11月24日,在“中藥合理應用與中藥流通創(chuang)新(xin)發展(zhan)2007南方中藥港國際論壇”上,專家(jia)提出了一(yi)條中藥質量監控的全新(xin)思路——
“中(zhong)(zhong)(zhong)藥(yao)(yao)應(ying)‘接軌(gui)’生物(wu)(wu)制(zhi)品的(de)(de)質(zhi)(zhi)量監(jian)控模式(shi),而不應(ying)‘吻合(he)’化學合(he)成藥(yao)(yao)的(de)(de)質(zhi)(zhi)量控制(zhi)模式(shi)。對(dui)于中(zhong)(zhong)(zhong)藥(yao)(yao)產品,從某(mou)種程度上講,生物(wu)(wu)效價(jia)檢測比化學成分含(han)量測定具有(you)實(shi)際價(jia)值和優勢(shi)。”在11月24日(ri)由世界中(zhong)(zhong)(zhong)醫藥(yao)(yao)學會聯合(he)會中(zhong)(zhong)(zhong)藥(yao)(yao)專業委員主辦,南方(fang)(fang)中(zhong)(zhong)(zhong)藥(yao)(yao)港承辦的(de)(de)“中(zhong)(zhong)(zhong)藥(yao)(yao)合(he)理應(ying)用(yong)與(yu)中(zhong)(zhong)(zhong)藥(yao)(yao)流通(tong)領域創新發展2007南方(fang)(fang)中(zhong)(zhong)(zhong)藥(yao)(yao)港國際論壇(tan)”上,解(jie)放軍(jun)(jun)302醫院全(quan)軍(jun)(jun)中(zhong)(zhong)(zhong)藥(yao)(yao)研(yan)究所所長(chang)肖小河(he)針對(dui)中(zhong)(zhong)(zhong)藥(yao)(yao)質(zhi)(zhi)量監(jian)控提(ti)出了一(yi)條全(quan)新思路。
中藥(yao)(yao)(yao)標準化(hua)問(wen)題(ti)一直是中藥(yao)(yao)(yao)走(zou)向(xiang)國(guo)際(ji)的(de)(de)“瓶(ping)頸(jing)”,中藥(yao)(yao)(yao)的(de)(de)質量(liang)(liang)控(kong)制(zhi)(zhi)和(he)評價(jia)一直是制(zhi)(zhi)約中藥(yao)(yao)(yao)現代化(hua)發(fa)展的(de)(de)關鍵問(wen)題(ti)之一,也是中醫藥(yao)(yao)(yao)研(yan)究的(de)(de)難點和(he)熱點。在此次論(lun)(lun)壇(tan)上,來自(zi)世界11國(guo)家(jia)(jia)(jia)及地區的(de)(de)500余位專家(jia)(jia)(jia)學者圍繞上述問(wen)題(ti)展開了廣(guang)泛的(de)(de)交(jiao)流與(yu)研(yan)討,并就“合(he)理用藥(yao)(yao)(yao)、流通創(chuang)(chuang)新”提交(jiao)了70多篇研(yan)究中藥(yao)(yao)(yao)學發(fa)展最新成果的(de)(de)論(lun)(lun)文,同時(shi),有(you)與(yu)會專家(jia)(jia)(jia)提出了應摒棄中藥(yao)(yao)(yao)質量(liang)(liang)監(jian)控(kong)與(yu)化(hua)學合(he)成藥(yao)(yao)(yao)進行比對的(de)(de)舊思(si)路,轉向(xiang)生物制(zhi)(zhi)品質量(liang)(liang)監(jian)控(kong)模式“接軌”的(de)(de)創(chuang)(chuang)新思(si)路。
“惟成分論”不(bu)具實(shi)際意義
