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目的优选洛伐他汀-β-环糊精(β-CD)包合物的制备工艺,提高洛伐他汀的溶出速率和生物利用度。方法用饱和溶液法制备包合物,并用正交设计法对洛伐他汀与β-CD摩尔比(A)、温度(B)、搅拌时间(C)、速度(D)四因素进行优化,得出洛伐他汀-β-环糊精包合物的最佳制备条件。结果根据包合物收率和药物利用率,得出洛伐他汀-β-环糊精最佳包合条件为:洛伐他汀:β-环糊精为1:3,包合温度为50℃,包合时间为3h,搅拌速度为300r.min-1。结论该包合工艺可提高洛伐他汀的溶出速率,工艺简便易行。
Objective To optimize the preparation of lovastatin-β-cyclodextrin (β-CD) inclusion complex and to improve the dissolution rate and bioavailability of lovastatin. Methods The inclusion complex was prepared by saturated solution method. The orthogonal design method was used to optimize the four factors of molar ratio (A), temperature (B), stirring time (C) and speed (D) Optimum conditions of preparation of lovastatin-β-cyclodextrin inclusion compound. Results According to the inclusion compound yield and drug utilization rate, the best inclusion conditions of lovastatin-β-cyclodextrin were lovastatin: β-cyclodextrin 1: 3, inclusion temperature 50 ℃ , Inclusion time 3h, stirring speed 300r.min-1. Conclusion The inclusion process can improve the dissolution rate of lovastatin, the process is simple and easy.