Equivalence in the modernization of Chinese medicine: A multi-dimensional analysis of active components, processing methods, and clinical outcomes in formula granules.

Abstract

The feasibility of substituting traditional decoction pieces with Chinese herbal formula granules fundamentally hinges on the equivalence of their active components. Formula granules face complex compositional changes during manufacturing: volatile oils suffer substantial losses (retention rates below 30% in aromatic herbs), thermolabile glycosides undergo degradation during high-temperature processing, and Maillard reactions generate novel compounds whose pharmacological contributions remain unclear. Although advanced analytical technologies such as ultra-performance liquid chromatography quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS) can identify thousands of components, existing quality control standards still rely on 1-3 pharmacopeial markers, and fingerprint similarity criteria lack uniformity (0.80-0.95), inadequately reflecting the true quality of multi-component systems. Bioequivalence studies demonstrate that formula granules generally exhibit 60-90% performance of traditional decoctions in vitro, with comparable area under the curve (AUC) and Cmax values for certain components but significant discrepancies for others. Critically, high chemical similarity cannot guarantee clinical therapeutic equivalence-the logical chain from"component equivalence" to "therapeutic equivalence" remains unestablished. Clinical research is sparse, with high-quality randomized controlled trials (RCTs) representing less than 5% of studies and head-to-head comparisons particularly scarce. Future research must develop volatile component preservation technologies, establish comprehensive synergistic effect evaluation methodologies, and most importantly, conduct large-scale clinical trials. Without these efforts, the scientific credibility and international acceptance of formula granules will remain questionable.