中药品质生物评价的历史与发展
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摘要
生物评价(biological assay)是药品质量控制的重要方法,由于中药成分的复杂性、功效的多样性特点,依靠化学成分理化分析的方法对中药进行品质评价还存在很大的局限性。近年来中药品质的生物评价日益得到广泛关注与应用。从中药历史发展的角度来看,中药品质生物评价的理念和方法自古有之,尤其是近年来我国CFDA及美国FDA强调了生物评价在中药或植物药新药注册与评审中的重要作用及意义,这标志着生物评价已成为国内外中药和植物药质量评控发展的共识性方向,当前正进入中药品质的生物评价时代。从回顾历史与展望发展的视角,对中药品质的生物评价进行了系统地梳理与总结,提出了以生物评价为核心的"中药整合质量观"。
Biological assay is an important method for quality control of drugs. There are limitations in the quality control system of Chinese materia medica(CMM) based on physico-chemical analysis methods due to the complicated chemical constituents and multifold pharmacodynamics of CMM. Recently, the application of biological assays to CMM attracted much attention and application. From the historical development perspective, the idea and method of biological assay for the quality control of CMM have existed since the ancient times. Especially in recent years, the introduction of biological assay to botanical drugs and CMM submitted in new drug applications were emphasized by both the U. S. and Chinese Food and Drug Administration. This means that a common view has been formed that using biological assay in the quality control of CMM and botanical drugs is proper. Now, a new era of biological assay for the quality control of CMM has come. Based on the review and expectation of biological assay for the quality control of CMM, we creatively put forward an integrated quality concept for CMM which takes biological assay as core.
Biological assay is an important method for quality control of drugs. There are limitations in the quality control system of Chinese materia medica(CMM) based on physico-chemical analysis methods due to the complicated chemical constituents and multifold pharmacodynamics of CMM. Recently, the application of biological assays to CMM attracted much attention and application. From the historical development perspective, the idea and method of biological assay for the quality control of CMM have existed since the ancient times. Especially in recent years, the introduction of biological assay to botanical drugs and CMM submitted in new drug applications were emphasized by both the U. S. and Chinese Food and Drug Administration. This means that a common view has been formed that using biological assay in the quality control of CMM and botanical drugs is proper. Now, a new era of biological assay for the quality control of CMM has come. Based on the review and expectation of biological assay for the quality control of CMM, we creatively put forward an integrated quality concept for CMM which takes biological assay as core.
引文
[1]中华中医药学会.中药品质评价方法指南[M].北京:中国中医药出版社,2017.
[2]沈伟涛,王明钰,王允坤,等.抗生素含量测定方法的分析概述[J].中国生物工程杂志,2016,36(6):119-126.
[3]Lei Y U,Rao C M,Shi X C,et al.A novel bioassay for the activitydetermination of therapeutic human brain natriuretic peptide(BNP)[J].PLo S One,2012,7(11):1-8.
[4]饶春明,王军志.2015年版《中国药典》生物技术药质量控制相关内容介绍[J].中国药学杂志,2015,50(20):1776-1781.
[5]Rao C M,Pei D N,Yu L,et al.Evaluation of a reporter gene assay for bioactivity determination of therapeutic interferons through a collaborative study[J].Curr Pharm Anal,2016,12(2):129-136.
[6]中国药典[S].三部.2015.
[7]饶春明.我国重组药物质量控制技术体系的建立和应用研究[J].中国药学杂志,2016,51(13):1057-1066.
[8]郭博信.中医药的鼻祖--神农氏[N].中国中医药报,2016-08-19(08).
[9]王家葵.本草鼻祖:《神农本草经》[J].文史知识,2016(1):58-62.
[10]魏琴,何林熹,杨翠花,等.《黄帝内经》寒热理论探要[J].湖南中医杂志,2016,32(5):158-160.
[11]张卫.“五味”理论溯源及明以前中药“五味”理论系统之研究[D].北京:中国中医科学院,2012.
[12]刘雅莉,谢琪,刘保延,等.临床试验百年历程概述[J].中国循证医学杂志,2016,16(11):1241-1249.
