旨在探討中藥質(zhì)量一致性評價問題,試圖借鑒化學(xué)仿制藥與原研藥、生物類似物與原創(chuàng)藥質(zhì)量一致性評價發(fā)展現(xiàn)狀和方法思路,結(jié)合中藥自身的特殊性,總結(jié)目前在中藥質(zhì)量一致性評價領(lǐng)域具有應(yīng)用潛力的技術(shù)手段,包括近紅外光譜分析技術(shù)、生物活性檢測方法、指紋圖譜等技術(shù)手段,試圖尋找合適的中藥質(zhì)量一致性評價方法,為保障中藥的安全、有效提供借鑒與思考。

The study on the evaluation of quality consistency of Chinese materia medica (CMM) was presented in this paper. Based on the present and specificity of consistency evaluation for generic drug with its reference listed drug as well as biosimilar with its reference listed drug, combined with the general idea and the particularity of consistency evaluation for TCM, the paper describes the application of near infrared spectroscopy, bioassay and fingerprint in the quality consistency of CMM and investigates its application perspective, and tries to find a suitable evaluation method which can provide reference and thought for security and effectiveness of TCM.