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自2005年版《中国药典》将金(山)银花分列后,纷争便不断上演,且愈演愈烈。尽管《中国药典》将“双花”分列,却没有给出两者在中药药性、功效主治、用法用量的差异以及具体解决办法,难以使中药行业人员信服。众所周知,在漫长的中药入药史上,一药多种,一种多药的现象俯首可拾;到底能合能分应该由临床等效情况确定。透过2015年版《中国药典》,仍可看出金(山)银花之纷争仍未找到科学的解决办法,这可能欠缺对中医临床治病的“异病同治”、“同病异治”与“同证多方”、“一方多证”的用药规律全面分析;更没有深邃分析中药多成分与经络脏腑作用超分子“印迹模板”自主作用规律;也没有关注中药复方多成分的有效性与安全性评价技术的进步;仍然受到了“一药一构一效”唯成分论用药模式影响;再加上中药临床前与临床中的生物等效性研究方法贫匮,终使问题得不到解决。金(山)银花分合列之争表象是地域经济、药物有效性与安全性的生物等效性之争,实际上却是中医药学科临床辨证施治治病的原理之争;更确切地说是中西医治病用药的药物观念之争。该文将梳理金(山)银花研究现状,结合中医临床治病的整体辨证施治与遣药组方治病的“异病同治”、“同病异治”与“同证多方”、“一方多证”的规律;运用超分子“印迹模板”自主作用规律阐明金(山)银花的“异质等效”的中药药理特有规律;并提出金(山)银花生物等效性的研究方法,为解决金(山)花的分合问题,促进中药材产业的发展奠定基础。
Since the 2005 edition of “Chinese Pharmacopoeia” will Jin (Hill) Silver Flower breakdown, the dispute will continue to staged, and intensified. Although the “Chinese Pharmacopoeia” will be “double flower ” is disaggregated, but did not give the two in the Chinese medicine, efficacy indications, differences in usage and specific solutions, it is difficult to convince the Chinese medicine industry. As we all know, in the long history of Chinese medicine into the medicine, a variety of drugs, a multi-drug phenomenon can bow to the end; in the end to meet the energy points should be determined by clinical equivalence. Through the 2015 edition of the “Chinese Pharmacopoeia”, we can still see that there is still no scientific solution to the disputes in the Golden Mountain (Silver Mountain), which may lack the scientific basis for clinical treatment of traditional Chinese medicine “There is no deep analysis of the autonomic rules of Chinese medicine multi-component and meridian organs” “imprinting template”; Not concerned about the effectiveness of multi-component traditional Chinese medicine compound and safety evaluation of the progress of the technology; still subject to “a drug a structure effect” “only component of the impact of the drug model; together with traditional Chinese medicine preclinical and clinical bioequivalence Poor research methods of sexuality, and ultimately the problem can not be solved. The dispute over the golden hill and the flower arrangement is actually a dispute over the bioequivalence of regional economy, drug effectiveness and safety, but it is actually a debate over the principle of clinical syndrome differentiation and treatment of traditional Chinese medicine To say that the Western medicine treatment of drug controversy. This article will sort out the current research status of Jin (Shan) Yin-hua, combining the syndrome differentiation and syndrome differentiation of traditional Chinese medicine clinical treatment with the prescription of ” Multi-card “, ” one party more card “rule; use super molecule ” imprinting template “autonomy law to clarify the unique law of” heterogeneous equivalent And proposed Jin (Hill) Silver Flower bioequivalence research methods, in order to solve the Jin (Shan) flowers division and integration, and promote the development of Chinese herbal medicine industry to lay the foundation.