中藥飲片是中(zhong)(zhong)藥(yao)(yao)(yao)(yao)材經過按中(zhong)(zhong)醫藥(yao)(yao)(yao)(yao)理論、中(zhong)(zhong)藥(yao)(yao)(yao)(yao)炮制方法,經過加(jia)工(gong)炮制后的(de),可直(zhi)接(jie)用于中(zhong)(zhong)醫臨床(chuang)的(de)中(zhong)(zhong)藥(yao)(yao)(yao)(yao)。這(zhe)個概念表明,中(zhong)(zhong)藥(yao)(yao)(yao)(yao)材、中(zhong)(zhong)藥(yao)(yao)(yao)(yao)飲(yin)(yin)片(pian)(pian)并沒有絕對的(de)界(jie)限(xian),中(zhong)(zhong)藥(yao)(yao)(yao)(yao)飲(yin)(yin)片(pian)(pian)包括了部分(fen)經產地加(jia)工(gong)的(de)中(zhong)(zhong)藥(yao)(yao)(yao)(yao)切片(pian)(pian),原形(xing)藥(yao)(yao)(yao)(yao)材飲(yin)(yin)片(pian)(pian)以及(ji)經過切制、炮炙(zhi)的(de)飲(yin)(yin)片(pian)(pian)。前兩類管理上應視為中(zhong)(zhong)藥(yao)(yao)(yao)(yao)材,只(zhi)是根據中(zhong)(zhong)醫藥(yao)(yao)(yao)(yao)理論在配(pei)方、制劑時作飲(yin)(yin)片(pian)(pian)理解。
而管理意義上(shang)的(de)飲(yin)片概(gai)念應理解為:“根據調(diao)配或制(zhi)劑的(de)需要,對(dui)經產地加工的(de)凈藥材進一(yi)步切(qie)制(zhi)、炮炙而成(cheng)的(de)成(cheng)品稱為中藥飲(yin)片”。
藥材是中藥(yao)(yao)飲片的原料。藥(yao)(yao)材(cai)指符合藥(yao)(yao)品(pin)標準,一般指藥(yao)(yao)材(cai)原植(zhi)、動、礦物(wu)除去非(fei)藥(yao)(yao)用(yong)部位的商品(pin)藥(yao)(yao)材(cai)。藥(yao)(yao)材(cai)未注明(ming)炮制(zhi)要求(qiu)的,均指生藥(yao)(yao)材(cai),應按照(zhao)附錄藥(yao)(yao)材(cai)炮制(zhi)通則的凈制(zhi)項(xiang)進行(xing)處理。
中(zhong)(zhong)(zhong)(zhong)成藥(yao)是以中(zhong)(zhong)(zhong)(zhong)藥(yao)材為(wei)原料,在(zai)中(zhong)(zhong)(zhong)(zhong)醫藥(yao)理論指導下,為(wei)了預防及(ji)治療(liao)(liao)疾病的(de)(de)需要(yao),按規定(ding)的(de)(de)處方和制劑工藝將其加(jia)工制成一定(ding)劑型的(de)(de)中(zhong)(zhong)(zhong)(zhong)藥(yao)制品(pin),是經國家藥(yao)品(pin)監督管理部門批準(zhun)的(de)(de)商品(pin)化的(de)(de)一類中(zhong)(zhong)(zhong)(zhong)藥(yao)制劑。因此(ci),作為(wei)供(gong)臨床(chuang)應(ying)用的(de)(de)中(zhong)(zhong)(zhong)(zhong)成藥(yao),不但要(yao)具(ju)備相應(ying)的(de)(de)藥(yao)名、用法(fa)用量、規格和特定(ding)的(de)(de)質量標(biao)準(zhun)及(ji)檢驗方法(fa),而且要(yao)有確(que)切的(de)(de)療(liao)(liao)效(xiao),明確(que)的(de)(de)適用范圍、應(ying)用禁忌與注意事(shi)項(xiang)。
同屬藥(yao)品范疇(chou),一(yi)直以來,二者無法定(ding)概念,人們通常(chang)都以“中藥(yao)”冠之,從而導致二者名稱混淆(xiao)不清,根據工(gong)作實(shi)踐,對二者進行(xing)了比(bi)較分析。
1、來源相同:中藥材和(he)中藥飲片的科名、植(動)物名、學(xue)名、藥用部位及采收季節和(he)產地(di)加工等(deng)都相同。所以二者(zhe)來源(yuan)相同。
2、部分中藥材和中藥飲片性狀相同:性狀包括藥品的外(wai)觀、質(zhi)地、橫斷面(mian)、臭、味、溶解度及物(wu)(wu)理(li)常數(shu)等,絕大多數(shu)細小種子、果實(shi)類(lei)(lei)藥物(wu)(wu)的藥材和生品飲(yin)片性狀完(wan)全(quan)相同,其他如花類(lei)(lei)、樹脂類(lei)(lei)等部(bu)位入(ru)藥的一些藥物(wu)(wu)也(ye)存在類(lei)(lei)似現象。因此,僅從性狀這(zhe)項不能完(wan)全(quan)區分(fen)二者。
3、鑒別反應相同:鑒(jian)(jian)別(bie)(bie)反應一般包括經驗鑒(jian)(jian)別(bie)(bie)、顯微(wei)鑒(jian)(jian)別(bie)(bie)和(he)理化(hua)鑒(jian)(jian)別(bie)(bie),中(zhong)藥(yao)材(cai)和(he)中(zhong)藥(yao)飲片(pian)除部分(fen)品種(zhong)因加(jia)工過程中(zhong)淀粉(fen)粒糊化(hua)而使顯微(wei)鑒(jian)(jian)別(bie)(bie)略有不同外,其他(ta)鑒(jian)(jian)別(bie)(bie)項則完全相同。
1、處方應付不同:同一(yi)藥物的藥材和飲(yin)片(pian)名稱雖然相同,但臨(lin)床處方應付不同,無(wu)特殊說明的,均(jun)付飲(yin)片(pian)。
2、加工方法不同:中(zhong)藥材(cai)只需經過簡單的產(chan)地(di)加工(gong),而(er)中(zhong)藥飲片則是將原藥材(cai)進行凈選、切制和其他炮(pao)制等工(gong)藝(yi)而(er)制成一定規格的炮(pao)制品(pin)。
