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中成藥走向國際市場的發展之路(一)

       我國的(de)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)歷史(shi)源遠流長(chang),博采豐(feng)富,不僅是(shi)(shi)(shi)我國非物質文化遺產一顆(ke)璀璨的(de)明珠,也是(shi)(shi)(shi)世界醫藥(yao)(yao)(yao)的(de)瑰寶。中(zhong)(zhong)(zhong)成(cheng)(cheng)藥(yao)(yao)(yao)是(shi)(shi)(shi)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)方(fang)劑(ji)中(zhong)(zhong)(zhong)的(de)精品,也是(shi)(shi)(shi)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)的(de)重要(yao)組(zu)成(cheng)(cheng)部(bu)分(fen),絕大(da)多數中(zhong)(zhong)(zhong)成(cheng)(cheng)藥(yao)(yao)(yao)的(de)品種(zhong),來(lai)(lai)源于經(jing)過長(chang)期臨床實(shi)踐(jian)且療(liao)效確切的(de)著名方(fang)劑(ji),還有一部(bu)分(fen)中(zhong)(zhong)(zhong)成(cheng)(cheng)藥(yao)(yao)(yao)來(lai)(lai)源于秘(mi)方(fang)、經(jing)驗方(fang)和研(yan)制(zhi)(zhi)方(fang)。中(zhong)(zhong)(zhong)成(cheng)(cheng)藥(yao)(yao)(yao)極少是(shi)(shi)(shi)單(dan)方(fang)制(zhi)(zhi)劑(ji),絕大(da)多數為復方(fang)制(zhi)(zhi)劑(ji),可分(fen)為傳統(tong)中(zhong)(zhong)(zhong)成(cheng)(cheng)藥(yao)(yao)(yao)和創新中(zhong)(zhong)(zhong)成(cheng)(cheng)藥(yao)(yao)(yao)。

       目前(qian)中成藥已(yi)(yi)發(fa)(fa)(fa)展到35大(da)類,43種劑型,9000余品(pin)種,臨床應用(yong)已(yi)(yi)非常廣(guang)泛和(he)普及(ji),成為保障人們(men)健(jian)康的(de)常用(yong)藥品(pin)種類。可以預測,隨著國(guo)家一帶(dai)一路的(de)高(gao)智慧(hui)發(fa)(fa)(fa)展戰略(lve),隨著高(gao)科技中成藥研發(fa)(fa)(fa)的(de)繼續深(shen)入與不斷(duan)創新(xin),其生產水平(ping)(ping)和(he)質量(liang)控制水平(ping)(ping)將(jiang)不斷(duan)飛(fei)躍提高(gao),中成藥必將(jiang)成為我國(guo)參與國(guo)際醫藥市場競爭的(de)支柱產業,也必將(jiang)對(dui)全世(shi)界人類健(jian)康做出(chu)更大(da)的(de)貢獻。

       不論(lun)中(zhong)西(xi)藥(yao)(yao)(yao)(yao),藥(yao)(yao)(yao)(yao)品的(de)價值最終體現(xian)在藥(yao)(yao)(yao)(yao)物的(de)實際應(ying)用(yong)中(zhong),重點關(guan)注藥(yao)(yao)(yao)(yao)品應(ying)用(yong)過程與藥(yao)(yao)(yao)(yao)品應(ying)用(yong)結果,已經在藥(yao)(yao)(yao)(yao)學(xue)領域的(de)臨床藥(yao)(yao)(yao)(yao)學(xue)專業廣(guang)(guang)泛展(zhan)開。臨床藥(yao)(yao)(yao)(yao)學(xue)的(de)深入(ru)(ru)研(yan)究和可持續(xu)發展(zhan),不僅(jin)要豐富了涵蓋中(zhong)西(xi)藥(yao)(yao)(yao)(yao)的(de)整(zheng)體藥(yao)(yao)(yao)(yao)學(xue)學(xue)科的(de)內(nei)涵,也(ye)要擴大國際醫(yi)(yi)學(xue)藥(yao)(yao)(yao)(yao)學(xue)研(yan)究者(zhe)、工作(zuo)者(zhe)的(de)視野。當(dang)我們在關(guan)心圍繞中(zhong)成(cheng)藥(yao)(yao)(yao)(yao)深入(ru)(ru)研(yan)發與國際市場(chang)(chang)推廣(guang)(guang)的(de)同時(shi),也(ye)要知道當(dang)前中(zhong)成(cheng)藥(yao)(yao)(yao)(yao)的(de)實際應(ying)用(yong)水(shui)平,參(can)與國際醫(yi)(yi)藥(yao)(yao)(yao)(yao)市場(chang)(chang)競爭與推廣(guang)(guang)的(de)短板(ban)在哪(na)里(li)?

