中藥片劑按其原料特(te)性有下述四種類型,即(ji)提純片、全粉末片、全浸膏片和半浸膏片。
系指將處方中藥材經過提取(qu),得(de)到單體或有效部位,以此提純(chun)物細粉為原料,加適宜的賦形劑(ji)制成的片劑(ji)。如北豆(dou)根片、銀(yin)黃(huang)片等(deng)。
系指將處方中全部藥材粉(fen)碎成細粉(fen)為原料(liao),加(jia)適宜的賦形劑制(zhi)成的片劑,如參茸片、安胃片等。
系指將藥材用適宜的(de)溶劑和方法(fa)提(ti)取制(zhi)得(de)浸膏(gao),以全量浸膏(gao)制(zhi)成的(de)片(pian)劑。如通塞脈片(pian)、穿心蓮(lian)片(pian)等。
系(xi)指將部分藥材細粉與稠浸膏混合制成的片(pian)(pian)(pian)劑(ji)。如藿香正氣片(pian)(pian)(pian)、銀(yin)翹解毒片(pian)(pian)(pian)等。此類型(xing)在中藥片(pian)(pian)(pian)劑(ji)中占(zhan)的比例最大。
由于中(zhong)藥材(cai)(cai)(cai)(cai)(cai)的(de)特殊性(xing),制(zhi)粒(li)中(zhong)經(jing)常(chang)會出(chu)現難(nan)以(yi)制(zhi)粒(li)的(de)現象(xiang),如(ru)以(yi)水為(wei)潤濕劑制(zhi)成(cheng)的(de)軟材(cai)(cai)(cai)(cai)(cai)太黏,以(yi)致制(zhi)粒(li)困難(nan)。在制(zhi)粒(li)過(guo)(guo)程中(zhong),如(ru)果處(chu)方(fang)(fang)總(zong)劑量較小,可將所有藥材(cai)(cai)(cai)(cai)(cai)粉(fen)碎后(hou)滅菌過(guo)(guo)篩(shai),加稀糖漿(稀糖漿濃度視物(wu)料而定(ding))制(zhi)成(cheng)軟材(cai)(cai)(cai)(cai)(cai),選14-16目的(de)篩(shai)網(wang)制(zhi)成(cheng)顆(ke)粒(li);如(ru)果是吸濕性(xing)不(bu)強的(de)藥材(cai)(cai)(cai)(cai)(cai),可將其直(zhi)接粉(fen)碎成(cheng)顆(ke)粒(li),過(guo)(guo)篩(shai)后(hou)即可直(zhi)接壓片。此外,當(dang)浸膏與處(chu)方(fang)(fang)中(zhong)部分藥材(cai)(cai)(cai)(cai)(cai)細粉(fen)混合后(hou)若黏性(xing)適(shi)中(zhong),可直(zhi)接制(zhi)成(cheng)軟材(cai)(cai)(cai)(cai)(cai),制(zhi)成(cheng)顆(ke)粒(li)。
如(ru)果藥材(cai)中(zhong)含有較多的(de)揮發油、脂肪(fang)油等,壓(ya)片(pian)(pian)易引(yin)起(qi)松片(pian)(pian),降低(di)片(pian)(pian)劑(ji)硬度,應采用壓(ya)榨法或石(shi)蠟脫脂法除去這些(xie)成分。隨(sui)著(zhu)顆粒的(de)含油量(liang)減少,其內聚力就會增(zeng)加,從而(er)提高片(pian)(pian)劑(ji)的(de)硬度。
中藥顆粒的粗細也會影響片劑的硬度,中藥顆(ke)粒(li)的(de)(de)(de)(de)(de)粗(cu)細(xi)由中(zhong)(zhong)藥片(pian)(pian)(pian)劑(ji)(ji)的(de)(de)(de)(de)(de)片(pian)(pian)(pian)重及直徑決定。大(da)片(pian)(pian)(pian)可以用相對(dui)較(jiao)大(da)的(de)(de)(de)(de)(de)顆(ke)粒(li)或小顆(ke)粒(li)來壓片(pian)(pian)(pian),但(dan)小片(pian)(pian)(pian)只能(neng)用小顆(ke)粒(li)來壓片(pian)(pian)(pian)。