进口天然药物优势及对我国中成药发展的借鉴意义
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摘要
中成药源于我国传统医药文化,其市场前景广阔。本文通过分析已在我国注册备案的进口天然药物,了解到日本、德国、中国香港等国家和地区的天然药物原材料更优、检验标准更严、制剂工艺更稳定、主要物质含量控制更好,并建议我国中成药应加强检验检测技术的建设、提高生产水平、优化工艺配置、发挥自身优势,为中成药服务社会,走向世界提供一些参考。
Chinese patent medicine originated from the culture of traditional Chinese medicine and its future market is prosperous. According to the analysis of the natural medicine registered in China, with the understanding that natural medicine raw material is with more superior, more stringent testing standards, more stable of the preparation process and better control of main material contained in national than local, such as Hong Kong, Japan, Germany. Recommendations in our proprietary Chinese medicine should strengthen inspection of the technology building, increase production levels, optimize process configuration, give play to their own advantages, and to provide some references for proprietary Chinese medicines in the community or to the world.
Chinese patent medicine originated from the culture of traditional Chinese medicine and its future market is prosperous. According to the analysis of the natural medicine registered in China, with the understanding that natural medicine raw material is with more superior, more stringent testing standards, more stable of the preparation process and better control of main material contained in national than local, such as Hong Kong, Japan, Germany. Recommendations in our proprietary Chinese medicine should strengthen inspection of the technology building, increase production levels, optimize process configuration, give play to their own advantages, and to provide some references for proprietary Chinese medicines in the community or to the world.
引文
[1]香港中医药管理委员会.中成药注册申请手册[M].香港:政府物流服务署,2003.
[2]霍卫.2013年1~9月份中药进出口贸易分[J].中国现代中药,2013,15(11):1006-1008.
[3]杨定乔,曾和平,曾志,等.中成药保济丸挥发性化学成分的研究[J].中草药,2001,32(12):1065-1067.
[4]李闯,王义,张美萍,等.人参不同部位皂苷成分的HPLC测定[J].吉林中医药,2010,30(4):347-349.
[5]杨哲萱,周立红,章顺楠,等.NIRS技术在中药生产中的应用及其验证方法探讨[J].中草药,2013,44(10):1342-1348.
[6]魏惠珍,张五萍,毛红梅,等.近红外光谱法在白芍提取物纯化过程中快速质量控制研究[J].中草药,2013,44(9):1128-1133.
[7]Howard C,Socratous E,Williams S,et al.Plant ID–DNAbased identification of multiple medicinal plants in complex mixtures[J].Chin Med,2012,7(1):18-26.
[8]Chen R,Dong J,Cui X,et al.DNA based identification of medicinal materials in Chinese patent medicines[J].Sci Rep,2012,2:958-962.
[9]吴晶,李欣.国外天然药物专利政策分析及对我国中药保护的启示[J].中草药,2010,41(11):1909-1912.
[10]王丽丽,夏会龙.我国中草药中农药残留的特点[J].中草药,2007,38(3):471-474.
[11]房德敏.中药指纹图谱技术的研究与应用[J].中草药,2005,36(4):632-634.
[12]赖小平,陈建南,刘中秋,等.关于进口“洋中药”问题的初步探讨[J].中药材,2001,24(2):136-142.
[13]董丽丽.国外天然药物发展概况及其对我国中药现代化的借鉴意义[D].沈阳:沈阳药科大学,2005.
[14]孙越,刘洋,方敏,等.中药材规范化种植基地的现状与发展趋势分析[J].国际中医中药杂志,2012,34(1):33-36.
[15]孙源源,施萍.借助中药配方颗粒推进中药国际化的对策研究[J].中草药,2013,44(8):929-934.
[16]杨明,伍振峰,王雅琪,等.中药制药装备技术升级的政策、现状与途径分析[J].中草药,2013,44(3):247-252.
[17]许钧钧,张辉,唐力英,等.进入中国的复方中药专利现状分析[J].中草药,2012,43(12):2321-2326.
[18]何毅,肖传学,朱永宏,等.从源头探讨中药国际化之路[J].中草药,2012,43(4):630-635.
