中藥成分對照標準品之標定與供應-Paeoniflorin

Qualitative Evaluation for the Establishment of Chinese Medicine Reference Standard-Paeoniflorin

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，進行芍藥苷(Paeoniflorin)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吸光度測定λ(下標 max)=231.8 nm，比吸光度E(上標 1% 下標 1cm)(MeOH)=270.1。IR吸光度測定在3400，1710，1605，1580及1280 cm^(-1)具有Paeoniflorin特有之吸收。高效液相層析檢測結果，6個參與實驗室分別檢出1~8個微量不純物，其不純物之含量均≦0.30%，總不純物含量亦均≦0.72%。以上數據顯示，本芍藥苷對照標準品原料，其品質應可做為芍藥苷對照標準品。本計畫除完成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，使中藥成分對照標準品品質邁向國際水準。

The raw material of paeoniflorin was examined prior to the preparation of the ”Paeoniflorin Reference Standard”. The physico-chemical properities of the candidate material were evaluated by a collaborative study from six laboratories. Analytical data obtained were summarized as follows: The UV maximum absorption wavelength: 231.8 nm and the specific absorbance at the maxima wavelength was 270.1. IR Spectra showed the IR absorption were at 3400, 1710, 1605, 1580 and 1280 cm^(-1). HPLC analysis showed 1~8 impurities where individual amount were ≦0.30% and the total amount from any single laboratory was ≦0.72%.Base on the above results, the candidate material met the requirement of authorization as the Paeoniflorin Reference Standard.