中国中药杂志

2016, v.41(08) 1367-1375

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中药饮片标准汤剂研究策略
Research strategies in standard decoction of medicinal slices

陈士林;刘安;李琦;杉田享;朱广伟;孙奕;代云桃;章军;张铁军;友田健久;刘昌孝;
CHEN Shi-lin;LIU An;LI Qi;Toru Sugita;ZHU Guang-wei;SUN Yi;DAI Yun-tao;ZHANG Jun;ZHANG Tie-jun;Takehisa Tomoda;LIU Chang-xiao;Institute of Chinese Materia Medica,China Academy of Chinese Medicinal Sciences;Shanghai Traditional Chinese Medicine Co.,Ltd.;TSUMURA & Co.;Research Center for New Drug Evaluation,Tianjin Institute of Pharmaceutical Research;

摘要(Abstract):

该文通过探讨国内外饮片标准汤剂相关研究状况,结合实验数据,提出中药饮片标准汤剂是以中医理论为指导、临床应用为基础,参考现代提取方法,经标准化工艺制备而成的单味中药饮片水煎剂,并规范了工艺参数和质量标准建立原则,建立标准汤剂的药效物质基准与生物学基准,提出了中药饮片标准汤剂制备及质量标准流程。中药饮片标准汤剂作为一种标准物质和标准体系,能够用于标化临床用药,规范目前临床广泛使用的包括配方颗粒在内的新型饮片形式,保障用药的准确性和剂量的一致性,解决目前饮片形式多样性带来的监管困境。中药饮片标准汤剂的研究将为配方颗粒、经典复方标准汤剂和中药药对标准汤剂的研究提供有益参考。
This paper discusses the research situation of the standard decoction of medicinal slices at home and abroad. Combined with the experimental data,the author proposes that the standard decoction of medicinal slices is made of single herb using standard process which should be guided by the theory of traditional Chinese medicine,based on clinical practice and referred to modern extraction method with a standard process. And the author also proposes the principles of establishing the specification of process parameters and quality standards and established the basis of drug efficacy material and biological reference. As a standard material and standard system,the standard decoction of medicinal slices can provide standards for clinical medication,standardize the use of the new type of medicinal slices especially for dispensing granules,which were widely used in clinical. It can ensure the accuracy of drugs and consistency of dose,and to solve current supervision difficulties. Moreover the study of standard decoction of medicinal slices will provide the research on dispensing granules,traditional Chinese medicine prescription standard decoction and couplet medicines standard decoction a useful reference.

关键词(KeyWords): 标准汤剂;中药饮片;配方颗粒
standard decoction;Chinese herbal medicines;dispensing granules

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作者(Author): 陈士林;刘安;李琦;杉田享;朱广伟;孙奕;代云桃;章军;张铁军;友田健久;刘昌孝;
CHEN Shi-lin;LIU An;LI Qi;Toru Sugita;ZHU Guang-wei;SUN Yi;DAI Yun-tao;ZHANG Jun;ZHANG Tie-jun;Takehisa Tomoda;LIU Chang-xiao;Institute of Chinese Materia Medica,China Academy of Chinese Medicinal Sciences;Shanghai Traditional Chinese Medicine Co.,Ltd.;TSUMURA & Co.;Research Center for New Drug Evaluation,Tianjin Institute of Pharmaceutical Research;

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