Establishment of Dissolution Curve of Diacerein Capsules and Its Correlation in Vivo and in Vitro
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.
diacerein capsuledissolution curvesimilarityin vivo and in vitro correlationconsistency evaluation
万方数据
维普
