溶出(chu)度實驗(yan)貫穿于整個藥(yao)研(yan)(yan)發和商品(pin)(pin)化生產(chan)過(guo)程。既是(shi)(shi)藥(yao)研(yan)(yan)發的(de)關鍵參考指(zhi)標，也是(shi)(shi)一(yi)(yi)致(zhi)性評價(jia)的(de)重(zhong)要環(huan)節，同時是(shi)(shi)產(chan)品(pin)(pin)質量控制和生產(chan)工藝(yi)考察的(de)重(zhong)要手段(duan)。常用于指(zhi)導藥(yao)物(wu)制劑的(de)研(yan)(yan)發、評價(jia)制劑批(pi)內批(pi)間質量的(de)一(yi)(yi)致(zhi)性、評價(jia)藥(yao)品(pin)(pin)工藝(yi)變更前后質量和的(de)一(yi)(yi)致(zhi)性。

中(zhong)國(guo)藥典五種溶出裝置：籃法(fa)、槳(jiang)法(fa)、小(xiao)杯(bei)(bei)法(fa)、槳(jiang)蝶法(fa)、轉(zhuan)(zhuan)(zhuan)筒法(fa) 。美(mei)國(guo)藥典增加兩種方法(fa)：流通池法(fa)、往復筒法(fa) 。槳(jiang)法(fa)一般(ban)50-75轉(zhuan)(zhuan)(zhuan)，推(tui)薦50轉(zhuan)(zhuan)(zhuan)。籃法(fa)一般(ban)50-100轉(zhuan)(zhuan)(zhuan)，推(tui)薦100轉(zhuan)(zhuan)(zhuan)。小(xiao)杯(bei)(bei)法(fa)適(shi)用于小(xiao)劑量(liang)片劑，一般(ban)35-50轉(zhuan)(zhuan)(zhuan)，推(tui)薦35轉(zhuan)(zhuan)(zhuan)。籃法(fa)100rpm≈槳(jiang)法(fa)50rpm≈小(xiao)杯(bei)(bei)法(fa)35rpm。

對(dui)于非崩(beng)解型(xing)藥物，采用(yong)籃(lan)(lan)(lan)(lan)(lan)法比(bi)較好。對(dui)于崩(beng)解型(xing)藥物，如果選(xuan)擇籃(lan)(lan)(lan)(lan)(lan)法，需要考(kao)(kao)慮溶(rong)出(chu)過程中(zhong)，籃(lan)(lan)(lan)(lan)(lan)孔的(de)(de)通透性，如果輔料特別(bie)是膠質(zhi)成(cheng)分、主藥影響轉籃(lan)(lan)(lan)(lan)(lan)的(de)(de)通透性，應考(kao)(kao)慮槳(jiang)法。制劑(ji)中(zhong)含(han)有難以(yi)溶(rong)解、難以(yi)擴(kuo)散的(de)(de)成(cheng)分，選(xuan)擇槳(jiang)法 。對(dui)于易漂浮的(de)(de)制劑(ji)，如果無籃(lan)(lan)(lan)(lan)(lan)孔堵塞現象，一般(ban)選(xuan)擇籃(lan)(lan)(lan)(lan)(lan)法。小杯法，一般(ban)用(yong)于低規格(ge)制劑(ji)，當溶(rong)出(chu)液濃度低，一般(ban)檢測(ce)方法無法準確檢測(ce)溶(rong)出(chu)量(liang)的(de)(de)時使用(yong)。

三種時(shi)間(jian)控(kong)制狀(zhuang)態(tai)可(ke)以獨立運(yun)(yun)用，也可(ke)在(zai)(zai)(zai)必要時(shi)結合起來(lai)靈活運(yun)(yun)用。如在(zai)(zai)(zai)藥品試驗(yan)運(yun)(yun)行中（配(pei)有自(zi)動(dong)(dong)取(qu)(qu)樣(yang)器）可(ke)從“計(ji)時(shi)狀(zhuang)態(tai)”或(huo)者(zhe)“周(zhou)期狀(zhuang)態(tai)”轉換(huan)到(dao)“定(ding)(ding)時(shi)狀(zhuang)態(tai)”以便(bian)執行自(zi)動(dong)(dong)定(ding)(ding)時(shi)關機；又如，可(ke)在(zai)(zai)(zai)“計(ji)時(shi)狀(zhuang)態(tai)”先運(yun)(yun)行一(yi)段時(shi)間(jian)，14杯(bei)溶(rong)出儀價格，再(zai)轉換(huan)到(dao)“周(zhou)期狀(zhuang)態(tai)”（不(bu)間(jian)斷試驗(yan)運(yun)(yun)行），這(zhe)對于長(chang)效制劑試驗(yan)（取(qu)(qu)樣(yang)周(zhou)期在(zai)(zai)(zai)10小時(shi)以上）來(lai)說，同樣(yang)也能有取(qu)(qu)樣(yang)信號(hao)了。● 當溶(rong)出杯(bei)內溶(rong)劑溫度穩定(ding)(ding)于規定(ding)(ding)值(zhi)時(shi)，方可(ke)開(kai)始溶(rong)出試驗(yan)。

