中药标准制剂控制模式发展历程和构建全质量关控制中药质量模式

对近10年中药定量指纹图谱发展过程进行归纳总结，论述中药标准制剂概念的诞生过程。中药标准指纹对照物系列只有在国家层面上法规化，以标准制剂控制模式作为标准指纹对照物与待测药物样品随行对照检验和同步操作，最大程度消除分析系统误差。以全质量关：中药质量平衡（TCM—MB）、中药能量平衡（TCM-EB）和中药药效平衡（TCM—AEB）为基础，用具有恒定化学组成和等效的标准指纹对照物系列来实现中药真实质量的安全、稳定、均一和等价等效控制。中药标准制剂控制模式适应中药复杂性科学特征，能整体、动态、有效地控制好中药质量，是中药走向国际的必由之路。

History of the control mode for standard preparation and construction of overall quality control for traditional Chinese medicine

The birth processes of the concept of traditional Chinese medicine （TCM） standard preparation were discussed after summarizing the development of TCM quantitative fingerprint theories for more than 10 years. At the national regula- tion level, the standard preparation control mode was built as the standard fingerprint reference .material to test and monitor the sample quality so big the systematic errors could be greatly eliminated. Base on OQC-TCM, material balance, TCM energy balance and TCM active effect balance, the standard fingerprint reference series that had both a constant chemical composition and a equivalent efficacy were selected to realize the authentic TCM quality in security, stability, consistency and equivalence. The control mode of TCM standard preparation adapted to the characteristics of complexity science and could overall, dynamically and efficiently control the quality of TCM. Only in this way can TCM become international.