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目的通过坎地沙坦酯自微乳软胶囊的制备工艺研究,确定其最佳工艺条件。方法采用伪三元相图优化了软胶囊内容物的配方,并制备和优化了载药自微乳软胶囊的工艺。结果内容物以乙酸乙酯为油相,RH40为乳化剂,聚乙二醇400为助乳化剂,且三者最佳配比为9∶14∶7。软胶囊囊壳材料最佳配比为明胶∶甘油∶水=1∶0.5∶1,且评价了坎地沙坦酯自微乳软胶囊的相关特性。结论本工艺简单、稳定、可靠。
OBJECTIVE To study the preparation process of candesartan cilexetil self-microemulsion soft capsules and determine its optimum technological conditions. Methods The pseudo-ternary phase diagram was used to optimize the formulation of soft capsule contents, and the process of self-microemulsion soft capsule preparation was optimized and optimized. Results The content of ethyl acetate as the oil phase, RH40 as emulsifier, polyethylene glycol 400 as co-emulsifier, and the three best ratio of 9:14:7. The optimal ratio of soft capsule shell materials was gelatin: glycerol: water = 1: 0.5: 1, and the related properties of candesartan cilexetil self-microemulsion soft capsules were evaluated. Conclusion The process is simple, stable and reliable.