经典名方物质基准研制的关键技术分析
|
摘要
中药经典名方开发已成为当下中医药界研究的热点之一,而其中经典名方物质基准的成功研制对于整个中药经典名方的申报极为关键。经典名方物质基准既是检测经典名方制剂质量的基准,同时又需反映整方的物质基础。中药成分众多而复杂,单成分的、化药式的研发与质量控制模式难以适用于整体药用的中药制剂的开发,亟需开辟一条中药专属的研发模式。以目前已有的现代科学技术,笔者建议将中药的遗传多态性、提取动力学、指纹图谱总量统计矩(相似度)法、超分子"印迹模板"等结合应用于经典名方物质基准的研制,探讨中药经典名方物质基准的质量控制技术,以期全面、准确地阐明药材-饮片-物质基准的成分群量值的传递规律,为推进中药经典名方的研制进程提供参考。
Research and development of classical prescription of Chinese medicine has become one of the hot spots in the research of traditional Chinese medicine(TCM),and the successful development of the primary standard is crucial to the application of the classical prescription of Chinese medicine. Primary standard of classical prescription is not only the benchmark to measure the quality of preparation of classical prescription,but also the material basis of whole prescription. The development and quality control mode of single component of western medicine is not suitable for the development of TCM preparation with integral medicinal function. Thus,it is very urgent to develop an exclusive research and development model for TCM. In order to break through the quality control technology of primary standard of classical prescription,and comprehensively and accurately elucidate the transmission rule of the component group value of medicinal materials-decoction pieces-primary standard of classical prescription with the present modern science and technology, the genetic polymorphism of TCM, extraction kinetics,total quantum statistical moment(similarity) method of fingerprint and supramolecular imprinting template were combined and applied to the development of primary standard of classical prescription. In this way,the development and quality control of TCM will be realized in a real sense and the development of classical prescription of Chinese medicine will be accelerated and promoted.
Research and development of classical prescription of Chinese medicine has become one of the hot spots in the research of traditional Chinese medicine(TCM),and the successful development of the primary standard is crucial to the application of the classical prescription of Chinese medicine. Primary standard of classical prescription is not only the benchmark to measure the quality of preparation of classical prescription,but also the material basis of whole prescription. The development and quality control mode of single component of western medicine is not suitable for the development of TCM preparation with integral medicinal function. Thus,it is very urgent to develop an exclusive research and development model for TCM. In order to break through the quality control technology of primary standard of classical prescription,and comprehensively and accurately elucidate the transmission rule of the component group value of medicinal materials-decoction pieces-primary standard of classical prescription with the present modern science and technology, the genetic polymorphism of TCM, extraction kinetics,total quantum statistical moment(similarity) method of fingerprint and supramolecular imprinting template were combined and applied to the development of primary standard of classical prescription. In this way,the development and quality control of TCM will be realized in a real sense and the development of classical prescription of Chinese medicine will be accelerated and promoted.
引文
[1]国家食品药品监督管理总局.总局办公厅公开征求《中药经典名方复方制剂简化注册审批管理规定(征求意见稿)》及申报资料要求(征求意见稿)意见[EB/OL].http://www.sda.gov.cn/WS01/CL0778/178324.html,2017-09-22/2018-06-10.
[2]国家中医药管理局.国家中医药管理局关于发布《古代经典名方目录(第一批)》的通知[EB/OL].http://kjs.satcm.gov.cn/zhengcewenjian/2018-04-16/7107.html,2018-04-13/2018-06-10.
[3]国家药品监督管理局.国家药品监督管理局关于发布古代经典名方中药复方制剂简化注册审批管理规定的公告(2018年第27号)[EB/OL].http://cnda.cfda.gov.cn/WS04/CL2050/228247.html,2018-05-29/2018-06-10.
[4]文旺,李莉,李德坤,等.经典名方的“遵古”研发思路探讨---以泻白散为例[J].中国实验方剂学杂志,2019,doi:10.13422/j.cnki.syfjx.20191446.
[5]Garst A D,Bassalo M C,Pines G,et al.Genome-wide mapping of mutations at single-nucleotide resolution for protein,metabolic and genome engineering[J].Nat Biotechnol,2017,35(1):48-55.
[6]李海英,贺鹏,樊启猛,等.桃红四物汤的HPLC指纹图谱总量统计矩及一次稳态投料量分析[J].中国实验方剂学杂志,2019,doi:10.13422/j.cnki.syfjx.20191462.
[7]贺福元,周宏灏,罗杰英,等.生物遗传多态性规律揭示中药材质量稳定性规律的探讨[J].中草药,2008,39(1):2-6,12.
[8]郑司浩.中药道地性生物学机制研究[D].北京:北京协和医学院,2016.
[9]黄璐琦,陆建伟,郭兰萍,等.第四次全国中药资源普查方案设计与实施[J].中国中药杂志,2013,38(5):625-628.
