The significance of quality for efficacy and safety of herbal medicinal products

被引:43
作者
Busse, W [1 ]
机构
[1] Dr Willmar Schwabe Pharmaceut, Regulatory & Sci Affairs Int Div, D-76209 Karlsruhe, Germany
来源
DRUG INFORMATION JOURNAL | 2000年 / 34卷 / 01期
关键词
herbal medicinal products; quality; safety; efficacy; labeling;
D O I
10.1177/009286150003400102
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
The efficacy and safety of any pharmaceutical product is determined by the compounds (desired and undesired) which if contains. The purpose of quality control is to ensure that each dosage Emit of the drug product delivers the same amount of active ingredients and is, as far as possible, free of impurities. As herbal medicinal products are complex mixtures which originate from biological sources, great efforts are necessary to guarantee a constant and adequate quality. By carefully selecting the plant material and a standardized manufacturing process the pattern and concentration of constituents of herbal medicinal products should be kept as constant as possible as this is a prerequisite for reproducible therapeutic results. With the increasing use of herbal products, particularly in the United States, the future worldwide labeling practice for herbal products should adequately address quality aspects.
引用
收藏
页码:15 / 23
页数:9
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