简要回顾我国对中西药复方制剂的管理历程，从注册监管和质量控制角度对该类制剂存在的问题进行分析，并指出改进措施。在注册监管方面，目前尚存在管理类别归属混乱、基础研究薄弱、一号多规、名称不统一以及规格描述不规范等问题；在质量控制方面，从关键项目（如有关物质、含量均匀性以及溶出度检查项）的缺失，与该类制剂在医疗安全方面存在的隐患进行了关联分析，探讨药品再评价的必要性，并提出了改进建议，以期为中西药复方制剂的科学监管提供有益参考。

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.