中藥定量用標準品之標定－Puerarin

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，除本局外，邀請其他6個實驗室共同參與試驗，進行葛根素（Puerarin）檢品原料之各項理化學共同試驗。彙整7個實驗室之試驗結果，UV光譜最大吸收波長λ（下標 max）＝249.9，305.7nm，比吸光度E（下標 1cm）（上標 1％）= 736.8，248.8。IR光譜吸收位置在3366，3234，1633，1515及1059 cm^-1具有Puerarin特有之吸收。高效液相層析檢測結果，7個參與實驗室分別檢出1－6個微量不純物，其不純物之含量均≦0.50%，總不純物之含量亦均≦0.84%。以上數據顯示，本批葛根素原料，其品質應可做為葛根素對照標準品。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。

關鍵字

葛根素；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 Puerarin was examined prior to the preparation of the ”Puerarin Reference Standard”. The physico-chemical properities of the candidate material were evaluated by a collaborative study among seven laboratories. Analytical data obtained were summarized as follows: the UV maximum absorption wavelengths and the corresponding specific absorbencies (E(superscript 1%)(subscript 1cm)) were 249.9, 305.7 nm, and 736.8, 248.8, respectively. IR Spectra showed that IR absorption at 3366, 3234, 1633, 1515 and 1059 cm^(-1). HPLC analysis revealed 1-6 impurities which individual amount was≤0.50% and the total amount from any single laboratory was ≤ 0.84%. Based on the above results, the candidate material met the requirement of authorization as the Puerarin Reference Standard.

並列關鍵字

puerarin ； Chinese medicine reference standard ； collaborative study

國際替代計量

中藥定量用標準品之標定－Puerarin

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