中藥成分對照標準品之標定與供應－Berberine chloride

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，進行氯化小蘗（生僉）(Berberine chloride)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)=227.8, 263.0, 344.6, 421.2 nm，比吸光度E(上標 196下標 1cm)=821.8, 796.7, 724.5, 154.8。IR光譜吸收位置在2846, 1634, 1567及1506 cm^(-1)具有Berberine chloride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3~8個微量不純物，其不純物之含量均≦0.41%，總不純物之含量亦均≦0.52%。以上數據顯示，本批氯化小蘗（生僉）品原料，其品質應可做為氯化小蘗（生僉）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

氯化小蘗（生僉）；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 berberine chloride was examined prior to the preparation of the ”Berberine Chloride Reference Standard”. The physico-chemical properties of the candidate material were evaluated by a collaborative study from seven laboratories. Analytical data obtained were summarized as follows: the UV maximum absorption wavelength and the corresponding specific absorbance were 227.8, 263.0, 344.6, 421.2 nm and 821.8, 796.7, 724.5, 154.8, respectively. IR Spectra showed IR absorption at 2846, 1634, 1567 and 1506 cm^(-1). HPLC analysis revealed 3-8 impurities where individual amount was ≦0.41% and the total amount from any single laboratory was ≦0.52%. Base on the above results, the candidate material met the requirement of authorization as the Berberine Chloride Reference Standard.

並列關鍵字

berberine chloride ； 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－Berberine chloride

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