中(zhong)(zhong)(zhong)藥(yao)為我(wo)國傳統醫(yi)藥(yao),用中(zhong)(zhong)(zhong)藥(yao)防病(bing)治病(bing)在我(wo)國具有悠(you)久的歷(li)史。由(you)于化學藥(yao)品的毒(du)副作用逐(zhu)漸被人們所認(ren)識及(ji)合(he)成一個新藥(yao)又需巨大的投資,西醫(yi)西藥(yao)對威協人類健(jian)康的常見病(bing)、疑難病(bing)的治療藥(yao)物(wu)還(huan)遠遠不能滿足臨床的需要,因此(ci),全世界范圍內(nei)掀起了中(zhong)(zhong)(zhong)醫(yi)中(zhong)(zhong)(zhong)藥(yao)熱。
中藥在(zai)我國(guo)(guo)作為(wei)天然(ran)藥物不但應用歷(li)史悠久。產(chan)量又居世界第一,然(ran)而,就(jiu)目前世界天藥物的貿(mao)易額看(kan).我國(guo)(guo)僅占18%左右。究其原(yuan)因(yin),主要(yao)是(shi)產(chan)業現(xian)代化(hua)工(gong)程技術水(shui)平不高(gao),制(zhi)備工(gong)藝(yi)和(he)劑型現(xian)代化(hua)水(shui)平還(huan)很落后等(deng)因(yin)素(su)所(suo)制(zhi)約。為(wei)此,要(yao)改(gai)變現(xian)狀必需從提取分(fen)離(li)工(gong)藝(yi)、制(zhi)劑工(gong)藝(yi)現(xian)代化(hua)。質(zhi)量控制(zhi)標(biao)準化(hua)、規范化(hua)上下(xia)手(shou)。面(mian)對科學技術,特別是(shi)醫藥工(gong)業的迅(xun)猛發展(zhan),國(guo)(guo)際間(jian)醫藥學術交流(liu)活動的日(ri)益(yi)頻繁以(yi)及藥品市場(chang)競爭越(yue)來越(yue)激(ji)烈,實現(xian)中藥現(xian)代化(hua),與國(guo)(guo)際接軌,已成為(wei)中醫藥工(gong)作者的共識。
在現(xian)代(dai)社(she)會,中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)生產(chan)(chan)中(zhong)(zhong)(zhong)的(de)(de)(de)(de)(de)大(da)桶煮(zhu)提(ti)(ti)、大(da)鍋蒸(zheng)(zheng)熬及匾、勺、缸類生產(chan)(chan)器具(ju)當家(jia)(jia)的(de)(de)(de)(de)(de)狀況(kuang)大(da)為(wei)改(gai)善,進(jin)而出現(xian)不(bu)銹鋼多(duo)功能提(ti)(ti)取(qu)罐、外(wai)(wai)循環蒸(zheng)(zheng)發(fa)、多(duo)效蒸(zheng)(zheng)發(fa)器,流化(hua)(hua)干燥器等(deng)設備,中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)(yao)的(de)(de)(de)(de)(de)劑(ji)(ji)(ji)型(xing)也有較大(da)的(de)(de)(de)(de)(de)發(fa)展,由(you)丸、散、膏、丹劑(ji)(ji)(ji)為(wei)主(zhu)發(fa)展成(cheng)為(wei)具(ju)有顆粒劑(ji)(ji)(ji)、片(pian)劑(ji)(ji)(ji)、膠(jiao)囊劑(ji)(ji)(ji)、口服液及少量(liang)(liang)粉針等(deng)劑(ji)(ji)(ji)型(xing)。然而,我國(guo)(guo)現(xian)階(jie)段創制(zhi)(zhi)的(de)(de)(de)(de)(de)中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)(yao)還難以(yi)(yi)在國(guo)(guo)外(wai)(wai)注(zhu)冊、合法銷售(shou)與使用(yong)。從(cong)目(mu)前全世界(jie)天然藥(yao)(yao)(yao)(yao)物的(de)(de)(de)(de)(de)貿(mao)易(yi)額來(lai)看,中(zhong)(zhong)(zhong)國(guo)(guo)僅占l%左右,與天然藥(yao)(yao)(yao)(yao)物主(zhu)產(chan)(chan)國(guo)(guo)的(de)(de)(de)(de)(de)地(di)位(wei)極(ji)不(bu)相(xiang)稱(cheng)。