CAJ | 학술논문

目的：建立硫辛酸片在不同pH值溶出介质中的溶出度方法。方法按照中国药典2010年版二部附录溶出度测定法第二法（桨法），以4种不同pH值溶液作为溶出介质，转速为75 r? min －1，采用HPLC法进行检测并计算溶出度。结果样品浓度在16．77～167．7μg? mL －1范围内呈良好的线性关系（r＝0．9999）；在4种溶出介质中的平均回收率分别为：99．28％、99．60％、99．39％、99．76％，RSD 分别为：0．32％、0．71％、0．49％、0．44％（ n＝9）。结论建立了硫辛酸片在4种溶出介质中相应的溶出度方法，该方法简单、准确，可为仿制药与原研药的质量一致性评价提供参考。
목적：건립류신산편재불동pH치용출개질중적용출도방법。방법안조중국약전2010년판이부부록용출도측정법제이법（장법），이4충불동pH치용액작위용출개질，전속위75 r? min －1，채용HPLC법진행검측병계산용출도。결과양품농도재16．77～167．7μg? mL －1범위내정량호적선성관계（r＝0．9999）；재4충용출개질중적평균회수솔분별위：99．28％、99．60％、99．39％、99．76％，RSD 분별위：0．32％、0．71％、0．49％、0．44％（ n＝9）。결론건립료류신산편재4충용출개질중상응적용출도방법，해방법간단、준학，가위방제약여원연약적질량일치성평개제공삼고。
OBJECTIVE To establish dissolution methods of Lipoic Acid Tablets in dissolution media with dif-ferent pH values.METHODS According to the second determination method of dissolution rate ( paddle method ) stated in Chinese Pharmacopoeia (2010 edition),the dissolution rate was analyzed and calculated by HPLC at the ro-tation speed of 75 r? min-1 in four kinds of dissolution media with different pH values .RESULTS The calibration was line in concentration range of 16.77μg? mL-1 ~167.7μg? mL-1 ( r=0.9999 );The average recovery respec-tively was 99.28%,99.60%,99.39%,99.76%( RSD respectively was 0.32%,0.71%,0.49%,0.44%) in four kinds of dissolution media .CONCLUSION It has been established that the dissolution methods of Lipoic Acid Tablets in four dissolution media ,which is simple ,accurate and a reference for the quality consistency evaluation be-tween generic drugs and original ones .