中药商业质量标准的研究
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摘要
随着全球健康观念的转变，中药在国际市场的接受度明显提高，中药成为极具市场潜力的行业，但是其发展却因为质量水平低下而受到严重牵制。
商业标准越来越受到企业的关注，但是国家更多是从宏观的层面给予方向性的指引，而技术专家的优势在于基础研究和技术支持，要真正建立有实用价值的商业标准，主体还是企业自己。本课题立足企业，以政策为导向，管理理念为支点，技术革新为保障，建立中药全面质量控制体系，用于指导企业建立产品的内控标准。同时结合知识产权，实现产品差异化，以提高企业核心竞争力，逐步扩大市场占有率，进而向国际市场渗透。
本课题研究了国际植物药注册和质量控制现状，总结出植物药质量控制的三种主要模式，并分析了以欧美为首的化学成分控制模式和日本为首的标准汤剂控制模式的相同点和不同点，探讨了植物药质量控制的发展趋势。
课题从企业的角度，提出了建立中药商业质量标准的指导思想，建议商业质量标准要结合管理理念和技术支持，还要注意与国家政策的衔接。在指标的建立上，不仅要追求卓越的品质，还要满足企业的可生产性，并兼顾中医药特色和国际化需求。在技术上，认为应采用非线性的质量控制模式，对种植、采收加工、饮片炮制、提取工艺、制剂工艺、质量检测等一系列过程进行严格控制，形成系统的质量控制链。并选取了天津天士力的复方丹参滴丸和河南宛西的浓缩六味地黄丸进行个案分析，印证了论文所提出的质量管理理念和控制模式的可行性。
课题引入了国际先进的管理理念，提出中药商业质量标准的建立应以客户为导向，以卓越质量为目标，并始终坚持系统化的思维。不同于以往的准入性的质量目标和纯技术性的标准建立思路。
课题还探讨了中药商业质量标准与官方标准的衔接问题，认为《药品注册管理办法》为国家标准和商业标准提供了很好的契合点，可以为企业自己建立的新的质量标准提供法律认可，有助于提高顾客对该产品的信赖度。
Obviously, Chinese medicine has been more receptible in the international market with the changing of the health conception. Though Chinese medicine come into being a most potential industry, it's development has been badly contained by the low quality.
Enterprises have paid more attention to the business standards, however, state government only give directions on the macroscopical level and technologic specialists always can't comprehend the operation mode of the enterprises, who only can provide technologic support. So the key to establish practical business standard is still depend on the enterprises themselves. We base upon enterprises, advance under the directions of the policies, take the manage concept as fulcrum and set up the whole quality control system of Chinese medicine to help enterprises establish their internal control standard.
We studied situation of the international botanical drug's registration and quality control, summarized three main modes of the quality control and analyze the difference and homology of the two control system represented by the Europe-USA & Japan separately. The development of botanical drug's quality control is also discussed in our study.
We based upon the enterprises, put forward the guidelines of Chinese medicine's business standards, which is advised should not only combine the manage concept and technological support, but also link up with the national policies. The establishment of the index must pursue excellence quality and satisfy the producibility in the enterprises, the character of the traditional Chinese medicine and requirement of the internationalization should also well considered.
Internationa] advanced manage concept is inducted in our study, we bring forward the establishment of Chinese medicine business standards should satisfy their clients, target the excellent quality and insist the thought of systematism.
The problem of how to link up the Chinese medicine's business quality stands with the national standards is also discussed. "Measures for the Administration of Drug's registration" is deemed to solve this question perfectly, which can provide the legally authorization and help clients trust the products.
商业标准越来越受到企业的关注，但是国家更多是从宏观的层面给予方向性的指引，而技术专家的优势在于基础研究和技术支持，要真正建立有实用价值的商业标准，主体还是企业自己。本课题立足企业，以政策为导向，管理理念为支点，技术革新为保障，建立中药全面质量控制体系，用于指导企业建立产品的内控标准。同时结合知识产权，实现产品差异化，以提高企业核心竞争力，逐步扩大市场占有率，进而向国际市场渗透。
本课题研究了国际植物药注册和质量控制现状，总结出植物药质量控制的三种主要模式，并分析了以欧美为首的化学成分控制模式和日本为首的标准汤剂控制模式的相同点和不同点，探讨了植物药质量控制的发展趋势。
课题从企业的角度，提出了建立中药商业质量标准的指导思想，建议商业质量标准要结合管理理念和技术支持，还要注意与国家政策的衔接。在指标的建立上，不仅要追求卓越的品质，还要满足企业的可生产性，并兼顾中医药特色和国际化需求。在技术上，认为应采用非线性的质量控制模式，对种植、采收加工、饮片炮制、提取工艺、制剂工艺、质量检测等一系列过程进行严格控制，形成系统的质量控制链。并选取了天津天士力的复方丹参滴丸和河南宛西的浓缩六味地黄丸进行个案分析，印证了论文所提出的质量管理理念和控制模式的可行性。
课题引入了国际先进的管理理念，提出中药商业质量标准的建立应以客户为导向，以卓越质量为目标，并始终坚持系统化的思维。不同于以往的准入性的质量目标和纯技术性的标准建立思路。
课题还探讨了中药商业质量标准与官方标准的衔接问题，认为《药品注册管理办法》为国家标准和商业标准提供了很好的契合点，可以为企业自己建立的新的质量标准提供法律认可，有助于提高顾客对该产品的信赖度。
Obviously, Chinese medicine has been more receptible in the international market with the changing of the health conception. Though Chinese medicine come into being a most potential industry, it's development has been badly contained by the low quality.
