中藥質(zhì)量均一、穩(wěn)定是確保臨床用藥安全有效的核心要素，受中藥材原料質(zhì)量、生產(chǎn)設(shè)備與工藝穩(wěn)定性和質(zhì)量標(biāo)準(zhǔn)控制體系等因素影響。中藥材及飲片作為中藥制劑生產(chǎn)的起始原料，處于產(chǎn)業(yè)鏈前端，其質(zhì)量評(píng)價(jià)與控制對(duì)中藥質(zhì)量提升具有引領(lǐng)作用。通過(guò)總結(jié)中藥材及飲片質(zhì)量波動(dòng)的評(píng)價(jià)控制方法和遺傳成因，探討基于藥用植物分子遺傳學(xué)和本草基因組學(xué)的DNA條形碼內(nèi)變異等遺傳多態(tài)性方法以評(píng)價(jià)和控制中藥材及飲片質(zhì)量均一性的可行性，包括增強(qiáng)基原品種鑒定的正確性及控制批內(nèi)/批間化學(xué)質(zhì)量波動(dòng)等策略，從品種選育、栽培、加工、投料等前期環(huán)節(jié)進(jìn)行質(zhì)量均一性控制，參與保障中藥材及飲片質(zhì)量穩(wěn)定，促進(jìn)中藥質(zhì)量均一、穩(wěn)定，推動(dòng)中醫(yī)藥大健康產(chǎn)業(yè)可持續(xù)發(fā)展。

The quality uniformity and stability of traditional Chinese medicine (TCM), which affected by numerous factors including the diverse sources of Chinese medicinal materials (CMMs), stability in pharmaceutical equipment and processes, and the imperfections of quality standards, are the foundation to ensure the safety and efficacy of their clinical applications. As the starting raw materials, CMMs are the forefront of production chain, its quality evaluation and control play a key role in improving the quality of TCM. By summarizing the evaluation and control methods and genetic causes of quality fluctuations of CMMs and decoction pieces, the feasibility of genetic polymorphism methods such as DNA barcode inner-variants based on medicinal plant molecular genetics and herbgenomics to evaluate and control the quality uniformity of CMMs and decoction pieces. The strategies are proposed to enhance the accuracy of germplasm origin identification and control the chemical quality fluctuations within and between batches, focusing on quality uniformity control on TCM germplasm, cultivation, processing, material input, and production inspection, with view to promoting the uniformity and stability of CMMs and decoction pieces and driving the sustainable development of TCM health industry.

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國(guó)家重點(diǎn)研發(fā)計(jì)劃（2023YFC3504000）；山西省科技創(chuàng)新人才團(tuán)隊(duì)專(zhuān)項(xiàng)資助項(xiàng)目（202204051001030）