據(ju)南方中(zhong)(zhong)(zhong)藥(yao)(yao)港(gang)董事(shi)會秘(mi)書江偉華介(jie)紹(shao),我國中(zhong)(zhong)(zhong)藥(yao)(yao)的商品化程度較低,雖(sui)然中(zhong)(zhong)(zhong)成藥(yao)(yao)多達1700種,但知名(ming)中(zhong)(zhong)(zhong)藥(yao)(yao)品牌(pai)與西藥(yao)(yao)相比,處于弱勢地位。由于濫用(yong)非道地藥(yao)(yao)材,不嚴(yan)格按照中(zhong)(zhong)(zhong)藥(yao)(yao)的用(yong)藥(yao)(yao)標準已(yi)經(jing)成為(wei)臨床上(shang)導(dao)致中(zhong)(zhong)(zhong)藥(yao)(yao)療效不佳的重要原(yuan)因。而如(ru)何(he)在中(zhong)(zhong)(zhong)藥(yao)(yao)質(zhi)量控制上(shang)區(qu)分(fen)道地藥(yao)(yao)材和非道地藥(yao)(yao)材顯得尤為(wei)重要。
“由于(yu)中(zhong)(zhong)(zhong)藥(yao)本身的(de)(de)(de)(de)復(fu)雜性(xing)(xing),科學(xue)技術條(tiao)件、研究思(si)路(lu)和(he)方法(fa)等因素的(de)(de)(de)(de)局限,現(xian)行中(zhong)(zhong)(zhong)藥(yao)質(zhi)控模式和(he)方法(fa)不(bu)僅(jin)難(nan)(nan)以(yi)有(you)效地控制和(he)評價中(zhong)(zhong)(zhong)藥(yao)的(de)(de)(de)(de)質(zhi)量,更難(nan)(nan)以(yi)反映其(qi)安全性(xing)(xing)和(he)有(you)效性(xing)(xing)。”肖小河向記者表示,現(xian)行中(zhong)(zhong)(zhong)藥(yao)質(zhi)量控制的(de)(de)(de)(de)基本模式是(shi)(shi)參照國外植物藥(yao)的(de)(de)(de)(de)質(zhi)量控制方法(fa),借鑒化學(xue)藥(yao)品質(zhi)量控制的(de)(de)(de)(de)模式建立的(de)(de)(de)(de),化學(xue)定(ding)(ding)性(xing)(xing)鑒別(bie)(bie)與指標(biao)(biao)成分(fen)(fen)檢測(ce)是(shi)(shi)其(qi)主(zhu)要內容(rong)。對于(yu)化學(xue)藥(yao)品而(er)言(yan),其(qi)分(fen)(fen)子結構(gou)清楚,構(gou)效關(guan)系明確,鑒別(bie)(bie)、檢查、含(han)量測(ce)定(ding)(ding)可以(yi)直接(jie)作(zuo)為療(liao)效評價的(de)(de)(de)(de)指標(biao)(biao),但對于(yu)中(zhong)(zhong)(zhong)醫理論指導下的(de)(de)(de)(de)中(zhong)(zhong)(zhong)藥(yao),尤其(qi)是(shi)(shi)復(fu)方制劑,檢測(ce)任何活性(xing)(xing)成分(fen)(fen)均不(bu)能體(ti)(ti)現(xian)其(qi)整體(ti)(ti)療(liao)效,是(shi)(shi)中(zhong)(zhong)(zhong)藥(yao)與化學(xue)藥(yao)品質(zhi)量標(biao)(biao)準的(de)(de)(de)(de)根(gen)本區別(bie)(bie)。
據統(tong)計,在(zai)《中(zhong)國藥(yao)典》2005年版(一部)共(gong)收(shou)載中(zhong)藥(yao)材(cai)(含飲片和提(ti)取(qu)物)572種(zhong),其(qi)中(zhong)只有60%有過化學成分研(yan)究報道,約20%進行過較系統(tong)的化學成分研(yan)究,至今已闡明其(qi)有效成分的品種(zhong)不到5%。