       比(bi)如,目前相當一部分的(de)(de)中(zhong)(zhong)成藥(yao)(yao)(yao)說明(ming)書內容(rong),其(qi)中(zhong)(zhong)的(de)(de)優勢與好處只(zhi)有我(wo)們自己(ji)人(ren)知道,而外人(ren)不(bu)知道;其(qi)說明(ming)書的(de)(de)內容(rong)還比(bi)較空泛,表述還過(guo)于簡(jian)單,遠遠不(bu)能滿(man)足參(can)與國(guo)際市場(chang)推廣其(qi)合(he)理(li)應(ying)用(yong)(yong)的(de)(de)要求,距(ju)離科學合(he)理(li)還差(cha)很(hen)遠,提高中(zhong)(zhong)成藥(yao)(yao)(yao)應(ying)用(yong)(yong)水(shui)平還有很(hen)多(duo)的(de)(de)事(shi)情需(xu)要做,也(ye)容(rong)易導(dao)致(zhi)其(qi)今后在國(guo)際市場(chang)的(de)(de)臨床應(ying)用(yong)(yong)中(zhong)(zhong),聯合(he)用(yong)(yong)藥(yao)(yao)(yao)出現偏差(cha),導(dao)致(zhi)藥(yao)(yao)(yao)物對患者安全性、有效(xiao)性出現問題。

       隨著(zhu)現(xian)代科學(xue)技(ji)術的(de)(de)發(fa)展(zhan),運用(yong)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)藥(yao)(yao)(yao)(yao)理學(xue),中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)化學(xue)等學(xue)科的(de)(de)研(yan)究(jiu)成(cheng)果,闡明中(zhong)(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)(yao)的(de)(de)藥(yao)(yao)(yao)(yao)理作(zuo)用(yong)及(ji)作(zuo)用(yong)機制,了(le)解其毒性及(ji)不(bu)良反應(ying),探索臨(lin)床療效(xiao)及(ji)其規律(lv),從(cong)而參與到新(xin)(xin)藥(yao)(yao)(yao)(yao)研(yan)發(fa)已成(cheng)趨勢。因此(ci),國(guo)家醫學(xue)藥(yao)(yao)(yao)(yao)學(xue)高等教育機構,大力支持、深化臨(lin)床中(zhong)(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)(yao)學(xue)的(de)(de)研(yan)究(jiu),對(dui)推動企(qi)業界(jie)劑(ji)型創新(xin)(xin)和(he)研(yan)發(fa)新(xin)(xin)的(de)(de)中(zhong)(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)(yao),指導臨(lin)床合理用(yong)藥(yao)(yao)(yao)(yao),提(ti)高臨(lin)床用(yong)藥(yao)(yao)(yao)(yao)質量,繼承和(he)發(fa)揚醫藥(yao)(yao)(yao)(yao)國(guo)粹,開拓中(zhong)(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)(yao)國(guo)際(ji)市場(chang),使中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)走向世(shi)界(jie)具有(you)重要意義。

       盡管當前(qian)世(shi)(shi)界各國(guo)(guo)對中成(cheng)(cheng)藥(yao)的(de)概念的(de)理解及(ji)(ji)其(qi)研究(jiu)(jiu),不盡相同;目前(qian)在世(shi)(shi)界不同地區和國(guo)(guo)家(jia),對中成(cheng)(cheng)藥(yao)進入(ru)該國(guo)(guo)市場(chang),還存在注冊、以及(ji)(ji)其(qi)他一些人為的(de)壁(bi)壘、障礙的(de)問題(ti),但(dan)是(shi)中醫藥(yao)及(ji)(ji)其(qi)制劑能治愈各類病證的(de)事實,也使許多(duo)中藥(yao)材、中成(cheng)(cheng)藥(yao)產(chan)品(pin)被眾多(duo)國(guo)(guo)外(wai)(wai)市場(chang)所(suo)接(jie)受。其(qi)中日本(ben)(ben)就是(shi)漢(han)方(fang)制劑的(de)主要生產(chan)國(guo)(guo),其(qi)研究(jiu)(jiu)機構(gou)遍布全國(guo)(guo),比如(ru)日本(ben)(ben)的(de)富山醫科藥(yao)科大學(xue)和漢(han)藥(yao)研究(jiu)(jiu)所(suo)等,日本(ben)(ben)現有大大小小的(de)漢(han)方(fang)藥(yao)廠200余家(jia),日本(ben)(ben)津村等漢(han)方(fang)制藥(yao)巨頭企業已深耕(geng)中國(guo)(guo)二(er)三十年。除了日本(ben)(ben)之外(wai)(wai),亞洲其(qi)他國(guo)(guo)家(jia),如(ru)朝鮮、韓國(guo)(guo)、泰國(guo)(guo)、印(yin)度(du)、菲律賓、越南、新加坡、印(yin)度(du)尼西亞等國(guo)(guo),也在生產(chan)和銷售中成(cheng)(cheng)藥(yao)。

