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作 者:冯泽岸[1,2] 廖明琪[1,2] 邵婷玑[1,2] 巩慧敏[1,2] 梁莉[1] 乔华[1] 王婷[1]
机构地区:[1]兰州大学第一医院国家药物临床试验机构,甘肃兰州730000 [2]兰州大学药学院,甘肃兰州730000
出 处:《中国医院药学杂志》2012年第9期699-703,共5页Chinese Journal of Hospital Pharmacy
基 金:2007年甘肃省中医药管理局科研项目[(编号:甘卫中发[2007]123号]
摘 要:目的:研制南沙参多糖分散片。方法:通过对原辅料粉体学性质的考察选择南沙参多糖分散片的制备工艺,单因素筛选和正交试验法优选南沙参多糖分散片的处方。结果:采用粉末直接压片法制备南沙参多糖分散片,优选出的处方为:南沙参多糖粉30%、磷酸氢钙43%、交联聚乙烯吡咯烷酮15%、聚乙二醇4000 10%、微粉硅胶1%、硬脂酸镁1%。实验表明该分散片崩解时限小于60 s,分散均匀性较好,15 min溶出度大于85%。结论:该片采用粉末直接压片法制备,工艺简便,制成的分散片质量符合2010年版中华人民共和国药典制剂通则项下分散片的相关规定。OBJECTIVE To prepare Radix Adenophorae Potanini Korsh polysaccharides dispersible tablets. METHODS The preparation technology was chosen by studying the micromeritics of drug and adjuvants. The prescription was optimized by single factor screening and orthogonal test method. RESULTS The powder pellets method was adopted in preparing the dispersible tablets. An optimized prescription assembly was 30% of Radix Adenophorae Potanini Korsh polysaccharides power, 43% of calcium hydrogen phosphate, 15 %of PVPP, 10% of PEG4000, 1 % of colloidal silicon dioxide and 1 %of magnesium stearate. The test showed that disintegration time was less than 60 seconds, dispersible homogeneity were good, and dissolution rate at 15 minutes was more than 85 %. CONCLUSION The preparation technology of the dispersible tablets was simple and convenient. The dispersible tablets could meet the requirements of relevant provisions of the dispersible tablets in the Chinese Pharmacopoeia 2010 edition of general prenarations
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