关键词: 卡托普利;缓释制剂;体外释放度;制备

    摘 要:目的 制备卡托普利缓释片剂. 方法 以体外释放度为筛选指标，通过三因素多水平的随机试验设计，比较研究不同的缓释材料(羟丙基甲基纤维素，黄原胶，聚丙烯酸树脂II号，乙基纤维素，十八醇)与工艺路线(粉末直接压片，湿法制粒，熔融制粒)的优劣，并在此基础上对填充剂(淀粉，乳糖，硫酸钙)进行筛选. 结果 最佳处方及制备工艺为:羟丙基甲基纤维素为缓释材料，粉末直接压片法为工艺路线，乳糖为填充剂.此外，聚丙烯酸树脂II号也具有较好的缓释作用. 结论 用优化的处方，工艺制备的三批卡托普利缓释片体外释放良好，符合Higuchi方程，持续释药12h以上.

    Optimal formulation and technology of captopril sustained┐release tablet

    GAO Ying-Chun，WEN Ai-Dong，JIANG Yong-Pei，ZHAO Lei

    Department of Pharmacy，Xijing Hospital，Fourth Military Medical University，Xi'an710033，China

    Keywords:captopril;sustained-release preparation;dissolu-tion;preparation

    Abstract:AIM To prepare captopril sustained-release tablets.METHODS With dissolution as the screening guideline，matrix materials(HPMC，XG，EII，EC，OA)and technical routine(direct compression method，wet granula-tion method，melting granulation method)were selected to design two-factor-multilevel complete random experiment.After these，the fillers(Starch，Lactose，CaSO4 )were sifted with the same guideline.RESULTS The optimal formula-tion and technology were as follows:HPMC as the matrix material ......