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曾俊,阮剑芳,孟霞,谢细妹,李倩雯,徐雄波
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阮剑芳,孟霞,,李倩雯 and 徐雄波
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摘要: 目的:比较不同厂家非那雄胺片在4种不同溶出介质中的溶出曲线,为全面评价药品质量提供依据。方法:采用桨法,以4种不同溶出介质各900 mL,转速为50 r?min-1,采用HPLC法,测定不同厂家非那雄胺片溶出曲线。结果:不同厂家的非那雄胺片在4种溶出介质中的溶出曲线不完全相似。结论:相关厂家应改进制剂的处方工艺,以改善制剂的溶出行为,提高药品质量。
Abstract: Objective: To compare the dissolution profiles of finasteride tablets from different pharmaceutical manufactures in 4 dissolution mediums,and provide the basis for a comprehensive evaluation of the quality of finasteride tablets. Methods: The dissolution profiles of finasteride tablets were determined by HPLC method with 900mL of different dissolution medium and 50rpm by paddle method. Results: The dissolution profiles of finasteride tablets produced by different manufacturers in 4 dissolution media are not completely similar.Conclusion: It is advised that pharmaceutical manufactures should improve the product quality by changing the formulation and process.
曾俊,阮剑芳,孟霞,谢细妹,李倩雯,徐雄波. 不同厂家非那雄胺片在4种溶出介质中的 溶出曲线比较研究[J]. .
阮剑芳,孟霞,,李倩雯 and 徐雄波. Comparative Studies on Dissolution Curves of Finasteride Tablets from Different Pharmaceutical Manufactures in 4 Dissolution Mediums[J]. .
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http://www.zgywpj.cn/CN/Y2016/V33/I6/481