傳統(tǒng)藥物產(chǎn)業(yè)化是中藥創(chuàng)新發(fā)展的重要途徑

杜冠華（中國(guó)藥理學(xué)會(huì)原理事長(zhǎng)，中國(guó)藥理學(xué)會(huì)中藥與天然藥物藥理專業(yè)委員會(huì)副主任委員，中國(guó)醫(yī)學(xué)科學(xué)院藥物研究所研究員，主要從事藥物發(fā)現(xiàn)、高通量藥物篩選、神經(jīng)藥理學(xué)和心腦血管藥理學(xué)研究。）

我國(guó)的傳統(tǒng)藥物有著悠久的臨床應(yīng)用歷史，并積累了豐富的臨床應(yīng)用經(jīng)驗(yàn)和資料，形成了比較完整的藥學(xué)科學(xué)理論體系和科學(xué)的應(yīng)用方式。我們目前認(rèn)識(shí)的中藥即傳統(tǒng)藥物在應(yīng)用的歷史過(guò)程中，主要有2種應(yīng)用方式。第一種是由醫(yī)生根據(jù)病情進(jìn)行遣藥組方，經(jīng)煎煮或一定的處理方法使用，并在治療過(guò)程中不斷對(duì)處方進(jìn)行調(diào)整，以達(dá)到最佳治療效果；第二種方式是經(jīng)過(guò)特定工藝制成固定處方的成藥，在臨床上給適合的患者使用，并根據(jù)患者的疾病情況進(jìn)行適當(dāng)?shù)膭┝空{(diào)整。這2種應(yīng)用方式互相補(bǔ)充，形成了傳統(tǒng)醫(yī)藥學(xué)的治療模式和系統(tǒng)?！綯CM has a long history of clinical application,and has accumulated a wealth of clinical experi?ence and information enough to form a relatively complete theoretical system of pharmaceutical science and scientific application.The TCM that we currently know has mainly two application modes in the process of application.The first is to prescribe TCM prescriptions by the doctor,which are used after boiling or after some processing and continue to be adjusted in order to achieve the best treatment effect according to the disease.The second way is a specific process formulated into a Chinese patent drug,which used for the right patients,followed by the appropriate dose adjustment according to the patient′s condition.These two application methods complement each other,forming a traditional medical treatment model and system.】

1 傳統(tǒng)藥物的現(xiàn)代產(chǎn)業(yè)化是傳統(tǒng)成藥的提升【Modern industrialization of traditional medi?cines contribute to improvement of Chinese traditional patent medicines】

中藥有大量的傳統(tǒng)成藥應(yīng)用于臨床，在防治人類疾病中發(fā)揮著積極作用?，F(xiàn)代工業(yè)化的技術(shù)引進(jìn)，實(shí)現(xiàn)這些成藥的產(chǎn)業(yè)化和規(guī)模化生產(chǎn)，不僅可以提高產(chǎn)量，更重要的是提高了產(chǎn)品的均一度，有效控制藥物的質(zhì)量。這些藥物可以按照傳統(tǒng)的方法使用，保持了全部傳統(tǒng)藥物的特點(diǎn)，在生產(chǎn)技術(shù)提升的基礎(chǔ)上實(shí)現(xiàn)規(guī)?；５?，傳統(tǒng)成藥的產(chǎn)業(yè)化對(duì)于藥物本身來(lái)說(shuō)，僅僅是對(duì)這些傳統(tǒng)藥物的傳承，并不能在根本上實(shí)現(xiàn)傳統(tǒng)藥物的提升和創(chuàng)新。【TCM has a large number of Chinese traditional patent medicines used in clinical practice,which are playing positive roles in prevention and treat?ment of human diseases.Due to the introduction of modern industrial technology,the industrializa?tion and large-scale production of Chinese tradi?tional patent medicines have been made possible,which not only improves the output but also,more importantly,increases the uniformity of products and effectively controls the quality of medicines.These drugs can be used in accordance with the traditional methods and maintain all the properties of TCM,based on the upgrading of production technology to remain large-scale.However,for medicine itself,the industrialization of TCM is merely the inheritance of traditional drugs,which cannot fundamentally bring about the promotion and innovation of TCM.】

2 傳統(tǒng)藥物的現(xiàn)代產(chǎn)業(yè)化發(fā)展推動(dòng)了傳統(tǒng)成藥的提升和改造【Modern industrialization of tradi?tional medicines has promoted upgrading and reform of Chinese traditional patent medi?cines】

長(zhǎng)期以來(lái)，人們已經(jīng)認(rèn)識(shí)到傳統(tǒng)的成藥，包括丸、散、膏和丹等各種劑型，與現(xiàn)代藥物相比具有極大的差異。為了改變這種現(xiàn)狀，科研人員進(jìn)行了改進(jìn)。經(jīng)過(guò)多年的努力，在中藥成藥的劑型方面取得了突破性進(jìn)步和發(fā)展。在劑型改造的同時(shí)，更重要的是通過(guò)研究，在藥物成分及有效性方面進(jìn)行了大量的確證性研究，也提升了這些藥物內(nèi)涵的水平。如傳統(tǒng)的六味地黃丸，現(xiàn)在已有六味地黃軟膠囊和六味地黃膠囊等?！綟or a long time,people have realized that the forms of TCM,including pills,powders,ointments and Dan,are considerably different from modern medicines.In order to change the status quo,scientists have made improvements.After years of efforts,we have made breakthroughs and development in the formu?lation of TCM.Along with formulation modifica?tion,more importantly,a large number of confir?matory studies have been conducted on the compo?sition and effectiveness of drugs through research,and the level of connotation of these drugs has also been raised.For example,Liuwei Dihuang Wanhas improved soft capsules and capsules dosage forms.】

