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 12
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 granulation method, melting granulation method) were selected to design two factor multilevel complete random experiment. After these, the fillers (Starch, Lactose, CaSO 4) were sifted with the same guideline. RESULTS The optimal formulation and technology were as follows: HPMC as the matrix material, Lactose as the filler and direct compression as the technical routine. Besides these, EII was also a rather goodsustained release matrix material. CONCLUSION Three bates of Cap sustained release tablets prepared according to this optimal formulation and technology conform to Higuchi equation and the drug can be sustainedly released over 12 h in vitro .
出处
《第四军医大学学报》
北大核心
2002年第11期1040-1042,共3页
Journal of the Fourth Military Medical University
关键词
卡托普利
缓释片
处方
体外释放度
制备
captopril
sustained release preparation
dissolution
preparation
