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  • 2022-04-20

    溶(rong)出(chu)度(du)(du)是(shi)一(yi)種控制(zhi)藥物制(zhi)劑質量(liang)的體(ti)外檢測(ce)(ce)方法(fa)(fa),是(shi)以實(shi)驗(yan)為基(ji)礎,以溶(rong)解為理(li)論(lun),并用數學分(fen)析(xi)手段(duan)處(chu)理(li)溶(rong)出(chu)度(du)(du)試驗(yan)數據,是(shi)研究制(zhi)劑所(suo)含主藥的晶型、粒度(du)(du)、處(chu)方組成、輔料(liao)品種和性質、生產工藝等對制(zhi)劑質量(liang)統一(yi)性的方法(fa)(fa)。影響溶(rong)出(chu)度(du)(du)的因素主要是(shi)藥品本身的質量(liang)問題(ti),但(dan)也(ye)有(you)測(ce)(ce)量(liang)方法(fa)(fa)存(cun)在的問題(ti)致使測(ce)(ce)定(ding)結果出(chu)現(xian)偏差,所(suo)以分(fen)析(xi)溶(rong)出(chu)測(ce)(ce)定(ding)結果偏離的原因,有(you)針對的解決及(ji)糾(jiu)正,對實(shi)際工作有(you)重(zhong)要意義(yi)。一(yi)、攪拌(ban)轉動裝置的晃動不管是(shi)籃法(fa)(fa)還是(shi)槳法(fa)(fa),介質在攪拌(ban)作用下(xia)的液流運動形成了通過固體(ti)的流體(ti)剪切力,槳或(huo)籃軸的晃動都(dou)會改...

  • 2022-04-18

    混懸(xuan)(xuan)注射(she)劑,是指將(jiang)固體(ti)(ti)藥(yao)物(wu)(wu)分散于液(ye)體(ti)(ti)中制成的(de)(de)一類供肌肉或靜脈(mo)注射(she)用(yong)制劑。混懸(xuan)(xuan)注射(she)劑一般通過降低(di)藥(yao)物(wu)(wu)溶(rong)(rong)(rong)解度(du)來增加單次給藥(yao)劑量、延長(chang)(chang)藥(yao)物(wu)(wu)釋(shi)(shi)放時(shi)長(chang)(chang)。目前大多(duo)數(shu)FDA批準的(de)(de)混懸(xuan)(xuan)注射(she)劑都具有持續的(de)(de)藥(yao)物(wu)(wu)釋(shi)(shi)放特性(xing)(xing)(從數(shu)小(xiao)時(shi)延長(chang)(chang)至數(shu)天或數(shu)周(zhou))。同時(shi),FDA認為,傳統(tong)溶(rong)(rong)(rong)出(chu)方(fang)法的(de)(de)高剪(jian)切(qie)力(li)特性(xing)(xing)可能會導(dao)致藥(yao)物(wu)(wu)的(de)(de)體(ti)(ti)外溶(rong)(rong)(rong)出(chu)度(du)結果與(yu)體(ti)(ti)內藥(yao)代動力(li)學行(xing)為之間存在(zai)顯著差異。在(zai)FDA溶(rong)(rong)(rong)出(chu)度(du)方(fang)法數(shu)據庫中,更低(di)流體(ti)(ti)剪(jian)切(qie)力(li)的(de)(de)流池法被(bei)收載用(yong)于多(duo)種混懸(xuan)(xuan)注射(she)劑的(de)(de)體(ti)(ti)外釋(shi)(shi)放度(du)測試,例如:醋酸(suan)倍他(ta)米(mi)松(song)/倍他(ta)米(mi)松(song)磷酸(suan)鈉注射(she)混懸(xuan)(xuan)液(ye)、醋...

