隨著藥物研發(fā)技術(shù)和檢測(cè)方法的快速發(fā)展，各國(guó)均制定了雜質(zhì)或有害物質(zhì)殘留控制的指導(dǎo)原則。遵循“建立研究目標(biāo)→確立雜質(zhì)檢測(cè)方法→樣品檢測(cè)→綜合評(píng)價(jià)→建立限度并進(jìn)行控制”的研究思路，根據(jù)雜質(zhì)的不同來(lái)源、雜質(zhì)的危害性、過(guò)程中去除的難易等因素來(lái)確定其在終產(chǎn)品中是否定入質(zhì)量標(biāo)準(zhǔn)。從以上幾方面綜述了近年來(lái)藥物中雜質(zhì)及有害物質(zhì)控制限度的研究進(jìn)展。

Along with the rapid development of the drug research technology and detection methods, many guidelines were introduced focusing on impurities or hazardous substances residual in drugs by various countries. According to the procedure "establish the study target → develop the impurities testing method → sample determination → overall evaluation → setting limit and control", the impurities may be evaluated whether to control in final products within the different factors, such as impurity sources, impurity harmfulness, removal difficulty from the final product, etc. Research progress on quality control of impurities or hazardous substances in drugs are summarized in this paper from above aspects.

國(guó)家科技重大專項(xiàng)資助項(xiàng)目（2014ZX09201022-004）