Huang Hong-Xia, Li Wen-Long, Qu Hai-Bin, Zhao Bu-Chang, Zhao Tao
Pharmaceutical Informatics Institute, Zhejiang University, Hangzhou 310058, China.
Zhongguo Zhong Yao Za Zhi. 2013 Jun;38(11):1663-6.
Extraction process trajectory of Danhong injection by near-infrared (NIR) spectroscopy in conjunction with multivariate data analysis techniques was developed for in-line monitoring of extraction process. To capture the variation of batch process, the use of score, Hotelling T2 and DModX control charts was investigated for real-time monitoring of extraction process. Various abnormal behaviors of the test batches were detected in time by comparing the extraction process trajectory. It was concluded that the process trajectory for in-line quality control based on NIR spectroscopy was a feasible technology tool of the total process quality control during traditional Chinese medicine (TCM) manufacturing process.
采用近红外（NIR）光谱结合多元数据分析技术，建立了丹红注射液提取过程轨迹，用于提取过程的在线监测。为了捕捉批次过程的变化，研究了使用得分图、霍特林T2控制图和DModX控制图对提取过程进行实时监测。通过比较提取过程轨迹，及时检测出了测试批次的各种异常行为。得出结论：基于近红外光谱的在线质量控制过程轨迹是中药制造过程中全过程质量控制的一种可行技术工具。
