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  • 2019-12-28

    溶(rong)(rong)(rong)出檢測是一(yi)(yi)種(zhong)模(mo)擬(ni)口(kou)服固體(ti)制(zhi)劑(ji)(ji)在(zai)胃腸(chang)道(dao)中的(de)崩解(jie)和(he)溶(rong)(rong)(rong)出的(de)體(ti)外試(shi)驗方法,它(ta)是評價藥物制(zhi)劑(ji)(ji)質(zhi)量和(he)日常監(jian)管的(de)一(yi)(yi)個重(zhong)(zhong)要指標,也是制(zhi)劑(ji)(ji)研(yan)發(fa)篩選處方所依賴(lai)的(de)一(yi)(yi)個重(zhong)(zhong)要工具(ju)。溶(rong)(rong)(rong)出現(xian)(xian)象(xiang)溶(rong)(rong)(rong)出試(shi)驗結果(guo)并不只有(you)溶(rong)(rong)(rong)出數據(ju),在(zai)考察或對(dui)(dui)比溶(rong)(rong)(rong)出曲線時,大(da)家只注(zhu)意(yi)溶(rong)(rong)(rong)出數據(ju),而忽略了對(dui)(dui)溶(rong)(rong)(rong)出現(xian)(xian)象(xiang)的(de)觀察。其實溶(rong)(rong)(rong)出現(xian)(xian)象(xiang)對(dui)(dui)原研(yan)制(zhi)劑(ji)(ji)的(de)處方分析和(he)自制(zhi)制(zhi)劑(ji)(ji)的(de)處方工藝調整具(ju)有(you)指導意(yi)義。如原研(yan)制(zhi)劑(ji)(ji)的(de)崩解(jie)現(xian)(xian)象(xiang)有(you):溶(rong)(rong)(rong)蝕(shi)型(可能(neng)處方中乳糖的(de)含量較(jiao)高(gao)),膨脹(zhang)型崩解(jie),有(you)“發(fa)煙(yan)”現(xian)(xian)象(xiang)(可能(neng)處方中微晶纖維素的(de)含量較(jiao)高(gao));片劑(ji)(ji)崩解(jie)后是否在(zai)杯底堆(dui)積(ji)...

  • 2019-12-18

    溶(rong)(rong)(rong)出(chu)(chu)(chu)(chu)儀應(ying)考慮哪(na)些機械(xie)性能?比(bi)如轉(zhuan)速、溫度(du)、同軸度(du)等(deng)10項(機械(xie)驗(yan)證(zheng)指(zhi)導原則(ze)),而(er)自動(dong)取(qu)樣部(bu)分尚(shang)無相(xiang)應(ying)的(de)評價指(zhi)標,或(huo)者一些無用指(zhi)標。實際上溶(rong)(rong)(rong)出(chu)(chu)(chu)(chu)包括、投(tou)(tou)藥(yao)、溶(rong)(rong)(rong)出(chu)(chu)(chu)(chu)、過濾、取(qu)樣、補液等(deng)過程(cheng),每個環節均影(ying)(ying)響溶(rong)(rong)(rong)出(chu)(chu)(chu)(chu)。對(dui)于緩控釋制劑尤其注意。1、投(tou)(tou)藥(yao)手動(dong)投(tou)(tou)藥(yao)的(de)時間偏差、位置偏差,片(pian)(pian)劑翻(fan)轉(zhuan)會影(ying)(ying)響片(pian)(pian)劑在(zai)溶(rong)(rong)(rong)出(chu)(chu)(chu)(chu)杯的(de)位置,都會影(ying)(ying)響溶(rong)(rong)(rong)出(chu)(chu)(chu)(chu),對(dui)緩釋片(pian)(pian)劑的(de)影(ying)(ying)響極大,片(pian)(pian)劑在(zai)底部(bu)中心就比(bi)在(zai)邊緣慢可能5%以上,造成批內(nei)差異大。因(yin)此自動(dong)投(tou)(tou)藥(yao)裝置很(hen)有(you)必要,而(er)且需要驗(yan)證(zheng)。2、溶(rong)(rong)(rong)出(chu)(chu)(chu)(chu)機械(xie)驗(yan)證(zheng)合(he)格,校(xiao)正(zheng)片(pian)(pian)可能不合(he)格,即使水楊酸...

