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目的:优化霉酚酸酯羟丙基-β-环糊精(HP-β-CD)包合物的包合工艺。方法:选用溶液-搅拌法制备包合物,采用正交试验来筛选影响HP-β-CD包合的主要因素,即HP-β-CD与药物的比例、包合温度、包合时间和搅拌速度,并以包封率和回收率为考察指标进行优选制备工艺,通过DSC验证包合物。结果:霉酚酸酯HP-β-CD的最佳包合条件为:HP-β-CD与药物配比为1:1,包合温度为80℃,包合时间为3h,搅拌速度为400 r.min~(-1)时,霉酚酸酯HP-β-CD包合物的包合工艺最佳。结论:霉酚酸酯羟丙基-β-环糊精(HP-β-CD)包合物的制备方法简便、可靠,并可大大提高霉酚酸酯的溶解度。
Objective: To optimize the inclusion process of mycophenolate mofetil-β-cyclodextrin (HP-β-CD) inclusion complex. Methods: The inclusion complex was prepared by solution-mixing method. The orthogonal test was used to screen the main factors affecting the inclusion of HP-β-CD, that is, the ratio of HP-β-CD to drug, inclusion temperature, inclusion time and stirring Speed, and the encapsulation efficiency and recovery as the index for the preparation of the preferred preparation process, verification of inclusion complex by DSC. Results: The optimal inclusion conditions of mycophenolic acid HP-β-CD were as follows: the ratio of HP-β-CD to drug was 1: 1, the inclusion temperature was 80 ℃, the inclusion time was 3h and the stirring speed was 400 r.min ~ (-1), mycophenolate HP-β-CD inclusion complex inclusion process is the best. CONCLUSION: The preparation method of mycophenolic acid-hydroxypropyl-β-cyclodextrin (HP-β-CD) inclusion complex is simple, reliable and can greatly enhance the solubility of mycophenolate mofetil.