制药工程专业英语 Unit 13 课文翻译.docx

制药工程专业英语Unit13课文翻译

第一篇：制药工程专业英语Unit13课文翻译Unit13SterileProductsSterileProductsSterileproductsaredosageformsoftherapeuticagentsthatarefreeofviablemicroorganisms.Principally，theseincludeparenteral，ophthalmic，irrigatingpreparations.Ofthese,andparenteralproductsareuniqueamongdosageformsofdrugsbecausetheyareinjectedthroughtheskinormucousmembranesintointernalbodycompartment.Thus，becausetheyhavecircumventedthehighlyefficientfirstlineofbodydefense，theskinandmucousmembranes，theymustbefreefrommicrobialcontaminationandfromtoxiccomponentsaswellaspossessanexceptionallyhighlevelofpurity.Allcomponentsandprocessesinvolvedinthepreparationoftheseproductsmustbeselectedanddesignedtoeliminate，asmuchaspossible，contaminationofalltypes，whetherofphysical，chemical，ormicrobiologicorigin.Preparationsfortheeye,thoughnotintroducedintointernalbodycavities，areplacedincontactwithtissuesthatareverysensitivetocontamination.Therefore，similarstandardsarerequiredforophthalmicpreparations).Irrigatingsolutionsarenowalsorequiredtomeetthesamestandardsasparenteralsolutionsbecauseduringanirrigationprocedure，substantialamountsofthesesolutionscanenterthebloodstreamdirectlythroughopenbloodvesselsofwoundsorabradedmucousmembranes.Therefore，thecharacteristicsandstandardspresentedinthischapterfortheproductionoflarge-volumeparenteralsolutionsapplyequallytoirrigatingsolutions.Sterileproductsaremostfrequentlysolutionsorsuspensions，butmayevenbesolidpelletsfortissueimplantation.Thecontrolofaprocesstominimizecontaminationforasmallquantityofsuchaproductcanbeachievedwithrelativeease.Asthequantityofproductincreases，theproblemsofcontrollingtheprocesstopreventcontaminationmultiply.Therefore，thepreparationofsterileproductshasbecomeahighlyspecializedareainpharmaceuticalprocessing.Thestandardsestablished，theattitudeofpersonnel，andtheprocesscontrolmustbeofa第13单元无菌产品无菌产品无菌产品是不含微生物活体的治疗剂剂型，其主要包括非肠道用的、眼用的和冲洗用的制剂。这之中，非肠道用产品在药物剂型当中是（较为）特别的因为它们是通过皮肤和黏膜被注射到人体内部的。这样，由于它们进入了高效率的人体第一道免疫防线——皮肤和黏膜，（所以）它们必须没有微生物感染和有毒成分，同时又（必须）具有特别高的纯度。这些产品的制备过