中藥飲片是(shi)(shi)中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)材(cai)經過(guo)按中(zhong)(zhong)(zhong)(zhong)(zhong)醫藥(yao)理論、中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)炮(pao)制(zhi)方(fang)(fang)法,經過(guo)加工炮(pao)制(zhi)后的,可直(zhi)接用于(yu)中(zhong)(zhong)(zhong)(zhong)(zhong)醫臨(lin)床(chuang)的中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)。這個概(gai)念表明,中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)材(cai)、中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)飲(yin)片(pian)(pian)并沒有絕對的界限,中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)飲(yin)片(pian)(pian)包(bao)括了部分經產(chan)地(di)加工的中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)切片(pian)(pian),原形藥(yao)材(cai)飲(yin)片(pian)(pian)以及經過(guo)切制(zhi)、炮(pao)炙的飲(yin)片(pian)(pian)。前兩類管理上應視(shi)為中(zhong)(zhong)(zhong)(zhong)(zhong)藥(yao)材(cai),只(zhi)是(shi)(shi)根據中(zhong)(zhong)(zhong)(zhong)(zhong)醫藥(yao)理論在配方(fang)(fang)、制(zhi)劑(ji)時作飲(yin)片(pian)(pian)理解。
而管理意義(yi)上的(de)(de)飲(yin)片(pian)(pian)概念(nian)應理解為:“根據調配或制(zhi)劑的(de)(de)需要,對經產地(di)加(jia)工(gong)的(de)(de)凈藥材(cai)進一步切制(zhi)、炮炙而成的(de)(de)成品稱為中(zhong)藥飲(yin)片(pian)(pian)”。
藥材是中藥(yao)(yao)(yao)飲片的(de)原料。藥(yao)(yao)(yao)材(cai)(cai)(cai)指符合藥(yao)(yao)(yao)品標準,一般(ban)指藥(yao)(yao)(yao)材(cai)(cai)(cai)原植、動、礦(kuang)物除去非藥(yao)(yao)(yao)用部位的(de)商品藥(yao)(yao)(yao)材(cai)(cai)(cai)。藥(yao)(yao)(yao)材(cai)(cai)(cai)未注(zhu)明炮制(zhi)要求(qiu)的(de),均(jun)指生藥(yao)(yao)(yao)材(cai)(cai)(cai),應按照(zhao)附錄(lu)藥(yao)(yao)(yao)材(cai)(cai)(cai)炮制(zhi)通則的(de)凈(jing)制(zhi)項(xiang)進行處理。
中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)(yao)(yao)是以中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)材為原料,在(zai)中(zhong)(zhong)(zhong)醫藥(yao)(yao)(yao)(yao)(yao)理(li)論指導下(xia),為了預(yu)防及(ji)治(zhi)療疾(ji)病(bing)的(de)需要(yao),按規定的(de)處(chu)方和(he)制(zhi)(zhi)劑工(gong)(gong)藝將其加工(gong)(gong)制(zhi)(zhi)成(cheng)一定劑型的(de)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)制(zhi)(zhi)品(pin),是經國家(jia)藥(yao)(yao)(yao)(yao)(yao)品(pin)監督管(guan)理(li)部(bu)門批準的(de)商品(pin)化的(de)一類中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)(yao)(yao)制(zhi)(zhi)劑。因此(ci),作為供臨床應用(yong)的(de)中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)(yao)(yao),不但要(yao)具備相應的(de)藥(yao)(yao)(yao)(yao)(yao)名、用(yong)法用(yong)量、規格和(he)特定的(de)質量標準及(ji)檢驗方法,而且要(yao)有確(que)切的(de)療效,明確(que)的(de)適用(yong)范(fan)圍、應用(yong)禁忌(ji)與(yu)注意事項。
同屬藥品范疇,一(yi)直以(yi)來,二(er)者無法定概念,人們通常都以(yi)“中藥”冠之(zhi),從而導致二(er)者名(ming)稱混淆不清(qing),根據工作實踐,對二(er)者進行了比較分析。
1、來源相同:中(zhong)(zhong)藥材和中(zhong)(zhong)藥飲片的(de)科名、植(動)物名、學名、藥用部位及采收季(ji)節和產地(di)加工等都(dou)相(xiang)同。所以二者來(lai)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)品的外(wai)觀、質(zhi)地(di)、橫斷面、臭(chou)、味、溶解度及物理常數等(deng)(deng),絕大多數細小種子、果實類(lei)(lei)藥(yao)物的藥(yao)材(cai)和(he)生品飲片(pian)性狀(zhuang)完全(quan)相(xiang)同,其他如花(hua)類(lei)(lei)、樹脂類(lei)(lei)等(deng)(deng)部位入藥(yao)的一些藥(yao)物也存在(zai)類(lei)(lei)似(si)現象。因此,僅(jin)從(cong)性狀(zhuang)這項不能完全(quan)區分二者。
