以清开灵注射液为代表的中药注射剂正面临着安全性问题的严峻挑战，清开灵注射液生产工艺复杂、周期长，整个工艺过程缺乏严密完善的监控手段，因而无法确保制剂质量的均一稳定，进而影响制剂的安全性。因此，本文从加强清开灵注射液生产工艺过程监控的角度出发，以金银花液生产过程为载体，研究先进控制策略———多元统计过程监控（MSPM）在中药生产工艺中的应用。该方法采用PCA 将金银花液生产过程中的40 个过程参数投影到主成分代表的空间，在合理选择主元数目的基础上建立主元得分图、SPE 图和Hotelling T2 图，用于生产过程的监控，并提供控制限。同时在此基础上研究了通过贡献图进行过程故障诊断的方法。从制剂生产过程监控角度出发，该研究结果将为降低中药注射剂安全性风险提供切实可行的思路。

Chinese medicine injections, represented by the Qingkailing injection, are confronted with the severe challenge on issue of clinical safety. Due to the complex and long production cycle of Qinkailing injection, there is a lack of rigid and perfect monitoring approach for the production process to assure the uniformity, stability and good quality of the final preparations. In order to strengthen the monitoring of manufacturing process of Qingkailing injection, the manufacturing process of Jinyinhua extract is chosen as a model to study the application of multivariate statistical process monitoring (MSPM) strategy on the manufacturing process of traditional Chinese medicine (TCM) preparation. The principle component score chart, SPE chart and Hotelling T2 chart are utilized in MSPM to provide necessary control limits. Furthermore, the mechanism of fault diagnosis of production process is developed based on the established MSPM model. The expected achievements of our research will provide feasible ways for solving the safety problems of Chinese medicine injections from the process monitoring point of view.

科学技术部国家“重大新药创制”科技重大专项（2010ZX09502-002）：清开灵注射液安全性关键技术研究，负责人：乔延江；北京中医药大学自主选题资助项目（JYB22-XS034）：基于递推PCA 的金银花醇沉统计过程控制研究，负责人：徐冰。