bulk active substance

Chinese translation: FYI

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:bulk active substance
Chinese translation:FYI
Entered by: Hui Zhi

08:56 Apr 18, 2018
English to Chinese translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: bulk active substance
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?
Hui Zhi
China
Local time: 19:49
FYI
Explanation:
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。
Selected response from:

Randy Wong
China
Local time: 19:49
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
5 +1散装活性物质
Weiping Tang
5活性成分
jyuan_us
4FYI
Randy Wong


  

Answers


7 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
FYI


Explanation:
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。


Randy Wong
China
Local time: 19:49
Native speaker of: Native in ChineseChinese
PRO pts in category: 4
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44 mins   confidence: Answerer confidence 5/5 peer agreement (net): +1
散装活性物质


Explanation:
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!

Weiping Tang
China
Local time: 19:49
Specializes in field
Native speaker of: Native in ChineseChinese
PRO pts in category: 79

Peer comments on this answer (and responses from the answerer)
agree  Lynch Lin
35 mins
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21 mins   confidence: Answerer confidence 5/5
活性成分


Explanation:
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“。

jyuan_us
United States
Local time: 07:49
Specializes in field
Native speaker of: Native in ChineseChinese
PRO pts in category: 178
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