盐酸地尔硫缓释片的制备工艺研究

PREPARATION OF SUSTAINED- RELEASE TABLETS OF DILTIAZEM HYDROCHLORIDE

应用羟丙甲纤维素、乙基纤维素为主要骨架材料，掺入适量的乳糖和海藻酸钠调节释药速率和片剂的重量，１５％ ＰＶＰ乙醇液作粘合剂，采用湿颗粒间接压片法制得了日服一次的盐酸地尔硫卓艹缓释片。采用均匀设计结合综合评分方法，经多元线性回归和多元逐步回归处理，建立了处方组成因素等对释药速率影响的多元定量关系式。缓释片中的药物释放基本符合一级方程。照相法描述了缓释片的体外膨胀行为。

With hydroxypropylmethylcellulose(HPMC) and ethylcellulose(EC) as carriers,lactose and sodium alginate as fillers to adjust the release rate,and 15% ethanolic polyvinylpyrrolidone solution as adhesive,the sustained release tablets were prepared by wet granulation process and indirect compressing technique.Uniform design method was used to optimize the formula and process.A multivariate regression equation was applied to predict the factors affecting drug release.The release mechanism was fitted to the first order kine tics. \;