Enterprises have paid more attention to the business standards, however, state government only give directions on the macroscopical level and technologic specialists always can't comprehend the operation mode of the enterprises, who only can provide technologic support. So the key to establish practical business standard is still depend on the enterprises themselves. We base upon enterprises, advance under the directions of the policies, take the manage concept as fulcrum and set up the whole quality control system of Chinese medicine to help enterprises establish their internal control standard.
We studied situation of the international botanical drug's registration and quality control, summarized three main modes of the quality control and analyze the difference and homology of the two control system represented by the Europe-USA & Japan separately. The development of botanical drug's quality control is also discussed in our study.
We based upon the enterprises, put forward the guidelines of Chinese medicine's business standards, which is advised should not only combine the manage concept and technological support, but also link up with the national policies. The establishment of the index must pursue excellence quality and satisfy the producibility in the enterprises, the character of the traditional Chinese medicine and requirement of the internationalization should also well considered.
Internationa] advanced manage concept is inducted in our study, we bring forward the establishment of Chinese medicine business standards should satisfy their clients, target the excellent quality and insist the thought of systematism.
The problem of how to link up the Chinese medicine's business quality stands with the national standards is also discussed. "Measures for the Administration of Drug's registration" is deemed to solve this question perfectly, which can provide the legally authorization and help clients trust the products.
引文
1 标准化的基本概念．http://www.chinapost.gov.cn/fgybz/st-day/6.htm
2 中质网．中国质检总局信息中心．http://www.cqi.gov.cn/bzfg/biaoz04_74.php
3 business standards, http://www.bsi-global.com/About+BSI/Standards/index.xalter
4 政策支持标准跟进，中药国际化装上发动机．http://www.wtolaw.gov.cn/display/displaylnfo.asp?IID=200304010828363810
5 唐小芬．质量竞争力研究．http://www.juransh.org.cn/zllt/w.html
6 中药国际化现状及对策。http://21tcm.com/shtml/31253534/200332115828.shtml
7 中国中医药行业调查分析．http://www.keywin.com.cn/show.asp?id=2186
8 得标准者得天下．http://news.xinhuanet.com/fortune/2002-O5/24/content_407358.htm
9 “洋中药”抢滩大陆．http://www.cmt.com.cr/article/030306/a0303061508.htm
10 Guidance for Industry Botanical Drug Products. CDER, August 2000.
11 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human use
12 2002/0008 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending the Directive 2001/83/EC as regards traditional herbal medicinal products
13 good agricultural practice
14 points to consider on good agricultural and collection practice for starting materials of herbal origion
15 LARRY Kelly．药检分析实验室面临草药的挑战．中药新药与临床药理2001；12(3)：152
16 中药国际化现状及对策.http://21tcm.com/shtml/31253534/200332115828.shtml
17 澳门的中医药现状．http://www.satcm.gov.cn/lanmu/gangao_yiyao/tcm030730aomen.htm
18 国家食品药品监督管理局．国食药监安[2003]251号
http://www.sda.gov.cn/webportal/portal.po?UID=DWV 1 _WOUID_URL_4244&TOC=COLUMN 4244&OBJ=36539545
19 清华同方．寻找数字电视领域的“高通”．http://finance.tom.com/Archive/1008/1011/2003/6/27-60514.html
20 我国原料药生产面临的形势．http://www.china-pharm.com/yiyaoxingshi．htm
