中藥飲片是中(zhong)(zhong)藥(yao)(yao)(yao)材(cai)(cai)經過按(an)中(zhong)(zhong)醫藥(yao)(yao)(yao)理論、中(zhong)(zhong)藥(yao)(yao)(yao)炮制(zhi)方法(fa),經過加工炮制(zhi)后的(de),可直接用于(yu)中(zhong)(zhong)醫臨床的(de)中(zhong)(zhong)藥(yao)(yao)(yao)。這個概(gai)念(nian)表明,中(zhong)(zhong)藥(yao)(yao)(yao)材(cai)(cai)、中(zhong)(zhong)藥(yao)(yao)(yao)飲(yin)(yin)片并(bing)沒有絕(jue)對的(de)界限(xian),中(zhong)(zhong)藥(yao)(yao)(yao)飲(yin)(yin)片包括了部分經產地加工的(de)中(zhong)(zhong)藥(yao)(yao)(yao)切片,原形藥(yao)(yao)(yao)材(cai)(cai)飲(yin)(yin)片以及經過切制(zhi)、炮炙的(de)飲(yin)(yin)片。前(qian)兩類管理上應視為中(zhong)(zhong)藥(yao)(yao)(yao)材(cai)(cai),只(zhi)是根據(ju)中(zhong)(zhong)醫藥(yao)(yao)(yao)理論在配方、制(zhi)劑(ji)時(shi)作飲(yin)(yin)片理解。
而(er)(er)管(guan)理意義上的(de)飲片概念應理解為:“根據調配(pei)或制劑(ji)的(de)需要,對經產地加工的(de)凈(jing)藥材進(jin)一(yi)步切制、炮炙(zhi)而(er)(er)成的(de)成品稱為中藥飲片”。
藥材是中藥(yao)飲片的原(yuan)料。藥(yao)材指(zhi)符合藥(yao)品(pin)標準,一般指(zhi)藥(yao)材原(yuan)植、動(dong)、礦物除去非藥(yao)用部位的商品(pin)藥(yao)材。藥(yao)材未注(zhu)明(ming)炮(pao)制要求(qiu)的,均指(zhi)生藥(yao)材,應按(an)照(zhao)附(fu)錄藥(yao)材炮(pao)制通則的凈制項進行處理(li)。
中(zhong)(zhong)成(cheng)藥(yao)(yao)是以(yi)中(zhong)(zhong)藥(yao)(yao)材為原料,在中(zhong)(zhong)醫藥(yao)(yao)理論指導下,為了預防及(ji)治療疾病的(de)(de)(de)需要(yao)(yao)(yao),按(an)規定(ding)的(de)(de)(de)處方和制(zhi)劑(ji)工藝將其加(jia)工制(zhi)成(cheng)一(yi)定(ding)劑(ji)型的(de)(de)(de)中(zhong)(zhong)藥(yao)(yao)制(zhi)品,是經國(guo)家藥(yao)(yao)品監督管理部門批準的(de)(de)(de)商(shang)品化的(de)(de)(de)一(yi)類中(zhong)(zhong)藥(yao)(yao)制(zhi)劑(ji)。因此,作(zuo)為供臨床應(ying)用(yong)的(de)(de)(de)中(zhong)(zhong)成(cheng)藥(yao)(yao),不但要(yao)(yao)(yao)具備相應(ying)的(de)(de)(de)藥(yao)(yao)名、用(yong)法用(yong)量、規格和特定(ding)的(de)(de)(de)質(zhi)量標(biao)準及(ji)檢驗方法,而且要(yao)(yao)(yao)有確(que)切的(de)(de)(de)療效,明確(que)的(de)(de)(de)適用(yong)范(fan)圍、應(ying)用(yong)禁忌與注意事項。
同屬藥(yao)品范疇(chou),一直以來,二(er)者無法定概念,人們通常都以“中藥(yao)”冠(guan)之(zhi),從而導致二(er)者名(ming)稱(cheng)混淆不清,根據工(gong)作實踐,對二(er)者進行了(le)比較(jiao)分析。
1、來源相同:中藥(yao)(yao)材和中藥(yao)(yao)飲片的(de)科名、植(動)物名、學名、藥(yao)(yao)用部位及采收季節(jie)和產地加工等都相同。所以(yi)二者來源(yuan)相同。
2、部分中藥材和中藥飲片性狀相同:性(xing)狀(zhuang)包(bao)括藥品(pin)(pin)的(de)外觀、質地、橫(heng)斷面、臭、味、溶解度及物理常數等(deng),絕大多數細小(xiao)種子、果實類藥物的(de)藥材和(he)生品(pin)(pin)飲(yin)片性(xing)狀(zhuang)完全相同,其他如花(hua)類、樹脂(zhi)類等(deng)部位(wei)入藥的(de)一些藥物也存在類似現象。因此,僅從性(xing)狀(zhuang)這項不能完全區分(fen)二(er)者。
3、鑒別反應相同:鑒(jian)別反應一般包括(kuo)經驗(yan)鑒(jian)別、顯(xian)微鑒(jian)別和理化鑒(jian)別,中(zhong)藥材和中(zhong)藥飲片除部分品種因加工過程中(zhong)淀粉粒糊化而使顯(xian)微鑒(jian)別略有不同外,其他鑒(jian)別項(xiang)則完全(quan)相同。
1、處方應付不同:同一(yi)藥物的藥材和飲片名稱雖然相同,但臨(lin)床處方(fang)應付(fu)不(bu)同,無特殊說明的,均付(fu)飲片。
2、加工方法不同:中藥(yao)材(cai)(cai)只(zhi)需經過簡單的產地加(jia)工,而中藥(yao)飲(yin)片(pian)則是(shi)將原藥(yao)材(cai)(cai)進行凈選、切制(zhi)(zhi)和其他炮(pao)制(zhi)(zhi)等工藝(yi)而制(zhi)(zhi)成(cheng)一(yi)定規格的炮(pao)制(zhi)(zhi)品(pin)。
