汉防己甲素固体分散片的制备及处方优化 点击下载
论文标题： 汉防己甲素固体分散片的制备及处方优化
英文标题：
中文摘要： 目的：优选汉防己甲素固体分散片的制备处方。方法： 采用直接压片法制备汉防己甲素固体分散片。采用单因素试验筛选常用辅料，以崩解时间为指标，以交联聚乙烯吡咯烷酮（PVPP）用量、乳糖-微晶纤维素比例、微粉硅胶用量为因素，采用正交试验对处方进行优化，并进行验证。比较所制片剂与汉防己甲素普通片的溶出度，测定最优处方所制片剂的含量。结果：最优处方为以9.5％ PVPP为崩解剂、乳糖-微晶纤维素（1 ∶ 2）为填充剂，混匀，加入1％的微粉硅胶为润滑剂，粉末直接压片。所制3批片剂的崩解时间分别为79、81、78 s，占标示量百分含量分别为98.66％、99.24％、99.85％，RSD分别为0.72％、1.16％、1.33％。与汉防己甲素普通片比较，所制片剂的溶出度明显提高。结论：成功制得汉防己甲素固体分散片，且处方合理、重复性好。
英文摘要： OBJECTIVE： To optimize preparation formulation of Tetrandrine solid dispersion tablets. METHODS： Tetrandrine solid dispersion tablets were prepared by direct compression method. Excipients were screened with single factor test. Taking disintegration time as index， the formulation of Tetrandrine solid dispersion tablets was optimized by orthogonal design using the amount of PVPP， lactose-microcrystalline cellulose proportion and the amount of gum acacia as factors. The optimized formulation was validated. Prepared tablets were compared with Tetrandrine common tablet in dissolution rate， and the contents of the tablets prepared by optimized formulation were also determined. RESULTS： Optimal formulation was as follows as 9.5％ PVPP as disintegrating agent， lactose-microcrystalline cellulose （1 ∶ 2） as filler， mixing， 1％ aerosil as lubricant， direct compression. For 3 batches of tablets， disintegration time were 79， 81 and 78 s； contents were 98.66％， 99.24％， 99.85％； RSDs were 0.72％， 1.16％， 1.33％， respectively. Combined with Tetrandrine common tablets， the dissolution rate of prepared tablets had been improved significantly. CONCLUSIONS： Tetrandrine solid dispersion tablets are prepared successfully with rational reproducible formulation.
期刊： 2016年第27卷第7期
作者： 陆仕华，黄兴振
英文作者： LU Shihua，HUANG Xingzhen
关键字： 汉防己甲素固体分散体；分散片；正交设计；制备工艺
KEYWORDS： Tetrandrine solid dispersion； Dispersion tablets； Orthogonal design； Preparation process
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