Liu Jia-Meng, Liu Yan, Peng Jia-Hui, Sun Bo, Yang Jing-Fan, Fu Yu, Ma Sheng-Jun, Zhu Guang-Wei
Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China.
Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China Henan University of Chinese Medicine Zhengzhou 450046, China.
Zhongguo Zhong Yao Za Zhi. 2024 Aug;49(16):4537-4544. doi: 10.19540/j.cnki.cjcmm.20240423.302.
Chinese patent medicine constitutes a vital segment of the traditional Chinese medicine(TCM) industry and stands as a significant emblem of TCM modernization. At present, the quality stability between batches of Chinese patent medicine preparations has become a pivotal factor directly restricting the high-quality development of the TCM industry. Consequently, addressing the homogeneity of Chinese patent medicines, this paper proposes a research scheme of homogenization feeding. It systematically elaborates on the object and pretreatment of homogenization, operational procedures of homogenization feeding, selection of homogenization evaluation indices, homogenization feeding algorithm, and homogenization feeding process. With the key quality control indicators as the homogenization target, the homogenization feeding process and its quality analysis were discussed. Finally, a demonstration strategy for homogenization feeding of Chinese patent medicine was formed, providing the scientific basis for advancing the research of quality consistency across batches of Chinese patent medicine preparations.
中成药是中医药产业的重要组成部分，是中医药现代化的重要标志。目前，中成药制剂批次间质量稳定性已成为直接制约中医药产业高质量发展的关键因素。为此，针对中成药同质化问题，本文提出了均匀化投料的研究方案。系统阐述了均匀化的对象与预处理、均匀化投料操作流程、均匀化评价指标的选择、均匀化投料算法以及均匀化投料过程。以关键质量控制指标为均匀化目标，探讨了均匀化投料过程及其质量分析。最后形成了中成药均匀化投料的示范策略，为推进中成药制剂批次间质量一致性研究提供科学依据。
