中藥飲片是中(zhong)(zhong)藥(yao)(yao)材(cai)經(jing)過(guo)(guo)按中(zhong)(zhong)醫藥(yao)(yao)理論、中(zhong)(zhong)藥(yao)(yao)炮制方法,經(jing)過(guo)(guo)加(jia)(jia)工(gong)炮制后的(de),可直接用于中(zhong)(zhong)醫臨床的(de)中(zhong)(zhong)藥(yao)(yao)。這個概念(nian)表明(ming),中(zhong)(zhong)藥(yao)(yao)材(cai)、中(zhong)(zhong)藥(yao)(yao)飲(yin)(yin)片(pian)并沒有(you)絕對的(de)界限(xian),中(zhong)(zhong)藥(yao)(yao)飲(yin)(yin)片(pian)包括了部(bu)分經(jing)產地加(jia)(jia)工(gong)的(de)中(zhong)(zhong)藥(yao)(yao)切(qie)片(pian),原形(xing)藥(yao)(yao)材(cai)飲(yin)(yin)片(pian)以及經(jing)過(guo)(guo)切(qie)制、炮炙的(de)飲(yin)(yin)片(pian)。前(qian)兩類管理上應視為中(zhong)(zhong)藥(yao)(yao)材(cai),只是根據中(zhong)(zhong)醫藥(yao)(yao)理論在(zai)配(pei)方、制劑時作飲(yin)(yin)片(pian)理解(jie)。
而管(guan)理意義上的(de)飲片(pian)概(gai)念(nian)應理解(jie)為(wei):“根據調(diao)配或(huo)制(zhi)(zhi)劑(ji)的(de)需(xu)要,對經產地加工的(de)凈(jing)藥(yao)材進一(yi)步切制(zhi)(zhi)、炮炙而成的(de)成品稱為(wei)中藥(yao)飲片(pian)”。
藥材是中(zhong)藥(yao)飲(yin)片的(de)原料(liao)。藥(yao)材(cai)(cai)指(zhi)符合藥(yao)品(pin)標準,一般指(zhi)藥(yao)材(cai)(cai)原植、動、礦物(wu)除去非藥(yao)用(yong)部位的(de)商(shang)品(pin)藥(yao)材(cai)(cai)。藥(yao)材(cai)(cai)未(wei)注明炮(pao)制要求的(de),均指(zhi)生藥(yao)材(cai)(cai),應按照附錄藥(yao)材(cai)(cai)炮(pao)制通則的(de)凈制項進行處理(li)。
中(zhong)(zhong)(zhong)(zhong)(zhong)成藥(yao)(yao)(yao)是(shi)以中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)材(cai)為原料,在(zai)中(zhong)(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)理論指導(dao)下,為了預防及治療疾病的需要(yao)(yao),按規定的處(chu)方(fang)和制劑(ji)工藝將(jiang)其加工制成一定劑(ji)型的中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)制品(pin)(pin),是(shi)經國家藥(yao)(yao)(yao)品(pin)(pin)監督管(guan)理部門批準的商品(pin)(pin)化的一類(lei)中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)制劑(ji)。因此,作為供臨床應用(yong)的中(zhong)(zhong)(zhong)(zhong)(zhong)成藥(yao)(yao)(yao),不但要(yao)(yao)具備相應的藥(yao)(yao)(yao)名、用(yong)法用(yong)量、規格(ge)和特定的質量標準及檢驗方(fang)法,而(er)且要(yao)(yao)有(you)確切(qie)的療效,明確的適用(yong)范(fan)圍(wei)、應用(yong)禁(jin)忌與注意事項。
同屬藥品范(fan)疇,一直以(yi)(yi)來(lai),二(er)者無(wu)法定概念,人(ren)們通常都(dou)以(yi)(yi)“中藥”冠之,從而導致二(er)者名(ming)稱混(hun)淆(xiao)不(bu)清(qing),根據工作實踐,對二(er)者進行了(le)比較分(fen)析(xi)。
1、來源相同:中(zhong)藥材(cai)和中(zhong)藥飲片(pian)的科名、植(動)物名、學名、藥用部位(wei)及采收季(ji)節和產地(di)加(jia)工(gong)等都相(xiang)同。所以(yi)二者來源相(xiang)同。
2、部分中藥材和中藥飲片性狀相同:性狀(zhuang)包括藥(yao)(yao)(yao)品的外觀、質地(di)、橫(heng)斷面(mian)、臭(chou)、味、溶解度及(ji)物(wu)理常數等,絕(jue)大多(duo)數細小種子、果實類(lei)藥(yao)(yao)(yao)物(wu)的藥(yao)(yao)(yao)材和生品飲(yin)片性狀(zhuang)完(wan)全相(xiang)同,其他如(ru)花類(lei)、樹脂類(lei)等部(bu)位入藥(yao)(yao)(yao)的一些(xie)藥(yao)(yao)(yao)物(wu)也存(cun)在類(lei)似現象。因此,僅(jin)從性狀(zhuang)這項不能完(wan)全區分二(er)者。
3、鑒別反應相同:鑒(jian)別(bie)反應一般包括(kuo)經驗鑒(jian)別(bie)、顯(xian)微(wei)鑒(jian)別(bie)和理化鑒(jian)別(bie),中藥(yao)(yao)材和中藥(yao)(yao)飲片除部分品種因加工過程中淀粉粒糊化而(er)使顯(xian)微(wei)鑒(jian)別(bie)略有(you)不(bu)同外(wai),其他鑒(jian)別(bie)項則完全相同。
1、處方應付不同:同(tong)一藥物的藥材(cai)和(he)飲(yin)片名(ming)稱雖然相同(tong),但臨床處(chu)方應付不同(tong),無特殊說(shuo)明的,均付飲(yin)片。
