近日(ri)，國家食品藥(yao)(yao)(yao)品監督管理局(ju)傳出消息，2010年版(ban)(ban)(ban)《中(zhong)(zhong)(zhong)國藥(yao)(yao)(yao)典》已(yi)經編(bian)制完(wan)成，年底(di)前將由中(zhong)(zhong)(zhong)國醫(yi)藥(yao)(yao)(yao)科技出版(ban)(ban)(ban)社出版(ban)(ban)(ban)發(fa)行，于明(ming)年7月1日(ri)正式實施。據了解(jie)，此(ci)次藥(yao)(yao)(yao)典的(de)修訂是我國近年來相關研究成果的(de)一(yi)個集中(zhong)(zhong)(zhong)體現。那(nei)么(me)，新版(ban)(ban)(ban)《中(zhong)(zhong)(zhong)國藥(yao)(yao)(yao)典》在(zai)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)方面到底(di)有(you)何(he)變化與亮點呢？記者就此(ci)采(cai)訪了有(you)關專家。

       亮點1：

       飲片首進藥典(dian)

       品種(zhong)不再“倒(dao)掛”

       據悉，新(xin)(xin)版《中(zhong)(zhong)(zhong)國藥(yao)(yao)(yao)(yao)(yao)(yao)典(dian)》最終確定收(shou)載(zai)品種4615種，新(xin)(xin)增1358種。其中(zhong)(zhong)(zhong)一部(bu)（中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)）收(shou)載(zai)2136種，新(xin)(xin)增990種，修(xiu)訂(ding)612種；附錄部(bu)分，一部(bu)（中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)）新(xin)(xin)增14個(ge)、修(xiu)訂(ding)54個(ge)，新(xin)(xin)增、修(xiu)訂(ding)比(bi)例(li)達(da)75%。《臨床用藥(yao)(yao)(yao)(yao)(yao)(yao)須知》除(chu)設(she)化(hua)學藥(yao)(yao)(yao)(yao)(yao)(yao)與(yu)生物(wu)制品卷(juan)、中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)(yao)(yao)(yao)卷(juan)外，還首(shou)次(ci)編纂中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)飲(yin)(yin)片(pian)卷(juan)。其中(zhong)(zhong)(zhong)，中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)(yao)(yao)(yao)卷(juan)共(gong)收(shou)載(zai)1640個(ge)成(cheng)方制劑，增收(shou)15％的(de)品種，中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)飲(yin)(yin)片(pian)卷(juan)共(gong)收(shou)載(zai)557味中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)飲(yin)(yin)片(pian)。

       國家藥(yao)(yao)(yao)典委員會中藥(yao)(yao)(yao)材(cai)(cai)(cai)(cai)專業委員會主任委員屠鵬飛教授認為，新版(ban)(ban)《中國藥(yao)(yao)(yao)典》最顯著的(de)變(bian)化在(zai)于品(pin)種(zhong)的(de)梳理。不僅對中成(cheng)藥(yao)(yao)(yao)的(de)品(pin)種(zhong)進行(xing)了(le)增(zeng)補，中藥(yao)(yao)(yao)材(cai)(cai)(cai)(cai)品(pin)種(zhong)也在(zai)2005年版(ban)(ban)的(de)基(ji)礎上增(zeng)補了(le)140余(yu)種(zhong)。這些品(pin)種(zhong)是從歷版(ban)(ban)藥(yao)(yao)(yao)典中收(shou)載中藥(yao)(yao)(yao)材(cai)(cai)(cai)(cai)品(pin)種(zhong)最多的(de)77版(ban)(ban)中梳理出(chu)的(de)基(ji)礎研究(jiu)比較充分的(de)品(pin)種(zhong)。收(shou)錄藥(yao)(yao)(yao)材(cai)(cai)(cai)(cai)品(pin)種(zhong)的(de)增(zeng)加解決了(le)在(zai)多版(ban)(ban)藥(yao)(yao)(yao)典中存在(zai)的(de)品(pin)種(zhong)“倒掛”問題——有些藥(yao)(yao)(yao)材(cai)(cai)(cai)(cai)品(pin)種(zhong)在(zai)中成(cheng)藥(yao)(yao)(yao)中出(chu)現，但(dan)藥(yao)(yao)(yao)材(cai)(cai)(cai)(cai)標準中卻(que)并未(wei)收(shou)錄；有些藥(yao)(yao)(yao)材(cai)(cai)(cai)(cai)附錄中有，藥(yao)(yao)(yao)典正文并未(wei)收(shou)錄。

       新(xin)版《中(zhong)(zhong)(zhong)國(guo)藥(yao)(yao)(yao)(yao)典(dian)(dian)》對中(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)(yao)生產(chan)、臨(lin)床將產(chan)生顯著(zhu)影響的一個重大變化(hua)是首次(ci)設立中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)飲片(pian)標(biao)(biao)準。長期以(yi)來，我國(guo)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)飲片(pian)質量(liang)標(biao)(biao)準基礎薄弱，藥(yao)(yao)(yao)(yao)典(dian)(dian)上只有中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)材標(biao)(biao)準，中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)飲片(pian)沒有單獨的標(biao)(biao)準。而市場上中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)飲片(pian)品種(zhong)混淆、染色(se)摻(chan)假、水分或灰分超標(biao)(biao)、含量(liang)差異大等問(wen)題極為(wei)突出(chu)。此次(ci)，與新(xin)版藥(yao)(yao)(yao)(yao)典(dian)(dian)配套出(chu)版的《臨(lin)床用藥(yao)(yao)(yao)(yao)須知》除(chu)原有的中(zhong)(zhong)(zhong)成藥(yao)(yao)(yao)(yao)卷外(wai)，首次(ci)編纂(zuan)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)飲片(pian)卷，共收載557味中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)飲片(pian)。

       屠鵬飛(fei)認為，新版(ban)藥(yao)(yao)典在中藥(yao)(yao)飲(yin)片(pian)標準(zhun)方(fang)面的突破，初步(bu)解決了(le)長期困擾中藥(yao)(yao)飲(yin)片(pian)產業(ye)發展(zhan)的國家標準(zhun)較少、質(zhi)控水平較低、地方(fang)炮制(zhi)規(gui)范不統一等問(wen)題，對于提高(gao)中藥(yao)(yao)飲(yin)片(pian)質(zhi)量，保(bao)證中醫臨(lin)床用藥(yao)(yao)的安全(quan)有效將(jiang)起到積(ji)極作用。

       亮點2：

       標準專屬性更強

       質控(kong)方法(fa)更(geng)“貼(tie)心”

    “齊敦(dun)果(guo)酸(suan)、蘆丁(ding)、熊果(guo)酸(suan)……這(zhe)些成分在(zai)不少植物(wu)中都有(you)，以它(ta)們作為檢(jian)測指標很難有(you)效控制藥材質量(liang)。新版藥典為了(le)避免這(zhe)種(zhong)情況，增加了(le)不少專屬性強(qiang)的(de)檢(jian)測方法。這(zhe)些方法的(de)應用，將更有(you)效地控制藥品質量(liang)。”據屠鵬飛介紹。