国产多潘立酮片溶出曲线评价研究

Evaluation of Dissolution Curves for Domestic-made Domperidone Tablets

目的:测定19家企业多潘立酮片在4种溶出介质中的溶出曲线,并与原研企业产品的溶出曲线进行比较,为全面评价药品质量的有效性提供依据。方法:采用桨法,以4种溶出介质各500 m L为溶出介质,转速50 r·min-1,采用紫外分光光度法测定溶出量绘制溶出曲线,并用f2因子法进行比较分析。结果:仅有1家企业的样品在4种溶出介质中与参比制剂完全相似,其他企业的产品都与参比制剂存在差异。结论:我国多潘立酮片的质量与参比制剂存在着较大的差距。建议与原研企业溶出曲线不一致的相关企业改进制剂的处方工艺以提高药品质量。

Objective：To determine the dissolution profiles of domperidone tablets of 19 pharmaceutical manufactures in 4 dissolution mediums,and compared with the original research enterprise and provide the basis for a comprehensive evaluation of the effectiveness of domperidone tablets.Methods：The paddle method was adopted at 50 r＆#183; min^-1 ,the dissolution profiles were determined with ultraviolet spectrophotometry（ UV） ,and comparatively analyzed by the f2 factor method.Results：Only one manufacture′s product was similar to ref-erence product in all 4 dissolution mediums, the others all had differences.Conclusion： There is a big gap between our domperidone quality and the reference product.It is advised that pharmaceutical manufactures should improve the product quality by changing the for-mulation and process.