一测多评法测定黄连配方颗粒中4个成分的含量

Determination of 4 Components in Coptis Chinensis Formula Granules by QAMS

目的验证2010年版《中国药典(一部)》测定黄连药材的方法能否适用于黄连配方颗粒,建立黄连配方颗粒的一测多评标准(QAMS)。方法仅测定其中小檗碱的含量,通过确定它与其余待测成分(巴马汀、黄连碱、表小檗碱)间的内在函数关系,建立其一测多评法的多指标质量控制方法。结果小檗碱、表小檗碱、黄连碱、巴马汀重复性试验结果的RSD分别为0.87%,0.73%,0.88%,1.23%,小檗碱进样量在0.227 37～0.909 49μg范围内与峰面积呈良好线性关系(r2=0.999 9),小檗碱平均回收率为103.23%,RSD为1.10%(n=6)。结论黄连配方颗粒中4个生物碱的含量可以用一测多评法进行测定,可用于黄连配方颗粒的质量控制。

Objective To validate whether the assay method of Coptis chinensis in the Chinese Pharmacopoeia （edition 2010） is suitable to Coptis Chinensis Formula Granules and to establish a standard of the quantitative assay of multi- components by single marker （QAMS） for Coptis Chinensis Formula Granules. Methods The multi-index quality control method of QAMS was established by only determining the content of berberine and establishing its intrinsic function relation with other compositions palmatine, coptisine and epiberberine. Results RSD in the repeatability test results for berberine, epiberberine, coptisine and palmatine were 0.87% ,0. 73%, 0. 88% and 1.23% respectively. The assay of berberine showed the good linear relationship （r^2=0. 999 9） in the range of 0. 227 37- 0. 909 49μg and its average recovery rate was 103.23% , RSD was 1.10% （n = 6）. Conclusion The contents of four alkaloids in Coptis Chinensis Formula Granules can be determined by QAMS,whieh can be used to control the quality of Coptis Chinensis Formula Granules.