簡要回顧我國對中西藥復(fù)方制劑的管理歷程，從注冊監(jiān)管和質(zhì)量控制角度對該類制劑存在的問題進行分析，并指出改進措施。在注冊監(jiān)管方面，目前尚存在管理類別歸屬混亂、基礎(chǔ)研究薄弱、一號多規(guī)、名稱不統(tǒng)一以及規(guī)格描述不規(guī)范等問題；在質(zhì)量控制方面，從關(guān)鍵項目（如有關(guān)物質(zhì)、含量均勻性以及溶出度檢查項）的缺失，與該類制劑在醫(yī)療安全方面存在的隱患進行了關(guān)聯(lián)分析，探討藥品再評價的必要性，并提出了改進建議，以期為中西藥復(fù)方制劑的科學(xué)監(jiān)管提供有益參考。

In this paper, the management process of Chinese-Western medicine compound preparation is briefly reviewed. the existing problems were analyzed from the perspective of registration supervision and quality control. It is pointed out that there are still some types of management in the registration of supervision, such as the weak basic research, approval number of multiple pecifications, not uniform name, and not standardized specification. In the area of quality control, correlation analysis between the lack of key items (such as related substances, uniformity of contents, and dissolution test items) and the hidden dangers in medical security of preparations was performed. To explore the need for reevaluation, and put forward some suggestions for improvement in order to provide a useful reference for the scientific supervision of Chinese-Western medicine compound preparation.