中藥飲片是中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)材經(jing)過按中(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)(yao)理(li)論、中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)炮制方(fang)法(fa),經(jing)過加工(gong)炮制后的(de),可直(zhi)接用(yong)于中(zhong)(zhong)(zhong)(zhong)醫臨床(chuang)的(de)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)。這個(ge)概念表明,中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)材、中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)飲片(pian)并(bing)沒有絕對的(de)界(jie)限,中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)飲片(pian)包(bao)括了部分(fen)經(jing)產(chan)地加工(gong)的(de)中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)切片(pian),原(yuan)形藥(yao)(yao)(yao)(yao)材飲片(pian)以(yi)及經(jing)過切制、炮炙的(de)飲片(pian)。前兩類管理(li)上(shang)應視為中(zhong)(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)材,只(zhi)是根據中(zhong)(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)(yao)理(li)論在配方(fang)、制劑時(shi)作飲片(pian)理(li)解。
而(er)管理意義(yi)上的飲片概念應理解為:“根據調配或制劑的需要,對經產地加(jia)工的凈藥材進一步切制、炮炙而(er)成(cheng)(cheng)的成(cheng)(cheng)品(pin)稱為中藥飲片”。
藥材是中(zhong)藥(yao)(yao)飲(yin)片(pian)的原料。藥(yao)(yao)材(cai)指(zhi)符(fu)合藥(yao)(yao)品標準,一般指(zhi)藥(yao)(yao)材(cai)原植、動、礦物除(chu)去非藥(yao)(yao)用部位的商品藥(yao)(yao)材(cai)。藥(yao)(yao)材(cai)未注明炮制要求的,均(jun)指(zhi)生藥(yao)(yao)材(cai),應按照附錄藥(yao)(yao)材(cai)炮制通則的凈制項進行(xing)處理。
中成(cheng)藥(yao)(yao)是以中藥(yao)(yao)材為原料,在中醫藥(yao)(yao)理(li)論指導(dao)下,為了預防及治療疾病的(de)(de)(de)需要(yao)(yao)(yao),按規定的(de)(de)(de)處方(fang)和制劑(ji)工藝將其加(jia)工制成(cheng)一(yi)定劑(ji)型(xing)的(de)(de)(de)中藥(yao)(yao)制品(pin),是經國家藥(yao)(yao)品(pin)監督管理(li)部門批準的(de)(de)(de)商(shang)品(pin)化(hua)的(de)(de)(de)一(yi)類中藥(yao)(yao)制劑(ji)。因此,作為供臨(lin)床應(ying)用(yong)的(de)(de)(de)中成(cheng)藥(yao)(yao),不但要(yao)(yao)(yao)具備相應(ying)的(de)(de)(de)藥(yao)(yao)名(ming)、用(yong)法用(yong)量、規格(ge)和特定的(de)(de)(de)質(zhi)量標(biao)準及檢驗(yan)方(fang)法,而且要(yao)(yao)(yao)有確切(qie)的(de)(de)(de)療效,明確的(de)(de)(de)適用(yong)范圍、應(ying)用(yong)禁忌與(yu)注意事項(xiang)。
同屬藥品(pin)范疇(chou),一(yi)直(zhi)以(yi)來,二者無(wu)法定概念,人們(men)通常(chang)都以(yi)“中藥”冠之,從而導致二者名稱混淆(xiao)不清,根據工(gong)作實踐(jian),對二者進(jin)行了比(bi)較分(fen)析(xi)。
1、來源相同:中(zhong)藥材(cai)和中(zhong)藥飲片的科名、植(動)物名、學名、藥用部位及(ji)采收季節和產地加工等都相同。所(suo)以(yi)二者來源(yuan)相同。
2、部分中藥材和中藥飲片性狀相同:性狀(zhuang)包括藥(yao)品(pin)的外觀(guan)、質(zhi)地、橫(heng)斷(duan)面、臭、味(wei)、溶解(jie)度(du)及物(wu)理(li)常(chang)數等(deng),絕大多數細小種子、果(guo)實(shi)類藥(yao)物(wu)的藥(yao)材和生(sheng)品(pin)飲(yin)片性狀(zhuang)完(wan)全相同,其(qi)他如花類、樹脂類等(deng)部位(wei)入藥(yao)的一些(xie)藥(yao)物(wu)也存在類似(si)現象(xiang)。因此,僅(jin)從性狀(zhuang)這(zhe)項不能(neng)完(wan)全區分(fen)二者。
3、鑒別反應相同:鑒(jian)別(bie)(bie)反應一般包括(kuo)經驗(yan)鑒(jian)別(bie)(bie)、顯微鑒(jian)別(bie)(bie)和(he)理化鑒(jian)別(bie)(bie),中(zhong)藥材和(he)中(zhong)藥飲片除部分(fen)品(pin)種因加工過程(cheng)中(zhong)淀(dian)粉(fen)粒糊化而使顯微鑒(jian)別(bie)(bie)略有不同(tong)外,其他鑒(jian)別(bie)(bie)項(xiang)則完全相(xiang)同(tong)。