[13]白璐.自然铜微生物浸出液的药理药效学初步研究[D].兰州:兰州大学,2008.
[14]程雅君,程雅群.《本草纲目》药理学的哲学渊源[J].哲学研究,2015(9):38-44.
[15]曼石.葛洪的实验思想[J].中药与临床,2010,1(3):14.
[16]徐锦博.曹植的神仙方术态度--兼论《释疑论》是否为葛洪伪作[J].天水师范学院学报,2015(5):57-62.
[17]黄丽萍,赵宝林,吴玲燕.陈延之《小品方》学术思想初探[J].甘肃中医学院学报,2012,29(1):23-26.
[18]楼之岑.植物性泻药的生物测定法[J].药学学报,1953,1(1):49-71.
[19]周重阳,陈海波,罗艳,等.用生物检定法测定大蒜油中大蒜辣素和大蒜新素的含量[J].中草药,1997,28(1):18-20.
[20]苑庆华,唐元泰,芮菁,等.复方丹参注射液中细菌内毒素定量检测研究[J].天津药学,2003,15(2):17-19.
[21]杨明华,王溶溶.益母草药材生物检定方法的研究(III)--鲜益母草胶囊和益母草流浸膏生物效价与临床疗效的相关性观察[J].中国现代应用药学,2004,21(2):124-126.
[22]左泽平,王志斌,高阳,等.柴胡注射液体外抑制PGE-2释放的生物活性测定法[J].中国中药杂志,2013,38(22):3957-3960.
[23]鄢丹,肖小河,金城,等.论中药质量管理模式的挑战与发展[J].中草药,2006,37(6):806-809.
[24]孙琴,肖小河,金城,等.中药质量控制和评价模式应多元化[J].中药材,2008,31(1):1-4.
[25]中国药典[S].一部.2010.
[26]Tilton R,Paiva A A,Guan J Q,et al.A comprehensive platform for quality control of botanical drugs(Phytomics QC):A case study of Huangqin Tang(HQT)and PHY906[J].Chin Med,2010,5(1):30-45.
[27]US Food and Drug Administration.Botanical drug development guidance for industry[EB/OL].[2017-03-01].http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm458484.pdf.
[28]李寒冰,鄢丹,王伽伯,等.基于神经氨酸酶活性检测的板蓝根品质的生物评价[J].药学学报,2009,44(2):162-166.
[29]罗云,金城,肖小河,等.基于环氧合酶抑制作用的人工麝香质量评价方法研究[J].药学学报,2011,46(4):438-442.
[30]肖小河,王伽伯,吕旸,等.一种用于何首乌及其中药制剂肝毒性评价的生物毒性效价检定方法:中国,CN201310276998.3[P].2013-10-16.
[31]王伽伯,金城,肖小河,等.泻下类中药质量的生物控制方法及基本问题探讨[J].药学学报,2009,44(5):500-505.
[32]山丽梅,赵艳玲,肖小河,等.三七止血活性与商品规格划分的相关分析[J].中草药,2011,42(9):1779-1782.
[33]Ren Y S,Zhang P,Yan D,et al.A strategy for the detection of quality fluctuation of a Chinese herbal injection based on chemical fingerprinting combined with biological fingerprinting[J].J Pharm Biomed Anal,2011,56(2):436-442.
[34]谷丽华,侴桂新,王峥涛.基于ABTS自由基的薄层色谱-生物自显影新方法的建立及其在中药抗氧化活性评价中的应用[J].上海中医药大学学报,2013,27(3):99-104.
[35]王俨如,李娜,曹亮,等.应用高内涵技术研究桂枝茯苓胶囊抗炎及免疫调节活性成分[J].中国中药杂志,2015,40(6):1005-1011.
[36]Poste G.Bring on the biomarkers[J].Nature,2011,4(69):156-157.
[37]刘昌孝,陈士林,肖小河,等.中药质量标志物(Q-Marker):中药产品质量控制的新概念[J].中草药2016,47(9):1443-1457.