3 中藥現(xiàn)代產(chǎn)業(yè)化是推動(dòng)傳統(tǒng)醫(yī)藥學(xué)進(jìn)步和創(chuàng)新的動(dòng)力【Modern industrialization of traditional Chinese medicine promotes progress and inno?vation of traditional medicine】

在中藥新藥研發(fā)的長(zhǎng)期努力中，我們始終在探討創(chuàng)新的內(nèi)容和創(chuàng)新的目標(biāo)。除了已有中成藥的升級(jí)改造之外，對(duì)傳統(tǒng)有效方劑的開(kāi)發(fā)成為中藥研究的主要內(nèi)容。也就是說(shuō)，實(shí)現(xiàn)中藥方劑的產(chǎn)業(yè)化，就是推動(dòng)了傳統(tǒng)藥物的創(chuàng)新。對(duì)于方劑的產(chǎn)業(yè)化研究，不僅是對(duì)藥物的物質(zhì)基礎(chǔ)、有效成分、藥理作用和有效性進(jìn)行系統(tǒng)的研究，更重要的是對(duì)這些方劑在治療過(guò)程中使用的特點(diǎn)進(jìn)行研究，畢竟產(chǎn)業(yè)化的產(chǎn)品不僅固定了處方，也固定了劑量，這樣與傳統(tǒng)中藥應(yīng)用方劑就有了顯著的差異。在這種情況下，如何保證產(chǎn)業(yè)化的產(chǎn)品能夠?qū)崿F(xiàn)臨床應(yīng)用的治療效果，不僅要研究藥物的作用，更要研究對(duì)疾病的精確的選擇性，這樣才有可能達(dá)到比較理想的治療效果?！綢n the long-term efforts devoted to new Chinese medicine research and development,we are always exploring innovative content and goals.In addition to the upgrading of TCM,the development of traditional and effective prescrip?tions has become a priority for TCM research.In other words,to achieve the industrialization of TCM prescriptions is to promote the innovation of TCM.For the industrialization of prescription research,not only is it necessary to make a systematic study of the material basis,active ingredients,pharmacological effects and effec?tiveness of drugs,but more importantly,the charac?teristics of these prescriptions used in the treat?ment process need to be studied.After all,indus?trialized products make not only the prescription fixed,but also the dose fixed,hence the great differ?ence compared with the TCM prescription.Under such circumstances,how to ensure that the industri?alized products can achieve the therapeutic effect in clinical application requires studies not only on the effect of the drug,but also on the exact selec?tivity of the disease so as to achieve the ideal therapeutic effect.】

4 中藥現(xiàn)代產(chǎn)業(yè)化是促進(jìn)中藥走向國(guó)際的重要渠道【Modern industrialization of traditional Chinese medicine is an important channel to promote traditional Chinese medicine to the world】

中藥現(xiàn)代研究的過(guò)程中，我們一直糾結(jié)于促進(jìn)中藥的國(guó)際化，這不僅是讓中藥造福于人類，更希望國(guó)際社會(huì)認(rèn)可或認(rèn)識(shí)中藥內(nèi)涵的科學(xué)性和先進(jìn)性。但是，讓中藥走向國(guó)際，現(xiàn)代產(chǎn)業(yè)化是必然的選擇。首先，現(xiàn)代產(chǎn)業(yè)化的中藥產(chǎn)品實(shí)現(xiàn)了技術(shù)規(guī)范、質(zhì)量穩(wěn)定、產(chǎn)品先進(jìn)，具備了國(guó)際社會(huì)接受的基本條件。沒(méi)有產(chǎn)業(yè)化的產(chǎn)品形式，實(shí)現(xiàn)國(guó)際化是不可能的。但是，僅有產(chǎn)業(yè)化的產(chǎn)品并不能走向國(guó)際，還需要這些產(chǎn)品具有可以被國(guó)際認(rèn)可的治療效果。因此，促進(jìn)中藥產(chǎn)業(yè)化發(fā)展，提升產(chǎn)品質(zhì)量水平，確保產(chǎn)品治療疾病的優(yōu)勢(shì)作用，將有效推動(dòng)中藥的產(chǎn)品和中藥的理論傳播到全世界?！綢n the process of modern TCM research,we have been committed to promoting the internationalization of TCM.It not only benefits TCM to the mankind,but shows our hope that the international community will accept and recognize the scientific validity and advance?ment of TCM.However,to make TCM globally used,modern industrialization is an inevitable choice.First of all,the modern industrialized TCM products have achieved technical specifications,stable quality and advanced products,which have met the basic requirements on the part of the inter?national community.Without industrialized product forms,it is impossible to achieve internationaliza?tion.Nevertheless,industrialized products alone cannot go globally,and they need the internationally recognized therapeutic benefits of these products.Therefore,to promote the industrialization of TCM,we have to improve the quality of products and ensure the superiority of products in the treatment of diseases.The products and theory of TCM need to be effectively promoted to the whole world.】