双醋瑞因胶囊溶出曲线的建立及体内外相关性研究

Establishment of Dissolution Curve of Diacerein Capsules and Its Correlation in Vivo and in Vitro

参考印度药典及进口注册标准中双醋瑞因胶囊的溶出度方法,建立了双醋瑞因胶囊具有区分力的溶出曲线测定法,并对此测定方法的区分力进行考察及方法学验证,最终用其评价自制双醋瑞因胶囊与参比制剂溶出曲线的相似性,同时通过体内生物等效性研究结合体外溶出试验结果分析体外溶出和体内吸收的相关性。结果显示,筛选得到的具有区分力的溶出方法可以用于区分不同处方工艺双醋瑞因胶囊的质量差异,且其方法学验证结果均符合规定,自制双醋瑞因胶囊和参比制剂在各介质中均具有相似的溶出特性,在体内具有生物等效性,提示该溶出曲线具有一定的体内外相关性。本研究为双醋瑞因胶囊的一致性评价提供了试验依据。

According to the dissolution method of diacerein capsules in Indian Pharmacopoeia and import registration standard,the discriminatory dissolution method of diacerein capsules was established,then its discriminatory power was investigated and the methodology was verified,finally,the similarity of dissolution curve between the self-made diacerein capsules and the reference preparation was evaluated,the bioequivalence study was used to analyze correlation between in vitro drug dissolution and in vivo drug absorption combined with dissolution test.The results showed that the discriminatory dissolution method obtained by screening can be used to distinguish the quality differences of diacerein capsules with different formulations,and its methodological verification results are in line with the regulations.The self-made diacerein capsules and reference preparations have similar dissolution characteristics in each medium and had good in vitro and in vivo correlation.This study could provide a experimental basis for the consistency evaluation of diacerein capsules.