[38]张海珠,肖小河,王伽伯,等.中药质量评控的第一要义:效应当量一致性[J].中草药,2015,46(11):1571-1575.
[39]熊吟,肖小河,鄢丹,等.综合量化集成的中药品质评控策略:效应成分指数[J].中草药,2014,45(1):1-7.
[40]肖小河,王伽伯,鄢丹,等.“道地综合指数”的构建及其应用价值[J].中国中药杂志,2012,37(11):1513-1516.
[41]Qin Y,Wang J B,Zhao Y L,et al.Establishment of a bioassay for the toxicity evaluation and quality control of Aconitum herbs[J].J Hazardous Mater,2012,199/200:350-357.
[42]肖小河,王伽伯,鄢丹.生物评价在中药质量标准化中的研究与应用[J].世界科学技术--中医药现代化,2014,16(3):514-518.
[43]肖小河,鄢丹,王伽伯,等.关于中药质量生物检定的几点商榷[J].世界科学技术--中医药现代化,2009,11(4):504-508.
[44]肖小河,张定堃,王伽伯,等.中药品质综合量化评控体系--标准评控力金字塔[J].中国中药杂志,2015,40(1):7-12.
[45]肖小河,金城,鄢丹,等.中药大质量观及实践[J].中草药,2010,41(4):505-508.
[2]沈伟涛,王明钰,王允坤,等.抗生素含量测定方法的分析概述[J].中国生物工程杂志,2016,36(6):119-126.
[3]Lei Y U,Rao C M,Shi X C,et al.A novel bioassay for the activitydetermination of therapeutic human brain natriuretic peptide(BNP)[J].PLo S One,2012,7(11):1-8.
[4]饶春明,王军志.2015年版《中国药典》生物技术药质量控制相关内容介绍[J].中国药学杂志,2015,50(20):1776-1781.
[5]Rao C M,Pei D N,Yu L,et al.Evaluation of a reporter gene assay for bioactivity determination of therapeutic interferons through a collaborative study[J].Curr Pharm Anal,2016,12(2):129-136.
[6]中国药典[S].三部.2015.
[7]饶春明.我国重组药物质量控制技术体系的建立和应用研究[J].中国药学杂志,2016,51(13):1057-1066.
[8]郭博信.中医药的鼻祖--神农氏[N].中国中医药报,2016-08-19(08).
[9]王家葵.本草鼻祖:《神农本草经》[J].文史知识,2016(1):58-62.
[10]魏琴,何林熹,杨翠花,等.《黄帝内经》寒热理论探要[J].湖南中医杂志,2016,32(5):158-160.
[11]张卫.“五味”理论溯源及明以前中药“五味”理论系统之研究[D].北京:中国中医科学院,2012.
[12]刘雅莉,谢琪,刘保延,等.临床试验百年历程概述[J].中国循证医学杂志,2016,16(11):1241-1249.
[13]白璐.自然铜微生物浸出液的药理药效学初步研究[D].兰州:兰州大学,2008.
[14]程雅君,程雅群.《本草纲目》药理学的哲学渊源[J].哲学研究,2015(9):38-44.
[15]曼石.葛洪的实验思想[J].中药与临床,2010,1(3):14.
[16]徐锦博.曹植的神仙方术态度--兼论《释疑论》是否为葛洪伪作[J].天水师范学院学报,2015(5):57-62.
[17]黄丽萍,赵宝林,吴玲燕.陈延之《小品方》学术思想初探[J].甘肃中医学院学报,2012,29(1):23-26.
[18]楼之岑.植物性泻药的生物测定法[J].药学学报,1953,1(1):49-71.
[19]周重阳,陈海波,罗艳,等.用生物检定法测定大蒜油中大蒜辣素和大蒜新素的含量[J].中草药,1997,28(1):18-20.
[20]苑庆华,唐元泰,芮菁,等.复方丹参注射液中细菌内毒素定量检测研究[J].天津药学,2003,15(2):17-19.
[21]杨明华,王溶溶.益母草药材生物检定方法的研究(III)--鲜益母草胶囊和益母草流浸膏生物效价与临床疗效的相关性观察[J].中国现代应用药学,2004,21(2):124-126.
