中藥質(zhì)量是中醫(yī)藥事業(yè)和產(chǎn)業(yè)高質(zhì)量發(fā)展的重要基石。在新的形勢(shì)下，如何科學(xué)理性地認(rèn)識(shí)中藥質(zhì)量的總體形勢(shì)和存在問題，如何破解長(zhǎng)期制約中藥現(xiàn)代化發(fā)展的質(zhì)量控制與標(biāo)準(zhǔn)化問題？從底層邏輯出發(fā)，重新審視中藥物質(zhì)內(nèi)涵的特質(zhì)性與質(zhì)控策略的合理性，并在原來(lái)基礎(chǔ)上補(bǔ)充修改提出新的“中藥大質(zhì)量觀”，即一組創(chuàng)新認(rèn)知、兩級(jí)監(jiān)管尺度、三維品質(zhì)內(nèi)涵、四象過程質(zhì)控策略、五級(jí)質(zhì)控力證據(jù)體。希冀為破解中藥質(zhì)量評(píng)控與標(biāo)準(zhǔn)化難題提供新理論、新策略、新方法。

The quality of traditional Chinese medicine (TCM) is a crucial cornerstone for the high-quality development of TCM industry and practice. Under the new situation, how can we develop a scientific and rational understanding of the overall state and existing challenges related to the quality of TCM? Furthermore, how can we solve the problems of quality control and standardization that have long restricted the modernization of TCM? From the perspective of underlying logic, this paper re-examines the characteristics of material connotation of TCM and the rationality of quality control strategies, and supplements and modifies the previous understanding to propose a new “macro-quality view” for TCM by supplementing and modifying the previous understanding. This perspective encompasses: a set of innovative cognitions, two-tier regulatory scales, three-dimensional quality connotations, four-phase process quality control strategies, and five-level evidence system for quality control effectiveness. It is hoped that this new perspective will offer novel theories, strategies, and methods for tackling the challenges associated with the quality evaluation and standardization of TCM.

中央本級(jí)重大增減支項(xiàng)目"名貴中藥資源可持續(xù)利用能力建設(shè)項(xiàng)目"(2060302);國(guó)家自然科學(xué)基金重點(diǎn)項(xiàng)目(81930110);國(guó)家自然科學(xué)基金重點(diǎn)項(xiàng)目(82230118)