Establishment of Dissolution Test Method for Multi-Components in Traditional Chinese Medicine Preparations Based on In Vitro-In Vivo Correlation.

ABSTRACT: In this study, a multi-component integrated dissolution evaluation system of Yuanhu Zhitong tablets (YZTs) was established based on in vitro and in vivo correlation (IVIVC). The dissolution tests of five quality markers (Q-markers), including tetrahydropalmatine, α-allocryptopine, protopine, corydaline, and byakangelicin, in YZTs were conducted under different dissolution conditions, and pharmacokinetic studies were performed in beagle dogs to construct a correlation model using numerical deconvolution. The data of the five ingredients were integrated in vitro and in vivo according to the biopharmaceutical classification system (BCS) to establish an IVIVC integrating multiple Q-markers. The dissolution media with the best correlation of components were obtained and validated. The results s

SUBMITTER: Guo P 

PROVIDER: S-EPMC11359531 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature