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【每日一句(段)有奖翻译】<二十九> Monograph Components(4)

专业英语

  • Added Substances, Excipients, and Ingredients in Official Products

    1. Suitable substances and excipients such as antimicrobial agents, pharmaceutical bases, carriers,
    coatings, flavors, preservatives, stabilizers, and vehicles may be added to an official product to enhance
    its stability, usefulness, or elegance, or to facilitate its preparation, unless otherwise specified in the
    individual monograph.


    2. Added substances and excipients employed solely to impart color may be incorporated into official
    products other than those intended for parenteral or ophthalmic use, in accordance with the regulations
    pertaining to the use of colors issued by the U.S.


    3. Food and Drug Administration (FDA), provided such added substances or excipients are otherwise
    appropriate in all respects.


    4. The proportions of the substances constituting the base in ointment and suppository products and
    preparations may be varied to maintain a suitable consistency under different climatic conditions,
    provided that the concentrations of active ingredients are not varied and provided that the bioavailability,
    therapeutic efficacy, and safety of the preparation are not impaired.
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  • f4forever

    第1楼2011/01/17

    法定标准品中的添加物质、辅料和成分

    1.法定标准品中可以适当添加一些物质和辅料,如抗菌剂、制药基质、载体、包衣、香料、防腐剂、稳定剂和赋形剂,以增强其稳定性、实用性或美观性,或者使其易于制剂,除非相应专论中另有说明。

    2.根据美国颁布的关于着色剂使用的规定,仅作着色之用的添加物质和辅料不能添加到非口服用药或眼科用药中。

    3.美国食品和药品管理局(FDA)提供的这些添加物质或辅料在各方面都很合适。(还是不太理解此句的意思,特别是“otherwise”在其中的作用。望高人指点!)

    4.只要保证活性成分的浓度不变,制剂的生物利用度、疗效和安全性不减,软膏剂和栓剂药品制剂中构成基质的各物质的组成比例可以发生变化,以在不同的气候条件下保持一定的粘稠度。

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  • poorlittle

    第2楼2011/01/17

    otherwise : in a different or opposite way from what has been mentioned

    (from http://www.onelook.com/?w=otherwise+&ls=a ) 可译作

    = = = = = =

    2.根据美国颁布的关于着色剂使用的规定,仅作着色之用的添加物质和辅料不能添加到非口服用药或眼科用药中。
    3.美国食品和药品管理局(FDA)提供的这些添加物质或辅料在各方面都合适


    當上文2. mentioned“物质和辅料不能添加”, 下文3.又說合适, 對這种opposite way, 便用otherwise.

    = = = = = =

    Further information :

    http://www.jukuu.com/show-otherwise-0.html

    Intuition is a middle ground between having consciously learned something and knowing something instinctively. If we have learned that things glowing red can burn us, we tend to classify all red-glowing things as potentially dangerous until proven otherwise.

    直觉是有意识学习和本能感知事物的中间阶段,如果已经知道烧红的物体会烫伤我们,我们会倾向于将它们归入潜在危险的事物一类,直到证明不是这样


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  • f4forever

    第3楼2011/01/18

    噢~原来如此!感谢poorlittle大虾的指点!在下甚有恍然大悟之感!

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