文档介绍：坎地沙坦酯自微乳软胶囊的制备*
李蓉蓉，李小莉，祝红达，刘明星**
（湖北工业大学生物工程学院制药工程系，武汉）
摘要：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::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。
关键词：坎地沙坦酯自微乳软胶囊；制备工艺；质量评价
中图分类号：R943 文献标识码：A
Preparation of Candesartan Cilexetile Self-microemulsifying Soft Capsules*
LI Rong-rong, LI Xiao-li, ZHU Hong-da, LIU Ming-xing**
(Department of Pharmacy, College of Bioengineering, Hubei University of Technology, Wuhan , China)
ABSTRACT: OBJECTIVE To investigate the optimal technology of preparation technique of candesartan cilexetile self-microemulsifying soft capsules. METHODS Pseudoternary phase diagrams were used to optimize the formulation of content of soft capsules. The technology of drug-loaded self-microemulsifying soft capsules were prepared and optimized. RESULTS The content of soft capsules were made of acetic ether (as oil), RH40 (as emulsifier), PEG400 (as co-emulsifier). The best ratio of three things is acetic ether RH40: PEG400=9:14:7. And the best ratio of soft capsules crust is
gelatin:glycerin:water=1::1. The correlative characteristic of candesartan cilexetile self-microemulsifying soft capsules were evaluated. CONCLUSION This preparation method is simple, stable and reliable.
KEY WORDS: candesartan cilexetile self-mic