Okada S, Kitajima A, Tanimoto T, Suzuki H, Satake M
Eisei Shikenjo Hokoku. 1995(113):121-6.
The raw material of berberine hydrochloride was examined for preparation of the "Berberine Hydrochloride Reference Standard". The candidate material was evaluated physico-chemically by a collaborative study in which five laboratories participated. Analytical data obtained were as follows: UV spectrum, lambda max = 228, 263, 345, and 421 nm and specific absorbance E1%1cm at each lambda max = 814, 794, 722, and 160, respectively; IR spectrum, specific absorption wave numbers at 2845, 1633, 1568, and 1506 cm-1; thin-layer chromatography, some laboratories detected a trace amount of one or two spot and others not detected; high-performance liquid chromatography, 2-5 impurities were detected and the amount of any impurities were estimated to be less than 0.05% and the total amount less than 0.2%. Based on the above results, the candidate material was authorized as the Berberine Hydorochloride Reference Standard of 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”。候选原料由五个实验室参与的协作研究进行了物理化学评估。获得的分析数据如下：紫外光谱，最大吸收波长λmax = 228、263、345和421 nm，各最大吸收波长处的比吸收系数E1%1cm分别为814、794、722和160；红外光谱，在2845、1633、1568和1506 cm-1处有特定吸收波数；薄层色谱，一些实验室检测到微量的一个或两个斑点，其他实验室未检测到；高效液相色谱，检测到2 - 5种杂质，任何一种杂质的含量估计小于0.05%，总量小于0.2%。基于上述结果，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。