[19]吕琳.中药进入国际医药主流市场的若干问题与建议[J].四川中医,2008,26(5):30-32.
[20]胡楚楚,李云飞,程翼宇.一种基于指纹图谱分析技术的中药生产工艺稳定性评价方法[J].中国中药杂志,2006,31(14):1151-1154.
[21]Xu Z,Liu Y,Li X,et al.Discriminant analysis of Chinese patent medicines based on near-infrared spectroscopy and principal component discriminant transformation[J].Spectrochim Acta A Mol Biomol Spectrosc,2015,149:985-990.
[22]马爱霞,朱娅莉,陈巧,等.欧盟植物药及中药进口与我国出口现状分析[J].中国天然药物,2007,5(6):470-474.
[23]郑永红,李先元.香港中成药注册管理工作概述[J].中国药事,2009,23(9):857-869.
[24]日本公定书协会.第十五改正日本药局方(JP15)[M].东京:南山堂株式会社,2006.
[25]代汉慧,陈冬东,彭涛,等.韩国中药材管理概况[J].中医药管理杂志,2013,21(1):8-10.
[26]王夏炎.现代分析技术在中药指纹图谱研究中的应用[J].中草药,2004,35(7):470-474.
[27]饶毅,魏惠珍,方少敏,等.近红外光谱技术在中药制药过程质控中的应用[J].中成药,2011,33(1):126-130.
[28]蔡延渠,朱盛山,李润萍.新型提取联用技术在中药提取中的应用进展[J].中成药,2011,33(5):863-866.
[29]Li MN,Dong X,Gao W,et al.Global identification and quantitative analysis of chemical constituents in traditional Chinese medicinal formula Qi-Fu-Yin by ultrahigh performance liquid chromatography coupled with mass spectrometry[J].J Pharm Biomed Anal,2015,114:376-389.
[30]Eshima S,Yokoyama S,Abe T,et al.Multi-pathway cellular analysis on crude natural drugs/herbs from Japanese kampo formulations[J].PLo S One,2015,10(6):e0128872.
[31]Xu GL,Xie M,Yang XY,et al.Spectrum-effect relationships as a systematic approach to traditional chinese medicine research:current status and future perspectives[J].Molecules,2014,19(11):17897-17925.
[32]Song XY,Li YD,Shi YP,et al.Quality control of traditional Chinese medicines:a review[J].Chin J Nat Med,2013,11(6):596-607.
[33]Uzuner H,Bauer R,Fan TP,et al.Traditional Chinese medicine research in the post-genomic era:good practice,priorities,challenges and opportunities[J].J Ethnopharmacol,2012,140(3):458-468.
[34]Chen J,Jiang Z,Li C,et al.Identification of ungulates used in a traditional Chinese medicine with DNA barcoding technology[J].Ecol Evol,2015,5(9):1818-1825.
[2]霍卫.2013年1~9月份中药进出口贸易分[J].中国现代中药,2013,15(11):1006-1008.
[3]杨定乔,曾和平,曾志,等.中成药保济丸挥发性化学成分的研究[J].中草药,2001,32(12):1065-1067.
[4]李闯,王义,张美萍,等.人参不同部位皂苷成分的HPLC测定[J].吉林中医药,2010,30(4):347-349.
[5]杨哲萱,周立红,章顺楠,等.NIRS技术在中药生产中的应用及其验证方法探讨[J].中草药,2013,44(10):1342-1348.
[6]魏惠珍,张五萍,毛红梅,等.近红外光谱法在白芍提取物纯化过程中快速质量控制研究[J].中草药,2013,44(9):1128-1133.
[7]Howard C,Socratous E,Williams S,et al.Plant ID–DNAbased identification of multiple medicinal plants in complex mixtures[J].Chin Med,2012,7(1):18-26.
[8]Chen R,Dong J,Cui X,et al.DNA based identification of medicinal materials in Chinese patent medicines[J].Sci Rep,2012,2:958-962.
[9]吴晶,李欣.国外天然药物专利政策分析及对我国中药保护的启示[J].中草药,2010,41(11):1909-1912.