21 林瑞超．中药材及其饮片质量控制http://www.stcsm.gov.cr/learning/lesson/shengwu/20030620/lesson-2.asp
22 中药国际化所遇到的问题及应采取的具体对策。http://www.gzyy.org/hyfx/hy0001.htm
23 陈仕江，金仕勇，张明．浅谈中药材的农药重金属污染与防治．世界科学技术—中药现代化．2002，4(4)：72
24 张曙明，郭怀忠，陈建民．黄芪、三七和西洋参中多种有机氯农药残留量分析．中国中药杂志．2000，25(7)：402．
25 abhout SGS-in brief, http://www.sgs.com/about_sgs/in__brief.htm
26 Consumer Testing Services. http://www.sgs.com/consumer_testing?lobld=5547
27 Automotive Services. http://www.sgs.com/automotive?lobld=5537
28 吴智勇．麦肯锡怎样做咨询——评《麦肯锡方法》．http://zhiyonwnew.www81.cn4e.com/p153.htm
29 “6 Sigma”品质管理的研究．http://www.printmarket.com.cn/iso/sigma.asp
30 六西格玛管理的六个主题．http://www.knowledgetrans.com/sigema/basehow.htm
31 王金德 张东莉．6 Sigma管理的基本原则http://www.juransh.org.cn/zxxx-xzc3a.htm
32 全欧洲中医药学会联合会中药专家特别小组．复方丹参滴丸．中国医药科技出版社
33 河南宛西制药企业网站．http://www.china-medicines.com/index．htm
34 孙耀志．探索中药复兴．http://www.cistc.gov.cn/info/infoview.asp?id=29806
35 中药亟需撑起专利保护伞．http://info.pharmacy.hc 360.com/HTML/001/001/004/11551.htm
2 中质网．中国质检总局信息中心．http://www.cqi.gov.cn/bzfg/biaoz04_74.php
3 business standards, http://www.bsi-global.com/About+BSI/Standards/index.xalter
4 政策支持标准跟进，中药国际化装上发动机．http://www.wtolaw.gov.cn/display/displaylnfo.asp?IID=200304010828363810
5 唐小芬．质量竞争力研究．http://www.juransh.org.cn/zllt/w.html
6 中药国际化现状及对策。http://21tcm.com/shtml/31253534/200332115828.shtml
7 中国中医药行业调查分析．http://www.keywin.com.cn/show.asp?id=2186
8 得标准者得天下．http://news.xinhuanet.com/fortune/2002-O5/24/content_407358.htm
9 “洋中药”抢滩大陆．http://www.cmt.com.cr/article/030306/a0303061508.htm
10 Guidance for Industry Botanical Drug Products. CDER, August 2000.
11 2001/83/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 6 November 2001 on the Community code relating to medicinal products for human use
12 2002/0008 Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending the Directive 2001/83/EC as regards traditional herbal medicinal products
13 good agricultural practice
14 points to consider on good agricultural and collection practice for starting materials of herbal origion
15 LARRY Kelly．药检分析实验室面临草药的挑战．中药新药与临床药理2001；12(3)：152
16 中药国际化现状及对策.http://21tcm.com/shtml/31253534/200332115828.shtml
17 澳门的中医药现状．http://www.satcm.gov.cn/lanmu/gangao_yiyao/tcm030730aomen.htm
18 国家食品药品监督管理局．国食药监安[2003]251号
http://www.sda.gov.cn/webportal/portal.po?UID=DWV 1 _WOUID_URL_4244&TOC=COLUMN 4244&OBJ=36539545
19 清华同方．寻找数字电视领域的“高通”．http://finance.tom.com/Archive/1008/1011/2003/6/27-60514.html
20 我国原料药生产面临的形势．http://www.china-pharm.com/yiyaoxingshi．htm
21 林瑞超．中药材及其饮片质量控制http://www.stcsm.gov.cr/learning/lesson/shengwu/20030620/lesson-2.asp
22 中药国际化所遇到的问题及应采取的具体对策。http://www.gzyy.org/hyfx/hy0001.htm
23 陈仕江，金仕勇，张明．浅谈中药材的农药重金属污染与防治．世界科学技术—中药现代化．2002，4(4)：72
24 张曙明，郭怀忠，陈建民．黄芪、三七和西洋参中多种有机氯农药残留量分析．中国中药杂志．2000，25(7)：402．
25 abhout SGS-in brief, http://www.sgs.com/about_sgs/in__brief.htm
26 Consumer Testing Services. http://www.sgs.com/consumer_testing?lobld=5547
27 Automotive Services. http://www.sgs.com/automotive?lobld=5537
28 吴智勇．麦肯锡怎样做咨询——评《麦肯锡方法》．http://zhiyonwnew.www81.cn4e.com/p153.htm
29 “6 Sigma”品质管理的研究．http://www.printmarket.com.cn/iso/sigma.asp
30 六西格玛管理的六个主题．http://www.knowledgetrans.com/sigema/basehow.htm
31 王金德 张东莉．6 Sigma管理的基本原则http://www.juransh.org.cn/zxxx-xzc3a.htm
32 全欧洲中医药学会联合会中药专家特别小组．复方丹参滴丸．中国医药科技出版社
33 河南宛西制药企业网站．http://www.china-medicines.com/index．htm
34 孙耀志．探索中药复兴．http://www.cistc.gov.cn/info/infoview.asp?id=29806
35 中药亟需撑起专利保护伞．http://info.pharmacy.hc 360.com/HTML/001/001/004/11551.htm