He Fu-Yuan, He Hong, Deng Kai-Wen, Yang Yan-Tao, Zhou Yi-Qun, Shi Ji-Lian, Liu Weng-Long, Tang Yu
Department of Pharmaceutics, Hunan University of Chinese Medicine, Changsha 410208, China.
Key Laboratory for Traditional Chinese Medicine Property and Pharmacodynamics, State Administration of Chinese Medicine, Changsha 410208, China.
Zhongguo Zhong Yao Za Zhi. 2016 Mar;41(6):1152-1160. doi: 10.4268/cjcmm20160630.
More and more disputes have happened to confront us continuously since the separation of Japanese(wild) honeysuckle flower in Chinese Pharmacopoeia in 2005. The state pharmacopeia committee decided to separate Japanese(wild) honeysuckle flower into two species for japanese(wild) honeysuckle flower, but didn't define their the convincing reasons still did not provide to us as a result that two medicines are not described the differences in natural properties, efficiency and indication, usage and dosage, as well as not given a resolving methodand specific solution. It was known for us that in the history of traditional Chinese medicine（TCM）, the phenomenenphenomena of the "one drug from multi-species" and "one species for multi-drug" are very ordinary thingswere ubiquitous. Whether separation of the drug species are separated shall be decided to by clinical efficiency. Through Chinese pharmacopoeia (2015 edition) issue of Chinese Pharmacopoeia the 2015 issue of the Chinese Pharmacopoeia, we still cannot find a scientific solution for the dispute of for Japanese (wild) honeysuckle flower, perhaps because of insufficient reorganization of TCM clinical medication regularities, such as "treatment of different diseases with same drug", " treatment of the same disease with different drugs" and "treatment of the same syndrome with multi-prescriptions", and "one prescription treating multiple syndromes"; lack of in-depth analysis for multi-component TCM compounds and autonomisation of "supermolecular template" for organs and meridians; less attention to the advance of efficacy and safety evaluation technologies for multi-component TCM compounds; impacts from the medication mode of "one ingredient-one composition-one effect"; as well as insufficient research methods for bioequivalent evaluation in preclinic and clinic studies . The dispute for species combination or separation for Japanese(wild) honeysuckle flower was apparently caused by regional economy, drug biological equivalent of efficacy and safety, but arising from clinical principles for systematical syndrome treatment with TCM, or concepts in the treatment of diseases with TCM or western medicines. This paper focused on current studies on Japanese(wild) honeysuckle flower in the combination with TCM clinical medication regularities, such as "treatment of different diseases with same drug", "treatment of the same disease with different drugs" and "treatment of the same syndrome with multi-prescriptions", and "one prescription treating multiple syndromes", expounded the specific pharmacological regularity of "heterogeneous equivalence" of Japanese (wild) honeysuckle flower, and put forward methods for studying bioequivalence of Japanese(wild) honeysuckle flower, in order to solve the combination and separation of Japanese(wild) honeysuckle flower and lay a foundation for promoting the development of Chinese herbal medicine industry.
自2005年日本（野生）金银花在《中国药典》中被单列出来后，越来越多的争议不断摆在我们面前。国家药典委员会决定将日本（野生）金银花分为两个品种，但未明确其令人信服的理由，且两种药材在自然属性、功效与主治、用法用量等方面未描述差异，也未给出解决方法和具体方案。我们知道，在中医药历史上，“一物多基原”和“一基原多物”的现象很普遍。药材品种是否分离应取决于临床疗效。通过《中国药典》（2015年版），我们仍未找到日本（野生）金银花争议的科学解决方案，这可能是由于对中医临床用药规律如“异病同治”“同病异治”“同证多方”“一方多证”的整理不足；对中药多成分化合物缺乏深入分析以及脏腑经络“超分子模板”的自主化；对中药多成分化合物功效和安全性评价技术进展关注较少；受“一成分一组成一效应”用药模式的影响；以及临床前和临床研究中生物等效性评价研究方法不足。日本（野生）金银花品种合并或分离的争议表面上是由区域经济、药材功效和安全性的生物等效性引起的，但根源在于中医系统辨证论治的临床原则，或中医与西医治疗疾病的理念。本文结合中医临床用药规律如“异病同治”“同病异治”“同证多方”“一方多证”，重点探讨了日本（野生）金银花目前的研究情况，阐述了日本（野生）金银花“异类等效”的具体药理规律，并提出了日本（野生）金银花生物等效性研究方法，以解决日本（野生）金银花的合并与分离问题，为促进中药产业发展奠定基础。
