目的：探讨基于中医医院制剂处方的中药创新药处方优化模式。方法：采取文献回顾的方法，对中医医院制剂处方的重要性、特点进行分析，并对医院制剂处方的优化程序和方法进行总结和探讨。结果：医院制剂处方是新药开发的基础和重要来源，且临床基础良好，具有多品种、多剂型、疗效确切、安全可靠的特点，为新药开发的筛选提供了雄厚的物质基础，可缩短新药开发周期，减少研究经费。但医院制剂与新药还有一定的差距。总结优化工作体会，医院制剂处方的优化需要遵循中药创新药处方优化的一般原则和程序，从处方的组方优化、临床验证设计方案优化和阶段评估3个部分进行。优化要有重点进行，以重点优化带动处方的全面优化。在优化前对被评价处方进行第1次定性和定量评估。根据申办者的最终修改后处方，在临床验证前进行第2 次定性和定量评估。根据临床验证结果，在临床验证后，对处方进行第3 次定性和定量评估。结论：为基于中医医院制剂处方的中药创新药处方提供优化模式。

This study was aimed to investigate the optimization model of innovative Chinese medicine formulations based on traditional Chinese medicine (TCM) hospital preparations. A literature review was conducted to analyze the importance and characteristics of TCM hospital preparations. And then the optimization process and methods of hospital preparations were summarized and explored. The results showed that hospital preparation is an important and fundamental resource of new drug development, with characteristics of abundant clinical experience, multiple formulations, multiple dosage forms, well-established efficacy and reliable safety. Thus, hospital preparations may provide a rich material foundation for the screening of new drug development, which can shorten the development cycle and reduce the research cost. However, there is still a gap between hospital preparations and innovative drugs. Based on our optimization work experiences, the optimization of hospital preparations should comply with general principles and process of optimizing innovative Chinese medicine formulations, which can be divided into three parts, i.e. optimization of component formulation, optimization of clinical trial protocols and assessment before and after clinical trials. The optimization process should be well-focused, so as to facilitate comprehensive optimization. Before optimization, the investigational prescription should undergo qualitative and quantitative evaluation for the first time. Based on sponsor's final revision, the second qualitative and quantitative evaluation should be performed before the initiation of clinical trials. After clinical trials, the prescription should undergo qualitative and quantitative evaluation for the third time according to the findings of clinical trials. It was concluded that it is possible to provide an optimization model of innovative Chinese medicine formulations based on TCM hospital preparations.

科学技术部国家“重大新药创制”科技重大专项资助（2009ZX09301-005）：综合性中药新药研究开发技术平台，负责人：曹洪欣。