不僅如此(ci),近二(er)三十(shi)年以(yi)來,歐(ou)洲(zhou)的植物(wu)藥(yao)市場發展,也(ye)要快于化學藥(yao),整個(ge)歐(ou)洲(zhou)生產植物(wu)藥(yao)的企業也(ye)達到兩三千家,其中(zhong)以(yi)法國(guo)(guo)應用(yong)和(he)推(tui)廣(guang)中(zhong)成藥(yao)為最早(zao),德國(guo)(guo)、英國(guo)(guo)、俄羅斯、東歐(ou)國(guo)(guo)家、美國(guo)(guo)、加拿大、澳大利亞等國(guo)(guo)醫藥(yao)學界,也(ye)逐(zhu)漸開始重視(shi)中(zhong)醫藥(yao)。

       中(zhong)(zhong)成(cheng)藥(yao)走向(xiang)國際市場的(de)發展之路,必(bi)須(xu)保(bao)(bao)持堅守(shou)傳(chuan)統(tong)(tong)(tong)與(yu)(yu)(yu)(yu)(yu)(yu)大(da)(da)膽創新相(xiang)(xiang)結合(he)(he),與(yu)(yu)(yu)(yu)(yu)(yu)現代商品經濟流通(tong)理(li)論相(xiang)(xiang)結合(he)(he),與(yu)(yu)(yu)(yu)(yu)(yu)國際藥(yao)學(xue)(xue)前沿發展趨勢相(xiang)(xiang)結合(he)(he)。首(shou)先(xian),必(bi)須(xu)保(bao)(bao)持堅守(shou)傳(chuan)統(tong)(tong)(tong)與(yu)(yu)(yu)(yu)(yu)(yu)大(da)(da)膽創新相(xiang)(xiang)結合(he)(he),就是(shi)要保(bao)(bao)持堅守(shou)傳(chuan)統(tong)(tong)(tong),就是(shi)要理(li)順中(zhong)(zhong)成(cheng)藥(yao)與(yu)(yu)(yu)(yu)(yu)(yu)方劑學(xue)(xue),中(zhong)(zhong)成(cheng)藥(yao)與(yu)(yu)(yu)(yu)(yu)(yu)中(zhong)(zhong)藥(yao)炮(pao)制學(xue)(xue),與(yu)(yu)(yu)(yu)(yu)(yu)中(zhong)(zhong)藥(yao)化學(xue)(xue),與(yu)(yu)(yu)(yu)(yu)(yu)中(zhong)(zhong)藥(yao)藥(yao)理(li)學(xue)(xue),與(yu)(yu)(yu)(yu)(yu)(yu)中(zhong)(zhong)藥(yao)藥(yao)劑學(xue)(xue)之間的(de)關系,從而(er)嚴(yan)把質量(liang)關,先(xian)談堅守(shou)傳(chuan)統(tong)(tong)(tong),再談大(da)(da)膽創新。

       中(zhong)(zhong)成藥(yao)(yao)是(shi)(shi)中(zhong)(zhong)藥(yao)(yao)方劑中(zhong)(zhong)的精品,中(zhong)(zhong)藥(yao)(yao)炮制的方法是(shi)(shi)一(yi)(yi)項傳統的中(zhong)(zhong)藥(yao)(yao)制藥(yao)(yao)技(ji)術,也(ye)是(shi)(shi)一(yi)(yi)種(zhong)現代化制藥(yao)(yao)工(gong)藝,實為中(zhong)(zhong)成藥(yao)(yao)制劑生產的“前加工(gong)”。先進的現代化中(zhong)(zhong)藥(yao)(yao)炮制技(ji)術,應(ying)該成為中(zhong)(zhong)成藥(yao)(yao)生產設計、質量把關流程中(zhong)(zhong)的一(yi)(yi)個(ge)重要(yao)組成部分,這也(ye)是(shi)(shi)當今區別中(zhong)(zhong)成藥(yao)(yao)與(yu)化學(xue)藥(yao)(yao)生產技(ji)術的最大(da)不同特色之一(yi)(yi),也(ye)是(shi)(shi)充分體現中(zhong)(zhong)成藥(yao)(yao)商品價值的一(yi)(yi)部分。

