我国中草药材加工业存在的问题及对策
|
摘要
中草药是自然界赋予中国的特色药物,是中华民族历史文化和现代文明的主要组成部分。在我国国民经济和社会发展具有重要贡献,是提高全民族健康素质的重要保证,在我国医药产业发展中发挥着极其重要的支柱性产业作用。在现代社会中,人们的世界发展观、消费观、医疗保健观变化正逐步由治疗向保健发生转化,中草药以其简便易得、价格便宜、疗效可靠、毒副作用小、无污染环境等的优势占据消费者的心理,推动中草药热在世界范围内兴起。
世界范围内有3个主要的国际天然药物市场,分别是以德国、美国为代表的西方市场,以日本、韩国为代表的汉方药和韩药市场以及以华裔及华裔社区为中心的传统中草药市场。纵观我国中草药发展,主要经历了雏形期、发展期、鼎盛期以及发展新时期4个阶段,形成了目前东北、内蒙古、黄河流域、西北、长江流域、东南华南、西南、西藏等8个主要的中草药材种植区,中药材资源占总量的63%。
结合国内外中草药原料生产、进出口、人才培养、知识产权和法律保护等现状研究发现中草药生产加工过程中存在的一些问题。在原料生产方面表现为中药材种植规模失控、中药材品种缺乏规范、栽培管理和加工缺乏科学依据;在进出口方面表现为进出口结构不合理、政策不配套、中药材跨境流通管理较混乱;在人才培养方面表现为人才培养观念淡薄,缺乏高科技人才,科研人员缺乏市场意识等;在知识产权方面表现为科研人员知识产权保护意识淡薄,低水平专利重复申请,企业知识产权机构不健全等;在法律保护方面表现为立法思想偏离、法律制度不健全等。
针对以上问题,归纳提出当前我国中草药加工业的发展对策。在原料生产方面要充分发挥政府宏观调控功能、合理筛选GAP基地,建立中草药资源保护区,区别对待野生资源和人工种植,中草药生产全过程严格实施中草药生产标准化操作规程(SOP);在进出口方面要积极开拓国际市场,完善进出口程序;在人才培养方面要深化中医药教育体系改革,建立起完善的中药新药研究开发科技人才培养系统;在知识产权保护方面要强化知识产权保护意识,掌握申报高技术含量专利的技巧,端正对知识产权认识,建立企业知识产权机构;在法律保护方面要制定统一的中药资源法律保护制度,立法强调资源可持续发展。
Chinese herbal medicine is nature-bestowed medicine with Chinese characteristics, a major component of Chinese historical culture and modern civilization. It has made great contributions to our national economy and social development, an critical guarantee to improve national health quality, plays a vitally important role in the development of our pharmaceutical industry. In the modern world, people's perspective of world development, view of consumption and medical care attitude has gradually shifted from therapy to health care. The advantages of easy to obtain, reasonable price, reliable efficacy, minor side effect and environmental friendly have successfully grabbed consumer's heart, and promote the arising popularity of Chinese herbal medicine over the world.
There are primarily three international natural medicine market across the world, of which Germany and U.S.A represent the western market, Japan and South Korea represent Hanfang medicine and Korea medicine market respectively as well as Chinese American and their community based traditional Chinese herbal medicine(CHM).Historically, CHM experienced embryonic period, development stage, peak stage and brand new era, formed 8 main CHM growth area including North East, Inner Mongolia, Yellow River area, North West, Yangtze River area, South China and South East, South West and Tibet, whose CHM resource accounts for 63% in China.
Combined with the status quo analyses of CHM raw material production, import and export, personnel training, intellectual property right and law protection, some problems were discovered during CHM production.The scale of CHM growth was out of control, CHM varieties lacked sufficient standardization,cultivation management and processing fell short of scientific evidence in terms of raw material production; The fabric of import and export was not reasonable, relevant policies were not compatible, the management of CHM transnational circulation was in chaos in the aspect of import and export; As to personnel cultivation, the concept of talent training was not well established, hi-tech talents were in short and researchers lacked marketing sense universally; For intellectual property right,awareness of intellectual property rights were largely ignored by researchers, low level patents were claimed repeatedly, the intellectual property right organization in corporation was not well developed; In respect to law protection, legislation thought was deviated and legal system existed some degrees of deficiency.
