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关于经典名方研发的一些重要关键信息和科学问题的几点看法 被引量:11

Views on Key Technical Problems in Research and Development of Famous Classical Formulas
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摘要 笔者拟针对中药经典名方研发中的重大关键技术问题进行分析,以期为经典名方的开发提供参考。首先,针对长期困惑行业的古代计量换算为现代计量单位的问题进行全面的阐述,认为“一两=3 g”更为合适。其次,针对从传统砂锅煎制的基准样品(ABS-C)的质量向实验室工艺、中试工艺、工业生产上的质量一致性转化的评价给出了评价模型和原则,一致性评价模型为ξ_(ABS-X)=K_(1)(Q_(1)^(ABS-X)/Q_(1)^(ABS-C))+K_(2)(Q_(2)^(ABS-X)/Q_(2)^(ABS-C))+……+K_(i)(Q_(i)^(ABS-X)/Q_(i)^(ABS-C))=∑K_(i)(Q_(i)^(ABS-X)/Q_(i)^(ABS-C))(i=1,2,3……n),式中ABS-X表示实验室基准样品(ABS-L),中试ABS-C(ABS-mP)或产业化生产ABS-C(ABS-P);ξ_(ABS-X)为ABS-L,ABS-mP,ABS-P各级工艺与ABS-C的质量一致率,K_(i)表示各质量评价指标(i)的权重,Q_(i)^(ABS-X)为ABS-L,ABS-mP,ABS-P的各质量评价指标(i)数据,Q_(i)^(ABS-C)为经典名方ABS-C中各质量评价指标的数据(或均值)。再次,针对药效物质不清楚药味的质量控制,应深入开展其化学成分研究,必要时,应依据经典名方的主要功效或适应症所对应的体外测定指标等开展生物测定法研究。最后,对于一些药味的特殊炮制,其炮制方法、工艺、饮片标准存在难以制定的问题,建议应深入梳理其特殊炮制方法的科学内涵和历史沿革,总结其工艺特性,模拟现代炮制工艺和路线,进而制定相应炮制方法和质量标准。 In this paper,the key technical problems in the research and development of famous classical formulas are analyzed.Firstly,the puzzled problem for a long-time,which is conversion relationship from medicinal metrology of Han dynasty(HD)to that of modern(gram,g),is comprehensively expounded that one Liang(两)of HD=3 g is more appropriate.Secondly,the model and principles of quality consistency evaluation are given for the transformation from the quality of authoritative basic sample prepared by casserole(ABS-C)to the quality consistency in Laboratory process,pilot-scale process and industrial production.The consistency evaluation model isξ_(ABS-X)=K_(1)(Q_(1)^(ABS-X)/Q_(1)^(ABS-C))+K_(2)(Q_(2)^(ABS-X)/Q_(2)^(ABS-C))+……+Ki(Q_(i)^(ABS-X)/Q_(i)^(ABS-C))=∑Ki(Q_(i)^(ABS-X)/Q_(i)^(ABS-C))(i=1,2,3……n).In the formula,ABS-X means laboratory reference sample ABS-C(ABS-L),pilot-scale ABS-C(ABS-mP)or industrial production ABS-C(ABS-P),ξ_(ABS-X) means the quality consistency rate or similarity degree of ABS-L,ABS-mP and ABS-P processes with ABS-C,K_(i) means the weight of each quality evaluation index(i),Q_(i)^(ABS-X) is the data of i in ABS-L,ABS-mP,ABS-P samples,and Q_(i)^(ABS-C) is the data(or mean)of i in ABS-C sample.Thirdly,in order to control the quality of the herbal medicines whose active ingredients were unknown,their chemical constituents should be studied deeply,and if necessary,the bioassay research should be carried out according to the main efficacy or indication of famous classical formulas.Finally,for the special processing of some herbal medicines,it is difficult to formulate the processing method,technology and standard of prepared slices.It is suggested that the scientific connotation and historical evolution of the special processing method should be thoroughly sorted out,and its technological characteristics are summarized,the modern processing technology and production processes are simulated,and then the corresponding processing methods and quality standards are formulated.
作者 王智民 刘菊妍 王德勤 李春 闫利华 刘晓谦 冯伟红 高慧敏 仝燕 朱晶晶 匡艳辉 陈两绵 WANG Zhi-min;LIU Ju-yan;WANG De-qin;LI Chun;YAN Li-hua;LIU Xiao-qian;FENG Wei-hong;GAOHui-min;TONG Yan;ZHU Jing-jing;KUANG Yan-hui;CHEN Liang-mian(National Engineering Laboratory for Quality Control Technology of Chinese Herbal Medicines,Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;Guangzhou Pharmaceutical Holdings Co.Ltd.,Guangzhou 510103,China;Guangzhou Baivunshan Hutchison Whampoa Chinese Medicine Co.Ltd.,Guangzhou 510515,China)
出处 《中国实验方剂学杂志》 CAS CSCD 北大核心 2022年第1期212-217,共6页 Chinese Journal of Experimental Traditional Medical Formulae
基金 国家“重大新药创制”科技重大专项(2018ZX09721004)。
关键词 中医药 经典名方 基准样品 古今剂量折算 质量一致性评价 炮制方法 traditional Chinese medicine famous classical formulas reference sample ancient and modern dose conversion quality consistency evaluation processing methods
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