制药工程专业英语-13单元

1、P131-Unit1314 制药工程-专英作业Sterile product are dosage forms of therapeutic agents that are free of viablemicroorganismsTranslations:无菌产品是不含微生物活体的治疗剂型。Principally ， theseincludeparenteral,ophthalmic,and。主要包括非肠道，眼药，冲洗制剂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，肠外给药在药物剂型中是独特的，因为它们是通过皮肤或粘膜注射到体内的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.须没有微生物的污染和有毒成分，以及具有非常高的纯度水平。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.翻译：在产品制备中涉及的所有组

4、分和工艺流程必须要筛选和设计以物的。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.眼用制剂，虽然没有被引入体腔内，但它仍然与对污染敏感的组织相接触。Therefore, similar standards are required for ophthalmic preparation.因此，对眼药制剂也要求类似的标准。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.冲洗液现在也要求满足到与非胃肠溶液一样的标准，因为在冲洗过程血流。characteristi

6、cs and standards presented in this chapter for the production of large-volume parenteral solutions apply equally to irrigatingsolutions.同样适用于冲洗液。Sterile products are most frequently solutions or suspensions,but may even be solid pellets for tissueimplantation.翻译：无菌产品通常是溶液或者悬浮液，但是甚至也可以是用于组织植入的固体药丸。Th

7、e control of a process to minimize contamination for a small quantity of such a product can be achieved with relativeease.对于少量的这种产品，使其污染降到最低的工艺控制可以相对容易的实现。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.翻译：因此,无菌产品的制备已经成为药品加工里一个高度特殊的区域。14：Thestandardsestablished,theattitudeofpersonnel,andprocesscontrol must be of a superiorlevel.翻译：标准的建立、员工的态度和控制过程必须是高水平的。By far the most frequently employed vehicle for sterile products is

9、 water , since it is the vehicle for all natural bodyfluids.到目前为止，最长被用于无菌产品的溶媒就是水，因为水是所有自然体液的溶媒。The superiorqualityrequiredforsuchuseisdescribedinmonograph on Water for Injection in the该用途要求的优良特性在美国药典的注射用水专题论文中有所描述。17 、 Requirements may be even more stringent for some products , however.译：然而，对某些药物的要

10、求可能会更苛刻。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.翻译：水质检查的一种普遍的测试是固体总含量，一种对水中解离和不解离的有机物和无机物在重量上的评估。原 文 ：However, a less time-consumin

11、g test, the electrolytic measurement of conductivity of the water, is the one most frequently used.译文：然而，一种用时较少的测试水导电性的电解测量则是最常用的测试方法，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.一种基于水中离子含量的测量方法。The conductance may be expressed by meter scale as conductivity in micromhos,resistance inmegohms,orinoiccontent aspartsmillion(ppm) of sodiumchloride电动率可以通过表头刻度盘一电导，微欧姆，电阻，兆欧姆或者离子含量，ppmNacl 的形式显示出来。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.作为水纯度的指示，这种测量方法的准确性只是推理性的，比如蒸馏和反渗透，可以将不解离的物质同那些解离的物质一起除去。Undissociated substances such aspyrogens, however, cou

14、ld be present in the absence of ions and not be disclosed by thetest.翻译：但是不解离的的物质如热原，可以不以离子的形式存在，因而不能被这种方法检测出来。Thereforeforcontaminantsotherthanionsadditionaltestsshould be performed.测。Additional tests for quality of Water for Injection with permitted limits are described in the USPmonographs.具有特殊用途

15、的注射用水的水质附加测试在美国药典中有专篇描述。 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.翻译：当把注射用水和无菌注射用水所允许的总固体含量作比较时， 你会发现无菌注射用水允许有相当高的值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.这是必要的，因为后者是经过灭菌的，通常是通过一种热途径，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，其固体含量会比没有灭菌的产品要高的多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，官方对于注射用水所允许的 10ppm 的固体总含量，对于许多产品来说作为溶媒其值可能太高了。In practice,waterforInjectionnormallyshouldnothavea conductivityofmorethan 1 micromho (1 megohm，approximately1ppmNaCl).事实上,注射用水其电导一般不应