Confronted with these challenges, we summarize some strategies in response to current development of CHM industry.In terms of raw material production, governmental macro-regulation function should be fully mobilized,GAP base selection should be rational;CHM resource preservation should be established; Wild resources and artificial cultivation should be treated differentially; SOP(Standard Operation Procedure) should be strictly implemented during the whole process of CHM production.In terms of import and export, we should exploit the international market actively, improve import and export procedure.As to personnel cultivation, we should deepen the reform of CHM educational system, build up improved talent cultivation system in CHM and new drug development.For intellectual property right, we should intensify the sense of intellectual property right protection, acquire the basic skill of hi-tech patent claim; We should form the correct attitude towards intellectual property right;We should establish intellectual property right organization in corporation. As for law protection, we should enact uniform legal system of CHM resource protection, and lay an emphasis on sustainable development.
世界范围内有3个主要的国际天然药物市场,分别是以德国、美国为代表的西方市场,以日本、韩国为代表的汉方药和韩药市场以及以华裔及华裔社区为中心的传统中草药市场。纵观我国中草药发展,主要经历了雏形期、发展期、鼎盛期以及发展新时期4个阶段,形成了目前东北、内蒙古、黄河流域、西北、长江流域、东南华南、西南、西藏等8个主要的中草药材种植区,中药材资源占总量的63%。
结合国内外中草药原料生产、进出口、人才培养、知识产权和法律保护等现状研究发现中草药生产加工过程中存在的一些问题。在原料生产方面表现为中药材种植规模失控、中药材品种缺乏规范、栽培管理和加工缺乏科学依据;在进出口方面表现为进出口结构不合理、政策不配套、中药材跨境流通管理较混乱;在人才培养方面表现为人才培养观念淡薄,缺乏高科技人才,科研人员缺乏市场意识等;在知识产权方面表现为科研人员知识产权保护意识淡薄,低水平专利重复申请,企业知识产权机构不健全等;在法律保护方面表现为立法思想偏离、法律制度不健全等。
针对以上问题,归纳提出当前我国中草药加工业的发展对策。在原料生产方面要充分发挥政府宏观调控功能、合理筛选GAP基地,建立中草药资源保护区,区别对待野生资源和人工种植,中草药生产全过程严格实施中草药生产标准化操作规程(SOP);在进出口方面要积极开拓国际市场,完善进出口程序;在人才培养方面要深化中医药教育体系改革,建立起完善的中药新药研究开发科技人才培养系统;在知识产权保护方面要强化知识产权保护意识,掌握申报高技术含量专利的技巧,端正对知识产权认识,建立企业知识产权机构;在法律保护方面要制定统一的中药资源法律保护制度,立法强调资源可持续发展。
Chinese herbal medicine is nature-bestowed medicine with Chinese characteristics, a major component of Chinese historical culture and modern civilization. It has made great contributions to our national economy and social development, an critical guarantee to improve national health quality, plays a vitally important role in the development of our pharmaceutical industry. In the modern world, people's perspective of world development, view of consumption and medical care attitude has gradually shifted from therapy to health care. The advantages of easy to obtain, reasonable price, reliable efficacy, minor side effect and environmental friendly have successfully grabbed consumer's heart, and promote the arising popularity of Chinese herbal medicine over the world.
There are primarily three international natural medicine market across the world, of which Germany and U.S.A represent the western market, Japan and South Korea represent Hanfang medicine and Korea medicine market respectively as well as Chinese American and their community based traditional Chinese herbal medicine(CHM).Historically, CHM experienced embryonic period, development stage, peak stage and brand new era, formed 8 main CHM growth area including North East, Inner Mongolia, Yellow River area, North West, Yangtze River area, South China and South East, South West and Tibet, whose CHM resource accounts for 63% in China.
Combined with the status quo analyses of CHM raw material production, import and export, personnel training, intellectual property right and law protection, some problems were discovered during CHM production.The scale of CHM growth was out of control, CHM varieties lacked sufficient standardization,cultivation management and processing fell short of scientific evidence in terms of raw material production; The fabric of import and export was not reasonable, relevant policies were not compatible, the management of CHM transnational circulation was in chaos in the aspect of import and export; As to personnel cultivation, the concept of talent training was not well established, hi-tech talents were in short and researchers lacked marketing sense universally; For intellectual property right,awareness of intellectual property rights were largely ignored by researchers, low level patents were claimed repeatedly, the intellectual property right organization in corporation was not well developed; In respect to law protection, legislation thought was deviated and legal system existed some degrees of deficiency.
