Glossary entry

English term or phrase:

bulk active substance

Chinese translation:

FYI

Added to glossary by Hui Zhi
Apr 18, 2018 08:56
6 yrs ago
7 viewers *
English term

bulk active substance

English to Chinese Medical Medical: Pharmaceuticals
生物制品-注射用A型肉毒毒素的相关词汇,是译为“活性物质原液”好,还是译为“原料药”好?

Proposed translations

7 mins
Selected

FYI

如果确定substance是液体,可以译为“活性物质原液”,否则用“原料”比较保险。
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44 mins

散装活性物质

这里的bulk是指没有经过分包装的,与packaged相对,标准译法即是散装活性物质。供参考!
Peer comment(s):

agree Lynch Lin
35 mins
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21 mins

活性成分

根据下列FDA定义active substance=active ingredient,就是活性成分,但是有的药厂将它称为“活性物质”,甚至“活性物资”。


Bulk Drug Substance: According to 21CFR207.3(a)(4) means any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances.

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Note added at 1 hr (2018-04-18 10:20:24 GMT)
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Bulk 不一定总是翻译成“散装”,如果你点击下列链接,你会看到这种bulk材料是pachaged 到小桶中的。

https://www.sylvane.com/santa-fe-bulk-carbon-granules.html?s...

我理解,无论其包装形式为何,制药用的原料在制成成品前都成为Bulk, 颇有“原”的含义。题主的这个短语中用了bulk,主要是用于区别是原料中的活性成分还是成品中的活性成分。如果整个短语翻译为“原料活性物质/原料活性成分”,bulk 的含义已经包含在其中了。

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Note added at 4 hrs (2018-04-18 13:24:33 GMT)
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在药厂,确实有把这种东西称为“原液”的,因为那些药厂用的active substance确实是液态。但是,active substance可以是液态,也可以是固态,比较保险的做法是翻译成“原料活性物质”/活性成分。

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Note added at 12 hrs (2018-04-18 21:29:37 GMT)
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因为题主的文章中曾有”B28 and B38 Hepatitis A bulk manufacturing facilities“这样的说法,估计两处的bulk 是同一个意思,都不宜翻译为”散装“。
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