制藥工程專業(yè)英語-13單元

1、P131-Unit1314 制藥工程-專英作業(yè)Sterile product are dosage forms of therapeutic agents that are free of viablemicroorganismsTranslations:無菌產品是不含微生物活體的治療劑型。Principally ， theseincludeparenteral,ophthalmic,and。主要包括非腸道，眼藥，沖洗制劑Of these , parenteral products are unique among dosage forms of drugs because they are

2、injected through the skin or mucous membranes into internal bodycompartment.其中，腸外給藥在藥物劑型中是獨特的，因為它們是通過皮膚或粘膜注射到體內的Thus, because they have circumvented the highly efficient first line of body defense,the skin and mucous membranes, they must be free from microbial, contamination and from toxic component

3、s as well as possess an exceptionally highly level ofpurity.須沒有微生物的污染和有毒成分，以及具有非常高的純度水平。原文：All compontents and processes involved in the preparation of these products must be selected and designed to eliminate,as much as possible,contamination ofalltypes,whether ofmicrobiologicorigin.翻譯：在產品制備中涉及的所有組

4、分和工藝流程必須要篩選和設計以物的。P131-6.Preparations for the eye , though not introduced into internal body cavities , are placed in contact with tissues that are very sensitive to contamination.眼用制劑，雖然沒有被引入體腔內，但它仍然與對污染敏感的組織相接觸。Therefore, similar standards are required for ophthalmic preparation.因此，對眼藥制劑也要求類似的標準。I

5、rrigating solutions are now also required to meet the same standards asparenteralsolutionsbecauseduringanirrigationsubstantial amounts of these solutions can enter the bloodstream directly through open blood vessels of wounds or abraded mucous membranes.沖洗液現(xiàn)在也要求滿足到與非胃腸溶液一樣的標準，因為在沖洗過程血流。characteristi

6、cs and standards presented in this chapter for the production of large-volume parenteral solutions apply equally to irrigatingsolutions.同樣適用于沖洗液。Sterile products are most frequently solutions or suspensions,but may even be solid pellets for tissueimplantation.翻譯：無菌產品通常是溶液或者懸浮液，但是甚至也可以是用于組織植入的固體藥丸。Th

7、e control of a process to minimize contamination for a small quantity of such a product can be achieved with relativeease.對于少量的這種產品，使其污染降到最低的工藝控制可以相對容易的實現(xiàn)。As the quantity of product increases , the problem of controlling the process to prevent contaminationmultiply.Therefore ,the preparation of ster

8、ile products has become a highly specialized area in pharmaceutical processing.翻譯：因此,無菌產品的制備已經(jīng)成為藥品加工里一個高度特殊的區(qū)域。14：Thestandardsestablished,theattitudeofpersonnel,andprocesscontrol must be of a superiorlevel.翻譯：標準的建立、員工的態(tài)度和控制過程必須是高水平的。By far the most frequently employed vehicle for sterile products is

9、 water , since it is the vehicle for all natural bodyfluids.到目前為止，最長被用于無菌產品的溶媒就是水，因為水是所有自然體液的溶媒。The superiorqualityrequiredforsuchuseisdescribedinmonograph on Water for Injection in the該用途要求的優(yōu)良特性在美國藥典的注射用水專題論文中有所描述。17 、 Requirements may be even more stringent for some products , however.譯：然而，對某些藥物的要

10、求可能會更苛刻。原 文 ： One of the most inclusive tests for the quality of water is the total solids content , a gravimetric evaluation of the dissociated and undissociated organic and inorganic substances present in the water.翻譯：水質檢查的一種普遍的測試是固體總含量，一種對水中解離和不解離的有機物和無機物在重量上的評估。原 文 ：However, a less time-consumin

11、g test, the electrolytic measurement of conductivity of the water, is the one most frequently used.譯文：然而，一種用時較少的測試水導電性的電解測量則是最常用的測試方法，第 20 句Instantaneous measurements can be obtained by immersing electrodes in the water and measuring the specific conductance, a measurement that depends on the ionic