Confronted with these challenges, we summarize some strategies in response to current development of CHM industry.In terms of raw material production, governmental macro-regulation function should be fully mobilized,GAP base selection should be rational;CHM resource preservation should be established; Wild resources and artificial cultivation should be treated differentially; SOP(Standard Operation Procedure) should be strictly implemented during the whole process of CHM production.In terms of import and export, we should exploit the international market actively, improve import and export procedure.As to personnel cultivation, we should deepen the reform of CHM educational system, build up improved talent cultivation system in CHM and new drug development.For intellectual property right, we should intensify the sense of intellectual property right protection, acquire the basic skill of hi-tech patent claim; We should form the correct attitude towards intellectual property right;We should establish intellectual property right organization in corporation. As for law protection, we should enact uniform legal system of CHM resource protection, and lay an emphasis on sustainable development.
引文
Edzard Ernst.2002.Toxic heavy metals and undeclared drugs in Asian herbal medicines.TRENDS in Pharmacological Science, 23(3):136
Jiang W Y. 2005.Therapeutic wisdom in traditional Chinese medicine;a perspective from modern science.TRENDS in Pharmacological Sciences, 26(11):558-563
Wang G,Mao B,Xiong Z Y,et al. 2007.The Quality of Reporting of Randomized Controlled Trials of Traditional Chinese Medicine:A Survery of 13 Randomly Selected Journals from Mainland China.Clinical Therapeutics, 29(7):1456-1467
Yuan R,Lin Y.2005.Traditional Chinese medicine:an approach to scientific proof and clinical validation[J].Health Policy, 71(2):133-149
蔡仲德,姜廷良.1999.中药领域强化专利保护的探讨[J].中国药房,10(1):1-3
陈峰.2002.推进中药产业成为我国战略产业的研究.[硕士学位论文].江苏浙江:浙江大学
陈晔.2007.中药产业发展存在的问题及其对策.甘肃中医, 20(7):1-5
陈哲娟.2005.我国中药产业的出口态势及竞争力分析.[硕士学位论文].山东:山东大学
邓伟根.2001.产业经济学研究.北京:经济管理出版社, 5,134-136
丁力.2004.农业产业化新论.北京:中国农业出版社:5-19
董丽丽.2005.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.[硕士学位论文].沈阳药科大学
方达任. 1996.刍议中药资源开发对策.中药材, 19(10): 531-532
冯晓青.2008.企业知识产权战略.第3版.北京:知识产权出版社,19-88
冯玉竑.2001.我国中成药工业发展战略研究.[硕士学位论文].沈阳:大连理工大学
