中国药业
中國藥業
중국약업
CHINA PHARMACEUTICALS
2015年
8期
39-42
,共4页
格列美脲片%固体分散体%聚维酮K30%溶出度%相似因子
格列美脲片%固體分散體%聚維酮K30%溶齣度%相似因子
격렬미뇨편%고체분산체%취유동K30%용출도%상사인자
Glimepiride Tablets%solid dispersion%PVP K30%dissolution rate%similarity factor
目的：利用固体分散技术提高格列美脲（GM）片的体外溶出度。方法以二氯甲烷为溶剂、聚维酮K30（PVP K30）为载体，用溶剂法制备GM固体分散体（SD）；采用显微扫描电镜( SEM )，X－射线衍射分析( XRD )，差示扫描量热分析( DSC )，红外光谱分析( FTIR )技术对GM固体分散体进行物相鉴定；制备GM普通片和SD片，测定溶出曲线，并用 f2因子法与以格列美脲片（亚莫利，赛诺菲安万特＜北京＞制药有限公司）为参比制剂的溶出曲线进行相似性比较。结果 GM：PVP K30=1：4制备的固体分散体中GM以非晶形态分散于PVP K30中，体外溶出度为89.28%，88.73%，90.76%，相似因子 f2为82.60，79.40，81.00。结论固体分散技术可显著提高GM片的体外溶出度，GM SD的溶出行为与参比制剂非常相似。
目的：利用固體分散技術提高格列美脲（GM）片的體外溶齣度。方法以二氯甲烷為溶劑、聚維酮K30（PVP K30）為載體，用溶劑法製備GM固體分散體（SD）；採用顯微掃描電鏡( SEM )，X－射線衍射分析( XRD )，差示掃描量熱分析( DSC )，紅外光譜分析( FTIR )技術對GM固體分散體進行物相鑒定；製備GM普通片和SD片，測定溶齣麯線，併用 f2因子法與以格列美脲片（亞莫利，賽諾菲安萬特＜北京＞製藥有限公司）為參比製劑的溶齣麯線進行相似性比較。結果 GM：PVP K30=1：4製備的固體分散體中GM以非晶形態分散于PVP K30中，體外溶齣度為89.28%，88.73%，90.76%，相似因子 f2為82.60，79.40，81.00。結論固體分散技術可顯著提高GM片的體外溶齣度，GM SD的溶齣行為與參比製劑非常相似。
목적：이용고체분산기술제고격렬미뇨（GM）편적체외용출도。방법이이록갑완위용제、취유동K30（PVP K30）위재체，용용제법제비GM고체분산체（SD）；채용현미소묘전경( SEM )，X－사선연사분석( XRD )，차시소묘량열분석( DSC )，홍외광보분석( FTIR )기술대GM고체분산체진행물상감정；제비GM보통편화SD편，측정용출곡선，병용 f2인자법여이격렬미뇨편（아막리，새낙비안만특＜북경＞제약유한공사）위삼비제제적용출곡선진행상사성비교。결과 GM：PVP K30=1：4제비적고체분산체중GM이비정형태분산우PVP K30중，체외용출도위89.28%，88.73%，90.76%，상사인자 f2위82.60，79.40，81.00。결론고체분산기술가현저제고GM편적체외용출도，GM SD적용출행위여삼비제제비상상사。
Objective To improve the dissolution rate in vitro of Glimepiride(GM)Tablets by using the solid dispersion(SD)technology. Methods The GM solid dispersion was prepared by the solvent method with polyvinyl pyrrolidone K30(PVP K30)as the carrier and methylene chloride as the solvent. The SEM,XRD,DSC and FTIR analytical techniques were adopted to perform the quantitative phase identification of GM in SD;the common tablets and SD tablets of GM were compared,the dissolution curve of GM was measured,its dissolution curve was performed the similarity comparison with the reference preparation Amaryl made by the Sanofi-Aventis(Beijing) pharmaceutical Co. Ltd. ,by using the f2 factor method. Results GM with the non-crystallite form was dispersed in PVP K30 within SD prepared under the GM and PVP K30 weight ratio of 1 :4,its dissolution in vitro and similarity factor f2 were 89. 28%,88. 73%, 90. 76% and 82. 60,79. 40,81. 00 respectively. Conclusion The SD technology can remarkably improve the dissolution rate in vitro of GM tablets and its dissolution behavior is similar to the reference preparation.