1、處方應付不同:同(tong)一(yi)藥物的(de)藥材和飲(yin)片名稱雖然(ran)相同(tong),但臨(lin)床處方應(ying)付(fu)不同(tong),無(wu)特殊說(shuo)明的(de),均付(fu)飲(yin)片。
2、加工方法不同:中藥(yao)(yao)材(cai)只需(xu)經過簡單的(de)產地加工,而中藥(yao)(yao)飲片則(ze)是將原(yuan)藥(yao)(yao)材(cai)進(jin)行凈選(xuan)、切制(zhi)和其他炮(pao)制(zhi)等工藝而制(zhi)成一定規格(ge)的(de)炮(pao)制(zhi)品。
3、監管方法不同:根據《中(zhong)(zhong)華人(ren)民共(gong)和國藥(yao)(yao)(yao)品(pin)管理(li)法(fa)(fa)》及《藥(yao)(yao)(yao)品(pin)流通監督管理(li)方法(fa)(fa)》(暫(zan)行)的(de)有(you)關(guan)規(gui)定,生產中(zhong)(zhong)藥(yao)(yao)(yao)飲(yin)(yin)片必(bi)(bi)須依(yi)法(fa)(fa)取得《藥(yao)(yao)(yao)品(pin)生產許可證》,批發中(zhong)(zhong)藥(yao)(yao)(yao)飲(yin)(yin)片必(bi)(bi)須是持有(you)經(jing)營范圍包括飲(yin)(yin)片的(de)《藥(yao)(yao)(yao)品(pin)經(jing)營許可證》的(de)藥(yao)(yao)(yao)品(pin)批發企業。因此,各有(you)關(guan)藥(yao)(yao)(yao)品(pin)生產、經(jing)營單(dan)位(wei)和醫療機構(gou)必(bi)(bi)須從具有(you)合(he)法(fa)(fa)資質的(de)單(dan)位(wei)采購中(zhong)(zhong)藥(yao)(yao)(yao)飲(yin)(yin)片,而在購進(jin)沒有(you)實施批準文號(hao)管理(li)的(de)中(zhong)(zhong)藥(yao)(yao)(yao)材(cai)時,國家未(wei)進(jin)行資質規(gui)定。可見,中(zhong)(zhong)藥(yao)(yao)(yao)飲(yin)(yin)片將(jiang)被視同成藥(yao)(yao)(yao)管理(li)。
中藥材和中藥飲片既有區別又有聯系(xi),對二(er)者(zhe)的界定只能視具(ju)體品種及不同情(qing)況(kuang)而定,一般來說,藥(yao)農采收的是藥(yao)材,而飲片(pian)加工廠經過凈選(xuan)、切制等加工處理,即為中(zhong)藥(yao)飲片(pian)。醫療機調(diao)劑使用的,不管從何處采購,都應是中(zhong)藥(yao)飲片(pian)。
而(er)中(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)是(shi)用(yong)一定的(de)配方將將中(zhong)(zhong)藥(yao)(yao)(yao)加工(gong)(gong)或(huo)提取后(hou)制(zhi)成(cheng)(cheng)(cheng)具有一定規格,可以直接用(yong)于防病治病的(de)一類藥(yao)(yao)(yao)品。中(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)有兩種概(gai)念:一種是(shi)狹義(yi)的(de)中(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao),它(ta)主要(yao)指由中(zhong)(zhong)藥(yao)(yao)(yao)材按一定治病原則(ze)配方制(zhi)成(cheng)(cheng)(cheng)、隨時可以取用(yong)的(de)現(xian)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)品,如中(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)中(zhong)(zhong)的(de)各種丸劑(ji)、散劑(ji)、沖劑(ji)等(deng)等(deng),這便是(shi)生活(huo)中(zhong)(zhong)人們常(chang)說(shuo)的(de)中(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao);另一種是(shi)廣義(yi)的(de)中(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao),它(ta)除包括狹義(yi)中(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)的(de)概(gai)念外,還包括一切(qie)經過(guo)炮(pao)制(zhi)工(gong)(gong)而(er)成(cheng)(cheng)(cheng)的(de)草藥(yao)(yao)(yao)藥(yao)(yao)(yao)材。那么中(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)屬于中(zhong)(zhong)藥(yao)(yao)(yao)飲(yin)片(pian)嗎?中(zhong)(zhong)成(cheng)(cheng)(cheng)藥(yao)(yao)(yao)是(shi)以中(zhong)(zhong)藥(yao)(yao)(yao)飲(yin)品為原料加工(gong)(gong)而(er)成(cheng)(cheng)(cheng)的(de)中(zhong)(zhong)藥(yao)(yao)(yao)制(zhi)品。