[10]王丽丽,夏会龙.我国中草药中农药残留的特点[J].中草药,2007,38(3):471-474.
[11]房德敏.中药指纹图谱技术的研究与应用[J].中草药,2005,36(4):632-634.
[12]赖小平,陈建南,刘中秋,等.关于进口“洋中药”问题的初步探讨[J].中药材,2001,24(2):136-142.
[13]董丽丽.国外天然药物发展概况及其对我国中药现代化的借鉴意义[D].沈阳:沈阳药科大学,2005.
[14]孙越,刘洋,方敏,等.中药材规范化种植基地的现状与发展趋势分析[J].国际中医中药杂志,2012,34(1):33-36.
[15]孙源源,施萍.借助中药配方颗粒推进中药国际化的对策研究[J].中草药,2013,44(8):929-934.
[16]杨明,伍振峰,王雅琪,等.中药制药装备技术升级的政策、现状与途径分析[J].中草药,2013,44(3):247-252.
[17]许钧钧,张辉,唐力英,等.进入中国的复方中药专利现状分析[J].中草药,2012,43(12):2321-2326.
[18]何毅,肖传学,朱永宏,等.从源头探讨中药国际化之路[J].中草药,2012,43(4):630-635.
[19]吕琳.中药进入国际医药主流市场的若干问题与建议[J].四川中医,2008,26(5):30-32.
[20]胡楚楚,李云飞,程翼宇.一种基于指纹图谱分析技术的中药生产工艺稳定性评价方法[J].中国中药杂志,2006,31(14):1151-1154.
[21]Xu Z,Liu Y,Li X,et al.Discriminant analysis of Chinese patent medicines based on near-infrared spectroscopy and principal component discriminant transformation[J].Spectrochim Acta A Mol Biomol Spectrosc,2015,149:985-990.
[22]马爱霞,朱娅莉,陈巧,等.欧盟植物药及中药进口与我国出口现状分析[J].中国天然药物,2007,5(6):470-474.
[23]郑永红,李先元.香港中成药注册管理工作概述[J].中国药事,2009,23(9):857-869.
[24]日本公定书协会.第十五改正日本药局方(JP15)[M].东京:南山堂株式会社,2006.
[25]代汉慧,陈冬东,彭涛,等.韩国中药材管理概况[J].中医药管理杂志,2013,21(1):8-10.
[26]王夏炎.现代分析技术在中药指纹图谱研究中的应用[J].中草药,2004,35(7):470-474.
[27]饶毅,魏惠珍,方少敏,等.近红外光谱技术在中药制药过程质控中的应用[J].中成药,2011,33(1):126-130.
[28]蔡延渠,朱盛山,李润萍.新型提取联用技术在中药提取中的应用进展[J].中成药,2011,33(5):863-866.
[29]Li MN,Dong X,Gao W,et al.Global identification and quantitative analysis of chemical constituents in traditional Chinese medicinal formula Qi-Fu-Yin by ultrahigh performance liquid chromatography coupled with mass spectrometry[J].J Pharm Biomed Anal,2015,114:376-389.
[30]Eshima S,Yokoyama S,Abe T,et al.Multi-pathway cellular analysis on crude natural drugs/herbs from Japanese kampo formulations[J].PLo S One,2015,10(6):e0128872.
[31]Xu GL,Xie M,Yang XY,et al.Spectrum-effect relationships as a systematic approach to traditional chinese medicine research:current status and future perspectives[J].Molecules,2014,19(11):17897-17925.
[32]Song XY,Li YD,Shi YP,et al.Quality control of traditional Chinese medicines:a review[J].Chin J Nat Med,2013,11(6):596-607.
[33]Uzuner H,Bauer R,Fan TP,et al.Traditional Chinese medicine research in the post-genomic era:good practice,priorities,challenges and opportunities[J].J Ethnopharmacol,2012,140(3):458-468.
[34]Chen J,Jiang Z,Li C,et al.Identification of ungulates used in a traditional Chinese medicine with DNA barcoding technology[J].Ecol Evol,2015,5(9):1818-1825.