若(ruo)中(zhong)(zhong)藥顆(ke)粒(li)粗(cu)細(xi)比例失調,顆(ke)粒(li)太粗(cu)會(hui)降(jiang)低顆(ke)粒(li)間的(de)(de)(de)(de)(de)內聚力,從而引(yin)(yin)起(qi)松(song)片(pian)(pian)(pian),降(jiang)低片(pian)(pian)(pian)劑(ji)(ji)的(de)(de)(de)(de)(de)硬度;但(dan)若(ruo)中(zhong)(zhong)藥顆(ke)粒(li)太細(xi)會(hui)引(yin)(yin)起(qi)顆(ke)粒(li)的(de)(de)(de)(de)(de)流動性差(cha),致顆(ke)粒(li)在沖模孔中(zhong)(zhong)的(de)(de)(de)(de)(de)填充量(liang)不足(zu)而引(yin)(yin)起(qi)松(song)片(pian)(pian)(pian),降(jiang)低片(pian)(pian)(pian)劑(ji)(ji)硬度。裂(lie)片(pian)(pian)(pian)也是壓片(pian)(pian)(pian)中(zhong)(zhong)經常出(chu)(chu)現(xian)的(de)(de)(de)(de)(de)現(xian)象(xiang),裂(lie)片(pian)(pian)(pian)的(de)(de)(de)(de)(de)出(chu)(chu)現(xian)一(yi)般認為是壓力調節(jie)不當或顆(ke)粒(li)過干、過濕所致。要解決裂(lie)片(pian)(pian)(pian)現(xian)象(xiang),
當(dang)顆(ke)粒制備符(fu)含(han)(han)要(yao)求(qiu)時(shi),關鍵就是(shi)(shi)(shi)對壓片(pian)(pian)機的(de)調(diao)節了,開始壓片(pian)(pian)時(shi)先在物料斗中放人(ren)少量顆(ke)粒試壓片(pian)(pian),調(diao)慢轉速(su),觀察是(shi)(shi)(shi)否(fou)有裂(lie)片(pian)(pian)、粘(zhan)(zhan)沖(chong)、崩裂(lie)等現象發生以及重量、硬度(du)是(shi)(shi)(shi)否(fou)符(fu)合(he)要(yao)求(qiu)。若(ruo)由于(yu)顆(ke)粒水分不足而引起裂(lie)片(pian)(pian)松片(pian)(pian)現象,則可加(jia)人(ren)90%左右乙醇進行混合(he)均勻,以增(zeng)(zeng)加(jia)含(han)(han)水量,實踐證明,適(shi)當(dang)提高(gao)含(han)(han)水量同(tong)時(shi)增(zeng)(zeng)大壓力(li),能使(shi)顆(ke)粒內部(bu)水分逸(yi)出(chu),附著于(yu)片(pian)(pian)面,有助于(yu)片(pian)(pian)劑的(de)成(cheng)型和(he)增(zeng)(zeng)加(jia)黏結(jie)力(li)。若(ruo)由于(yu)顆(ke)粒含(han)(han)水量太多(duo),出(chu)現粘(zhan)(zhan)沖(chong)現象,則可將顆(ke)粒放人(ren)烘箱再烘干即可。
中(zhong)(zhong)(zhong)(zhong)草(cao)藥制成素(su)片(pian)(pian)后(hou),為了解(jie)決中(zhong)(zhong)(zhong)(zhong)藥浸膏片(pian)(pian)的吸潮(chao)、霉(mei)變(bian)等問題,中(zhong)(zhong)(zhong)(zhong)藥片(pian)(pian)劑大多數都要進行(xing)包(bao)糖衣的工(gong)序,以(yi)增(zeng)加(jia)藥物的穩(wen)定性(xing),延長(chang)保質期,同時可以(yi)增(zeng)加(jia)中(zhong)(zhong)(zhong)(zhong)藥片(pian)(pian)劑的美觀程度,使患者(zhe)樂于服用。在包(bao)衣工(gong)序中(zhong)(zhong)(zhong)(zhong)經常發(fa)現(xian)有(you)黏片(pian)(pian)、露邊、龜裂、色斑等現(xian)象發(fa)生中(zhong)(zhong)(zhong)(zhong)藥片(pian)(pian)劑在包(bao)衣工(gong)序中(zhong)(zhong)(zhong)(zhong)之所以(yi)會出(chu)現(xian)黏片(pian)(pian)、露邊、龜裂、色斑等現(xian)象,由于黏片(pian)(pian)素(su)片(pian)(pian)表面(mian)不太光滑,單糖漿加(jia)入過量且溫度低,水分蒸發(fa)慢(man),攪拌不及時,而(er)出(chu)現(xian)彼此黏附(fu)。