  • 2022-04-15

    溶(rong)(rong)出(chu)儀(yi)(yi)溶(rong)(rong)出(chu)取(qu)(qu)樣(yang)(yang)(yang)的(de)(de)(de)(de)過(guo)(guo)(guo)濾(lv)(lv)方式(shi)(shi)及(ji)取(qu)(qu)樣(yang)(yang)(yang)高度(du)調節溶(rong)(rong)出(chu)儀(yi)(yi)是一(yi)款專(zhuan)門(men)用來做溶(rong)(rong)出(chu)實驗的(de)(de)(de)(de)精密儀(yi)(yi)器(qi),在使用該(gai)儀(yi)(yi)器(qi)的(de)(de)(de)(de)時(shi)候(hou),溶(rong)(rong)出(chu)取(qu)(qu)樣(yang)(yang)(yang)是重要的(de)(de)(de)(de)步驟,取(qu)(qu)樣(yang)(yang)(yang)的(de)(de)(de)(de)好壞直接影響溶(rong)(rong)出(chu)結果。今天我們(men)專(zhuan)門(men)為大(da)家介(jie)紹一(yi)下溶(rong)(rong)出(chu)取(qu)(qu)樣(yang)(yang)(yang)的(de)(de)(de)(de)過(guo)(guo)(guo)濾(lv)(lv)方式(shi)(shi)及(ji)取(qu)(qu)樣(yang)(yang)(yang)高度(du)調節,希望(wang)大(da)家在使用該(gai)儀(yi)(yi)器(qi)的(de)(de)(de)(de)時(shi)候(hou)都能(neng)夠做到正確(que)取(qu)(qu)樣(yang)(yang)(yang)。溶(rong)(rong)出(chu)取(qu)(qu)樣(yang)(yang)(yang)的(de)(de)(de)(de)過(guo)(guo)(guo)濾(lv)(lv)方式(shi)(shi)操(cao)作者如(ru)果使用手動(dong)取(qu)(qu)樣(yang)(yang)(yang)樣(yang)(yang)(yang)式(shi)(shi),一(yi)般(ban)通(tong)過(guo)(guo)(guo)取(qu)(qu)樣(yang)(yang)(yang)針(zhen)(zhen)尾部的(de)(de)(de)(de)濾(lv)(lv)膜(mo)進行過(guo)(guo)(guo)濾(lv)(lv),也有(you)一(yi)些自動(dong)取(qu)(qu)樣(yang)(yang)(yang)器(qi)會使用針(zhen)(zhen)尾的(de)(de)(de)(de)濾(lv)(lv)板來過(guo)(guo)(guo)濾(lv)(lv)。還有(you)一(yi)種(zhong)過(guo)(guo)(guo)濾(lv)(lv)方式(shi)(shi)就(jiu)是通(tong)過(guo)(guo)(guo)針(zhen)(zhen)頭處過(guo)(guo)(guo)濾(lv)(lv),這種(zhong)過(guo)(guo)(guo)濾(lv)(lv)方式(shi)(shi)是讓整個過(guo)(guo)(guo)濾(lv)(lv)過(guo)(guo)(guo)程(cheng)在液面下進行,這樣(yang)(yang)(yang)藥(yao)劑的(de)(de)(de)(de)顆(ke)粒物(wu)不(bu)能(neng)夠進...

  • 2022-04-07

    藥物溶(rong)出度(du)儀(yi)(yi)是(shi)在(zai)體外對體內藥物生(sheng)物利用度(du)進(jin)行研究(jiu)和(he)評(ping)價(jia)的(de)(de)(de)有效的(de)(de)(de)替代方法,也是(shi)保證和(he)衡量(liang)(liang)(liang)固體口服(fu)制劑生(sheng)產(chan)(chan)工藝及質(zhi)量(liang)(liang)(liang)是(shi)否(fou)合(he)理和(he)穩定(ding)(ding)的(de)(de)(de)一項重(zhong)要(yao)手段。在(zai)進(jin)行溶(rong)出度(du)測定(ding)(ding)前,必須檢查溶(rong)出儀(yi)(yi)的(de)(de)(de)穩定(ding)(ding)性、轉(zhuan)速(su)和(he)溫(wen)度(du)等是(shi)否(fou)符合(he)要(yao)求。①儀(yi)(yi)器運轉(zhuan)時,整套裝置應保持平穩,不(bu)能產(chan)(chan)生(sheng)明顯的(de)(de)(de)晃動(dong)或振動(dong)(包括儀(yi)(yi)器裝置所處的(de)(de)(de)環境)。因為它(ta)能夠(gou)改變(bian)液體的(de)(de)(de)流型及增加動(dong)力(li)學不(bu)必要(yao)的(de)(de)(de)能量(liang)(liang)(liang),并(bing)(bing)因此改變(bian)溶(rong)出速(su)率。②轉(zhuan)軸應在(zai)中心(xin)孔(kong)并(bing)(bing)保持垂直(zhi)狀態(tai),旋轉(zhuan)應平穩無顫(zhan)動(dong),儀(yi)(yi)器應處于(yu)良好的(de)(de)(de)穩定(ding)(ding)轉(zhuan)動(dong)狀態(tai)。USP要(yao)求轉(zhuan)軸的(de)(de)(de)軸線與溶(rong)出杯(bei)的(de)(de)(de)軸...

