五肽,油相为长链甘油酯、中链甘油酯、非甘油酯等各因素不同组成对反相微乳形成的影响,筛选最优处方。结果:以中链甘油酯为油相制得的反相微乳具有最大的W/O区域面积;确定最终处方为蒸馏水/司盘-80/吐温-80/辛癸酸三甘油酯(2∶3∶6∶9),胸腺五肽溶于水相中较宜。结论:乳化剂及油相组成、药物均对反相微乳的形成有影响,实际制备中应对各因素水平进行优化。

Study on the Influence Factors for the Preparation of Reverse Microemulsions and the Optimization of Its Formula

OBJECTIVE：To study the effect of oil phase,emulsifier and drugs on reverse microemulsion.METHODS：Pseudo-ternary phase diagram was adopted to study the effect of Span-80/Tween-80（emulsifier）,thymopentin（model drug）, long-chain glyceride,medium-chain glyceride,non-glyceride（oil phase）.on the preparation of reverse microemulsions.Optimal formula of reverse microemulsions was selected.RESULTS：The largest water-in-oil（W/O）area was obtained in reverse microemulsion which was prepared using medium-chain glyceride as oil phase.Final formula was confirmed and contained distilled water/ Span-80/Tween-80/caprylic/capric triglyceride（2∶3∶6∶9）.In addition,thymopentin was incorporated into the aqueous phase.CONCLUSIONS：The preparation of reverse microemulsions will be influenced by emulsifier,constitution of oil phase and drug.The influence factors for the actual preparation of reverse microemulsions should be optimized.