  • 2019-12-05

    市面上的(de)溶(rong)出(chu)(chu)杯(bei)幾乎皆為人工燒制(zhi),且(qie)厚度(du)不(bu)(bu)易燒制(zhi)均(jun)一,表面不(bu)(bu)易光滑(hua),因(yin)此便導(dao)致溶(rong)出(chu)(chu)杯(bei)內(nei)部底(di)部形狀為一不(bu)(bu)規(gui)則半(ban)球形,轉動時形成“亂流”,得到(dao)的(de)試驗(yan)結果很有(you)(you)(you)可(ke)能(neng)(neng)(neng)存在(zai)偏差。溶(rong)出(chu)(chu)試驗(yan)結果并不(bu)(bu)只(zhi)有(you)(you)(you)溶(rong)出(chu)(chu)數據,在(zai)考察(cha)或對比溶(rong)出(chu)(chu)曲(qu)線時,大家只(zhi)注(zhu)意溶(rong)出(chu)(chu)數據,而忽略了對溶(rong)出(chu)(chu)現(xian)象(xiang)的(de)觀察(cha)。其實溶(rong)出(chu)(chu)現(xian)象(xiang)對原研(yan)制(zhi)劑(ji)(ji)的(de)處(chu)方(fang)分析和自制(zhi)制(zhi)劑(ji)(ji)的(de)處(chu)方(fang)工藝調整具有(you)(you)(you)指導(dao)意義(yi)。如原研(yan)制(zhi)劑(ji)(ji)的(de)崩解現(xian)象(xiang)有(you)(you)(you):溶(rong)蝕型(xing)(可(ke)能(neng)(neng)(neng)處(chu)方(fang)中乳糖的(de)含量(liang)較高),膨(peng)脹型(xing)崩解,有(you)(you)(you)“發煙”現(xian)象(xiang)(可(ke)能(neng)(neng)(neng)處(chu)方(fang)中微(wei)晶纖維素(su)的(de)含量(liang)較高);片劑(ji)(ji)崩解后是否在(zai)杯(bei)底(di)堆積...

  • 2019-11-29

    溶(rong)出(chu)儀(yi)的使(shi)用(yong)(yong)相(xiang)對來說還不算復雜,按部就班即可:1、將溶(rong)出(chu)杯(bei)放入儀(yi)器的六(liu)個孔內(nei),用(yong)(yong)同心環(huan)蓋調(diao)整(zheng)位(wei)置(zhi)(zhi),然(ran)后用(yong)(yong)定位(wei)片(pian)固定。2、根據質量(liang)標準提(ti)供的方法選(xuan)擇轉籃(lan)或(huo)轉漿(jiang),用(yong)(yong)定位(wei)桿各(ge)調(diao)整(zheng)轉籃(lan)或(huo)轉漿(jiang)與溶(rong)出(chu)杯(bei)底的間距,然(ran)后旋緊旋鈕固定轉籃(lan)或(huo)轉漿(jiang)。3、給溶(rong)出(chu)杯(bei)中(zhong)加入規定量(liang)的溶(rong)劑,再給水(shui)浴箱注水(shui)到(dao)水(shui)線位(wei)置(zhi)(zhi)。4、插(cha)上電源插(cha)座,開(kai)啟電源開(kai)關,通過控(kong)制面板的各(ge)鍵預置(zhi)(zhi)好(hao)規定的轉速、溶(rong)出(chu)時間、抽樣間隔時間及(ji)水(shui)溫控(kong)制參數。5、當杯(bei)內(nei)溶(rong)劑溫度(du)經水(shui)浴達到(dao)37±0.5℃恒溫時,將供試品6片(pian)(粒)分別投...