  • 2022-04-01

    在(zai)納(na)米(mi)(mi)(mi)晶(jing)片劑中,原(yuan)料(liao)藥(yao)一(yi)般會被(bei)納(na)米(mi)(mi)(mi)化成(cheng)(cheng)為粒(li)徑小(xiao)于1μm的藥(yao)物(wu)顆粒(li)。通(tong)過將(jiang)原(yuan)料(liao)藥(yao)進行納(na)米(mi)(mi)(mi)化,可以達到(dao)增(zeng)加溶(rong)(rong)解度(du)和溶(rong)(rong)出度(du)、增(zeng)大對生(sheng)物(wu)膜的黏(nian)附(fu)性(xing)、降低(di)(di)食物(wu)干(gan)擾等目(mu)的。例(li)如,西(xi)羅莫(mo)司(si)(Sirolimus)是一(yi)種新型高效(xiao)的第三代(dai)免疫抑(yi)制劑,是目(mu)前為止發現的低(di)(di)毒(du)性(xing)有巨大應用潛力(li)的免疫抑(yi)制劑。但(dan)西(xi)羅莫(mo)司(si)水溶(rong)(rong)性(xing)差、溶(rong)(rong)出度(du)低(di)(di),導(dao)致其(qi)難以被(bei)人體吸收、生(sheng)物(wu)利用度(du)不佳。而將(jiang)其(qi)進行納(na)米(mi)(mi)(mi)化處理后,則能有效(xiao)改善其(qi)溶(rong)(rong)解度(du)低(di)(di)和藥(yao)物(wu)生(sheng)物(wu)利用度(du)低(di)(di)等問題(ti)。而相對地,由于原(yuan)料(liao)藥(yao)會被(bei)納(na)米(mi)(mi)(mi)化成(cheng)(cheng)為粒(li)徑小(xiao)于1μm的顆粒(li),某些...

  • 2022-03-23

    乳(ru)劑是(shi)指互不(bu)相溶(rong)的(de)(de)兩相液體(ti)(ti)(ti),其中(zhong)(zhong)一(yi)相以小液滴狀態分(fen)(fen)(fen)散于另(ling)一(yi)相液體(ti)(ti)(ti)中(zhong)(zhong)形成的(de)(de)非均勻分(fen)(fen)(fen)散的(de)(de)液體(ti)(ti)(ti)制(zhi)劑,可用(yong)于注射、口服和局(ju)部用(yong)藥(yao)等多種給藥(yao)途徑(jing)。體(ti)(ti)(ti)外(wai)釋放度是(shi)乳(ru)劑的(de)(de)一(yi)項(xiang)重要(yao)的(de)(de)質量控制(zhi)指標,但傳(chuan)統(tong)溶(rong)出方法很難滿足乳(ru)劑體(ti)(ti)(ti)外(wai)釋放度的(de)(de)測試需求:一(yi)方面是(shi)由于乳(ru)劑的(de)(de)粒徑(jing)較小,傳(chuan)統(tong)的(de)(de)溶(rong)出方法很難將(jiang)乳(ru)劑粒子(zi)與(yu)已(yi)經釋放的(de)(de)游離藥(yao)物進行分(fen)(fen)(fen)離;另(ling)一(yi)方面是(shi)某些(xie)藥(yao)物的(de)(de)溶(rong)解度比較低,樣(yang)品在體(ti)(ti)(ti)外(wai)釋放過程中(zhong)(zhong)很難達到漏槽(cao)條件。目前,有(you)不(bu)少研究文獻提出可以使用(yong)更加現代(dai)的(de)(de)方法來進行乳(ru)劑的(de)(de)體(ti)(ti)(ti)外(wai)釋放度測定,例(li)如流池法、透(tou)析(xi)法、取...

