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| 題 名 | 國際中草藥品質規範探討與研析=Study and Analysis on the International Specification of Chinese Herbal Medicine |
|---|---|
| 作 者 | 王靜瓊; | 書刊名 | 中醫藥年報 |
| 卷 期 | 13 2024.10[民113.10] |
| 頁 次 | 頁(16)1-(16)148 |
| 分類號 | 414.3 |
| 關鍵詞 | 歐洲藥典之中草藥及其產品; 臺灣中藥典; 植物化學小組13B; 日本藥局方; 韓國藥典; Herbal drug and herbal drug products of European Pharmacopoeia; Taiwan Herbal Pharmacopeia; The Council of European; Phytochemistry groups 13B; Japanese Pharmacopoeia; Korean Pharmacopoeia; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | 目的: 為因應國際藥典中藥品質規格、檢驗技術方法及法規不斷推陳出新,將透過國際藥 典分析比較,俾使臺灣中藥品質規範與國際接軌。研究方法:透過比較英文版之韓國藥 典、日本藥局方與臺灣中藥典相同品目之內容,及分類歐洲藥典之中草藥品項及品質規 格。參與歐洲藥典中草藥及其製備 13B 專家小組的編修工作,汲取國際藥典編修經驗。 舉辦專家討論會議,彙整意見擬定建議,提供給未來臺灣中藥典編修參考。 結果: 臺灣、中國、韓國及日本藥典收載的品項類似,以藥品使用的品項為主,而歐洲藥 典則是廣泛收載植物性萃取物,包括了蔬菜水果及花草茶等非常用傳統醫藥的植物。臺 灣中藥典、韓國藥典及日本藥局方都收載甘草及加味逍遙散,臺灣中藥典收載皆為濃縮 顆粒製劑;日本藥局方則為浸膏;韓國藥典甘草為浸膏及加味逍遙散為濃縮顆粒。而加 味逍遙散之組成皆不相同,且訂定的指標成分亦不相同。異常物質的規範中,韓國藥典 和日本藥局方相對較為不足,以歐洲藥典較為嚴謹,項目有夾雜物、農藥殘留、黃麴毒 素、微生物限量管理以及吡咯聯啶生物鹼 (PAs)之汙染;而臺灣中藥典規範較嚴謹為重 金屬及二氧化硫限量管理。 結論: 經專家會議討論後,含量分析除訂定指標成分含量外,應增加有毒成分限量值規範。臺灣藥用植物應嚴謹評估確認成為中藥典品項之可能性,擴充藥典的內容。新興的異常 物質應該設專案研究其限量值。 |
| 英文摘要 | Aim: In order to keep up with the quality specifications, inspection techniques and regulations of Traditional Chinese Medicines (TCM) in the international pharmacopoeias. We had analyze and compare them through the international pharmacopoeias, so as to bring the quality of TCM products in Taiwan into line with international standards. Methods: Comparing the contents of the same items in the English version of the Korean Pharmacopoeia (KP), Japanese Pharmacopoeia (JP) and Taiwan Herbal Pharmacopeia (THP), and classifying the herbal medicine items and quality specifications of the European Pharmacopoeia (EP). Participating the editorial meetings of the EP herbal products and preparations, the 13B expert group to learn from the international pharmacopoeia editing experience. Organizing expert discussion meetings to gather opinions and formulate suggestions for reference in the future compilation of THP. Results: The similar items of THP, China Pharmacopeia (CP), KP and JP, are the items that are mainly used in traditional medicines. Meanwhile, EP widely includes plant extracts, including vegetables, fruits, and herbal teas that are not commonly used in traditional medicine. THP, KP and JP all contain licorice and Jia-Wei-Xiao-Yao San (JWXYS). Among them, THP described both licorice and JWXYS as concentrated granular preparations; JP described both as extracts; while KP described licorice as an extract and JWXYS as a concentrated granular preparations.In addition, the composition and reference standards for quality control of JWXYS are different among the three pharmacopoeias. EP is more rigorous than KP and JP for the regulation of impurities test, including inclusions, pesticide residues, aflatoxins, microbial limits, and pyrrolizidine alkaloids (PAs); while THP regulations are more stringent at heavy metals and sulfur dioxide limit management. Conclusion: After discussion at the expert meeting, in addition to setting the index component content, the content analysis should increase (loosen / tighten) the limit value of toxic components. Taiwan should add more indigenous medicinal plants to the pharmacopoeia to expand and enrich the content of its pharmacopoeia. Moreover, new studies should be conducted to set suitable limits for the emerging anomalous substances. |
本系統中英文摘要資訊取自各篇刊載內容。