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題名 | 探討歷年中藥材之異常物質背景值研究及建立相關限量標準草案=A Survey on the Background Values of Anomalous Substances in Chinese Herbal Medicine and to Establish a Draft of Relevant Standard Limits |
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作 者 | 許秀蘊; | 書刊名 | 中醫藥年報 |
卷期 | 光碟版1:9 2012.10[民101.10] |
頁次 | 頁20-108 |
專輯 | 中醫藥產業實務規範 |
分類號 | 414.3 |
關鍵詞 | 中藥材; 異常物質; 背景值; 限量標準; Traditional Chinese medicine; Anomalous substance; Background values; Standard limitation; |
語文 | 中文(Chinese) |
中文摘要 | 由於中藥材之品質因產地環境、栽培方式、生長季節、採收時間、藥用部位、或儲存條件等因素,導致品質不易控制,造成市售中藥材之品質有極大差異,為顧及國人之用藥安全,及國際之競爭力,故彙整中藥材之異常物質背景值,並建立相關限量標準草案。 經歸納分析歷年中藥材含異常物質之背景值研究,及整理衛生署歷年之相關公告、並參考各國藥典之限量標準,及邀請國內產官學者、專家,由其是製造業者等,提出草案之建立及建議,以利政策推行。 本計畫彙整以類別為主之中藥材含重金屬、農藥殘留及微生物汙染等異常物質之限量標準及草案之建議,以提升中藥材之品質。 |
英文摘要 | Commercially available Chinese herbal medicine products vary greatly in their quality. Factors including origin environment, cultivation methods, the growing season, harvest time, medicinal parts, or storage conditions all have an impact on the quality of herbal medicine, therefore making quality control difficult to manage. In order to take care of people's drug safety and international competitiveness, we collect the data of the background values of anomalous substances in Chinese herbal medicines, and establish a draft of relevant standard limits. To facilitate the implementation of the policy, we analyzed studies on the background values of anomalous substances in Chinese herbal medicine, organized the relevant announcement of the Department of Health over the years, referred to standard limits set by different international pharmacopoeia, and invited domestic scholars and experts, especially the manufacturers, to propose and establish the draft. The project collected standard limits of anomalous substances, including categories of Chinese herbal medicines containing heavy metals, pesticide residues and microbial contamination, and proposed a draft to improve the quality of Chinese herbal medicines. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。