Zhao An-Yi, Ni Feng-Yan, Chen Peng-Yue, Liu Yan, Liu An
Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China School of Pharmacy,Shanxi Medical University Taiyuan 030001, China.
Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences Beijing 100700, China Jiangxi University of Traditional Chinese Medicine Nanchang 330004, China.
Zhongguo Zhong Yao Za Zhi. 2020 Aug;45(15):3740-3748. doi: 10.19540/j.cnki.cjcmm.20200506.601.
The consistency of quality on Chinese patent drugs is a hotspot and difficulty in the control of traditional Chinese medicine preparations, and has become one of the bottlenecks restricting its internationalization. Based on the analysis of current studies on quality and problems of Chinese patent drugs, this paper explored relevant methods of quality evaluation on Chinese patent drugs and possible factors affecting the consistency of quality in the pharmaceutical cycle by consulting relevant literatures about quality evaluation methods and consistency control techniques of large-scale Chinese patent drugs. And it put forward the evaluation system on high-quality Chinese patent drugs with "consistency" as the core, so as to promote the overall improvement of the quality of Chinese patent drugs, guide the rational price of Chinese patent drugs of the same species, and provide a new reference model for the quality evaluation of Chinese patent drug.
中药专利药品质量的一致性是中药制剂质量控制中的热点和难点，已成为制约其国际化的瓶颈之一。在分析中药专利药品质量及问题的现有研究基础上，本文通过查阅大规模中药专利药品质量评价方法和一致性控制技术的相关文献，探讨了中药专利药品质量评价的相关方法以及药品生产周期中影响质量一致性的可能因素。并提出了以“一致性”为核心的优质中药专利药品评价体系，以促进中药专利药品质量的整体提升，引导同品种中药专利药品合理定价，为中药专利药品质量评价提供新的参考模式。
