中藥成分對照標準品之標定與供應－Glycyrrhizinic acid

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，除本局外，共邀請5個實驗室參與，進行甘草酸(Glycyrrhizinic acid)對照標準品原料之各項理化學共同試驗。彙整6個實驗室之試驗結果，UV吸收光譜λ(下标 max)=251.1nm，比吸光度E(上标 196 下标 1cm)(EtOH)=140.8。IR吸收光譜在1719，1654，1216及1170cm^(-1)具有Glycyrrhizinic acid特有之吸收。另薄層層析檢測結果，僅1家實驗室，除主斑點外，亦檢測出2個不明顯之斑點。至於高效液相層析檢測結果，6個參與實驗室分別檢出1~7個微量不純物，其不純物之含量均≤0.22%，總不純物含量亦均≤0.50%。另實驗材料之融點測定結果為213~215℃。以上數據顯示，本甘草酸對照標準品原料，其品質應可做為甘草酸對照標準品。本計畫除完成我國第一個具有公認品質基礎之中藥成分對照標準品，供應所需外，亦建立未來製造中藥成分對照標準品之品管模式，使我國中藥成分對照標準品品質邁向國際水準。

關鍵字

甘草酸；中藥成分對照標準品；實驗室間共同試驗

並列摘要

The raw material of glycyrrhizinic acid was examined prior to the preparation of the ”Glycyrrhizinic Acid Reference Standard”. The candidate material was evaluated physico-chemically by a collaborative study in which six laboratories participated. Analytical data obtained were as follows: The UV absorption maximum showed at 251.1 nm and the specific absorbance at the maxima was 140.8. IR Spectrum showed specific absorption at 1719, 1654, 1216 and 1170 cm^(-1). Only one laboratory detected trace amount of two spots by thinlayer chromatography. HPLC analysis showed 1~7 impurities where individual amount were estimated to be equal to or less than 0.22% and the total amount from a single laboratory was equal to or less than 0.50%. Base on the above results, the candidate material was authorized as the Glycyrrhizinic Acid Reference Standard.

並列關鍵字

glycyrrhizinic acid ； Chinese medicine reference standard ； collaborative study

國際替代計量

中藥成分對照標準品之標定與供應－Glycyrrhizinic acid

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