3、監管方法不同:根據《中(zhong)(zhong)(zhong)華人民共和(he)國(guo)藥(yao)(yao)(yao)品管理(li)(li)法(fa)(fa)》及(ji)《藥(yao)(yao)(yao)品流通(tong)監(jian)督管理(li)(li)方法(fa)(fa)》(暫行)的(de)(de)有(you)關(guan)規定(ding),生產(chan)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)飲(yin)(yin)(yin)片(pian)必須依法(fa)(fa)取得《藥(yao)(yao)(yao)品生產(chan)許可(ke)證》,批(pi)發中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)飲(yin)(yin)(yin)片(pian)必須是持有(you)經(jing)營范圍包括飲(yin)(yin)(yin)片(pian)的(de)(de)《藥(yao)(yao)(yao)品經(jing)營許可(ke)證》的(de)(de)藥(yao)(yao)(yao)品批(pi)發企業。因此,各有(you)關(guan)藥(yao)(yao)(yao)品生產(chan)、經(jing)營單(dan)位和(he)醫療機構必須從具(ju)有(you)合法(fa)(fa)資質的(de)(de)單(dan)位采購中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)飲(yin)(yin)(yin)片(pian),而在購進沒有(you)實施批(pi)準文號管理(li)(li)的(de)(de)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)材時,國(guo)家未進行資質規定(ding)。可(ke)見,中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)飲(yin)(yin)(yin)片(pian)將被視同成藥(yao)(yao)(yao)管理(li)(li)。
中藥材和中藥飲片既有區(qu)別又有聯系,對二(er)者的(de)界定(ding)(ding)只能視具體品種及不同情況而(er)定(ding)(ding),一般來說,藥農采(cai)收的(de)是藥材,而(er)飲(yin)片加(jia)工廠經過(guo)凈選、切制等(deng)加(jia)工處理,即為中藥飲(yin)片。醫(yi)療機(ji)調(diao)劑使用(yong)的(de),不管從何處采(cai)購,都(dou)應是中藥飲(yin)片。
而(er)(er)中(zhong)成(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)是(shi)(shi)用(yong)一定的(de)(de)(de)配方(fang)將將中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)加(jia)(jia)工或(huo)提取后制(zhi)成(cheng)(cheng)具有(you)一定規格,可以(yi)直接用(yong)于(yu)防病(bing)治病(bing)的(de)(de)(de)一類藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin)。中(zhong)成(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)有(you)兩種(zhong)(zhong)概(gai)(gai)念:一種(zhong)(zhong)是(shi)(shi)狹(xia)義的(de)(de)(de)中(zhong)成(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao),它(ta)主要指由中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)材(cai)按一定治病(bing)原(yuan)(yuan)則配方(fang)制(zhi)成(cheng)(cheng)、隨時可以(yi)取用(yong)的(de)(de)(de)現成(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)品(pin),如(ru)中(zhong)成(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)中(zhong)的(de)(de)(de)各種(zhong)(zhong)丸(wan)劑(ji)、散劑(ji)、沖劑(ji)等等,這便(bian)是(shi)(shi)生活中(zhong)人們(men)常(chang)說的(de)(de)(de)中(zhong)成(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao);另一種(zhong)(zhong)是(shi)(shi)廣義的(de)(de)(de)中(zhong)成(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao),它(ta)除(chu)包括狹(xia)義中(zhong)成(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)的(de)(de)(de)概(gai)(gai)念外,還包括一切經過(guo)炮(pao)制(zhi)工而(er)(er)成(cheng)(cheng)的(de)(de)(de)草藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)材(cai)。那(nei)么(me)中(zhong)成(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)屬于(yu)中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)飲片嗎?中(zhong)成(cheng)(cheng)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)是(shi)(shi)以(yi)中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)飲品(pin)為原(yuan)(yuan)料加(jia)(jia)工而(er)(er)成(cheng)(cheng)的(de)(de)(de)中(zhong)藥(yao)(yao)(yao)(yao)(yao)(yao)(yao)制(zhi)品(pin)。