肖小(xiao)河指出(chu),目前這種(zhong)質(zhi)控(kong)模式既難以(yi)有(you)(you)效地監(jian)控(kong)中藥質(zhi)量(liang),也不能(neng)評價中藥質(zhi)量(liang),更難以(yi)反映其(qi)(qi)安全性和有(you)(you)效性。如冬蟲夏草測(ce)定腺苷含量(liang)、板(ban)藍根檢測(ce)精氨(an)酸(suan)的(de)存在,而腺苷和精氨(an)酸(suan)既不是其(qi)(qi)主要有(you)(you)效成(cheng)(cheng)分(fen),也不是其(qi)(qi)專(zhuan)屬性成(cheng)(cheng)分(fen),檢測(ce)它們對其(qi)(qi)中藥質(zhi)量(liang)控(kong)制幾乎(hu)沒(mei)有(you)(you)實際意義。
肖小河(he)認為,中(zhong)藥質(zhi)量控(kong)(kong)制(zhi)(zhi)(zhi)的(de)根(gen)本(ben)或(huo)(huo)最終目標(biao)應該是(shi)(shi)保(bao)(bao)證(zheng)(zheng)(zheng)安(an)(an)全(quan)有(you)(you)效(xiao)(xiao),而(er)中(zhong)藥質(zhi)控(kong)(kong)的(de)現代目標(biao)是(shi)(shi)保(bao)(bao)證(zheng)(zheng)(zheng)中(zhong)藥材或(huo)(huo)制(zhi)(zhi)(zhi)劑(ji)的(de)一致(zhi)性和(he)(he)穩(wen)定(ding)(ding)性;中(zhong)藥質(zhi)量控(kong)(kong)制(zhi)(zhi)(zhi)模式(shi)基本(ben)上是(shi)(shi)“惟成分(fen)(fen)論(lun)”的(de),即通過對個別(bie)指(zhi)標(biao)性成分(fen)(fen)進行定(ding)(ding)性或(huo)(huo)定(ding)(ding)量分(fen)(fen)析(xi)來實現質(zhi)量控(kong)(kong)制(zhi)(zhi)(zhi)和(he)(he)評(ping)價(jia)。但是(shi)(shi),個別(bie)或(huo)(huo)部分(fen)(fen)指(zhi)標(biao)性成分(fen)(fen)一致(zhi)性和(he)(he)穩(wen)定(ding)(ding)性不(bu)等于其(qi)制(zhi)(zhi)(zhi)劑(ji)質(zhi)量一致(zhi)性和(he)(he)穩(wen)定(ding)(ding)性,制(zhi)(zhi)(zhi)劑(ji)質(zhi)量一致(zhi)性和(he)(he)穩(wen)定(ding)(ding)性也保(bao)(bao)證(zheng)(zheng)(zheng)其(qi)臨床安(an)(an)全(quan)性和(he)(he)有(you)(you)效(xiao)(xiao)性。也就是(shi)(shi)說,這種“以管窺豹”或(huo)(huo)迂回曲折的(de)質(zhi)控(kong)(kong)模式(shi)和(he)(he)策(ce)略(lve),既難以保(bao)(bao)證(zheng)(zheng)(zheng)穩(wen)定(ding)(ding)可(ke)控(kong)(kong),也難以保(bao)(bao)證(zheng)(zheng)(zheng)安(an)(an)全(quan)有(you)(you)效(xiao)(xiao)。因(yin)此(ci),有(you)(you)必(bi)要(yao)重新審(shen)視和(he)(he)明確中(zhong)藥質(zhi)量控(kong)(kong)制(zhi)(zhi)(zhi)和(he)(he)評(ping)價(jia)的(de)目標(biao)與(yu)策(ce)略(lve)、模式(shi)與(yu)方法(fa);有(you)(you)必(bi)要(yao)建立一套既能保(bao)(bao)證(zheng)(zheng)(zheng)“穩(wen)定(ding)(ding)可(ke)控(kong)(kong)”,又能直(zhi)接(jie)關切“安(an)(an)全(quan)有(you)(you)效(xiao)(xiao)”的(de)“雙(shuang)保(bao)(bao)險”新型中(zhong)藥質(zhi)量控(kong)(kong)制(zhi)(zhi)(zhi)管理方法(fa)體系。
