中藥注射劑作為中藥現(xiàn)代化的重要代表，已成為中醫(yī)藥產(chǎn)業(yè)不可或缺的一部分。中藥注射劑質(zhì)量控制研究決定其安全性與有效性。針對中藥注射劑成分復(fù)雜、藥效物質(zhì)基礎(chǔ)不明確等問題，利用高效液相色譜法、氣相色譜法等對其內(nèi)在成分進(jìn)行定量，從單一指標(biāo)到多指標(biāo)，結(jié)合指紋圖譜、模式識別、譜效關(guān)系、質(zhì)量標(biāo)志物（Q-marker）的研究也取得很大的進(jìn)展。從多指標(biāo)定量測定、指紋圖譜以及譜效關(guān)系和Q-marker等方面，對近年來中藥注射劑質(zhì)量控制研究成果進(jìn)行綜述。

As an important representative of modern Chinese medicine, traditional Chinese medicine injections (TCMI) have become an indispensable part of the Chinese medicine industry. The quality standard researches of TCMI determine the safety and effectiveness of TCMI. In view of the complex ingredients of TCMI and unclear pharmacological material basis, modern pharmacy researches have made a lot of remarkable progress on the determination of intrinsic components by high performance liquid chromatography, gas chromatography and so on; From single-index to multi-index, combined with fingerprints, pattern recognition, spectrum-effect relationships, and quality markers, which bring new hope for the development of TCMI industry. In this paper, the progress on quality control of TCMI was summarized in aspect of the quantitative determination of multi-index, fingerprint spectrum, spectrum-effect relationship, Q-marker etc.

“重大新藥創(chuàng)制”科技重大專項（2013ZX09402202）