百部新碱口腔崩解片的制备 点击下载
论文标题： 百部新碱口腔崩解片的制备
英文标题：
中文摘要： 目的：制备百部新碱口腔崩解片，优化其处方和制备工艺。方法：采用粉末直接压片法制备百部新碱口腔崩解片，以物料休止角、崩解时限、口感评价为指标，单因素试验筛选填充剂、崩解剂、助流剂、矫味剂；以崩解时限为指标，以填充剂微晶纤维素（MCC）+甘露醇、崩解剂交联聚乙烯吡咯烷酮（PVPP）、助流剂微粉硅胶、矫味剂阿司帕坦+甜菊素用量占片质量百分比为考察因素，设计L9（34）正交试验，优化处方并进行验证试验。结果：优化处方为MCC+甘露醇（1 ∶ 1）50％、PVPP 20％、微粉硅胶2％、阿司帕坦+甜菊素（10 ∶ 1）7％，所制3批百部口腔崩解片表面光滑，口感良好，崩解时限为（22.6±2.1） s，片重差异、硬度、含量均在规定范围内（RSD≤0.97％，n＝3）。结论：筛选的百部新碱口腔崩解片处方及工艺合理，各质量指标均符合口腔崩解片的要求。
英文摘要： OBJECTIVE： To prepare Stemoninine orally disintegrating tablets， and to optimize its formulation and preparation technology. METHODS： Direct powder compression method was used to prepare Stemoninine orally disintegrating tablets. Using material angle of repose， disintegration time and taste evaluation as index， single factor test was used to screen several factors as bulking agent， disintegrating agent， glidant and flavoring agent； using disintegration time as index， L9（34） orthogonal test was used to optimize the formulation with ratio of MCC+mannitol， PVPP， silica powder and aspartame+stevia as factors. Validation test was also conducted. RESULTS： Optimized formulation was that MCC+mannitol （1 ∶ 1） was 50％， PVPP was 20％， silica powder was 2％ and aspartame+stevia （10 ∶ 1） was 7％. 3 batches of prepared Stemoninine orally disintegrating tablets were smooth in surface and good in taste； their disintegrating time was （22.6±2.1） s， and weight variation， hardness， contents were within the specified range （all RSD≤0.97％， n＝3）. CONCLUSIONS： The formulation and technology of Stemoninine orally disintegrating tablets are reasonable， and the quality indexes are all in line with the requirements of orally disintegrating tablets.
期刊： 2016年第27卷第16期
作者： 吴旖，谢敏
英文作者： WU Yi，XIE Min
关键字： 百部新碱；口腔崩解片；处方优化；制备；正交试验；崩解时限
KEYWORDS： Stemoninine； Orally disintegrating tablets； Formulation optimization； Preparation； Orthogonal test； Disintegration time
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