高美梅.2005.中国中药产业国际化问题探讨.[硕士学位论文].南京:南京理工大学
高永志,黄北新. 2003.对建立跨区域河流污染经济补偿机制的探讨.环境保护,45-47
勾瑞波,李军,孙福强. 2005.中药产业化流弊之我见.国际医药卫生导报, 11(3) : 97-99
郭晓珍.2005.我国中药标准化发展战略研究.[硕士学位论文].广州:第一军医大学
郝刚.2011.我国中药产业发展策略研究.[博士学位论文].武汉:华中科技大学
洪净,王一涛,王为,等. 1999.中药知识产权保护的对策.世界科学技术,1:1-2
洪净.2003.中药知识产权保护.北京:中国中医药出版社:133
吉寿如. 2002.努力建设具有中国特色的中医药产业.中国卫生, 8(9) : 17-19
李莉.2006.我国中药产业发展问题研究.[硕士学位论文].长春:吉林大学
李全新.2006.中药材加工业组织与政策.[博士学位论文].陕西杨凌:西北农林科技大学
凌子平,陈英华,张伟波,等. 2005.中药知识产权保护的现状、问题及对策.中国医药报
刘梅.2003.中药产业国际化进程中的知识产权保护策略研究.成都理工大学学报:自燃科学版, 30(11):246-248
路新林. 2006.浅谈定西市中药材产业现状及可持续发展途径.甘肃农业, (8):152
马晓彤,刘燕池. 2003.中药产业化的主要问题与对策.软科学, 17(5): 28-30
屈援,陈利国. 2003.中药产业面临的问题及相关对策研究.上海中药杂志, 37(10): 6-8
宋继鑫,王志远.2001.影响中药发展的因素及对策.长春中医学院学报, 17(3):7
孙保华. 2005.新世纪中药研发的对策研究.[博士学位论文].沈阳:沈阳药科大学
孙长森. 2003中国医药产业现状及其发展对策.内蒙古科技与经济,(4):23
孙跃文.2002.我国中药行业目前的竞争形势及发展战略研究.[硕士学位论文].北京:对外经济贸易大学
唐若维. 2010.中国中药产业技术创新研究[博士学位论文].沈阳:沈阳药科大学
王北婴,刘保延. 2000.中药产业”十五”期间发展规划的构想.中国新药杂志, 9(5) : 289-293
王冬梅. 2001.中药材市场制假售假的调查.中药研究与信息, 3(5):27-28
王广平. 2009.中药产业国际化进程中的影响因素分析与发展研究.[博士学位论文].广州:暨南大学
王智民. 2006.中药行业发展急需解决的关键问题分析.中国中药杂志, 31(1): 81-84
吴晓川. 2002.以规范化标准化促进中药现代化.中国医药报,
夏圣彪. 2005.促进中药产业快速发展.科技潮, 7(2): 43
熊季霞,李洁. 2009.加快高等教育改革,推进中医药国际化.浙江中医药大学学报, 33(4):589-591
熊季霞. 2007.中药国际化面临的机遇与困难.中国药业, 18:1-3
徐顽强,邹珊刚. 2004.试论中药产业国际化的人力资源平台建设.中国行政管理, 9:38-41
徐顽强,邹珊刚. 2004.中药产业国际化的人力资源培养研.高等工程教育研究,(6):48-52
余承文. 2007.论我国中药资源的法律保护.[博士学位论文].南京:河海大学
袁松范.2000.从日本医药工业的发展看我国的医药工业.中国医药情报, 6(1):39-40
张博文,赵宪军,周剑. 2009.河北省中药材种植业发展现状及对策.广东农业科学, (11):207-208
张博文. 2010.河北省中药产业发展战略研究.[硕士学位论文].河北保定:河北农业大学
张芳. 2001.中国中药材生产发展对策研究[硕士学位论文].辽宁:沈阳药科大学
张建武,肖诗鹰,杨旭杰,等. 2010.中药标准化与知识产权战略的协同发展研究.中华中医药杂志,12:2250-2256.
张建武.2010.中药标准化与知识产权战略的协同发展研究.[博士学位论文].北京:北京中医药大学
张珂. 2004.浅析中药材进出口边境贸易的管理.中国药事, 18(2):80
张清奎. 2008.医药及生物技术领域知识产权战略实务.北京:知识产权出版社:19-32
张中朋,刘张林. 2008.2007年中药材与植物提取物出口情况概述.国外医药·植物药分册, 23(3):135-136
Jiang W Y. 2005.Therapeutic wisdom in traditional Chinese medicine;a perspective from modern science.TRENDS in Pharmacological Sciences, 26(11):558-563
Wang G,Mao B,Xiong Z Y,et al. 2007.The Quality of Reporting of Randomized Controlled Trials of Traditional Chinese Medicine:A Survery of 13 Randomly Selected Journals from Mainland China.Clinical Therapeutics, 29(7):1456-1467
Yuan R,Lin Y.2005.Traditional Chinese medicine:an approach to scientific proof and clinical validation[J].Health Policy, 71(2):133-149
