Research on comprehensive quality consistency evaluation strategy for TCM Granules: A case study with sugar-free Yangwei Granules produced by fluid-bed granulation
Objective: To develop a quality consistency evaluation strategy for traditional Chinese medicine (TCM) granules using sugar free Yangwei Granules as a model drug, and demonstrate the effectiveness of the developed method. Methods: The strategy integrates several methods including, HPLC fingerprint and physical fingerprint methods analyze the similarity in chemical and physical properties of the TCM granule samples. Nearinfrared (NIR) spectroscopy with principal components cluster analysis method is used to monitor normal operating conditions (NOC) samples accurately and to identify different types of abnormal operating conditions (AOC) samples, particularly those that deviate from the normal range. Results: The combined use of HPLC fingerprint and physical fingerprint provides insights into the chemical and physical properties of the samples. NIR spectroscopy, combined with principal components cluster analysis, achieves high accuracy in monitoring NOC samples and identifying AOC samples without misjudgment. The approach proves useful as a complementary method in cases where HPLC fingerprint and physical fingerprint alone lack sufficient resolution. Conclusion: This study establishes the feasibility and utility of the integrated approach for assessing the quality consistency of TCM granules. The strategy shows a high degree of generalization and holds significant importance for enhancing the quality control processes of TCM granules.
关键词:
化学计量学;多变量分析;近红外光谱;质量一致性评价策略;无糖型养胃颗粒;中药颗粒
Keywords:
Project Supported:
This work was supported by the National Key Research and Development Program of China (No. 2023YFC3504501), the China Postdoctoral Science Foundation (No. 2024M752839), the National Natural Science Foundation of China (No. 82404868), and Postdoctoral Fellowship Program of CPSF (No. GZC20232358).
Jie Zhao, Geng Tian, Haibin Qu *. Research on comprehensive quality consistency evaluation strategy for TCM Granules: A case study with sugar-free Yangwei Granules produced by fluid-bed granulation[J]. Chinese Herbal Medicines (CHM),2025,17(3):575-583
