CAJ | 학술논문

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 mL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。
목적：측정19가기업다반립동편재4충용출개질중적용출곡선，병여원연기업산품적용출곡선진행비교，위전면평개약품질량적유효성제공의거。방법：채용장법，이4충용출개질각500 mL위용출개질，전속50 r· min－1，채용자외분광광도법측정용출량회제용출곡선，병용f2인자법진행비교분석。결과：부유1가기업적양품재4충용출개질중여삼비제제완전상사，기타기업적산품도여삼비제제존재차이。결론：아국다반립동편적질량여삼비제제존재착교대적차거。건의여원연기업용출곡선불일치적상관기업개진제제적처방공예이제고약품질량。
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· 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.