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1、<711>DISSOLUTION溶出度(USP39-NF34Page540)Generalchapter?Dissolution?<711>?isbeingharmonizedwiththecorrespondingtextsofthe?EuropeanPharmacopoeia?and/orthe?JapanesePharmacopoeia.Thesepharmacopeiashaveundertakentonotmakeanyunilateralchangetothisharmonizedchapter.通則<
2、711>溶出度與歐盟藥典和日本藥典中的相應(yīng)部分相統(tǒng)一。這三部藥典承諾不做單方面的修改。Portionsofthepresentgeneralchaptertextthatarenational?USP?text,andthereforenotpartoftheharmonizedtext,aremarkedwithsymbolstospecifythisfact.本章中的部分文字為本國USP內(nèi)容，并沒有與其他藥典統(tǒng)一。此部分以（???）標(biāo)注。Thistestisprovidedtodeterminecomplian
3、cewiththedissolutionrequirements??wherestatedintheindividualmonograph??fordosageformsadministeredorally.Inthisgeneralchapter,adosageunitisdefinedas1tabletor1capsuleortheamountspecified.??Ofthetypesofapparatusdesignsdescribedherein,usetheonespecifiedintheindivi
4、dualmonograph.Wherethelabelstatesthatanarticleisentericcoatedandadissolutionordisintegrationtestdoesnotspecificallystatethatitistobeappliedto?delayed-release?articlesandisincludedintheindividualmonograph,theprocedureandinterpretationgivenfor?Delayed-ReleaseDos
5、ageForms?areapplied,unlessotherwisespecifiedintheindividualmonograph.本測試用于檢測藥品口服制劑的溶出度是否符合各論中的規(guī)定。本章中，除另有規(guī)定外，單位制劑定義為1片或1粒膠囊。對于本章中所述多種儀器，使用各論中規(guī)定的種類。除各論中另有規(guī)定外，如果檢品是腸溶衣片且各論中的溶出度或崩解時限檢查項(xiàng)下沒有特別指出適用遲釋劑的，使用本章中適用于遲釋劑的流程和解釋。?FORDOSAGEFORMSCONTAININGORCOATEDWITHGELATIN涂有或
6、包含明膠的劑型Ifthedosageformcontaininggelatindoesnotmeetthecriteriaintheappropriate?AcceptanceTable?(see?Interpretation,?Immediate-ReleaseDosageForms,?Extended-ReleaseDosageForms,or?Delayed-ReleaseDosageForms)becauseofevidenceofthepresenceofcross-linking,thedissolut
7、ionprocedureshouldberepeatedwiththeadditionofenzymestothemedium,asdescribedbelow,andthedissolutionresultsshouldbeevaluatedstartingatthefirststageoftheappropriate?AcceptanceTable.Itisnotnecessarytocontinuetestingthroughthelaststage(upto24units)whencriteriaareno
8、tmetduringthefirststagetesting,andevidenceofcross-linkingisobserved.如果劑型中含有明膠，其不符合驗(yàn)收表中的標(biāo)準(zhǔn)（見判斷，速釋制劑，延釋制劑，緩釋制劑），因?yàn)榇嬖诿髂z交聯(lián)結(jié)合作用，它的溶解過程與外加的媒介酶是重復(fù)的，見下面的描述，并且溶解結(jié)果可以通過適當(dāng)?shù)尿?yàn)收表的開始的第一階段標(biāo)準(zhǔn)進(jìn)行評估。如