質控應重療效
據記者了解,經過(guo)近年來在道地(di)優(you)質(zhi)藥(yao)(yao)材和(he)藥(yao)(yao)性(xing)理(li)論研(yan)究工作方(fang)面的研(yan)究和(he)實踐(jian),肖小河提(ti)出,應進一(yi)步補充和(he)完善現行(xing)中藥(yao)(yao)生產質(zhi)量(liang)(liang)(liang)控(kong)(kong)制(zhi)管理(li)體(ti)系,并(bing)提(ti)出了構建基于道地(di)優(you)質(zhi)藥(yao)(yao)材和(he)生物效價(jia)(jia)檢測的中藥(yao)(yao)質(zhi)量(liang)(liang)(liang)控(kong)(kong)制(zhi)與(yu)評(ping)價(jia)(jia)新模式,將生物效價(jia)(jia)檢測方(fang)法(fa)引入(ru)中藥(yao)(yao)質(zhi)量(liang)(liang)(liang)控(kong)(kong)制(zhi)和(he)評(ping)價(jia)(jia)體(ti)系。“引入(ru)生物準(zhun)備價(jia)(jia)檢測方(fang)法(fa)不僅可以鑒定品種和(he)質(zhi)量(liang)(liang)(liang),而且可以評(ping)價(jia)(jia)藥(yao)(yao)效,甚至(zhi)觀察毒(du)副作用,尤其在無法(fa)對中藥(yao)(yao)未知復雜成分(fen)用成分(fen)檢控(kong)(kong)的方(fang)法(fa)控(kong)(kong)制(zhi)其質(zhi)量(liang)(liang)(liang)時,更能凸現其優(you)越性(xing)。”
“中(zhong)(zhong)藥的(de)繼承與創(chuang)(chuang)新(xin)(xin)應(ying)體現在療(liao)效而不是形式(shi)上(shang)”,作為國家食品(pin)藥品(pin)監督(du)管理局的(de)評審(shen)專家,江蘇省中(zhong)(zhong)醫藥研(yan)究院中(zhong)(zhong)藥制劑研(yan)究室主(zhu)任(ren)賈曉斌(bin)博士亦對(dui)“穩(wen)定可(ke)控”與“安全有效”的(de)“雙保險”中(zhong)(zhong)藥質控模式(shi)表示認(ren)可(ke),并認(ren)為中(zhong)(zhong)藥制劑的(de)創(chuang)(chuang)新(xin)(xin)關鍵(jian)在于療(liao)效穩(wen)定。
賈曉斌向記者表(biao)示,應(ying)通過(guo)現(xian)代科技(ji)和(he)(he)管(guan)理對中(zhong)(zhong)藥(yao)生產流通以及(ji)臨床療效(xiao)評價等進(jin)行全面(mian)質量規(gui)范(fan)和(he)(he)科技(ji)指(zhi)導,以便(bian)原汗(han)原味地保存(cun)和(he)(he)繼(ji)承中(zhong)(zhong)醫(yi)藥(yao)的寶貴遺產。同時,通過(guo)研(yan)究中(zhong)(zhong)藥(yao)各(ge)單體成(cheng)分的配伍配比,結合現(xian)代的生物效(xiao)應(ying)研(yan)究,大膽創新,從中(zhong)(zhong)藥(yao)中(zhong)(zhong)提取(qu)精華,研(yan)發安(an)全有效(xiao)的現(xian)代化藥(yao)物。
江偉華(hua)向記(ji)者透露,南方中(zhong)藥港國際論壇今(jin)后將每季度定期舉行,并就中(zhong)藥合理應用與(yu)流通創新(xin)進(jin)行更為(wei)深入的研(yan)討(tao)。
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