       從現(xian)(xian)代醫藥學的(de)(de)觀點來看(kan),與化學藥的(de)(de)成(cheng)分(fen)類比,中(zhong)(zhong)成(cheng)藥所(suo)含的(de)(de)有效成(cheng)分(fen),也(ye)是(shi)其(qi)發揮(hui)臨床療效的(de)(de)物(wu)質基礎。對(dui)(dui)中(zhong)(zhong)成(cheng)藥中(zhong)(zhong)的(de)(de)化學成(cheng)分(fen)及其(qi)活(huo)性成(cheng)分(fen)進行深(shen)入的(de)(de)研(yan)究(jiu)(jiu),也(ye)是(shi)中(zhong)(zhong)藥現(xian)(xian)代化的(de)(de)關鍵和(he)核(he)心(xin)。深(shen)入研(yan)究(jiu)(jiu)中(zhong)(zhong)藥化學,既有利于揭示(shi)中(zhong)(zhong)成(cheng)藥的(de)(de)作用(yong)機制(zhi)、方劑理論、配伍(wu)規律,又可(ke)對(dui)(dui)優(you)化生(sheng)產制(zhi)劑技術創新,制(zhi)定(ding)更高的(de)(de)質量控制(zhi)標準,從而實現(xian)(xian)中(zhong)(zhong)藥的(de)(de)現(xian)(xian)代化應用(yong),使國際(ji)市(shi)場充(chong)分(fen)接(jie)納具有重要的(de)(de)意義。

       由于中成(cheng)(cheng)藥(yao)往往含有(you)多(duo)(duo)種活(huo)性(xing)或有(you)效(xiao)成(cheng)(cheng)分,其(qi)臨(lin)床療效(xiao)必然(ran)是多(duo)(duo)種成(cheng)(cheng)分相(xiang)互作用的(de)綜合(he)結果。因此,對中成(cheng)(cheng)藥(yao)傳統劑(ji)型的(de)改進與(yu)更新,必須(xu)結合(he)其(qi)功能與(yu)主(zhu)(zhu)治,并根據藥(yao)品主(zhu)(zhu)要(yao)活(huo)性(xing)成(cheng)(cheng)分的(de)理(li)化性(xing)質(zhi),采取相(xiang)應的(de)提取方法和制備工(gong)藝(yi),盡可能使其(qi)所含的(de)活(huo)性(xing)成(cheng)(cheng)分不(bu)變(bian)化或者無損失,從而控制成(cheng)(cheng)品中活(huo)性(xing)成(cheng)(cheng)分含量穩定(ding),確保(bao)中成(cheng)(cheng)藥(yao)質(zhi)量,確保(bao)臨(lin)床療效(xiao)。

       中(zhong)(zhong)(zhong)成藥(yao)與(yu)中(zhong)(zhong)(zhong)藥(yao)藥(yao)劑(ji)學(xue)的(de)結合點(dian),重(zhong)點(dian)在于(yu)(yu)中(zhong)(zhong)(zhong)藥(yao)制(zhi)(zhi)劑(ji)和中(zhong)(zhong)(zhong)藥(yao)調劑(ji)。就藥(yao)物劑(ji)型(xing)及制(zhi)(zhi)備工藝而(er)論,中(zhong)(zhong)(zhong)藥(yao)制(zhi)(zhi)劑(ji)要求(qiu)(qiu)詳細介紹各種劑(ji)型(xing)的(de)概(gai)念、特點(dian)及制(zhi)(zhi)備方(fang)法等,中(zhong)(zhong)(zhong)藥(yao)調劑(ji)則側重(zhong)于(yu)(yu)藥(yao)物的(de)稱重(zhong)、處方(fang)調配、用(yong)藥(yao)禁忌(ji)、劇毒藥(yao)管理等要求(qiu)(qiu),要求(qiu)(qiu)掌(zhang)握(wo)每種藥(yao)物的(de)性能(neng)、特點(dian)、用(yong)法、用(yong)量、功能(neng)與(yu)主(zhu)治,以便指導(dao)患者(zhe)合理使用(yong)。藥(yao)物發(fa)明人、中(zhong)(zhong)(zhong)成藥(yao)企(qi)業(ye)除了(le)以上(shang)要求(qiu)(qiu)外,還應(ying)掌(zhang)握(wo)中(zhong)(zhong)(zhong)成藥(yao)臨床藥(yao)學(xue)的(de)研究方(fang)法,以便能(neng)夠(gou)參與(yu)、結合、指導(dao)和監督臨床用(yong)藥(yao),并(bing)根據用(yong)藥(yao)反饋(kui)意見進行統計學(xue)分析,得出用(yong)藥(yao)規律,從而(er)用(yong)于(yu)(yu)指導(dao)中(zhong)(zhong)(zhong)成藥(yao)生產和新產品的(de)開發(fa)。