  • 2022-03-18

    自(zi)動(dong)取樣透皮(pi)擴散系(xi)統(tong)用于注(zhu)射用藥的(de)(de)熱(re)(re)(re)原檢(jian)查和解(jie)熱(re)(re)(re)藥的(de)(de)藥理(li)研究,以及用于觀察(cha)藥物對動(dong)物家兔(tu)體溫的(de)(de)影響等,它是檢(jian)驗針劑質量(liang)和研究藥物藥理(li)的(de)(de)專用檢(jian)測(ce)儀器(qi)它采用電(dian)腦控制,熱(re)(re)(re)原檢(jian)測(ce)應(ying)用系(xi)統(tong)軟件,能(neng)進行(xing)熱(re)(re)(re)原測(ce)試,新兔(tu)挑選,打印(yin)測(ce)試報告和磁盤(pan)存取(軟盤(pan)移動(dong)硬盤(pan))等,均具有(you)漢字顯示功能(neng),直(zhi)觀、清(qing)晰(xi)。自(zi)動(dong)取樣透皮(pi)擴散系(xi)統(tong)均基于連(lian)續流動(dong)原理(li),多(duo)通(tong)(tong)道蠕動(dong)泵通(tong)(tong)過分配歧管從容器(qi)中(zhong)吸收(shou)受體溶(rong)液,然(ran)后將(jiang)其發送到串(chuan)聯(lian)單元。通(tong)(tong)過加(jia)熱(re)(re)(re)器(qi)/循環(huan)(huan)器(qi)將(jiang)電(dian)池加(jia)熱(re)(re)(re),該加(jia)熱(re)(re)(re)器(qi)/循環(huan)(huan)器(qi)將(jiang)水加(jia)熱(re)(re)(re)通(tong)(tong)過串(chuan)聯(lian)電(dian)池所在的(de)(de)電(dian)池加(jia)熱(re)(re)(re)器(qi)。填...

  • 2022-03-14

    智能(neng)脫(tuo)氣(qi)(qi)(qi)(qi)系(xi)(xi)(xi)統(tong)(tong)在(zai)循(xun)環(huan)水(shui)(shui)(shui)(shui)系(xi)(xi)(xi)統(tong)(tong)中存(cun)有(you)大(da)量氣(qi)(qi)(qi)(qi)體(ti),如(ru)果(guo)不加以脫(tuo)除,系(xi)(xi)(xi)統(tong)(tong)容易產(chan)生氣(qi)(qi)(qi)(qi)阻,從(cong)而造(zao)(zao)成局(ju)部或整(zheng)個(ge)系(xi)(xi)(xi)統(tong)(tong)的(de)(de)(de)(de)循(xun)環(huan)不暢。同(tong)時由于水(shui)(shui)(shui)(shui)中含有(you)氧氣(qi)(qi)(qi)(qi)而使得(de)供熱(制(zhi)冷)管(guan)道(dao)和鋼(gang)制(zhi)散熱器腐蝕、穿(chuan)孔、漏水(shui)(shui)(shui)(shui),會直接(jie)影響到(dao)整(zheng)個(ge)系(xi)(xi)(xi)統(tong)(tong)的(de)(de)(de)(de)安全(quan)。系(xi)(xi)(xi)統(tong)(tong)中存(cun)有(you)的(de)(de)(de)(de)氣(qi)(qi)(qi)(qi)體(ti)還會造(zao)(zao)成水(shui)(shui)(shui)(shui)泵的(de)(de)(de)(de)氣(qi)(qi)(qi)(qi)蝕,并在(zai)系(xi)(xi)(xi)統(tong)(tong)管(guan)網中產(chan)生噪(zao)音,影響設備效果(guo)。智能(neng)脫(tuo)氣(qi)(qi)(qi)(qi)系(xi)(xi)(xi)統(tong)(tong)的(de)(de)(de)(de)特點:1、集自動(dong)(dong)定壓、膨脹、補水(shui)(shui)(shui)(shui)、脫(tuo)氣(qi)(qi)(qi)(qi)為一體(ti)。2、自動(dong)(dong)脫(tuo)除水(shui)(shui)(shui)(shui)中的(de)(de)(de)(de)氣(qi)(qi)(qi)(qi)體(ti),系(xi)(xi)(xi)統(tong)(tong)始終(zhong)處(chu)于滿負荷運(yun)行狀態。3、極(ji)大(da)縮(suo)短供熱或冷卻系(xi)(xi)(xi)統(tong)(tong)初次注水(shui)(shui)(shui)(shui)后的(de)(de)(de)(de)排氣(qi)(qi)(qi)(qi)時間,有(you)利于系(xi)(xi)(xi)統(tong)(tong)的(de)(de)(de)(de)調試(shi)運(yun)行。4、有(you)效防止泵被...

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