| 利用光纤溶出仪测定布洛芬软胶囊的体外溶出度 |
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| 引用本文： | 孙荧,;胡敏,;聂善化.利用光纤溶出仪测定布洛芬软胶囊的体外溶出度[J].武警医学院学报,2014(12):1002-1004. |
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| 作者姓名： | 孙荧 ;胡敏 ;聂善化 |
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| 作者单位： | [1]湖北省食品药品监督检验研究院,湖北武汉430064; [2]武警湖北总队卫生处,湖北武汉430070 |
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| 摘 要： | 【目的】考察国内外共3个厂家布洛芬软胶囊的体外溶出度,为质量控制提供依据。【方法】采用FODT-601FX光纤溶出度仪,桨法,转速50 r/min,测定在4种p H溶出介质中的溶出曲线,并与液相色谱法测定结果进行了比较。【结果】FODT法测定结果与液相色谱法一致。国内产品较国外产品溶出略快,但均一性较差。与日本橙皮书中颗粒剂、片剂的参比制剂相比,软胶囊溶出更为迅速、完全。【结论】光纤溶出仪可对软胶囊的释放过程实时、连续监测。
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| 关 键 词： | 布洛芬 软胶囊 溶出度 光纤传感 |
Fiber dissolution tester for in vitro dissolution study of ibuprofen soft capsules |
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| Institution: | SUN Ying, HU Min, NIE Shan-hua( Hu Bei Institute For Food and Drug Control,Wuhan 430064, China) |
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| Abstract: | Objective ] To research the dissolution efficiency of ibuprofen soft capsules from 3 manufacturers. Methods ] The release profiles in 4 kinds of dissolution medium were recorded by FODT-601FX fiber dissolution system, with paddle at speed of 50 r/min, and compared with the result of HPLC. Results]The result of FODT was same with HPLC＇ s. With poor uniformity, products of domestic were dissolved faster than these from CVS. And Ibuprofen soft capsules were dissolved more completely than the reference of lbuprofen granules and Ibuprofen tablet in Japanese Orange Book. Conclusions] As an online analysis, real time information about dissolution behavior of preparations can be obtained effectively by fiber-optic sensor system. |
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| Keywords: | Ihuprofen Soft capsules Dissolution Fiber-optic sensor |
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