12、content of the water.一種基于水中離子含量的測量方法。The conductance may be expressed by meter scale as conductivity in micromhos,resistance inmegohms,orinoiccontent aspartsmillion(ppm) of sodiumchloride電動率可以通過表頭刻度盤一電導，微歐姆，電阻，兆歐姆或者離子含量，ppmNacl 的形式顯示出來。The validity of this measurement as an indication of the purity

13、of the water is inferential in that methods of producing high-purity water,such asdistillationandreverseosmosis,canbeexpectedtoundissociated substances along with those that aredissociated.作為水純度的指示，這種測量方法的準確性只是推理性的，比如蒸餾和反滲透，可以將不解離的物質同那些解離的物質一起除去。Undissociated substances such aspyrogens, however, cou

14、ld be present in the absence of ions and not be disclosed by thetest.翻譯：但是不解離的的物質如熱原，可以不以離子的形式存在，因而不能被這種方法檢測出來。Thereforeforcontaminantsotherthanionsadditionaltestsshould be performed.測。Additional tests for quality of Water for Injection with permitted limits are described in the USPmonographs.具有特殊用途

15、的注射用水的水質附加測試在美國藥典中有專篇描述。 comparingthe totalsolids permittedfor Water for Injection with that for Sterile Water for Injection, one will note that considerably higher values are permitted for Sterile Water for Injection.翻譯：當把注射用水和無菌注射用水所允許的總固體含量作比較時， 你會發(fā)現(xiàn)無菌注射用水允許有相當高的值This is necessary because the lat

16、ter product has been sterilized, usually by a thermal method , in a container that has dissolved to some extent in the water.這是必要的，因為后者是經(jīng)過滅菌的，通常是通過一種熱途徑，在一定程度上溶解于水的容器中。Therefore,the solids content will be greater than forthenonsterilized product.因此，其固體含量會比沒有滅菌的產品要高的多On the other hand,the 10 ppm tota

17、l solids officially permitted for Water for Injection may be much too high when ues as the vehicle for manyproducts另一方面，官方對于注射用水所允許的 10ppm 的固體總含量，對于許多產品來說作為溶媒其值可能太高了。In practice,waterforInjectionnormallyshouldnothavea conductivityofmorethan 1 micromho (1 megohm，approximately1ppmNaCl).事實上,注射用水其電導一般不應

18、該超過 1 微歐姆（1 兆歐，大約ppmNaCl）31 原文:Substances added to aproduct to enhance its stability are essential for almost everyproduct.翻譯:添加到產品當中用以提高產品穩(wěn)定性的物質，對于幾乎每種產品來說都是必不可少的。Such substances include solubilizers , antioxidants , chelating agents,buffers , tonicity contributors , antibacterial agents , antifung

19、al agents , hydrolysisinhibitors,antifoammgagents,andhumeroussubstances for specializedpurposes.這樣的物質包括增溶劑、抗氧劑、螯合劑、緩沖劑、張度調節(jié)劑、抗At the same time , these agentsmustbepreventedfrom affecting theproduct.同時，這些組分不能對產物有不利影響。In general , added substances must be nontoxic in the quantity administered to thepa

20、tient.一般來說，添加劑必須在病人的給藥量范圍是無毒的They should not interfere with the therapeutic efficacy nor with the assay of the active therapeuticcompound.它們（輔料）不應該干擾療效，也不能干擾有效活性化合物的測定。they must also be present and active when needed throughout the useful life of theproduct翻譯：在產品的整個有效期內，需要他們時，他們必須存在并且有效。.agents must

21、 be selected with greatcare ，and they must be evaluated as to their effect upon the entireformulation.的影響也必須進行評估An extensive review of excipients used in parenteral products upon and the means for adjusting PH of these products has recently been published and should be referred to for more detailed

22、information.一篇關于用在非腸道用產品中的賦形劑和調節(jié)這些產品 pH 的方法的綜述，最近已經(jīng)出版，更多的詳細信息可參閱之。The formulation of a parenteral product involves the combination of oneormoreingredientswithamedicinalagenttoenhanceconvenience ,acceptability ,or effectiveness of theproduct.非腸道用產品的處方涉及一個或者更多組成部分間的結合，這些組成（各自有效成分。Rarely is it preferab

