Regulatory Technology: Column on Quality Control of Traditional Chinese Medicine
Wu Rui, Wu Dongxue, Xiao Meng, Lian Chaojie, Hu Xiaoru, Liu Jie, Wei Feng, Dai Shengyun, Zheng Jian
Objective: To establish the characteristic chromatograms and develop a high performance liquid chromatography (HPLC) method for the determination of multiple components in Zukamu granules, and to evaluate the quality of this preparation using chemical pattern recognition technology, thereby providing a basis for its quality control. Methods: The “Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System (2012 Edition)” was used to establish the HPLC characteristic chromatograms of 12 batches of Zukamu granules. The common peaks were identified and similarity evaluations were performed. An HPLC content determination method for five active components, namely gallic acid, rosmarinic acid, nicotiflorin, ethyl p-methoxycinnamate, and ammonium glycyrrhizinate in the samples was established, and the content determination was conducted. Cluster analysis and orthogonal partial least squares discriminant analysis were performed on Zukamu granules using SPSS 23.0 and SIMCA 14.1 software, with variable importance projection (VIP) values > 1.0 as the criterion for screening components affecting the quality of this preparation. Results: The characteristic chromatograms of 12 batches of samples and the multi-component determination method applied to 18 batches of samples were all verified by methodological studies. Among these, the similarity of the characteristic chromatograms of 12 batches of Zukamu granules was 0.993, 0.971, 0.987, 1.000, 0.999, 0.997, 0.994, 0.998, 0.999, 1.000, 0.999, and 0.999, respectively. A total of 10 common peaks were identified, with 5 of them identified by comparison with reference substances. In addition, the average contents of gallic acid, rosmarinic acid, nicotiflorin, ethyl p-methoxycinnamate, and ammonium glycyrrhizinate in 18 batches of Zukamu granules were determined to be 0.506, 0.124, 0.071, 0.003, and 0.089 mg · g-1, respectively. The results of cluster analysis and orthogonal partial least squares discriminant analysis indicated that the 18 batches of Zukamu granules could be grouped into two categories, with ZKM03, ZKM05, and ZKM13 in one category and the rest in another. The VIP values of peaks 1, 7, and 9 were above 1.0. Conclusion: The established characteristic chromatograms and content determination method are stable and reliable. Combined with chemical pattern recognition technology, they can be used to evaluate the overall quality of Zukamu granules. Gallic acid, nicotiflorin, and ethyl p-methoxycinnamate are the differential components affecting the quality of Zukamu granules.