頁籤選單縮合
題 名 | 中藥成分對照標準品之標定--Sennoside A=Qualitative Evaluation for the Preparation of Chinese Medicine Reference Standard--Sennoside A |
---|---|
作 者 | 徐雅慧; 陳思慧; 王承中; 劉宜祝; 施養志; | 書刊名 | 食品藥物研究年報 |
卷 期 | 4 2013.11[民102.11] |
頁 次 | 頁206-215 |
分類號 | 412.36 |
關鍵詞 | 中藥成分對照標準品; 實驗室間共同試驗; Sennoside A; Chinese medicine reference standard; Collaborative study; |
語 文 | 中文(Chinese) |
中文摘要 | 中草藥品質評估試驗中,用於檢驗分析比對之中藥成分對照標準品,因缺乏公認之標準,其品質參差不齊。本計畫依前所建立之「中藥成分對照標準品實驗室間共同比對試驗機制」模式,除 TFDA外,邀請其他 8個實驗室共同參與試驗,進行 Sennoside A (番瀉苷 A)檢品原料之各項理化學共同試驗。彙整 9個實驗室之試驗結果, UV光譜最大吸收波長 λmax = 269.8,333.5nm,比吸光度 E= 218.4,164.8。IR光譜吸收位置在 3421,1710,1636及 1072 cm-1具有 Sennoside A特有之吸收。高效液相層析檢測結果, 9個參與實驗室分別檢出 1-13個微量不純物,其不純物之含量均≦ 0.56%,總不純物之含量亦均≦ 1.50%。以上數據顯示,本批 Sennoside A原料,其品質可做為 Sennoside A對照標準品。本計畫除供應具有公認品質基礎之中藥成分對照標準品外,亦建立未來供應中藥成分對照標準品之品管模式,使中藥成分對照標準品品質邁向國際水準。 |
英文摘要 | The raw material of sennoside A was examined prior to the preparation of the “Sennoside A Reference Standard”. The physico-chemical properities of the candidate material were evaluated through a collaborative study of nine laboratories. Analytical data obtained were summarized as following, the UV maximum absorption wavelength(λmax): 269.8 and 333.5 nm; the corresponding specific absorbance (E11%1cm) at the maxima wavelength: 218.4 and 164.8, respectively. IR spectra presented IR absorption at 3421, 1710, 1636 and 1072 cm-1. HPLC analysis showed 1-13 impurities where individual amount was ≦ 0.56% and data from each single laboratory indicated the total impurity amount was ≦ 1.50%. Based on the above results, the candidate material met the requirement of authorization as the “Sennoside A Reference Standard.” |
本系統中英文摘要資訊取自各篇刊載內容。