3、監管方法不同:根(gen)據《中(zhong)(zhong)華人民(min)共(gong)和(he)國藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)管(guan)(guan)(guan)理法(fa)(fa)》及《藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)流(liu)通(tong)監(jian)督管(guan)(guan)(guan)理方法(fa)(fa)》(暫(zan)行)的(de)有(you)(you)關規定,生(sheng)產(chan)(chan)中(zhong)(zhong)藥(yao)(yao)(yao)(yao)飲片(pian)(pian)必須(xu)依法(fa)(fa)取得《藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)生(sheng)產(chan)(chan)許可(ke)證》,批發(fa)中(zhong)(zhong)藥(yao)(yao)(yao)(yao)飲片(pian)(pian)必須(xu)是持有(you)(you)經營范圍包括(kuo)飲片(pian)(pian)的(de)《藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)經營許可(ke)證》的(de)藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)批發(fa)企業。因此,各有(you)(you)關藥(yao)(yao)(yao)(yao)品(pin)(pin)(pin)生(sheng)產(chan)(chan)、經營單位和(he)醫療機構必須(xu)從(cong)具有(you)(you)合法(fa)(fa)資質(zhi)的(de)單位采購(gou)中(zhong)(zhong)藥(yao)(yao)(yao)(yao)飲片(pian)(pian),而在(zai)購(gou)進(jin)沒有(you)(you)實施批準文號管(guan)(guan)(guan)理的(de)中(zhong)(zhong)藥(yao)(yao)(yao)(yao)材時,國家未(wei)進(jin)行資質(zhi)規定。可(ke)見,中(zhong)(zhong)藥(yao)(yao)(yao)(yao)飲片(pian)(pian)將(jiang)被視同成藥(yao)(yao)(yao)(yao)管(guan)(guan)(guan)理。
中藥材和中藥飲片既有(you)區別又有(you)聯系,對(dui)二者的(de)(de)界(jie)定(ding)只能視具體品(pin)種及(ji)不同情(qing)況而定(ding),一般(ban)來說,藥(yao)農采收的(de)(de)是藥(yao)材,而飲(yin)(yin)片(pian)加(jia)工廠經(jing)過凈(jing)選(xuan)、切制等加(jia)工處理,即(ji)為中藥(yao)飲(yin)(yin)片(pian)。醫(yi)療機調劑使用的(de)(de),不管(guan)從(cong)何處采購(gou),都(dou)應是中藥(yao)飲(yin)(yin)片(pian)。
而(er)中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)是(shi)(shi)用(yong)一(yi)定(ding)的(de)配(pei)方(fang)將將中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)加工(gong)或(huo)提取后(hou)制(zhi)成(cheng)具有(you)一(yi)定(ding)規(gui)格,可以直(zhi)接用(yong)于防病治病的(de)一(yi)類(lei)藥(yao)(yao)(yao)品。中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)有(you)兩種概(gai)(gai)念:一(yi)種是(shi)(shi)狹義(yi)的(de)中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao),它主要指由(you)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)材(cai)按一(yi)定(ding)治病原則(ze)配(pei)方(fang)制(zhi)成(cheng)、隨(sui)時可以取用(yong)的(de)現成(cheng)藥(yao)(yao)(yao)品,如(ru)中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)中(zhong)(zhong)(zhong)的(de)各種丸劑、散劑、沖劑等(deng)等(deng),這便是(shi)(shi)生活中(zhong)(zhong)(zhong)人們常(chang)說的(de)中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao);另一(yi)種是(shi)(shi)廣義(yi)的(de)中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao),它除包(bao)括狹義(yi)中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)的(de)概(gai)(gai)念外,還包(bao)括一(yi)切經過炮制(zhi)工(gong)而(er)成(cheng)的(de)草(cao)藥(yao)(yao)(yao)藥(yao)(yao)(yao)材(cai)。那么(me)中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)屬于中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)飲片嗎?中(zhong)(zhong)(zhong)成(cheng)藥(yao)(yao)(yao)是(shi)(shi)以中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)飲品為原料加工(gong)而(er)成(cheng)的(de)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)制(zhi)品。