其原因主(zhu)要(yao)是(shi)(shi)產(chan)(chan)業(ye)現(xian)代(dai)工程技術(shu)水平不(bu)高,制(zhi)(zhi)備工藝和劑(ji)(ji)(ji)型(xing)現(xian)代(dai)化(hua)(hua)方面還很落后;生產(chan)(chan)過程的(de)(de)(de)(de)(de)許多(duo)方面缺(que)乏(fa)科(ke)學的(de)(de)(de)(de)(de)、嚴格的(de)(de)(de)(de)(de)工藝操作參數(shu),不(bu)僅導(dao)(dao)致了消耗高、效率低(di),而且還出現(xian)有效成(cheng)分(fen)損(sun)失、療效不(bu)穩定、劑(ji)(ji)(ji)量(liang)(liang)大(da)服用(yong)不(bu)方便、產(chan)(chan)品外(wai)(wai)觀顏色差、內(nei)在質(zhi)(zhi)(zhi)量(liang)(liang)不(bu)穩定;同時還出現(xian)缺(que)少系(xi)統的(de)(de)(de)(de)(de)量(liang)(liang)化(hua)(hua)指標(biao),大(da)多(duo)數(shu)產(chan)(chan)品缺(que)乏(fa)療效基(ji)本一致的(de)(de)(de)(de)(de)內(nei)在質(zhi)(zhi)(zhi)量(liang)(liang)標(biao)準;許多(duo)復方制(zhi)(zhi)劑(ji)(ji)(ji)還難以(yi)(yi)搞清楚其作用(yong)的(de)(de)(de)(de)(de)物質(zhi)(zhi)(zhi)基(ji)礎。"丸、散、膏、丹,神(shen)仙(xian)難辨" 的(de)(de)(de)(de)(de)狀況(kuang)尚未(wei)根本改(gai)變(bian)。要(yao)改(gai)變(bian)這種現(xian)狀,讓西方醫(yi)藥(yao)(yao)(yao)(yao)界(jie)接(jie)受中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao),增(zeng)強中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)在國(guo)(guo)際(ji)市場上(shang)的(de)(de)(de)(de)(de)競爭地(di)位(wei),主(zhu)要(yao)途徑是(shi)(shi),以(yi)(yi)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)理(li)論為(wei)指導(dao)(dao),采用(yong)先(xian)進(jin)的(de)(de)(de)(de)(de)技術(shu),實現(xian)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)現(xian)代(dai)化(hua)(hua)。中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)產(chan)(chan)品現(xian)代(dai)化(hua)(hua)的(de)(de)(de)(de)(de)重點可簡單(dan)地(di)用(yong)8個(ge)字來(lai)描述(shu),即(ji)"有效、量(liang)(liang)小、安全、可控(kong)"。實際(ji)上(shang),它(ta)涉(she)及范圍十分(fen)廣泛,要(yao)解(jie)決的(de)(de)(de)(de)(de)問(wen)題比較復雜(za),但首先(xian)關鍵的(de)(de)(de)(de)(de)問(wen)題就是(shi)(shi)要(yao)提(ti)(ti)取(qu)分(fen)離(li)工藝、制(zhi)(zhi)劑(ji)(ji)(ji)工藝現(xian)代(dai)化(hua)(hua),質(zhi)(zhi)(zhi)量(liang)(liang)控(kong)制(zhi)(zhi)標(biao)準化(hua)(hua)、規范化(hua)(hua)。為(wei)此,許多(duo)醫(yi)藥(yao)(yao)(yao)(yao)專家(jia)(jia)多(duo)次提(ti)(ti)出要(yao)采用(yong)超臨(lin)界(jie)流體技術(shu)、膜分(fen)離(li)技術(shu)、冷凍(dong)干燥技術(shu)、微波輻(fu)射誘導(dao)(dao)萃(cui)取(qu)技術(shu)、緩控(kong)釋(shi)制(zhi)(zhi)劑(ji)(ji)(ji)技術(shu)、各種先(xian)進(jin)的(de)(de)(de)(de)(de)色譜、光譜分(fen)析等(deng)先(xian)進(jin)技術(shu),進(jin)行(xing)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)研究(jiu)開發(fa)及產(chan)(chan)業(ye)化(hua)(hua)。"