2、加工方法不同:中藥(yao)材(cai)只需經過(guo)簡單的產地加工,而中藥(yao)飲片則是(shi)將原藥(yao)材(cai)進(jin)行凈選(xuan)、切制和其(qi)他炮制等工藝而制成一定規格的炮制品。
3、監管方法不同:根據《中華人(ren)民共和國藥(yao)(yao)(yao)品(pin)管(guan)理法(fa)》及《藥(yao)(yao)(yao)品(pin)流通監督管(guan)理方法(fa)》(暫行)的(de)(de)有關規定(ding),生產(chan)(chan)中藥(yao)(yao)(yao)飲(yin)片(pian)必(bi)須依(yi)法(fa)取得(de)《藥(yao)(yao)(yao)品(pin)生產(chan)(chan)許(xu)可(ke)證》,批(pi)發(fa)中藥(yao)(yao)(yao)飲(yin)片(pian)必(bi)須是(shi)持有經營范圍包括飲(yin)片(pian)的(de)(de)《藥(yao)(yao)(yao)品(pin)經營許(xu)可(ke)證》的(de)(de)藥(yao)(yao)(yao)品(pin)批(pi)發(fa)企(qi)業。因此,各有關藥(yao)(yao)(yao)品(pin)生產(chan)(chan)、經營單位和醫療(liao)機(ji)構(gou)必(bi)須從具有合法(fa)資質的(de)(de)單位采購中藥(yao)(yao)(yao)飲(yin)片(pian),而在購進沒有實施批(pi)準(zhun)文號(hao)管(guan)理的(de)(de)中藥(yao)(yao)(yao)材(cai)時,國家未(wei)進行資質規定(ding)。可(ke)見,中藥(yao)(yao)(yao)飲(yin)片(pian)將被視同(tong)成(cheng)藥(yao)(yao)(yao)管(guan)理。
中藥材和中藥飲片既有(you)區別又(you)有(you)聯系,對二者的界定只(zhi)能視具體品(pin)種(zhong)及不同情況而(er)定,一般(ban)來說,藥(yao)(yao)農(nong)采收的是藥(yao)(yao)材,而(er)飲(yin)片加工廠經過(guo)凈選(xuan)、切制等加工處理,即為中(zhong)藥(yao)(yao)飲(yin)片。醫療機調劑(ji)使用的,不管從何(he)處采購,都(dou)應是中(zhong)藥(yao)(yao)飲(yin)片。
而中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)是(shi)用一(yi)(yi)定的(de)(de)(de)配方將將中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)加工(gong)或提取后(hou)制(zhi)(zhi)成(cheng)(cheng)(cheng)具有一(yi)(yi)定規格,可以直接用于(yu)防病(bing)治病(bing)的(de)(de)(de)一(yi)(yi)類藥(yao)(yao)(yao)(yao)(yao)品。中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)有兩種(zhong)概念:一(yi)(yi)種(zhong)是(shi)狹義的(de)(de)(de)中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao),它(ta)主要指由中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材(cai)按(an)一(yi)(yi)定治病(bing)原則配方制(zhi)(zhi)成(cheng)(cheng)(cheng)、隨時可以取用的(de)(de)(de)現成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)品,如(ru)中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)中(zhong)(zhong)(zhong)(zhong)(zhong)的(de)(de)(de)各種(zhong)丸劑(ji)(ji)、散(san)劑(ji)(ji)、沖劑(ji)(ji)等等,這便是(shi)生活中(zhong)(zhong)(zhong)(zhong)(zhong)人們常說的(de)(de)(de)中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao);另一(yi)(yi)種(zhong)是(shi)廣義的(de)(de)(de)中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao),它(ta)除包括狹義中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)的(de)(de)(de)概念外,還包括一(yi)(yi)切經過(guo)炮制(zhi)(zhi)工(gong)而成(cheng)(cheng)(cheng)的(de)(de)(de)草藥(yao)(yao)(yao)(yao)(yao)藥(yao)(yao)(yao)(yao)(yao)材(cai)。那么中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)屬于(yu)中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)飲片嗎?中(zhong)(zhong)(zhong)(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)是(shi)以中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)飲品為原料加工(gong)而成(cheng)(cheng)(cheng)的(de)(de)(de)中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)制(zhi)(zhi)品。