中藥與天然藥物研發(fā)途徑的選擇

齊云（中國藥理學(xué)會中藥與天然藥物藥理專業(yè)委員會委員，中國醫(yī)學(xué)科學(xué)院藥用植物研究所研究員，主要從事植物藥的抗炎免疫及中藥注射劑速發(fā)性毒性分子機(jī)制研究。）

中藥新藥及健康產(chǎn)品研發(fā)當(dāng)然應(yīng)當(dāng)在國家的政策法規(guī)之下運(yùn)行。剛剛頒布的中藥、天然藥物注冊分類對中藥及天然藥物有明確的限定。中藥是指在我國中醫(yī)藥理論指導(dǎo)下使用的天然藥物及其制劑，而天然藥物則為在現(xiàn)代醫(yī)藥理論指導(dǎo)下使用的天然藥用物質(zhì)及其制劑。具體分了5類，分別為創(chuàng)新藥、改良型新藥、古代經(jīng)典名方、同方類似藥及進(jìn)口藥。在創(chuàng)新藥中又包括單方與復(fù)方制劑2種。研究開發(fā)的途徑從注冊分類的角度，不外就2種，即在中醫(yī)藥理論指導(dǎo)下的中藥新藥（及健康產(chǎn)品）的研發(fā)，及在現(xiàn)代醫(yī)藥理論指導(dǎo)下的天然藥物新藥（及健康產(chǎn)品）的研發(fā)?？陀^上講，2種完全不同的研發(fā)途徑長期并存且常有孰優(yōu)孰劣、甚至孰正孰邪的爭議。其實(shí)，從國家的層面及患者的角度看，無論是從哪條途徑開發(fā)出來的產(chǎn)品，只要符合安全、有效及質(zhì)量可控的三大條件，均是有益于社會的，是應(yīng)當(dāng)受到歡迎的。不存在什么途徑優(yōu)（或正）或什么途徑劣（或邪）的問題。因此，跳出小行業(yè)局限，從更高層級去考慮這個問題，會發(fā)現(xiàn)糾結(jié)于是在中醫(yī)藥理論指導(dǎo)還是現(xiàn)代醫(yī)藥理論指導(dǎo)下進(jìn)行研究，其實(shí)是沒有任何實(shí)際意義的。對國家而言，關(guān)注的是是否能促進(jìn)社會的進(jìn)步；對患者而言，關(guān)注的是是否對疾病確有療效；對研究者而言，選擇什么樣的途徑進(jìn)行產(chǎn)品的研發(fā)，往往與其自身知識結(jié)構(gòu)、遇到的實(shí)際問題等密切相關(guān)，并非完全由主觀意愿所決定。以屠呦呦教授發(fā)現(xiàn)青蒿素而言，可能在研發(fā)階段更多的采用的是現(xiàn)代醫(yī)藥理論指導(dǎo)，具有更多的天然藥物研發(fā)的特征，諾獎委員會在頒獎中特別申明這不是針對中醫(yī)藥的獎項(xiàng)。但從屠呦呦教授實(shí)際研發(fā)過程，我們又能清楚地看到，屠教授在提取抗瘧有效成分時，明顯受到了傳統(tǒng)用藥經(jīng)驗(yàn)的影響，甚至對獲得青蒿素起到了決定性作用。因此，任何一個務(wù)實(shí)的研究者，都應(yīng)當(dāng)把如何才能研發(fā)出優(yōu)良的產(chǎn)品［而真正優(yōu)良的產(chǎn)品為世界所接受（即國際化）只是一個時間問題］放到考量的第一位，能夠達(dá)成這個目標(biāo)的途徑就是好的途徑。其實(shí)，在青蒿素的研究中，屠呦呦教授既采用現(xiàn)代醫(yī)藥理論指導(dǎo)，又充分重視傳統(tǒng)中醫(yī)的臨床經(jīng)驗(yàn)。行業(yè)與學(xué)會將來應(yīng)當(dāng)把關(guān)注重點(diǎn)與途徑轉(zhuǎn)向關(guān)注產(chǎn)品，好產(chǎn)品不問出身。只有這樣，才能在行業(yè)形成一個百花齊放、產(chǎn)品層出不窮的局面。希望我們一起為這個局面而努力?！綯he research and development of new drugs and health products of TCM should of course proceed under the policies and regula?tions of the country.In the Guidelines for Regis?tration and Classification of TCM and Nature Drugs which were published recently,there are clear definitions of TCM and natural drugs.TCM refers to natural medicines and their prepara?tions under the guidance of TCM theory,while natural drugs are natural medicinal substances and their preparations under the guidance of modern medicine theory.These medicines are divided into five categories,namely innovative drugs,modified new drugs,historic classic recipes and their analogues and imported drugs.Besides,innovative drugs include single and compound preparations.Seen from the perspective of regis?tration and classification,there are no more than two ways to research and develop,namely the research and development of new drugs(and health products)under the guidance of TCM theory,or modern medicine theory.Objectively speaking,the two absolutely different ways will coexist for a long time and a dispute persists about which is superior.In fact,from both the country′s and patients′points of view,whatever the way products are developed,society will benefit as long as the products meet the top three requirements of safety,effectiveness and quality control,and they should be welcomed.There is no telling which is superior or inferior.Therefore,breaking the limitations of small industries and considering this problem at a higher level,we will find that it makes no sense to be entangled with the problem of which guidance to follow,the TCM or the modern medicine theory.The country is concerned with whether it can promote social progress;for patients,the concern is whether there is a curative effect on diseases;for the researchers,which research approach to take is closely related to their own knowledge structure and the practical problems encountered rather than being completely determined by subjective intention.Take Professor TU′s discovery of arte?misinin as an instance,she may have applied more modern medicine theory in the course of development which is more characterized by the natural drugs development,so the Nobel Prize Committee stated in the awards that it was not an award for TCM.But from the actual process of development,we can see clearly that Professor TU′s extraction of antimalarial active ingredients was obviously influenced by the traditional expe?rience of drug use,which even played a decisive role in the obtainment of artemisinin.Therefore,any pragmatic researchers should give top priority to how to develop excellent products[the world?wide recognition of which is only a matter of time].Any way to achieve the goal is a good one.In fact,in the study of artemisinin,Professor TU not only applied modern medical theory but gave much weight to clinical experience of TCM.Both the practitioners in industries and the researchers in the society should switch atten?tion to products in the future,since the true good product will never be stopped by its origin.Only in this way can all flowers blossom together and products emerge in an endless stream in the industry,to which I hope we will work together and make a difference.】