右佐匹克隆口腔崩解片的制备及处方优化
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篇名: 右佐匹克隆口腔崩解片的制备及处方优化
TITLE:
摘要: 目的:制备右佐匹克隆口腔崩解片,并优化其处方。方法:采用粉末直接压片法制备右佐匹克隆口腔崩解片,以物料休止角、崩解时限、口感评价为指标,单因素试验筛选处方中填充剂、崩解剂、润滑剂、矫味剂种类或用量;以崩解时限为指标,正交试验优化处方中填充剂比例、崩解剂用量、润滑剂用量、矫味剂用量,并考察最优处方所制右佐匹克隆口腔崩解片的硬度和主成分含量。结果:最优处方中填充剂甘露醇-微晶纤维素质量比为1 ∶ 4、崩解剂交联聚维酮用量为15%、润滑剂硬脂酸镁用量为1.0%、矫味剂甜菊苷用量为3.0%。所制3批右佐匹克隆口腔崩解片的表面光滑、口感微甜,崩解时限分别为(26.7±1.2)、(26.7±0.6)、(27.6±0.9) s,硬度分别为(3.59±0.19)、(3.49±0.18)、(3.27±0.16) kg,右佐匹克隆含量分别为(99.47±0.15)%、(99.53±0.05)%、(99.46±0.20)%,RSD均≤0.87%(n=3)。结论:所制右佐匹克隆口腔崩解片各项质量指标均符合口腔崩解片的要求。
ABSTRACT: OBJECTIVE: To prepare Dexzopiclone orally disintegrating tablets (DODT), and to optimize its formulation. METHODS: Direct powder compression method was used to prepare DODT. Using repose angle of material, disintegration time and taste evaluation as indexes, single factor test was used to screen the types or amount of bulking agent, disintegrating agent, glidant and flavoring agent; using disintegration time as index, orthogonal experiment was applied to optimize the proportion of bulking agent, the amount of disintegrating agent, glidant and flavoring agent. Then the hardness and main component contents of DODT prepared by optimal formulation were determined. RESULTS: The optimal formulation was as follows as the ratio of mannitol-MCC 1 ∶ 4, the amount of disintegrating agent PVPP was 15%, the amount of glidant magnesium stearate was 1.0%, the amount of flavoring agent stevia was 3.0%. Three batches of prepared DODT were smooth in surface and good in taste; their disintegration time were(26.7±1.2), (26.7±0.6), (27.6±0.9)s, hardness were (3.59±0.19), (3.49±0.18), (3.27±0.16) kg, and contents were (99.47±0.15)%,(99.53±0.05)%,(99.46±0.20)%, respectively (all RSDs≤0.87%,n=3). CONCLUSIONS: Prepared DODT are all in line with the quality requirements of orally disintegrating tablets.
期刊: 2018年第29卷第1期
作者: 李辉,罗红梅,田清青,陈双华,唐闻汉,宛玉祥
AUTHORS: LI Hui,LUO Hongmei,TIAN Qingqing,CHEN Shuanghua,TANG Wenhan,WAN Yuxiang
关键字: 右佐匹克隆;口腔崩解片;处方优化;正交试验;崩解时限
KEYWORDS: Dexzopiclone; Orally disintegrating tablets; Formulation optimization; Orthogonal experiment; Disintegration time
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