Koide T, Iwata M, Maekawa K, Saito H, Tanimoto T, Okada S
Kokuritsu Iyakuhin Shokuhin Eisei Kenkyusho Hokoku. 2001(119):97-100.
The raw material of Berberine Hydrochloride was examined for preparation of the "Berberine Hydrochloride Reference Standard". The analytical data obtained were: UV spectrum: lambda max, 420, 345, 263 and 228 nm and specific absorbance (E1ca1%) in ethanol at each lambda max, 155, 724, 796 and 820, respectively; IR spectrum, specific absorptions at 2844, 1635, 1569, and 1506 cm-1; and the spectrum of raw material was consistent with that of Standard (Control 941). Also, thin-layer chromatography, an impurity was detected; high-performance liquid chromatography, several impurities were detected. The amount of each impurity was estimated at less than 0.1% and the total amount of impurities was less than 0.2%. Based on the above results, the candidate material was authorized as the Berberine Hydrochloride Reference Standard (Control 001) of the National Institute of Health Sciences.
对盐酸小檗碱的原料进行了检验，以制备“盐酸小檗碱对照品”。获得的分析数据如下：紫外光谱：最大吸收波长λmax为420、345、263和228nm，在各λmax处乙醇中的比吸收系数（E1cm1%）分别为155、724、796和820；红外光谱，在2844、1635、1569和1506cm-1处有特征吸收；且原料光谱与标准品（对照品941）一致。此外，薄层色谱法检测到一种杂质；高效液相色谱法检测到几种杂质。每种杂质的含量估计小于0.1%，杂质总量小于0.2%。基于上述结果，该候选原料被批准为国立卫生科学研究所的盐酸小檗碱对照品（对照品001）。