[10]于江泳,袁媛,金艳,等.基于全国中药资源普查中药材质量基本数据研究思路[J].中国现代中药,2016,18(11):1386-1389.
[11]仝小林,刘文科,焦拥政.论经方用量策略[J].中医药导报,2012,18(8):1-3.
[12]邓哲,刘德文,杜杰,等.经典名方研发建议的梳理和探讨[J].中国实验方剂学杂志,2019,doi:10.13422/j.cnki.syfjx.20190554.
[13]李艳,白明,宋亚刚,等.中药标准汤剂的研究与思考[J].中草药,2018,49(17):3977-3980.
[14]肖贵南,李瑾翡,陈浩桉.生物活性测定在中药质量控制中应用的可行性及研究思路[J].中药材,2008,31(4):473-475.
[15]XIE P,CHEN S,LIANG Y,et al.Chromatographic fingerprint analysis---a rational approach for quality assessment of traditional Chinese herbal medicine[J].JChromatogr A,2006,1112(1/2):171-180.
[16]石继连.炮制火候数学模型的建立及对槐米的研究[D].北京:北京中医药大学,2013.
[17]贺福元,邓凯文,吴德智,等.左金方与黄连中小檗碱型生物碱提取动力学差异性的研究[J].中成药,2009,31(9):1354-1359.
[18]贺福元,邓凯文,罗杰英,等.中药复方成分提取动力学数学模型的初步研究[J].中国中药杂志,2007,32(6):490-495.
[19]刘红宇,贺福元,罗杰英.中药(复方)成分提取动力学数学模型建立及粒径对六味地黄汤中梓醇浓度的影响[J].中国药房,2009,20(36):2804-2807.
[20]贺福元,邓凯文,黄胜,等.总量统计矩标准相似度数学模型的建立及应用研究[J].药学学报,2013,48(9):1453-1458.
[21]贺福元,邓凯文,刘文龙,等.中药复方药物动力学总量统计矩法的实验验证研究[J].中国中药杂志,2013,38(2):253-262.
[22]周晋,邓凯文,段晓鹏,等.指纹图谱总量统计矩分析法参数的计算及积分条件的确定[J].中华中医药学刊,2012,30(3):505-508.
[23]段晓鹏,贺福元,周晋,等.补阳还五汤指纹图谱总量统计矩加合性的研究[J].中国中药杂志,2011,36(23):3247-3252.
[24]肖美凤,张雨恬,杨岩涛,等.基于鱼腥草挥发性成分动态性的中药制剂“印迹模板”一致性分析[J].中国实验方剂学杂志,2019,doi:10.13422/j.cnki.syfjx.20190446.
[25]贺福元,贺红,邓凯文,等.超分子“印迹模板”(药素)特征的中药药理学研究方法探索[J].中国中药杂志,2015,40(21):4313-4318.
[26]王绚,蔡宝昌.中药炮制研究的现状与思路[J].江西中医学院学报,2010,22(2):12-14.
[27]王智民,刘菊妍,刘晓谦,等.谈经典名方的化学生产和质量控制研发和监管[J].中国中药杂志,2017,42(10):1819-1824.
[28]张艳斌,崔元璐,何永志.分子印迹技术与中药研究[J].中药材,2008,31(4):616-619.
[29]夏赞韶,贺福元,邓凯文,等.中药分子印迹技术对中医药理论的特殊影响[J].中国中药杂志,2013,38(8):1266-1270.
[30]陶叶琴,唐闻汉,刘金玲,等.基于超分子“印迹模板”理论的甘草增助溶特征研究[J].中国中药杂志,2016,41(10):1849-1854.
[31]贺福元,邓凯文,杨大坚,等.中药材成分提取动力学数学模型的建立及参数分析[J].数理医药学杂志,2005,18(6):513-517.
[32]贺福元,马家骅,刘文龙,等.中药材吸水膨胀动力学数学模型的建立及对大黄的验证实验研究[J].中成药,2004,26(10):788-791.
[33]贺福元,邓凯文,杨岩涛,等.基于超分子化学的中药药性理论研究方法探讨(Ⅰ)中药归经[J].中国中药杂志,2015,40(8):1624-1629.
[2]国家中医药管理局.国家中医药管理局关于发布《古代经典名方目录(第一批)》的通知[EB/OL].http://kjs.satcm.gov.cn/zhengcewenjian/2018-04-16/7107.html,2018-04-13/2018-06-10.
[3]国家药品监督管理局.国家药品监督管理局关于发布古代经典名方中药复方制剂简化注册审批管理规定的公告(2018年第27号)[EB/OL].http://cnda.cfda.gov.cn/WS04/CL2050/228247.html,2018-05-29/2018-06-10.
[4]文旺,李莉,李德坤,等.经典名方的“遵古”研发思路探讨---以泻白散为例[J].中国实验方剂学杂志,2019,doi:10.13422/j.cnki.syfjx.20191446.
[5]Garst A D,Bassalo M C,Pines G,et al.Genome-wide mapping of mutations at single-nucleotide resolution for protein,metabolic and genome engineering[J].Nat Biotechnol,2017,35(1):48-55.
