【论文】六味地黄新剂型—分散片的制备及质量标准的初步建立.pdfVIP

毕业设计说明书（论文）中文摘要 目的：制备六味地黄分散片以提高其崩解和溶出性能，并初步建立质量标准。 方法：在实验前期通过对六味地黄各种药材进行不同的工艺处理，制备出分散片 中的主药成分。在分散片的成型工艺中，通过崩解剂、填充剂的用量以及黏合剂 浓度等的考察，并采用正交试验筛选出分散片的最佳处方，即：崩解剂CMS - Na 的 用量为8% ,加入方法为内加和外加相结合，其中内加6%，外加2%，微晶纤维素（MCC） 作为填充剂，用量为45%，黏合剂为8%（g/mL）的聚乙烯吡咯烷酮（PVP）的水溶 液。后期通过对六味地黄分散片进行外观检查、脆碎度、硬度、重量差异、崩解 时间、牡丹皮中丹皮酚的溶出度检查及含量测定等，初步制定了六味地黄分散片 的质量标准。结果：优选处方的分散片崩解时间在3min左右，分散均匀；体外溶 出效果较好。结论：本文设计的六味地黄分散片基本符合《中国药典》中有关分 散片的要求，而且制备工艺简单，类似于普通片剂的制备。 关键词 六味地黄，分散片，质量标准 毕业设计说明书（论文）外文摘要 Title Preparation of Liuweidihuang Dispersible Tablet and the Preliminary Establishment of Quality Standard Abstract Objective:To prepare liuweidihuang dispersible tablet for the elevation of disintegration and dissolution properties，and to establish the preliminary quality standard. Methods: Various herbs of Liuweidihuang using different techniques to prepare the main component of this kind of tablets. In the molding process of the dispersible tablets, we study the amount of disintegrator and filler and the concentration of the felted agents, and orthogonal pilot selected the best prescription of the tablets, namely: the amount of disintegrant CMS-Na was 8% to raise and plus combination, which added 6%, plus 2% separately. Microcrystalline cellulose (MCC) as a filler, the amount was 45%. The concentration of the felted agents polyvinylpyrrolidone (PVP) was 8%(mL) in aqueous solution. By late Liuweidihuang dispersible tablets inspection for appearance, Friability, hardness, weight variation, collapse time, Paeonol from the dissolution of inspection and determination, developed Liuweidihuang tabl