中藥(yao)生(sheng)產(chan)現(xian)(xian)代化和(he)質(zhi)(zhi)量標準(zhun)科學化是(shi)發(fa)展(zhan)中藥(yao),走(zou)向世(shi)界的(de)(de)關鍵.在(zai)中藥(yao)研制和(he)開發(fa)中,必(bi)須逆循“三效(xiao)(xiao)(xiao)(xiao)“(速(su)效(xiao)(xiao)(xiao)(xiao)、高(gao)效(xiao)(xiao)(xiao)(xiao)、長效(xiao)(xiao)(xiao)(xiao)),"三小(xiao)"(劑(ji)量小(xiao)、副作用(yong)(yong)(yong)(yong)小(xiao)、毒性(xing)(xing)小(xiao)),"五方(fang)便"(生(sheng)產(chan)、運輸、儲(chu)藏、攜帶、使(shi)用(yong)(yong)(yong)(yong)方(fang)便)為目的(de)(de)之(zhi)原則.為此,必(bi)須選用(yong)(yong)(yong)(yong)一(yi)些現(xian)(xian)代高(gao)新(xin)工藝技(ji)(ji)(ji)術.近年發(fa)展(zhan)的(de)(de)SFE技(ji)(ji)(ji)術用(yong)(yong)(yong)(yong)于提取(qu)(qu)(qu)天(tian)然(ran)(ran)藥(yao)物中的(de)(de)有(you)(you)效(xiao)(xiao)(xiao)(xiao)成分(fen),特別適(shi)合(he)對濕熱不穩(wen)(wen)定的(de)(de)物質(zhi)(zhi),又無殘留(liu)溶(rong)(rong)劑(ji)、無回收(shou)(shou)溶(rong)(rong)劑(ji)造成環境污染的(de)(de)缺陷,而(er)且(qie)提取(qu)(qu)(qu)速(su)度快、可縮(suo)短生(sheng)產(chan)周期。無疑是(shi)既(ji)可提高(gao)收(shou)(shou)率及產(chan)品(pin)純度、又可降(jiang)低成本(ben)的(de)(de)一(yi)種(zhong)高(gao)新(xin)技(ji)(ji)(ji)術可推(tui)廣使(shi)用(yong)(yong)(yong)(yong).但是(shi)因為本(ben)法采(cai)取(qu)(qu)(qu)的(de)(de)萃(cui)取(qu)(qu)(qu)劑(ji)均為脂溶(rong)(rong)性(xing)(xing),所以對極性(xing)(xing)偏大或(huo)分(fen)子量偏大(一(yi)般大于500時)的(de)(de)有(you)(you)效(xiao)(xiao)(xiao)(xiao)成分(fen)提取(qu)(qu)(qu)收(shou)(shou)率較差(cha),今(jin)后必(bi)須在(zai)選用(yong)(yong)(yong)(yong)合(he)適(shi)夾(jia)帶劑(ji)加入(ru)方(fang)面(mian)下功夫.當(dang)然(ran)(ran),國外(wai)已有(you)(you)報道應用(yong)(yong)(yong)(yong)全氟聚醚碳(tan)酸銨可使(shi)SFE法擴展(zhan)到水溶(rong)(rong)性(xing)(xing)體系,使(shi)難以提取(qu)(qu)(qu)的(de)(de)強極性(xing)(xing)化合(he)物如(ru)蛋(dan)白(bai)等成分(fen)由(you)SFE法萃(cui)取(qu)(qu)(qu).近年來SFE技(ji)(ji)(ji)術又與色(se)(se)譜、質(zhi)(zhi)譜、高(gao)壓(ya)液相色(se)(se)譜等高(gao)新(xin)分(fen)析(xi)儀器聯用(yong)(yong)(yong)(yong),成為一(yi)種(zhong)有(you)(you)效(xiao)(xiao)(xiao)(xiao)的(de)(de)分(fen)離(li)、分(fen)析(xi)手段,能(neng)高(gao)效(xiao)(xiao)(xiao)(xiao)、快速(su)地(di)進行藥(yao)物成分(fen)的(de)(de)分(fen)析(xi)。使(shi)一(yi)些中藥(yao)制劑(ji)能(neng)借此制訂出能(neng)指導生(sheng)產(chan)操作和(he)反映產(chan)品(pin)內在(zai)質(zhi)(zhi)量均一(yi)性(xing)(xing)、有(you)(you)效(xiao)(xiao)(xiao)(xiao)性(xing)(xing)、穩(wen)(wen)定性(xing)(xing)、重(zhong)現(xian)(xian)性(xing)(xing)的(de)(de)可控(kong)指標,實施質(zhi)(zhi)量標推(tui)科學化.