23、le to dispense a drug singly as a sterile dry powder unless the formulation of a stable liquid preparation is notpossible.（人們）很少愿意把藥物僅僅以一種無菌的、干燥的粉末（的形式）配售，除非（把它做成）穩(wěn)定的液體制劑處方，否則是行不通的。On the other hand,a therapeutic agent is a chemical compound subject to the physical and chemical reactions characteris

24、tic of the class of compounds to which itbelongs.翻譯：另一方面，一個藥物制劑是一個遵從物理和化學反應支配特性的化合物。（藥物的有效成分物理和化學反應特性的一種化合物。Therefore ,a careful evaluation must be made of every combination Of two or more ingredients to ascertain whether or not adverse interaction occur ,and if they do, of ways to modify the formul

25、ation so that the reactions are eliminated orminimized.因此對每一個兩種或更多組成部分間的結合都必須有一個仔細的評以使反應消除或者降低到最小。the formulation of sterile products is challenging,therefore ,to the kno wledge and ingenuity of the personsresponsible.翻譯：無菌產品的制定是具有挑戰(zhàn)性的，因此，需要具有學問和聰明的人負責。因此，無菌產品的配方是對負責人員知識和獨創(chuàng)性的一個挑戰(zhàn)。the amount of infor

26、mation available to the formulator concerning the physical and chemical properties of a therapeutic agent,particularly if it i s a new compound,is often quitemeager.可用的信息量配方設計師關于治療劑的物理和化學性質 ,特別是如果這是一個新的化合物,通常是很微薄的（藥物的有效成分質的信息量通常是很少的，尤其當治療藥物是一種新的化合物時。Information concerning basic properties muse be ob

27、tained, including molecular weight, solubility, purity, colligative properties , and chemical reactivity, before an intelligent approach to formulation canbegin.溶解性、純度、依數(shù)性等信息關于（治療劑）基本性質的信息，包括分子量、溶解度、純度、依數(shù)性和化學反應性必須在一種好的組建配方的方法可以開始之前得到46.Improvementsinformulationareacontinuingprocess,since important p

28、roperties of a drug or of the total formulation may not becomeevident untiltheproduct hasbeenstored orusedfora prolongedtime.翻譯：改進處方是一個持續(xù)的過程，因為一種藥物或者一種處方的重要性質直到這種藥品被存放或者使用了很長時間才會變得明顯。處方的改進是一個持續(xù)的過程，因為藥物或整體配方的一些重要性質只有在貯存或者使用了很長時間之后才可能會變得明顯。47.However,because of the extensive test documentation require

29、d by the U.S. Food and DrugAdministration,onlyoutstanding formulations can be justified for continuance to the state of a maketed product. 然而由于美國食品和藥物管理局要求的廣泛的測試文件只有優(yōu)的制劑才能被證明能夠持續(xù)產品的狀態(tài)。（使得）只有那些杰出的配方才能繼續(xù)發(fā)展成為上市產品48 The production process includes all of the steps from the accumulation and combining of

30、the ingredients of the formula to the enclosing of the product in the individual container for distribution.生成過程包括從配方的各個組成部分的積聚和結合到產品封裝用于分售的單個包裝內的所有步驟。生產過程包括從配方的各個組成部分的積累和結合到產品封裝入用于分售的單個包裝內的所有步驟。Intimately associated with these processes are the personnel who carry them out and the facilities in whi

31、ch they areperformed與這些過程密切相關的是執(zhí)行它們的人員和執(zhí)行它們的設施和這些過程有緊密聯(lián)系的是搬運人員和執(zhí)行這些步驟的設備。The most ideally planned processes can be rendered ineffective by personnel who do not have the right attitude or training, or by facilities that do not provide an efficiently controlledenvironment.最理想的計劃過程，可以使無效的人員沒有正確的態(tài)度或培訓，或

32、設施，不提供有效的控制環(huán)境。計劃出來的最理想的過程也會因為沒有正確態(tài)度或沒有接受正確培訓的人員或者不能提供一個有效的控制環(huán)境的設備而變得無效。To enhance the assurance of successful manufacturing operation , all process steps must be carefully reduced to writing after being shown to beeffective加強生產操作成功的保證,所有流程步驟必須被小心地減少到標準下被證明是有效的后都要仔細地歸納成書面材料，These written procee steps are offen called sta