  • 2019-11-18

    溶出(chu)度檢(jian)測中(zhong),無論檢(jian)驗(yan)員采用手動(dong)取(qu)樣(yang)還是自動(dong)取(qu)樣(yang),都會遇(yu)到樣(yang)品(pin)過濾的問題,傳統(tong)的操作是用采用注射器和濾膜手動(dong)取(qu)樣(yang)過濾,再將樣(yang)品(pin)轉移(yi)到檢(jian)測,計量(liang)(liang)含量(liang)(liang)。表(biao)面(mian)活性(xing)劑(ji)在溶出(chu)實驗(yan)中(zhong)的應用介(jie)(jie)紹:1、溶出(chu)實驗(yan)方(fang)法開發中(zhong),截止時間內,藥(yao)物在所(suo)有溶出(chu)介(jie)(jie)質(zhi)中(zhong)平均溶出(chu)量(liang)(liang)均達(da)不到85%時,可優化(hua)溶出(chu)條件(jian),直至出(chu)現一(yi)種溶出(chu)介(jie)(jie)質(zhi)達(da)到85%以上(shang)。在優先(xian)提高轉速(su)未果情(qing)況下,可考慮加入適量(liang)(liang)的表(biao)面(mian)活性(xing)劑(ji)、酶等添加物進行優化(hua)。2、采用表(biao)面(mian)活性(xing)劑(ji)能增(zeng)加片(pian)劑(ji)的潤濕(shi)性(xing),使(shi)水分迅速(su)滲透到片(pian)芯起崩(beng)解作用,大大提高片(pian)劑(ji)的溶出(chu)...

  • 2019-10-15

    如(ru)何安(an)(an)(an)裝攪(jiao)拌槳(jiang)(籃(lan)(lan))?在(zai)溶(rong)(rong)(rong)出(chu)(chu)儀出(chu)(chu)廠、安(an)(an)(an)裝時(shi),都需進行機械驗證(zheng)。在(zai)驗證(zheng)通過(guo)(guo)后(hou)的(de)(de)(de)使(shi)用(yong)過(guo)(guo)程中,我們安(an)(an)(an)裝攪(jiao)拌槳(jiang)(籃(lan)(lan))的(de)(de)(de)位置(zhi)(zhi)與驗證(zheng)時(shi)的(de)(de)(de)安(an)(an)(an)裝位置(zhi)(zhi)不(bu)相(xiang)同(tong),就會(hui)影(ying)響攪(jiao)拌槳(jiang)(籃(lan)(lan))與溶(rong)(rong)(rong)出(chu)(chu)杯的(de)(de)(de)同(tong)軸度,進而影(ying)響溶(rong)(rong)(rong)出(chu)(chu)杯內溶(rong)(rong)(rong)出(chu)(chu)介質的(de)(de)(de)流(liu)動(dong)狀態,使(shi)樣(yang)品的(de)(de)(de)溶(rong)(rong)(rong)出(chu)(chu)數據發生(sheng)變化。另外,有些廠家的(de)(de)(de)溶(rong)(rong)(rong)出(chu)(chu)儀的(de)(de)(de)攪(jiao)拌槳(jiang)(籃(lan)(lan))是(shi)需要(yao)調節安(an)(an)(an)裝高度的(de)(de)(de),但常(chang)常(chang)我們為方便下次使(shi)用(yong),在(zai)清洗設備時(shi)不(bu)拆除攪(jiao)拌槳(jiang)(籃(lan)(lan)),總(zong)認為已調好攪(jiao)拌槳(jiang)(籃(lan)(lan))高度,不(bu)需再(zai)調節。但是(shi),在(zai)使(shi)用(yong)過(guo)(guo)程中因攪(jiao)拌槳(jiang)(籃(lan)(lan))的(de)(de)(de)晃動(dong),會(hui)使(shi)固(gu)定好的(de)(de)(de)攪(jiao)拌槳(jiang)(籃(lan)(lan))松(song)動(dong)。長(chang)時(shi)間使(shi)用(yong)后(hou)...