[22]左泽平,王志斌,高阳,等.柴胡注射液体外抑制PGE-2释放的生物活性测定法[J].中国中药杂志,2013,38(22):3957-3960.
[23]鄢丹,肖小河,金城,等.论中药质量管理模式的挑战与发展[J].中草药,2006,37(6):806-809.
[24]孙琴,肖小河,金城,等.中药质量控制和评价模式应多元化[J].中药材,2008,31(1):1-4.
[25]中国药典[S].一部.2010.
[26]Tilton R,Paiva A A,Guan J Q,et al.A comprehensive platform for quality control of botanical drugs(Phytomics QC):A case study of Huangqin Tang(HQT)and PHY906[J].Chin Med,2010,5(1):30-45.
[27]US Food and Drug Administration.Botanical drug development guidance for industry[EB/OL].[2017-03-01].http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm458484.pdf.
[28]李寒冰,鄢丹,王伽伯,等.基于神经氨酸酶活性检测的板蓝根品质的生物评价[J].药学学报,2009,44(2):162-166.
[29]罗云,金城,肖小河,等.基于环氧合酶抑制作用的人工麝香质量评价方法研究[J].药学学报,2011,46(4):438-442.
[30]肖小河,王伽伯,吕旸,等.一种用于何首乌及其中药制剂肝毒性评价的生物毒性效价检定方法:中国,CN201310276998.3[P].2013-10-16.
[31]王伽伯,金城,肖小河,等.泻下类中药质量的生物控制方法及基本问题探讨[J].药学学报,2009,44(5):500-505.
[32]山丽梅,赵艳玲,肖小河,等.三七止血活性与商品规格划分的相关分析[J].中草药,2011,42(9):1779-1782.
[33]Ren Y S,Zhang P,Yan D,et al.A strategy for the detection of quality fluctuation of a Chinese herbal injection based on chemical fingerprinting combined with biological fingerprinting[J].J Pharm Biomed Anal,2011,56(2):436-442.
[34]谷丽华,侴桂新,王峥涛.基于ABTS自由基的薄层色谱-生物自显影新方法的建立及其在中药抗氧化活性评价中的应用[J].上海中医药大学学报,2013,27(3):99-104.
[35]王俨如,李娜,曹亮,等.应用高内涵技术研究桂枝茯苓胶囊抗炎及免疫调节活性成分[J].中国中药杂志,2015,40(6):1005-1011.
[36]Poste G.Bring on the biomarkers[J].Nature,2011,4(69):156-157.
[37]刘昌孝,陈士林,肖小河,等.中药质量标志物(Q-Marker):中药产品质量控制的新概念[J].中草药2016,47(9):1443-1457.
[38]张海珠,肖小河,王伽伯,等.中药质量评控的第一要义:效应当量一致性[J].中草药,2015,46(11):1571-1575.
[39]熊吟,肖小河,鄢丹,等.综合量化集成的中药品质评控策略:效应成分指数[J].中草药,2014,45(1):1-7.
[40]肖小河,王伽伯,鄢丹,等.“道地综合指数”的构建及其应用价值[J].中国中药杂志,2012,37(11):1513-1516.
[41]Qin Y,Wang J B,Zhao Y L,et al.Establishment of a bioassay for the toxicity evaluation and quality control of Aconitum herbs[J].J Hazardous Mater,2012,199/200:350-357.
[42]肖小河,王伽伯,鄢丹.生物评价在中药质量标准化中的研究与应用[J].世界科学技术--中医药现代化,2014,16(3):514-518.
[43]肖小河,鄢丹,王伽伯,等.关于中药质量生物检定的几点商榷[J].世界科学技术--中医药现代化,2009,11(4):504-508.
[44]肖小河,张定堃,王伽伯,等.中药品质综合量化评控体系--标准评控力金字塔[J].中国中药杂志,2015,40(1):7-12.
[45]肖小河,金城,鄢丹,等.中药大质量观及实践[J].中草药,2010,41(4):505-508.