辛伐他汀胃漂浮型緩釋片的制備及體外釋放研究

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1、辛伐他汀胃漂浮型緩釋片的制備及體外釋放研究吳瑾，張曉林，彭霞?陳章寶氣西南大學(xué)藥學(xué)院?重慶400715)摘要：目的篩選辛伐他汀胃漂浮型緩釋片最優(yōu)處方?并考察其漂浮性能及體外釋藥情況。方法采用正交法篩選出辛伐他汀胃漂浮型緩釋片最優(yōu)處方，采用濕法制粒壓片制備胃漂浮型緩釋片，對制備的胃漂浮型緩釋片進行漂浮性與體外釋放度測定。結(jié)果辛伐他汀胃漂浮型緩釋片起漂時間小于1min,持續(xù)漂浮時間大于Mh,在2,8和14h藥物累積釋放度分別達(dá)到8.66%,56.44%和95.17%?體外釋藥符合Higuchi方程。結(jié)論制備的辛伐他汀胃漂浮型緩釋片漂浮性能良好.達(dá)到緩釋藥物的目的。關(guān)鍵詞：辛

2、伐他汀；胃漂浮型緩釋片；正交實驗；體外釋藥doi：1().3969/j.issn.1004-2407.2012.02.021中圖分類號:R944.4文獻(xiàn)標(biāo)志碼：A文章編號：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基金項目何慶市科委車點攻關(guān)資助項H(CKTC-2009AB1181)作者簡介：吳瑾?女，2008級木科生通信作者：陳章寶，男?副教授，碩士表8甘草黃酮膠囊工藝驗證結(jié)果Tab.8ProcessverificationresultsofLicoriceFlavonoidsCapsuls批號091201091202091203成品生產(chǎn)R窣提取物4270270270乳齬/g202020預(yù)膠化淀粉/

7、g404040微晶纖堆素/g707070微粉硅膠/g111平均粒質(zhì)址0.10240.41110.4278成品理論數(shù)/粒100010001000成品實際數(shù)/粒945952958成品率/%94.595,295.8評價指標(biāo)外觀性狀內(nèi)容物為棕色顆視內(nèi)容物為棕色顆粒內(nèi)容物為棕色顆牠削解時限8min20s9min0s8min13s水分/%3.22.83.6總黃酮含量/mg?粒5&456.457.2甘草昔含fi/mg?粒5.95.35.62.4.6穩(wěn)定性實驗結(jié)果按照《屮國藥典))2010年版二部有關(guān)藥物穩(wěn)定性實驗指導(dǎo)原則，對3批產(chǎn)品進行了6個月加速穩(wěn)定