OBJECTIVE To discuss the difficulties in t he development of complex preparations and puts forward solutions ，in order to provide some reference for the development and preparation of complex preparations. METHODS Based on the development status of complex preparations ，the challenges faced by the development of complex preparations were analyzed ，and the countermeasures for the development of complex preparations were proposed. RESULTS & CONCLUSIONS The development of complex preparations required high quality of personnel ，and was limited by pharmaceutical excipients ，delivery devices and pharmaceutical equipment. The preparation process was complex ，there were many quality control parameters and patent barriers. Complex preparation development enterprises need to pay more attention to talents ，pharmaceutical excipients ，delivery devices and pharmaceutical equipment ，and clarify the impact of key technology on preparation production and quality characteristics ；in addition，they need to strengthen independent research and development ，crack the patent layout of original research enterprises and protect their own innovative achievements. Domestic complex preparation development enterprises can combine imitation and innovation to develop complex preparation products with independent brands to better meet the needs of patients.