中国药房2018，Vol.29Issue(1)：46-49,4.DOI:10.6039/j.issn.1001-0408.2018.01.12
右佐匹克隆口腔崩解片的制备及处方优化
Preparation of Dexzopiclone Orally Disintegrating Tablets and Formulation Optimization
摘要
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.关键词
右佐匹克隆/口腔崩解片/处方优化/正交试验/崩解时限Key words
Dexzopiclone/Orally disintegrating tablets/Formulation optimization/Orthogonal experiment/Disintegration time分类
医药卫生引用本文复制引用
李辉,罗红梅,田清青,陈双华,唐闻汉,宛玉祥..右佐匹克隆口腔崩解片的制备及处方优化[J].中国药房,2018,29(1):46-49,4.基金项目
湖南省教育厅科研一般项目(No.15C1077) （No.15C1077）