蔡仲德,姜廷良.1999.中药领域强化专利保护的探讨[J].中国药房,10(1):1-3
陈峰.2002.推进中药产业成为我国战略产业的研究.[硕士学位论文].江苏浙江:浙江大学
陈晔.2007.中药产业发展存在的问题及其对策.甘肃中医, 20(7):1-5
陈哲娟.2005.我国中药产业的出口态势及竞争力分析.[硕士学位论文].山东:山东大学
邓伟根.2001.产业经济学研究.北京:经济管理出版社, 5,134-136
丁力.2004.农业产业化新论.北京:中国农业出版社:5-19
董丽丽.2005.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.[硕士学位论文].沈阳药科大学
方达任. 1996.刍议中药资源开发对策.中药材, 19(10): 531-532
冯晓青.2008.企业知识产权战略.第3版.北京:知识产权出版社,19-88
冯玉竑.2001.我国中成药工业发展战略研究.[硕士学位论文].沈阳:大连理工大学
高美梅.2005.中国中药产业国际化问题探讨.[硕士学位论文].南京:南京理工大学
高永志,黄北新. 2003.对建立跨区域河流污染经济补偿机制的探讨.环境保护,45-47
勾瑞波,李军,孙福强. 2005.中药产业化流弊之我见.国际医药卫生导报, 11(3) : 97-99
郭晓珍.2005.我国中药标准化发展战略研究.[硕士学位论文].广州:第一军医大学
郝刚.2011.我国中药产业发展策略研究.[博士学位论文].武汉:华中科技大学
洪净,王一涛,王为,等. 1999.中药知识产权保护的对策.世界科学技术,1:1-2
洪净.2003.中药知识产权保护.北京:中国中医药出版社:133
吉寿如. 2002.努力建设具有中国特色的中医药产业.中国卫生, 8(9) : 17-19
李莉.2006.我国中药产业发展问题研究.[硕士学位论文].长春:吉林大学
李全新.2006.中药材加工业组织与政策.[博士学位论文].陕西杨凌:西北农林科技大学
凌子平,陈英华,张伟波,等. 2005.中药知识产权保护的现状、问题及对策.中国医药报
刘梅.2003.中药产业国际化进程中的知识产权保护策略研究.成都理工大学学报:自燃科学版, 30(11):246-248
路新林. 2006.浅谈定西市中药材产业现状及可持续发展途径.甘肃农业, (8):152
马晓彤,刘燕池. 2003.中药产业化的主要问题与对策.软科学, 17(5): 28-30
屈援,陈利国. 2003.中药产业面临的问题及相关对策研究.上海中药杂志, 37(10): 6-8
宋继鑫,王志远.2001.影响中药发展的因素及对策.长春中医学院学报, 17(3):7
孙保华. 2005.新世纪中药研发的对策研究.[博士学位论文].沈阳:沈阳药科大学
孙长森. 2003中国医药产业现状及其发展对策.内蒙古科技与经济,(4):23
孙跃文.2002.我国中药行业目前的竞争形势及发展战略研究.[硕士学位论文].北京:对外经济贸易大学
唐若维. 2010.中国中药产业技术创新研究[博士学位论文].沈阳:沈阳药科大学
王北婴,刘保延. 2000.中药产业”十五”期间发展规划的构想.中国新药杂志, 9(5) : 289-293
王冬梅. 2001.中药材市场制假售假的调查.中药研究与信息, 3(5):27-28
王广平. 2009.中药产业国际化进程中的影响因素分析与发展研究.[博士学位论文].广州:暨南大学
王智民. 2006.中药行业发展急需解决的关键问题分析.中国中药杂志, 31(1): 81-84
吴晓川. 2002.以规范化标准化促进中药现代化.中国医药报,
夏圣彪. 2005.促进中药产业快速发展.科技潮, 7(2): 43
熊季霞,李洁. 2009.加快高等教育改革,推进中医药国际化.浙江中医药大学学报, 33(4):589-591
熊季霞. 2007.中药国际化面临的机遇与困难.中国药业, 18:1-3
徐顽强,邹珊刚. 2004.试论中药产业国际化的人力资源平台建设.中国行政管理, 9:38-41
徐顽强,邹珊刚. 2004.中药产业国际化的人力资源培养研.高等工程教育研究,(6):48-52
余承文. 2007.论我国中药资源的法律保护.[博士学位论文].南京:河海大学
袁松范.2000.从日本医药工业的发展看我国的医药工业.中国医药情报, 6(1):39-40
张博文,赵宪军,周剑. 2009.河北省中药材种植业发展现状及对策.广东农业科学, (11):207-208
张博文. 2010.河北省中药产业发展战略研究.[硕士学位论文].河北保定:河北农业大学
张芳. 2001.中国中药材生产发展对策研究[硕士学位论文].辽宁:沈阳药科大学
张建武,肖诗鹰,杨旭杰,等. 2010.中药标准化与知识产权战略的协同发展研究.中华中医药杂志,12:2250-2256.
张建武.2010.中药标准化与知识产权战略的协同发展研究.[博士学位论文].北京:北京中医药大学
张珂. 2004.浅析中药材进出口边境贸易的管理.中国药事, 18(2):80
张清奎. 2008.医药及生物技术领域知识产权战略实务.北京:知识产权出版社:19-32
张中朋,刘张林. 2008.2007年中药材与植物提取物出口情况概述.国外医药·植物药分册, 23(3):135-136