(单词翻译:单击)
In 1906, the US government sets standards for drug quality and purity.
1906年,美国政府制定了药品质量和纯度标准 。
There are 2 official publications: the United States Pharmacopoeia, USP, and the National Formulary.
两个法定出版物为《美国药典》(USP) 和《国家处方集》 。
They set standard for drug strength, quality, purity, packaging, safety, labeling and dosage form.
它们规定了药品的药力、质量、纯度、包装、安全、商标和剂型的标准 。
In Canada, the British Pharmacopoeia, BP, sets similar standards.
加拿大使用《英国药典》规定了类似的标准 。
These publications are important.
这些出版物十分重要 。
With the standards, physicians, nurses and pharmacists can make sure that patients get pure drugs in safe and effective dosages.
医护人员和药剂师依据它们可以保证患者服用安全、有效的纯净药物 。
Accepted standards must be met in 5 areas:
以下五方面的通用标准必须满足:
a, purity. Manufacturers must meet purity standards. The standards refer to the type and concentration of extraneous substances that are allowed in drug products.
一,纯净度 。生产商生产药品必须达到纯度标准 。标准中规定了药品的剂型和和非活性成分的浓度 。
b, potency. The concentration of active drug in the preparation affects the strength or potency.
二,药效 。药品中活性药物成分的浓度决定药品的药力和药效 。
c, bioavailability. The ability of a drug to be released from its dosage form, and resolved, absorbed, and transported by the body to its site of action.
三,生物有效性 。这是指药品从其药剂形式溶解吸收,并被输送到体内作用部位过程中的利用度 。
d, efficacy. Detailed laboratory studies can help determine a drug's effectiveness.
四,药效 。药品的效果需要经过精细的实验室研究才能被确定 。
e, safety. Drug should be continually evaluated to determine their side effects.
五,安全性 。药品需要被不但检验,以确定其副作用 。
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