Multivariate Statistical Process Monitoring for Manufacturing Process of Jinyinhua Extract in Qingkailing Injection
清开灵注射液中金银花液生产工艺多元统计过程监控研究

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.