[6]李海英,贺鹏,樊启猛,等.桃红四物汤的HPLC指纹图谱总量统计矩及一次稳态投料量分析[J].中国实验方剂学杂志,2019,doi:10.13422/j.cnki.syfjx.20191462.
[7]贺福元,周宏灏,罗杰英,等.生物遗传多态性规律揭示中药材质量稳定性规律的探讨[J].中草药,2008,39(1):2-6,12.
[8]郑司浩.中药道地性生物学机制研究[D].北京:北京协和医学院,2016.
[9]黄璐琦,陆建伟,郭兰萍,等.第四次全国中药资源普查方案设计与实施[J].中国中药杂志,2013,38(5):625-628.
[10]于江泳,袁媛,金艳,等.基于全国中药资源普查中药材质量基本数据研究思路[J].中国现代中药,2016,18(11):1386-1389.
[11]仝小林,刘文科,焦拥政.论经方用量策略[J].中医药导报,2012,18(8):1-3.
[12]邓哲,刘德文,杜杰,等.经典名方研发建议的梳理和探讨[J].中国实验方剂学杂志,2019,doi:10.13422/j.cnki.syfjx.20190554.
[13]李艳,白明,宋亚刚,等.中药标准汤剂的研究与思考[J].中草药,2018,49(17):3977-3980.
[14]肖贵南,李瑾翡,陈浩桉.生物活性测定在中药质量控制中应用的可行性及研究思路[J].中药材,2008,31(4):473-475.
[15]XIE P,CHEN S,LIANG Y,et al.Chromatographic fingerprint analysis---a rational approach for quality assessment of traditional Chinese herbal medicine[J].JChromatogr A,2006,1112(1/2):171-180.
[16]石继连.炮制火候数学模型的建立及对槐米的研究[D].北京:北京中医药大学,2013.
[17]贺福元,邓凯文,吴德智,等.左金方与黄连中小檗碱型生物碱提取动力学差异性的研究[J].中成药,2009,31(9):1354-1359.
[18]贺福元,邓凯文,罗杰英,等.中药复方成分提取动力学数学模型的初步研究[J].中国中药杂志,2007,32(6):490-495.
[19]刘红宇,贺福元,罗杰英.中药(复方)成分提取动力学数学模型建立及粒径对六味地黄汤中梓醇浓度的影响[J].中国药房,2009,20(36):2804-2807.
[20]贺福元,邓凯文,黄胜,等.总量统计矩标准相似度数学模型的建立及应用研究[J].药学学报,2013,48(9):1453-1458.
[21]贺福元,邓凯文,刘文龙,等.中药复方药物动力学总量统计矩法的实验验证研究[J].中国中药杂志,2013,38(2):253-262.
[22]周晋,邓凯文,段晓鹏,等.指纹图谱总量统计矩分析法参数的计算及积分条件的确定[J].中华中医药学刊,2012,30(3):505-508.
[23]段晓鹏,贺福元,周晋,等.补阳还五汤指纹图谱总量统计矩加合性的研究[J].中国中药杂志,2011,36(23):3247-3252.
[24]肖美凤,张雨恬,杨岩涛,等.基于鱼腥草挥发性成分动态性的中药制剂“印迹模板”一致性分析[J].中国实验方剂学杂志,2019,doi:10.13422/j.cnki.syfjx.20190446.
[25]贺福元,贺红,邓凯文,等.超分子“印迹模板”(药素)特征的中药药理学研究方法探索[J].中国中药杂志,2015,40(21):4313-4318.
[26]王绚,蔡宝昌.中药炮制研究的现状与思路[J].江西中医学院学报,2010,22(2):12-14.
[27]王智民,刘菊妍,刘晓谦,等.谈经典名方的化学生产和质量控制研发和监管[J].中国中药杂志,2017,42(10):1819-1824.
[28]张艳斌,崔元璐,何永志.分子印迹技术与中药研究[J].中药材,2008,31(4):616-619.
[29]夏赞韶,贺福元,邓凯文,等.中药分子印迹技术对中医药理论的特殊影响[J].中国中药杂志,2013,38(8):1266-1270.
[30]陶叶琴,唐闻汉,刘金玲,等.基于超分子“印迹模板”理论的甘草增助溶特征研究[J].中国中药杂志,2016,41(10):1849-1854.
[31]贺福元,邓凯文,杨大坚,等.中药材成分提取动力学数学模型的建立及参数分析[J].数理医药学杂志,2005,18(6):513-517.
[32]贺福元,马家骅,刘文龙,等.中药材吸水膨胀动力学数学模型的建立及对大黄的验证实验研究[J].中成药,2004,26(10):788-791.
[33]贺福元,邓凯文,杨岩涛,等.基于超分子化学的中药药性理论研究方法探讨(Ⅰ)中药归经[J].中国中药杂志,2015,40(8):1624-1629.