自身对照法在阿司匹林肠溶片溶出曲线一致性评价中的应用

Application of self-control method in consistency evaluation of dissolution curve of Aspirin Enteric-coated Tablets

目的建立自身对照法测定阿司匹林肠溶片溶出曲线,探讨自身对照法在仿制药质量一致性评价中的应用,并比较3个厂家的样品在3种溶出介质中的溶出曲线,考察仿制制剂与参比制剂是否一致。方法采用自身对照法测定阿司匹林肠溶片溶出度并和高效液相色谱法进行比较,采用篮法,溶出介质为p H 1.0盐酸溶液、p H6.8缓冲液和p H 7.4缓冲液3种,转速100 rpm。结果自身对照法在10~120μg·m L-1浓度范围内呈线性(r=1.000),3种介质的方法回收率为100.7%~101.8%,RSD为0.71%~0.94%,溶出量测定结果与高效液相色谱法基本一致。在p H 1.0盐酸溶液中3个生产厂家的阿司匹林肠溶片溶出度基本一致,在其他2种溶出介质中,仿制制剂的溶出曲线均与参比制剂不相似。结论自身对照法方法简便、准确、可行,可作为仿制药质量一致性评价中溶出度测定的方法加以推广应用。

Objective To establish a self-control method for the determination of dissolution curves of Aspirin Enteric-coated Tablets and explore the method in the quality of generic drug evaluation.To compare the dissolution curves of aspirin enteric-coated tablets from 3 pharmaceutical manufactures in 3 dissolution mediums and discuss on the quality consistency between reference listed drug( RLD) and generic drug.Methods Basket method was adopted at 100 rpm,dissolution mediums was hydrochloride acid solution( p H 1.0) and phosphate buffer( p H 6.8 and p H 7.4),the dissolution profiles were determined with self-control method and HPLC.Results The linear range of aspirin was 10 ~ 120 μg·m L-1 and the correlation coefficient was 1.000.The recoveries were 100.7% ~ 101.8%,with RSDs of 0.71% ~ 0.94% in 3 dissolution mediums.The results of dissolution test are basically the same as those of HPLC.In the p H 1.0 hydrochloric acid solution,the dissolution of aspirin enteric-coated tablets from three manufacturers was basically the same.In the other two dissolution media,the dissolution profiles of the generic drug were not similar to the RLD.Conclusion The self-control method was simple,accurate and feasible.It can be used as a method for the determination of dissolution in the quality consistency evaluation of generic drug.