　● 選(xuan)擇計時狀(zhuang)態或周期(qi)狀(zhuang)態。或按[復位]鍵使(shi)之回復起(qi)始狀(zhuang)態。

　● 將供試品投入溶劑(ji)中(zhong)，蓋(gai)好(hao)杯(bei)蓋(gai)。對于籃(lan)法(fa)，須升起機頭(tou)，14杯(bei)溶出儀廠家，將供試品放入網籃(lan)并(bing)安(an)裝好(hao)，再降(jiang)下(xia)機頭(tou)，蓋(gai)好(hao)杯(bei)蓋(gai)。

　● 立即按轉(zhuan)速[啟/停]鍵，14杯溶出儀多少錢，啟動轉(zhuan)桿(gan)運(yun)行。

在(zai)溶(rong)(rong)(rong)(rong)(rong)(rong)出(chu)(chu)(chu)實驗投樣(yang)時(shi)，樣(yang)品(pin)的(de)位(wei)置應在(zai)溶(rong)(rong)(rong)(rong)(rong)(rong)出(chu)(chu)(chu)杯的(de)特定(ding)位(wei)置。如：槳(jiang)法(fa)時(shi)，樣(yang)品(pin)應都在(zai)溶(rong)(rong)(rong)(rong)(rong)(rong)出(chu)(chu)(chu)杯底，槳(jiang)的(de)正下方。若(ruo)投藥后(hou)部分(fen)片(pian)劑帖壁，14杯溶(rong)(rong)(rong)(rong)(rong)(rong)出(chu)(chu)(chu)儀，則會造(zao)成溶(rong)(rong)(rong)(rong)(rong)(rong)出(chu)(chu)(chu)實驗結(jie)果(guo)RSD偏(pian)大(da)(da)，樣(yang)品(pin)溶(rong)(rong)(rong)(rong)(rong)(rong)出(chu)(chu)(chu)速度增加。因此，在(zai)溶(rong)(rong)(rong)(rong)(rong)(rong)出(chu)(chu)(chu)試(shi)驗時(shi)還應注(zhu)意，每次投樣(yang)后(hou)注(zhu)意觀(guan)(guan)察，樣(yang)品(pin)在(zai)溶(rong)(rong)(rong)(rong)(rong)(rong)出(chu)(chu)(chu)杯中的(de)位(wei)置是否合理(li)（或相同）溶(rong)(rong)(rong)(rong)(rong)(rong)出(chu)(chu)(chu)試(shi)驗結(jie)果(guo)并不(bu)只(zhi)有(you)溶(rong)(rong)(rong)(rong)(rong)(rong)出(chu)(chu)(chu)數據，在(zai)考察或對比溶(rong)(rong)(rong)(rong)(rong)(rong)出(chu)(chu)(chu)曲線時(shi)，大(da)(da)家只(zhi)注(zhu)意溶(rong)(rong)(rong)(rong)(rong)(rong)出(chu)(chu)(chu)數據，而忽略了(le)對溶(rong)(rong)(rong)(rong)(rong)(rong)出(chu)(chu)(chu)現象的(de)觀(guan)(guan)察。其實溶(rong)(rong)(rong)(rong)(rong)(rong)出(chu)(chu)(chu)現象對原研制劑的(de)分(fen)析和自制制劑的(de)工藝調(diao)整具有(you)指導意義。

如原(yuan)研制(zhi)劑(ji)的崩(beng)(beng)(beng)解現象有：溶蝕(shi)型（可(ke)能中乳糖的含(han)(han)量(liang)較高），膨脹型崩(beng)(beng)(beng)解，有 “發煙”現象（可(ke)能中微晶(jing)纖維素的含(han)(han)量(liang)較高）；片劑(ji)崩(beng)(beng)(beng)解后(hou)是(shi)否在(zai)杯(bei)底堆積成沙(sha)丘狀。 又如原(yuan)研制(zhi)的崩(beng)(beng)(beng)解后(hou)時顆(ke)粒，還是(shi)粉(fen)末。微丸的包衣膜是(shi)漲(zhang)破，還是(shi)溶解，微丸在(zai)溶解過程中是(shi)否膨脹等。