基于“效-毒”相关的经典名方复方制剂质量及制药过程一致性评价的研究思路探讨  

Discussion on the research idea of quality and pharmaceutical process consistency of classical compound prescriptions based on “efficacy-toxicity”

作　　者：徐男[1,2] 孙蓉 黄欣[4] 徐新刚 刘善新[1] 程立方[1] 王亮[1] 时海燕[4] XU Nan;SUN Rong;HUANG Xin;XU Xin-gang;LIU Shan-xin;CHENG Li-fang;WANG Liang;SHI Hai-yan(Shandong Research Academy of Traditional Chinese Medicine,Shandong Ji'nan 250014,China;Shandong University of Traditional Chinese Medicine,Chinese Medicine Postdoctoral Mobile Station,Shandong Ji'nan 250355,China;Shandong University,Institute of Advanced Medical Sciences,Shandong Ji'nan 250012,China;The First Affiliated Hospital of Shandong First Medical University,Shandong Ji'nan 250014,China)

机构地区：[1]山东省中医药研究院,山东济南250014 [2]山东中医药大学中医学博士后流动站,山东济南250355 [3]山东大学高等医学研究院,山东济南250012 [4]山东第一医科大学第一附属医院,山东济南250014

出　　处：《中国医院药学杂志》2019年第20期2118-2125,共8页Chinese Journal of Hospital Pharmacy

基　　金：山东省中医药科技发展计划项目(编号:2017-136),山东省中医药科技发展计划项目(编号:2019-0368),山东省中医药科技发展计划项目(编号:2013Z002-1,2,3,4);山东省重点研发计划项目(编号:2017CXGC1308);山东省自然科学基金项目(编号:ZR2015HL117);山东省泰山学者工程专项(编号:ts201511107)

摘　　要：为贯彻落实中医药法,国家中医药管理局及药品监督管理局先后发布了古代经典名方中药复方制剂开发的相关鼓励性政策,但是研究过程中的一些关键问题尚需进一步探讨。本文结合古代经典名方,尤其是包含有毒药味品种自身的特殊性,总结目前在中药一致性评价领域具有应用潜力的技术手段,包括色谱(高效液相、超高压液相等)指纹图谱技术、光谱分析(紫外光谱、近红外光谱等)技术、生物活性检测等技术手段,探讨从药学等效性和生物等效性(生物效价和毒价)两个角度构建经典名方复方制剂质量及制药过程一致性评价研究思路,实现传统制法与现代制药工艺间的"基本一致",保证经典名方复方制剂与传统汤剂内在质量、疗效及安全性的一致性,为中药经典名方复方制剂的开发提供借鉴与思考。In order to implement the law of traditional Chinese medicine, the State Administration of Traditional Chinese Medicine and the Drug Administration have issued incentive policies for the development of traditional Chinese medicine compound preparations, but some key issuesduring the research process have not yet reached consensus. Based on the particularity of ancient classical prescriptions, especially those containing toxic flavors, this paper summarizes the potential technical means in the field of consistency evaluation of traditional Chinese medicine, including chromatographic(high performance liquid chromatography, ultra-high pressure liquid chromatography, etc.) fingerprint technology, spectral analysis(ultraviolet spectrum, near infrared spectrum, etc.), and biological activity detection.The consistency evaluation model of the quality and pharmaceutical process of classical famous prescription compound preparation from two perspectives of equivalence and bioequivalence was investigated, to realize the "basic consistency" between traditional preparation method and modern pharmaceutical technology, ensuring the consistency of the internal quality, safety and efficacy between classical famous prescription, compound preparation and traditional decoction, and to provide reference and consideration for the development of classical famous prescription compound preparation of traditional Chinese medicine.

关 键 词：经典名方 "效-毒"相关 质量 制药过程 一致性评价 

分 类 号：R96[医药卫生—药理学]