安徽医药
安徽醫藥
안휘의약
ANHUI MEDICAL AND PHARMACEUTICAL JOURNAL
2014年
6期
1050-1052
,共3页
盐酸二甲双胍缓释片%释放度%相似因子f2
鹽痠二甲雙胍緩釋片%釋放度%相似因子f2
염산이갑쌍고완석편%석방도%상사인자f2
metformin hydrochloride sustained-release tablets%release rate%f2 similarity factor
目的：对不同厂家的盐酸二甲双胍缓释片进行体外释放度考察，为临床合理用药提供依据。方法根据盐酸二甲双胍缓释片标准（进口药品注册标准JX20010451）及相关参考文献，采用溶出度转篮法的装置进行体外释放实验，以pH 6．8磷酸盐缓冲液1000 mL为释放介质，转速为100 r·min-1，温度为（37±0．5）℃，用紫外分光光度法进行含量测定。分别对不同厂家的盐酸二甲双胍缓释片，进行体外释放试验，计算累积释放百分率，绘制释放曲线；计算f2相似因子。结果两种进口制剂的相似因子f2为93．54。不同国产制剂与进口制剂的相似因子f2依次为：47．80、48．10、49．67、66．27、47．65、70．53、67．05；各国产制剂与BIOVAIL制剂的相似因子f2依次为：49．21、49．49、51．25、67．00、49．05、68．22、67．21。结论不同国产制剂与进口制剂的体外释药行为存在明显差异。
目的：對不同廠傢的鹽痠二甲雙胍緩釋片進行體外釋放度攷察，為臨床閤理用藥提供依據。方法根據鹽痠二甲雙胍緩釋片標準（進口藥品註冊標準JX20010451）及相關參攷文獻，採用溶齣度轉籃法的裝置進行體外釋放實驗，以pH 6．8燐痠鹽緩遲液1000 mL為釋放介質，轉速為100 r·min-1，溫度為（37±0．5）℃，用紫外分光光度法進行含量測定。分彆對不同廠傢的鹽痠二甲雙胍緩釋片，進行體外釋放試驗，計算纍積釋放百分率，繪製釋放麯線；計算f2相似因子。結果兩種進口製劑的相似因子f2為93．54。不同國產製劑與進口製劑的相似因子f2依次為：47．80、48．10、49．67、66．27、47．65、70．53、67．05；各國產製劑與BIOVAIL製劑的相似因子f2依次為：49．21、49．49、51．25、67．00、49．05、68．22、67．21。結論不同國產製劑與進口製劑的體外釋藥行為存在明顯差異。
목적：대불동엄가적염산이갑쌍고완석편진행체외석방도고찰，위림상합리용약제공의거。방법근거염산이갑쌍고완석편표준（진구약품주책표준JX20010451）급상관삼고문헌，채용용출도전람법적장치진행체외석방실험，이pH 6．8린산염완충액1000 mL위석방개질，전속위100 r·min-1，온도위（37±0．5）℃，용자외분광광도법진행함량측정。분별대불동엄가적염산이갑쌍고완석편，진행체외석방시험，계산루적석방백분솔，회제석방곡선；계산f2상사인자。결과량충진구제제적상사인자f2위93．54。불동국산제제여진구제제적상사인자f2의차위：47．80、48．10、49．67、66．27、47．65、70．53、67．05；각국산제제여BIOVAIL제제적상사인자f2의차위：49．21、49．49、51．25、67．00、49．05、68．22、67．21。결론불동국산제제여진구제제적체외석약행위존재명현차이。
Objective To study the release rate of metformin hydrochloride sustained-release tablets in vitro by different manufacturers, in order to provide the basis for clinical rational drug use.Methods According to the standard of metformin hydrochloride sustained-release tablets (imported drug registration standard JX2001 0451 )and related references,the stripping device of rotating basket method was adopted for the release experiment in vitro.Phosphate buffer solution 1 000 mL with pH 6.8 was used as medium,at 1 00 rpm rota-tion speed,and the temperature was at (37 ±0.5 )℃.The content was determined by UV spectrophotometry.In vitro release tests of metformin hydrochloride sustained-release tablets of different manufacturers were taken and the cumulative release percentage,drawing stripping curve and f2 similarity factor were calculated.Results The f2 similarity factor of two kinds of imported preparation was 93.54.The f2 similarity factors of the domestic preparation and Bristol-Myers Squibb formulation were 47.80,48.1 0,49.67,66.27, 47.65,70.53,67.05,respectively;and the f2 similarity factors of the domestic preparation and BIOVAIL formulation are 49.21 , 49.49,51 .25,67.00,49.05,68.22,67.21 ,respectively.Conclusions The domestic and imported preparations have significant differ-ences in drug release behavior in vitro.