目前 SFE主要用(yong)(yong)(yong)在(zai)天然(ran)藥(yao)物中有效成分的萃取,而且多用(yong)(yong)(yong)于單個藥(yao)物中純天然(ran)成分提(ti)取.我(wo)們認為對我(wo)國應(ying)用(yong)(yong)(yong)歷(li) 史(shi)悠久的古方中一些中成藥(yao)復方制劑,以及許(xu)多中藥(yao)中具很強藥(yao)理活性,參與(yu)(yu)(yu)生命功能活動的多糖成分.也(ye)應(ying)該進行采用(yong)(yong)(yong)SFE提(ti)取工藝的研究與(yu)(yu)(yu)新藥(yao)開發(fa),這也(ye)是使中藥(yao)與(yu)(yu)(yu)國際接(jie)軌(gui),實(shi)現中藥(yao)現代(dai)化的必經之路。)
在(zai)超(chao)臨(lin)界流(liu)體技術中(zhong),研究及開發應(ying)用(yong)較多的是超(chao)臨(lin)界流(liu)體萃取技術,由于其(qi)自身的特點,國(guo)內外己(ji)廣(guang)泛應(ying)用(yong)于食品(pin)、香料等領(ling)域。我(wo)國(guo)有豐富的自然資源,超(chao)臨(lin)界萃取技術有極大的推廣(guang)價值。有些交通不發達的山區(qu),特產資源十分豐富,尤其(qi)盛(sheng)產中(zhong)草藥(yao)材。處理(li)這(zhe)些藥(yao)材,要(yao)用(yong)相當大的裝(zhuang)置,且(qie)運輸(shu)不便,如(ru)能在(zai)這(zhe)些山區(qu)建立CO2超(chao)臨(lin)界萃取設備,可用(yong)以提取中(zhong)藥(yao)中(zhong)最為有用(yong)的精華部(bu)分,這(zhe)不僅(jin)減少了(le)大量(liang)的運輸(shu)成(cheng)本,而且(qie)大大增強(qiang)了(le)重(zhong)要(yao)的附(fu)加值。
而(er)目前的中(zhong)藥領域(yu),國外或(huo)國內大多數(shu)從事SFE技術(shu)(shu)的單位研究開(kai)發(fa)應用(yong)(yong)雖有(you)(you)(you)(you)報(bao)道,但缺乏系(xi)統性,大多只(zhi)停留在中(zhong)藥有(you)(you)(you)(you)效(xiao)(xiao)成分或(huo)中(zhong)間原(yuan)料提取方(fang)(fang)面,這僅僅是用(yong)(yong)于中(zhong)藥的一個方(fang)(fang)面。中(zhong)藥的研究與開(kai)發(fa)具(ju)有(you)(you)(you)(you)特殊性,即必須具(ju)有(you)(you)(you)(you)藥理臨(lin)床(chuang)效(xiao)(xiao)果,因(yin)此,SFE技術(shu)(shu)用(yong)(yong)于中(zhong)藥必須結(jie)合(he)藥理臨(lin)床(chuang)研究。只(zhi)有(you)(you)(you)(you)工藝上優越(yue),藥理臨(lin)床(chuang)效(xiao)(xiao)果又保證或(huo)更(geng)好(hao),SFE技術(shu)(shu)在該領域(yu)的生命(ming)力(li)或(huo)潛(qian)力(li)才(cai)能(neng)真正體現。