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1、<711>DISSOLUTION溶出度(USP39-NF34Page540)Generalchapter?Dissolution?<711>?isbeingharmonizedwiththecorrespondingtextsofthe?EuropeanPharmacopoeia?and/orthe?JapanesePharmacopoeia.Thesepharmacopeiashaveundertakentonotmakeanyunilateralchangetothisharmonizedchapter.通則<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
2、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(guó)USP內(nèi)容,并沒有與其他藥典統(tǒng)一。此部分以(???)標(biāo)注。Thistestisprovidedtodeterminecompliancewiththedissolutionrequirements??wherestatedintheindividual
3、monograph??fordosageformsadministeredorally.Inthisgeneralchapter,adosageunitisdefinedas1tabletor1capsuleortheamountspecified.??Ofthetypesofapparatusdesignsdescribedherein,usetheonespecifiedintheindividualmonograph.Wherethelabelstatesthatanarticleisentericcoatedandadissolutionordisintegrati
4、ontestdoesnotspecificallystatethatitistobeappliedto?delayed-release?articlesandisincludedintheindividualmonograph,theprocedureandinterpretationgivenfor?Delayed-ReleaseDosageForms?areapplied,unlessotherwisespecifiedintheindividualmonograph.本測(cè)試用于檢測(cè)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
5、膠囊。對(duì)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(shí)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涂有或包含明膠的劑型Ifthedosageformcontaininggelatindoesnotmeetthecriteriaintheappropriate?AcceptanceTable?(see?Interpretation,?Immediate-ReleaseDosageForms,?Exten
6、ded-ReleaseDosageForms,or?Delayed-ReleaseDosageForms)becauseofevidenceofthepresenceofcross-linking,thedissolutionprocedureshouldberepeatedwiththeadditionofenzymestothemedium,asdescribedbelow,andthedissolutionresultsshouldbeevaluatedstartingatthefirststageoftheappropriate?AcceptanceTable.It
7、isnotnecessarytocontinuetestingthroughthelaststage(upto24units)whencriteriaarenotmetduringthefirststagetesting,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(píng)估。如