资源描述:
《制药工程专业英语课件.pptx》由会员上传分享,免费在线阅读,更多相关内容在教育资源-天天文库。
1、TheprofessionalEnglishofpharmaceuticalengineeringWangHaifengPART3INDUSTRIALPHARMACYUnit13SterileProducts无菌产品无菌产品是不含活体微生物的治疗剂剂型,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。SterileProductsSterileProductsaredosageformsoftherapeuti
2、cagentsthatarefreeofviablemicroorganisms.Principally,theseincludeparenteral,ophthalmic,andirrigatingpreparations.Ofthese,parenteralproductsareuniqueamongdosageformsofdrugsbecausetheyareinjectedthroughtheskinormucousmembranesintointernalbodycompartment.
3、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。这些产品的制备过程中涉及到的所有组分和(工艺)流程都必须经过选择和设计以尽可能地消除各种类型的污染,无论是来自物理的、化学的,还是微生物的。Thus,becausetheyhavecircumventedthehighlyefficientfirstlineofbodydefense,theskinandmucousmembranes,theymustbefreef
4、rommicrobialcontaminationandfromtoxiccomponentsaswellaspossessanexceptionallyhighlevelofpurity.Allcomponentsandprocessesinvolvedinthepreparationoftheseproductsmustbeselectedanddesignedtoeliminate,asmuchaspossible,contaminationofalltypes,whetherofphysic
5、al,chemical,ormicrobiologicorigin.Preparationsfortheeye,thoughnotintroducedintointernalbodycavities,areplacedincontactwithtissuesthataresensitivetocontamination.Therefore,similarstandardsarerequiredforophthalmicpreparations.眼用制剂尽管没有被引入到内部体腔,但它仍与对污染(物)敏
6、感的组织有接触,因此,对眼用制剂也要求(与非肠道用制剂)类似的标准。Irrigatingsolutionsarenowalsorequiredtomeetthesamestandardsasparenteralsolutionsbecauseduringanirrigationprocedure,substantialamountsofthesesolutionscanenterthebloodstreamdirectlythroughopenbloodvesselsofwoundsorabrade
7、dmucousmembranes.Therefore,thecharacteristicsandstandardspresentedinthischapterfortheproductionoflarge-volumeparenteralsolutionsapplyequallytoirrigatingsolutions.冲洗液现在也要求满足和非肠道用溶液一样的标准,因为在冲洗过程中,大量的冲洗液都可以通过伤口的敞开血管或者擦伤的黏膜组织直接进入到血流中/血液。因此,本章中描述的有关非肠道用大容量输
8、液生产的特点和标准,对于冲洗液同样适用。Sterileproductsaremostfrequentlysolutionsorsuspensions,butmayevenbesolidpelletsfortissueimplantation.Thecontrolofaprocesstominimizecontaminationforasmallquantityofsuchaproductcanbeachievedwithrelativeease.Asthequanti