  • 2019-10-08

    溶(rong)(rong)出(chu)儀(yi)(yi)需要(yao)(yao)進(jin)行(xing)必(bi)要(yao)(yao)的(de)溶(rong)(rong)出(chu)度(du)測(ce)試(shi),期間都要(yao)(yao)注意(yi)哪些情況溶(rong)(rong)出(chu)儀(yi)(yi)具有完整的(de)計(ji)(ji)算機系統審計(ji)(ji)跟(gen)蹤(zong)功能,可(ke)(ke)(ke)以連續記(ji)(ji)錄整個測(ce)試(shi)過程中每個操作者(zhe)在每個時(shi)刻的(de)每個操作,并可(ke)(ke)(ke)以*輸出(chu)審計(ji)(ji)跟(gen)蹤(zong)。無法關閉審計(ji)(ji)跟(gen)蹤(zong)功能。在樣本(ben)測(ce)試(shi)結果發布之前,應該(gai)完成審計(ji)(ji)追蹤(zong)記(ji)(ji)錄的(de)審閱(yue),確認測(ce)試(shi)過程中沒有出(chu)現(xian)不符合數據完整性要(yao)(yao)求的(de)行(xing)為。溶(rong)(rong)出(chu)儀(yi)(yi)用(yong)途:可(ke)(ke)(ke)模擬(ni)人體進(jin)行(xing)片劑(ji)(ji)、顆(ke)粒劑(ji)(ji)、及(ji)膠囊(nang)劑(ji)(ji)等(deng)藥品(pin)(pin)溶(rong)(rong)出(chu)度(du)儀(yi)(yi)的(de)測(ce)定,還可(ke)(ke)(ke)以應用(yong)于食品(pin)(pin)及(ji)化(hua)妝品(pin)(pin)行(xing)業,進(jin)行(xing)必(bi)要(yao)(yao)的(de)溶(rong)(rong)出(chu)度(du)測(ce)試(shi)。溶(rong)(rong)出(chu)儀(yi)(yi)使用(yong)環境:藥品(pin)(pin)檢(jian)驗(yan)部門、學校實(shi)驗(yan)室、科研部門、及(ji)各(ge)大(da)藥廠...

  • 2019-09-29

    在(zai)維(wei)護(hu)溶出(chu)儀(yi)的過程中容易碰到這些問題,看(kan)完本文以(yi)后就知(zhi)道(dao)怎(zen)么處理啦溶出(chu)儀(yi)使用標準(zhun)操作1.1將溶出(chu)杯放入(ru)儀(yi)器的六個孔內,用同心環(huan)蓋調整(zheng)位置,然后用定(ding)位片固定(ding)。1.2根據(ju)質(zhi)量標準(zhun)提供的方法選擇轉(zhuan)(zhuan)籃(lan)或轉(zhuan)(zhuan)漿(jiang),用定(ding)位桿各(ge)調整(zheng)轉(zhuan)(zhuan)籃(lan)或轉(zhuan)(zhuan)漿(jiang)與溶出(chu)杯底的間距,然后旋(xuan)緊旋(xuan)鈕固定(ding)轉(zhuan)(zhuan)籃(lan)或轉(zhuan)(zhuan)漿(jiang)。1.3給(gei)溶出(chu)杯中加入(ru)規定(ding)量的溶劑,再(zai)給(gei)水(shui)(shui)浴箱注水(shui)(shui)到水(shui)(shui)線位置。1.4插上電源插座,開啟電源開關,通過控(kong)制(zhi)面板(ban)的各(ge)鍵預置好(hao)規定(ding)的轉(zhuan)(zhuan)速、溶出(chu)時間、抽樣間隔時間及水(shui)(shui)溫控(kong)制(zhi)參(can)數。1.5當杯內溶劑溫度經水(shui)(shui)浴達到37&plu...

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