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題名 | 中藥成分對照標準品之標定--Sennoside B=Qualitatively Evaluating the Preparation of Chinese Medicine: Sennoside B Reference Standard |
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作者 | 徐雅慧; 王承中; 陳思慧; 廖振翔; 劉宜祝; 林美智; 陳惠芳; 施養志; Hsu, Ya-hui; Wang, Chen-chung; Chen, Szu-hui; Liu, Yi-chu; Lin, Mei-chih; Cheng, Hwei-fang; Shih, Yang-chih; |
期刊 | 食品藥物研究年報 |
出版日期 | 20141200 |
卷期 | 5 2014.12[民103.12] |
頁次 | 頁224-234 |
分類號 | 412.36 |
語文 | chi |
關鍵詞 | 中藥成分對照標準品; 實驗室間共同試驗; Sennoside B; Chinese medicine reference standard; Collaborative study; |
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。本研究依前所建立之「中藥成分對照標準品實驗室間 共同比對試驗機制」模式,除本署外,邀請其他8個實驗室共同參與試驗,進行 Sennoside B (番瀉苷B)檢品原料之各項理化學共同試驗。彙整各實驗室之試驗結果, UV光譜最大吸收波長λmax = 269.4、303.6及349.3 nm,比吸光度E1 % 1cm = 224.3、183.9及 170.2。IR光譜吸收位置在3421,1712,1637及1074 cm-1具有Sennoside B特有之吸 收。高效液相層析檢測結果,參與實驗室分別檢出2-10個微量不純物,其不純物之含 量均≦0.70 %,總不純物之含量亦均≦1.26%。以上數據顯示,本批Sennoside B原 料,其品質可做為Sennoside B對照標準品。本研究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 B was examined prior to the preparation of the “Sennoside B Reference Standard”. The physiochemical properities of the candidate material were evaluated by a collaborative study of nine laboratories. The analytical data obtained can be summarized as the following: the UV maximum absorption wavelength (λmax): 269.4, 303.6, and 349.3 nm; the corresponding specific absorbance (E1 % 1cm) at the maxima wavelength: 224.3, 183.9, and 170.2, respectively. IR spectra presented IR absorption at 3421, 1712, 1637, and 1074 cm-1. HPLC analysis showed 2-10 impurities where the individual amount was ≦0.7% and data from each laboratory indicated that the total impurity amount was ≦1.26%. Based on the results above, the candidate material met the requirements as authorized by the “Sennoside B Reference Standard.” |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。