安神缓释片的初步研究化学工程与技术专业论文.docxVIP

(1)制剂的处方工艺：以释放度为指标，采用单因素试验与正交设计 (1)制剂的处方工艺：以释放度为指标，采用单因素试验与正交设计 试验，得到安神缓释片的最佳的处方组成是原料药的用量为50％，羟丙基甲 基纤维素K15M的用量为30％、乳糖的用量为15％、微晶纤维素的用量为 5％，硬脂酸镁的用量为O．5％。以此工艺制备的安神缓释片，可达到1h内 释放37．5％～42．5％，4h内释放67．5％～72．5％，8h内释放87．5～92．5％的药物， 符合目标片剂的要求。安神缓释片的释药特性符合Higuchi方程，且为非 Fick，S扩散，因此属于药物扩散和骨架溶蚀的协同作用。 (2)制剂的质量评价：安神缓释片的性状、理化鉴别、重量差异、片 剂脆碎度检查、释放度均符合《中国药典》2015版中缓释制剂的要求。规 定安神缓释片中酸枣仁总皂苷的含量不得低于75mg／片，酸枣仁皂苷A的含 量不得低于5mg／片。并对安神缓释片进行了高温试验、高湿试验、加速试 验，以及正在进行中的长期试验，表明其稳定性良好。 由此得出结论：从酸枣仁中提取纯化后的酸枣仁总皂苷具有良好的稳定 性与安神作用；利用纯化的酸枣仁总皂苷制备亲水性凝胶骨架型缓释片，可 制得符合药典要求的具有安神作用的缓释片，且质量可控，稳定性好。 关键词：酸枣仁，总皂苷，安神，缓释片 万方数据 The The Preliminary Study on Sedative Sustained．．Released Tablets ABSTRACT Ziziphi spinosae semen is the preferred hypnotics in traditional Chinese medicine．Saponin is the one of hypnosis active ingredient in ziziphi spinosae semen．We collected 878 ancient and modem prescriptions．as well as 236 related literatures，got the same result by Chinese medicine theory combined and modem statistic．Because of the 10W content about saponin in ziziphi spinosae semen，the processing of existing traditional compound preparation is not fining， clinical application widely but the effect faintly．To use the resource of ziziphi spinosae semen reasonably and improve the sedative effect of preparation preferably,the saponin of ziziphi spinosae semen，purity，and accumulative release percentage were taken as indexs to study on the preparation and evaluation about crude drug and sustained-released tablet in this paper．From the research content，the results could be concluded as follows： Preparation and evaluation for crude drug： Pretreatment condition of ziziphi spinosae semen：The saponin of ziziphi spinosae semen was taken as indexs were taken as index．The highest content of saponin was the ziziphi spinosae semen，which was 3．00mg。g～． Extraction condition of saponins in ziziphi spinosae semen：The saponin of ziziphi spinosae semen was taken as index．Comparing the different methods to determine the optimal process，the optimum condi