辛伐他汀胃漂浮型缓释片的制备及体外释放研究

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1、辛伐他汀胃漂浮型缓释片的制备及体外释放研究吴瑾，张晓林，彭霞•陈章宝气西南大学药学院•重庆400715)摘要：目的筛选辛伐他汀胃漂浮型缓释片最优处方•并考察其漂浮性能及体外释药情况。方法采用正交法筛选出辛伐他汀胃漂浮型缓释片最优处方，采用湿法制粒压片制备胃漂浮型缓释片，对制备的胃漂浮型缓释片进行漂浮性与体外释放度测定。结果辛伐他汀胃漂浮型缓释片起漂时间小于1min,持续漂浮时间大于Mh,在2,8和14h药物累积释放度分别达到8.66%,56.44%和95.17%・体外释药符合Higuchi方程。结论制备的辛伐他汀胃漂浮型缓释片漂浮性能良好.达到缓釋药物的目的。关键词：辛

2、伐他汀；胃漂浮型缓释片；正交实验；体外释药doi：1().3969/j.issn.1004-2407.2012.02.021中图分类号:R944.4文献标志码：A文章编号：1004-2407(2012)02-0147-03StudyonpreparationandinvitroreleaseofSimvastatinIntragastricFloatingSustainedReleaseTabletsWUJin,ZHANGXiaolin,PENGXia,CHENZhangbao(CollegeofPharmaceuticalSciences,SouthwestUniv

3、ersity,Chong(iing400715,China)Abstract:ObjectiveToscreenthebestprescriptionofSirnvatatinIntragastricFloatingSustainedReleaseTabletsandstudyonitsfloatationandinvitroreleasecharacteristics.MethodsAnorthogonalexperimentaldesignwasadoptedtoscreenthebestprescriptionofSimvalatinIntragastricFl

4、oatingSustainedReleaseTabletsfandthewetgranulecompressionmethodwasusedtopreparethetablets.Andthenthecharacteristicsoffloatingandthevitroreleasewerestudied.Results「hebeginningfloattimeofthetabletswaslessthan1minfandtheirsustainingtimewaslongerthan1411TheaccuniulalcdreleasepercentageofSir

5、nvatatinIntragastricFloatingSustainedReleaseTabletsat2,8and14hrespectivelyreached&66%,56.44%and95.17%,andthetabletswasconsistentwithHiguchiequation・Conclusions匚、hefloatingcharacteristicsofSirnvatatinIntragastricFloatingSustainedReleaseTabletsisgoodanditsreleaseratesaresustained・Keywords:

6、sirnvatatin;IntragastricFloatingSustainedReleaseTablets;orthogonalcxperirncnl;invitrorelease基金项目何庆市科委車点攻关资助项H(CKTC-2009AB1181)作者简介：吴瑾•女，2008级木科生通信作者：陈章宝，男•副教授，硕士表8甘草黄酮胶囊工艺验证结果Tab.8ProcessverificationresultsofLicoriceFlavonoidsCapsuls批号091201091202091203成品生产R窣提取物4270270270乳齬/g202020预胶化淀粉/

7、g404040微晶纤堆素/g707070微粉硅胶/g111平均粒质址0.10240.41110.4278成品理论数/粒100010001000成品实际数/粒945952958成品率/%94.595,295.8评价指标外观性状内容物为棕色颗视内容物为棕色颗粒内容物为棕色颗牠削解时限8min20s9min0s8min13s水分/%3.22.83.6总黄酮含量/mg•粒5&456.457.2甘草昔含fi/mg•粒5.95.35.62.4.6稳定性实验结果按照《屮国药典))2010年版二部有关药物稳定性实验指导原则，对3批产品进行了6个月加速稳定