       中(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)要(yao)(yao)走向(xiang)國際市場,中(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)與化學藥(yao)(yao)(yao)物聯(lian)合用(yong)藥(yao)(yao)(yao),將會(hui)成(cheng)(cheng)(cheng)為(wei)一種主要(yao)(yao)的發展(zhan)趨勢,一定要(yao)(yao)特(te)別注重中(zhong)(zhong)(zhong)西(xi)(xi)(xi)藥(yao)(yao)(yao)聯(lian)用(yong)的問題(ti)。其中(zhong)(zhong)(zhong)中(zhong)(zhong)(zhong)西(xi)(xi)(xi)藥(yao)(yao)(yao)聯(lian)用(yong)主要(yao)(yao)有三種形式,一是中(zhong)(zhong)(zhong)西(xi)(xi)(xi)藥(yao)(yao)(yao)組成(cheng)(cheng)(cheng)復(fu)方制劑(ji),二(er)是中(zhong)(zhong)(zhong)西(xi)(xi)(xi)藥(yao)(yao)(yao)復(fu)方制劑(ji)與西(xi)(xi)(xi)藥(yao)(yao)(yao)聯(lian)用(yong),三是中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(包括(kuo)中(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)或中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)湯劑(ji))與西(xi)(xi)(xi)藥(yao)(yao)(yao)先后序貫使用(yong),即(ji)根據病情需要(yao)(yao)先服(fu)(fu)西(xi)(xi)(xi)藥(yao)(yao)(yao),后服(fu)(fu)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao),或者先服(fu)(fu)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao),后服(fu)(fu)西(xi)(xi)(xi)藥(yao)(yao)(yao)等等。

       近幾十年以(yi)來,隨著中(zhong)(zhong)成(cheng)藥臨床(chuang)應用的(de)(de)(de)發展,中(zhong)(zhong)西醫(yi)結合(he)治(zhi)療疾病已(yi)成(cheng)為(wei)一(yi)種獨(du)特且奇(qi)效的(de)(de)(de)治(zhi)療方法,而迅速發展。臨床(chuang)上(shang)為(wei)了取長補(bu)短,提高療效,中(zhong)(zhong)成(cheng)藥和西藥聯用已(yi)日(ri)趨(qu)普(pu)遍,由于中(zhong)(zhong)成(cheng)藥與西藥目前(qian)尚(shang)未殊途(tu)同歸(gui),暫分屬兩個截然不同的(de)(de)(de)醫(yi)療體系(xi),各自有著不同的(de)(de)(de)理(li)論基礎和用藥經驗,因此中(zhong)(zhong)西藥聯用自然要(yao)面對很多新的(de)(de)(de)問題。

       這些問(wen)題有利有弊,或協同增效(xiao)(xiao),或降低(di)西藥(yao)(yao)的(de)(de)不(bu)(bu)良反應,或產生拮抗(kang)作用(yong)(yong),或降低(di)療效(xiao)(xiao)或增加毒性作用(yong)(yong),因此中西藥(yao)(yao)聯(lian)用(yong)(yong)是(shi)把雙刃劍,完(wan)全看應用(yong)(yong)的(de)(de)好(hao)與不(bu)(bu)好(hao)。醫藥(yao)(yao)和(he)醫務工(gong)作者,只有充分了解中藥(yao)(yao)和(he)西藥(yao)(yao)各自的(de)(de)特點及其(qi)相互作用(yong)(yong)的(de)(de)機制(zhi),才能(neng)因勢利導充分發揮中藥(yao)(yao)和(he)西藥(yao)(yao)的(de)(de)優勢,增強療效(xiao)(xiao),避免出現藥(yao)(yao)效(xiao)(xiao)降低(di)的(de)(de)現象,減(jian)少不(bu)(bu)良反應。

2024年(nian)11月(yue)4日 14:57