Quality consistency evaluation between dispensing granules and traditional decoction of Gardeniae Fructus based on chemical similarity and bioequivalence.

Dispensing granules of Chinese herbal medicines are gaining more and more recognition. Despite this, how to evaluate the quality consistency between traditional decoction and its corresponding dispensing granules is a challenging task. In this work, we attempted to propose a comprehensive strategy through in vitro and in vivo comparisons to overcome this challenge, taking Gardeniae Fructus as a typical case. On one hand, HPLC fingerprinting and multi-component quantification were performed to evaluate chemical similarity. On the other hand, pharmacokinetic profiling was conducted to estimate bioequivalence in terms of concentration-time curve and key pharmacokinetic parameters. The in vitro and in vivo comparison results demonstrated that there were no significant differences between these two dosage forms. This proposed strategy is applicable not only for quality consistency evaluation between dispensing granules and traditional decoction but also for broader application scenarios.