18、该超过 1 微欧姆（1 兆欧，大约ppmNaCl）31 原文:Substances added to aproduct to enhance its stability are essential for almost everyproduct.翻译:添加到产品当中用以提高产品稳定性的物质，对于几乎每种产品来说都是必不可少的。Such substances include solubilizers , antioxidants , chelating agents,buffers , tonicity contributors , antibacterial agents , antifung

19、al agents , hydrolysisinhibitors,antifoammgagents,andhumeroussubstances for specializedpurposes.这样的物质包括增溶剂、抗氧剂、螯合剂、缓冲剂、张度调节剂、抗At the same time , these agentsmustbepreventedfrom affecting theproduct.同时，这些组分不能对产物有不利影响。In general , added substances must be nontoxic in the quantity administered to thepa

20、tient.一般来说，添加剂必须在病人的给药量范围是无毒的They should not interfere with the therapeutic efficacy nor with the assay of the active therapeuticcompound.它们（辅料）不应该干扰疗效，也不能干扰有效活性化合物的测定。they must also be present and active when needed throughout the useful life of theproduct翻译：在产品的整个有效期内，需要他们时，他们必须存在并且有效。.agents must

21、 be selected with greatcare ，and they must be evaluated as to their effect upon the entireformulation.的影响也必须进行评估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.一篇关于用在非肠道用产品中的赋形剂和调节这些产品 pH 的方法的综述，最近已经出版，更多的详细信息可参阅之。The formulation of a parenteral product involves the combination of oneormoreingredientswithamedicinalagenttoenhanceconvenience ,acceptability ,or effectiveness of theproduct.非肠道用产品的处方涉及一个或者更多组成部分间的结合，这些组成（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.（人们）很少愿意把药物仅仅以一种无菌的、干燥的粉末（的形式）配售，除非（把它做成）稳定的液体制剂处方，否则是行不通的。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.翻译：另一方面，一个药物制剂是一个遵从物理和化学反应支配特性的化合物。（药物的有效成分物理和化学反应特性的一种化合物。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.因此对每一个两种或更多组成部分间的结合都必须有一个仔细的评以使反应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.翻译：无菌产品的制定是具有挑战性的，因此，需要具有学问和聪明的人负责。因此，无菌产品的配方是对负责人员知识和独创性的一个挑战。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.可用的信息量配方设计师关于治疗剂的物理和化学性质 ,特别是如果这是一个新的化合物,通常是很微薄的（药物的有效成分质的信息量通常是很少的，尤其当治疗药物是一种新的化合物时。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、纯度、依数性等信息关于（治疗剂）基本性质的信息，包括分子量、溶解度、纯度、依数性和化学反应性必须在一种好的组建配方的方法可以开始之前得到46.Improvementsinformulationareacontinuingprocess,since important p

28、roperties of a drug or of the total formulation may not becomeevident untiltheproduct hasbeenstored orusedfora prolongedtime.翻译：改进处方是一个持续的过程，因为一种药物或者一种处方的重要性质直到这种药品被存放或者使用了很长时间才会变得明显。处方的改进是一个持续的过程，因为药物或整体配方的一些重要性质只有在贮存或者使用了很长时间之后才可能会变得明显。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. 然而由于美国食品和药物管理局要求的广泛的测试文件只有优的制剂才能被证明能够持续产品的状态。（使得）只有那些杰出的配方才能继续发展成为上市产品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.生成过程包括从配方的各个组成部分的积聚和结合到产品封装用于分售的单个包装内的所有步骤。生产过程包括从配方的各个组成部分的积累和结合到产品封装入用于分售的单个包装内的所有步骤。Intimately associated with these processes are the personnel who carry them out and the facilities in whi

31、ch they areperformed与这些过程密切相关的是执行它们的人员和执行它们的设施和这些过程有紧密联系的是搬运人员和执行这些步骤的设备。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.最理想的计划过程，可以使无效的人员没有正确的态度或培训，或

32、设施，不提供有效的控制环境。计划出来的最理想的过程也会因为没有正确态度或没有接受正确培训的人员或者不能提供一个有效的控制环境的设备而变得无效。To enhance the assurance of successful manufacturing operation , all process steps must be carefully reduced to writing after being shown to beeffective加强生产操作成功的保证,所有流程步骤必须被小心地减少到标准下被证明是有效的后都要仔细地归纳成书面材料，These written procee steps are offen called sta