In 1906, the US government sets standards for drug quality and purity.
1906年,美國政府制定了藥品質量和純度標準。
There are 2 official publications: the United States Pharmacopoeia, USP, and the National Formulary.
兩個法定出版物為《美國藥典》(USP) 和《國家處方集》。
They set standard for drug strength, quality, purity, packaging, safety, labeling and dosage form.
它們規(guī)定了藥品的藥力、質量、純度、包裝、安全、商標和劑型的標準。
In Canada, the British Pharmacopoeia, BP, sets similar standards.
加拿大使用《英國藥典》規(guī)定了類似的標準。
These publications are important.
這些出版物十分重要。
With the standards, physicians, nurses and pharmacists can make sure that patients get pure drugs in safe and effective dosages.
醫(yī)護人員和藥劑師依據它們可以保證患者服用安全、有效的純凈藥物。
Accepted standards must be met in 5 areas:
以下五方面的通用標準必須滿足:
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,純凈度。生產商生產藥品必須達到純度標準。標準中規(guī)定了藥品的劑型和和非活性成分的濃度。
b, potency. The concentration of active drug in the preparation affects the strength or potency.
二,藥效。藥品中活性藥物成分的濃度決定藥品的藥力和藥效。
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。這是指藥品從其藥劑形式溶解吸收,并被輸送到體內作用部位過程中的利用度。
d, efficacy. Detailed laboratory studies can help determine a drug's effectiveness.
四,藥效。藥品的效果需要經過精細的實驗室研究才能被確定。
e, safety. Drug should be continually evaluated to determine their side effects.
五,安全性。藥品需要被不但檢驗,以確定其副作用。
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