中藥注射劑近年來(lái)較頻繁地出現(xiàn)臨床不良反應(yīng)，其制備不規(guī)范以及臨床使用不當(dāng)是主要原因，但中藥注射劑質(zhì)量存在安全性風(fēng)險(xiǎn)以及質(zhì)量標(biāo)準(zhǔn)門檻過(guò)低也是原因之一。筆者在參加國(guó)家首批中藥注射液中的脈絡(luò)寧注射液評(píng)價(jià)性抽樣工作過(guò)程中，收獲了一些體會(huì)和研究思路，有必要?dú)w納總結(jié)，與同行交流，并供參考。

Chinese medicinal injection (CMI) has been presenting a series of adverse drug reactions (ADRs) for recent years. The main reasons are non-normative preparation and improper clinical usage, by which there are some riskness in safety and the quality standards of CMIs are too inferior. After the research work was undertaken on Mailuoning Injection that is in the first list of CMIs to be compulsively conducted a quality evaluation by SFDA, some experiences and research ideas have been obtained, which is necessary to summarize for an academic communication and to provide a reference for similar work.