3、鑒別反應相同:鑒(jian)(jian)(jian)(jian)別反應一般(ban)包(bao)括經驗鑒(jian)(jian)(jian)(jian)別、顯微(wei)鑒(jian)(jian)(jian)(jian)別和理化鑒(jian)(jian)(jian)(jian)別,中(zhong)藥(yao)材和中(zhong)藥(yao)飲片除部分品種因加工過程中(zhong)淀粉粒(li)糊化而使顯微(wei)鑒(jian)(jian)(jian)(jian)別略有不同外(wai),其他鑒(jian)(jian)(jian)(jian)別項(xiang)則完全相同。
1、處方應付不同:同一藥物的(de)藥材和飲(yin)片名稱雖然相同,但(dan)臨床處(chu)方應(ying)付不同,無特殊(shu)說明的(de),均付飲(yin)片。
2、加工方法不同:中(zhong)藥(yao)材只需經過簡單的(de)產地加(jia)工(gong)(gong),而中(zhong)藥(yao)飲片則(ze)是將原藥(yao)材進行凈選(xuan)、切制和其他炮制等工(gong)(gong)藝而制成一(yi)定規格的(de)炮制品。
3、監管方法不同:根(gen)據《中(zhong)華人民共和國藥(yao)品(pin)(pin)管理(li)法(fa)(fa)》及《藥(yao)品(pin)(pin)流通監督(du)管理(li)方(fang)法(fa)(fa)》(暫行(xing))的有關規(gui)(gui)定,生(sheng)(sheng)產(chan)(chan)中(zhong)藥(yao)飲(yin)片必須(xu)依(yi)法(fa)(fa)取(qu)得《藥(yao)品(pin)(pin)生(sheng)(sheng)產(chan)(chan)許可(ke)證》,批(pi)發(fa)中(zhong)藥(yao)飲(yin)片必須(xu)是持有經(jing)營(ying)范圍(wei)包括飲(yin)片的《藥(yao)品(pin)(pin)經(jing)營(ying)許可(ke)證》的藥(yao)品(pin)(pin)批(pi)發(fa)企業。因(yin)此,各有關藥(yao)品(pin)(pin)生(sheng)(sheng)產(chan)(chan)、經(jing)營(ying)單(dan)(dan)位(wei)和醫療機構必須(xu)從具有合(he)法(fa)(fa)資質的單(dan)(dan)位(wei)采購(gou)中(zhong)藥(yao)飲(yin)片,而在(zai)購(gou)進(jin)(jin)沒有實施批(pi)準文號管理(li)的中(zhong)藥(yao)材(cai)時,國家未(wei)進(jin)(jin)行(xing)資質規(gui)(gui)定。可(ke)見,中(zhong)藥(yao)飲(yin)片將被視同成藥(yao)管理(li)。
中藥材和中藥飲片既有(you)區別又有(you)聯系,對二(er)者的界(jie)定只能(neng)視具體品(pin)種及不(bu)同情況而定,一般來(lai)說,藥(yao)(yao)農采收的是(shi)藥(yao)(yao)材,而飲(yin)片(pian)(pian)加工廠經過凈選、切(qie)制(zhi)等加工處理,即(ji)為中藥(yao)(yao)飲(yin)片(pian)(pian)。醫療機調(diao)劑(ji)使用(yong)的,不(bu)管從何處采購(gou),都(dou)應(ying)是(shi)中藥(yao)(yao)飲(yin)片(pian)(pian)。
而(er)中(zhong)成(cheng)(cheng)(cheng)(cheng)藥(yao)(yao)(yao)是(shi)用(yong)一(yi)(yi)定的(de)(de)配方將將中(zhong)藥(yao)(yao)(yao)加工(gong)(gong)或提取后制成(cheng)(cheng)(cheng)(cheng)具(ju)有一(yi)(yi)定規(gui)格,可以(yi)(yi)直(zhi)接用(yong)于防病治病的(de)(de)一(yi)(yi)類藥(yao)(yao)(yao)品。中(zhong)成(cheng)(cheng)(cheng)(cheng)藥(yao)(yao)(yao)有兩(liang)種概念:一(yi)(yi)種是(shi)狹義的(de)(de)中(zhong)成(cheng)(cheng)(cheng)(cheng)藥(yao)(yao)(yao),它主要指由中(zhong)藥(yao)(yao)(yao)材(cai)按(an)一(yi)(yi)定治病原則(ze)配方制成(cheng)(cheng)(cheng)(cheng)、隨(sui)時(shi)可以(yi)(yi)取用(yong)的(de)(de)現成(cheng)(cheng)(cheng)(cheng)藥(yao)(yao)(yao)品,如中(zhong)成(cheng)(cheng)(cheng)(cheng)藥(yao)(yao)(yao)中(zhong)的(de)(de)各種丸劑(ji)、散劑(ji)、沖(chong)劑(ji)等(deng)等(deng),這(zhe)便是(shi)生活中(zhong)人們常說的(de)(de)中(zhong)成(cheng)(cheng)(cheng)(cheng)藥(yao)(yao)(yao);另(ling)一(yi)(yi)種是(shi)廣義的(de)(de)中(zhong)成(cheng)(cheng)(cheng)(cheng)藥(yao)(yao)(yao),它除包(bao)括狹義中(zhong)成(cheng)(cheng)(cheng)(cheng)藥(yao)(yao)(yao)的(de)(de)概念外,還包(bao)括一(yi)(yi)切經(jing)過炮制工(gong)(gong)而(er)成(cheng)(cheng)(cheng)(cheng)的(de)(de)草藥(yao)(yao)(yao)藥(yao)(yao)(yao)材(cai)。那(nei)么中(zhong)成(cheng)(cheng)(cheng)(cheng)藥(yao)(yao)(yao)屬于中(zhong)藥(yao)(yao)(yao)飲片嗎?中(zhong)成(cheng)(cheng)(cheng)(cheng)藥(yao)(yao)(yao)是(shi)以(yi)(yi)中(zhong)藥(yao)(yao)(yao)飲品為原料(liao)加工(gong)(gong)而(er)成(cheng)(cheng)(cheng)(cheng)的(de)(de)中(zhong)藥(yao)(yao)(yao)制品。