當顆粒含(han)水量過大(da)、壓(ya)片(pian)(pian)機壓(ya)力調節不(bu)(bu)(bu)當時(shi)(shi)素(su)片(pian)(pian)就會有毛邊(bian),在(zai)(zai)加入(ru)糖(tang)(tang)(tang)漿(jiang)(jiang)(jiang)后,素(su)片(pian)(pian)邊(bian)緣(yuan)毛邊(bian)部(bu)位黏附的(de)(de)(de)糖(tang)(tang)(tang)漿(jiang)(jiang)(jiang)量多,經包(bao)衣(yi)鍋(guo)內摩擦,糖(tang)(tang)(tang)漿(jiang)(jiang)(jiang)漸失去,就會使(shi)片(pian)(pian)子邊(bian)緣(yuan)露出。若素(su)片(pian)(pian)硬(ying)度不(bu)(bu)(bu)符合(he)要(yao)求,當素(su)片(pian)(pian)的(de)(de)(de)張力大(da)于包(bao)衣(yi)層的(de)(de)(de)表面(mian)張力時(shi)(shi),即會出現龜裂。如果(guo)素(su)片(pian)(pian)片(pian)(pian)面(mian)凸凹不(bu)(bu)(bu)平,上色漿(jiang)(jiang)(jiang)時(shi)(shi),可(ke)溶性色素(su)在(zai)(zai)干(gan)燥過程中發(fa)生遷移(yi),片(pian)(pian)溫(wen)過高,色漿(jiang)(jiang)(jiang)調配不(bu)(bu)(bu)均或每次加入(ru)量不(bu)(bu)(bu)等(deng)時(shi)(shi),就容易出現包(bao)好(hao)的(de)(de)(de)片(pian)(pian)子上色澤不(bu)(bu)(bu)均,呈(cheng)色斑狀。對于包(bao)衣(yi)工序中出現的(de)(de)(de)黏片(pian)(pian)、露邊(bian)、龜裂、色斑等(deng)現象,首先糖(tang)(tang)(tang)漿(jiang)(jiang)(jiang)溫(wen)度應控制在(zai)(zai)40~50℃,糖(tang)(tang)(tang)漿(jiang)(jiang)(jiang)與素(su)片(pian)(pian)的(de)(de)(de)量宜為30~40 ml/kg。固(gu)定糖(tang)(tang)(tang)漿(jiang)(jiang)(jiang)的(de)(de)(de)含(han)糖(tang)(tang)(tang)量,攪拌(ban)要(yao)及時(shi)(shi)、均勻。
將(jiang)素片(pian)水分(fen)控(kong)(kong)制在(zai)(zai)3%左右(you)。素片(pian)在(zai)(zai)過篩(shai)除去小顆粒時(shi),可稍加(jia)用力,并適當增(zeng)加(jia)包(bao)衣層數,做到層層干(gan)燥,但也要控(kong)(kong)制好(hao)鍋(guo)內溫度(du),以免水分(fen)散(san)發過快。
素片的(de)硬度適中能夠減少包衣過程中水分內滲(shen),除控制糖漿(jiang)和(he)滑石粉的(de)用(yong)量外,還要(yao)注意調(diao)節好鍋內溫度,做到多次(ci)薄(bo)層快干。
不溶性色素如(ru)“色淀”等;還要(yao)使包衣片(pian)片(pian)面平整光(guang)滑,一旦出現(xian)色斑,用“淡色漿拉(la)”處理,控制(zhi)鍋溫及吹風時間;配制(zhi)色漿一定要(yao)完全攪勻(yun)。
除了在包衣工序中(zhong)出現的黏片、露邊、龜裂、色斑等現象,中(zhong)藥(yao)糖衣片還易(yi)吸潮、褪色和霉變(bian)等,為糖類、蛋白質等引濕受潮、素(su)片本身(shen)含(han)水(shui)量(liang)過(guo)大、糖衣片未(wei)做到(dao)層層干燥(zao)、殘(can)留水(shui)分(fen)過(guo)多等原因所致,那么(me)這(zhe)就要求(qiu)除去雜質,加干燥(zao)劑硫(liu)酸鈣,在包隔(ge)離層前將片芯(xin)置包衣鍋中(zhong)滾(gun)動,加糖漿、滑石粉適(shi)量(liang),使其(qi)黏著在片劑表(biao)面,延長加熱時間,使片芯(xin)水(shui)分(fen)盡量(liang)逸出,糖衣片嚴格做到(dao)層層干燥(zao)。
中藥片劑過(guo)期一(yi)年可(ke)以用嗎?過(guo)期的中藥片劑建議(yi)不要再(zai)服用,一(yi)般的藥物過(guo)期后(hou),其藥效減弱或是完全失去藥效,而且可(ke)能帶來副作用。