本文選題：植物藥　切入點(diǎn)：植物藥產(chǎn)品　出處：《上海交通大學(xué)》2010年碩士論文　論文類型：學(xué)位論文

【摘要】： 在回歸自然的世界潮流下,隨著醫(yī)療保健費(fèi)用越來越昂貴,人口的老齡化發(fā)展,人們更加看重養(yǎng)生保健。植物藥因其直接來源于自然,毒副作用相對化學(xué)藥和天然藥較小,同時成本較低,日益受到美國民眾的青睞。美國是全球最為發(fā)達(dá)的醫(yī)藥市場,它的發(fā)展與變化直接影響著世界醫(yī)藥市場。 亞洲是傳統(tǒng)的植物藥發(fā)源地,尤其是中國。中國作為中藥的發(fā)源地,使用歷史悠久,中藥中絕大多數(shù)是植物藥。當(dāng)前我國中藥的發(fā)展仍處于較低的水平,中藥市場的國際貿(mào)易中主要是出口初級的原材料和提取物。如何促進(jìn)我國中藥,尤其是促進(jìn)植物藥的發(fā)展并與歐美主流醫(yī)藥市場接軌,這是當(dāng)前國內(nèi)制藥業(yè)界面對的主要問題。 美國是全球最大的藥品市場,要把植物藥推向美國市場,必須首先了解美國對于植物藥的有關(guān)法律、法規(guī)。同時,隨著植物藥技術(shù)的發(fā)展和美國民眾對植物藥產(chǎn)品的實(shí)際需求, FDA(Food and Drug Administration)對植物藥的政策不斷轉(zhuǎn)變。2004年6月《植物藥指南》的正式發(fā)布,以及2006年10月底FDA成功批準(zhǔn)的第一個植物藥上市表明,植物藥以藥品形式在美國上市成為可能。如何根據(jù)當(dāng)前FDA評審政策的要求,促進(jìn)國內(nèi)企業(yè)對美國FDA法規(guī)熟悉和了解,促進(jìn)我國植物藥走向美國等世界醫(yī)藥市場,是我們迫切面待和需要解決的問題。 本研究采用統(tǒng)計(jì)分析、比較對照、案例研究等方法進(jìn)行,明確美國將是植物藥潛在的巨大市場;同時分析植物藥產(chǎn)品在美國上市的兩條主要途徑飲食補(bǔ)充劑和藥品;而藥品又包括非處方藥和新藥申請(NDA, New Drug Application)兩種截然不同的形式。研究闡述了以飲食補(bǔ)充劑和藥品上市所涉及的法規(guī)的差異,提出以藥品形式上市將是植物藥產(chǎn)品發(fā)展的主流方向�！吨参锼幹改稀肥侵参锼幍钠髽I(yè)研究和FDA批準(zhǔn)的法規(guī)性依據(jù),本文總結(jié)了指南中植物藥臨床前研究和臨床研究的要求。通過FDA批準(zhǔn)的第一只植物藥VeregenTM產(chǎn)品進(jìn)行案例分析,提出我國植物藥發(fā)展的幾點(diǎn)思考,希望能促進(jìn)國內(nèi)企業(yè)對美國上市植物藥法規(guī)有深入的了解。
[Abstract]:In the natural world, with health care costs more and more expensive, the development of aging population, people pay more attention to health care. Because of its medicinal plants directly from nature, side effects of chemical medicine and natural medicine is relatively small, and low cost, has been to the United States the United States is the most popular among people. Developed medicine market in the world, its development and change directly affects the pharmaceutical market in the world.
Asia is the birthplace of traditional medicinal plants, especially China. Chinese as the birthplace of traditional Chinese medicine, has a long history, the vast majority of Chinese medicine is plant medicine. The current development of Chinese medicine in our country is still at a relatively low level of Chinese medicine market in international trade is the main export of raw materials and how to promote the extract. China's traditional Chinese medicine, especially in promoting the development of plant medicine and integration with the mainstream pharmaceutical market in Europe and the United States, this is the main problem facing the domestic pharmaceutical industry.
The United States is the world's largest pharmaceuticals market to plant drugs into the U.S. market, we must first understand the relevant laws of the United States, for plant medicine regulations. At the same time, along with the development of plant medicine technology and the American people on the actual demand of herbal products, FDA (Food and Drug Administration) to plant medicine policy changing.2004 June < > plant medicine guide officially released, and the first plant medicine at the end of October 2006 FDA approved listing shows that plant medicine in the form of drugs listed in the United States as possible. According to the current FDA review policy requirements, promote domestic enterprises to understand and familiar with FDA of the United States laws and regulations, promote our country to plant drugs such as the United States the pharmaceutical market, we face to be urgent and need to solve the problem.
This study uses statistical analysis, comparative method, case study, made clear that the United States would be a huge market potential and analysis of medicinal plants; herbal products in the United States listed the two main ways of dietary supplements and drugs; and drugs including non prescription drugs and new drug application (NDA, New Drug Application) two distinct the study illustrates the differences in form. Dietary supplements and drugs listed related regulations, presented in the form of drugs listed will be the mainstream direction of plant medicine product development. Plant medicine guidelines > is a legal basis for approval of plant medicine enterprise research and FDA, this paper summarizes the requirements of plant medicine preclinical research and clinical research the guide for case analysis. Through the FDA approved the first drug VeregenTM plant products, proposes several thoughts for development of plant medicine in China, hoping to promote the domestic enterprises of the United States There is a deep understanding of the listed plant drug regulations.

【學(xué)位授予單位】：上海交通大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2010
【分類號】：D971.2;DD912.1

【引證文獻(xiàn)】

相關(guān)期刊論文 前2條

1 敬志剛;陳永法;葉正良;董海鷗;章順楠;;淺析中藥FDA注冊的制約因素及對策[J];北方藥學(xué);2013年04期

2 孫瑩;;國際上傳統(tǒng)藥物管理對我國中藥材管理制度的啟示[J];世界中醫(yī)藥;2013年02期

，

本文編號：1584397