炎可宁片中黄柏浸膏的质量标准研究  

Study on Quality Standard of Cortex Phellodendri Extract in Yankening Tablets

作　　者：迟江 杜成兴 潘年琼 李松 杨迺嘉[1] CHI Jiang;DU Chengxing;PAN Nianqiong;Ll Song;YANG Naijia(Guizhou Biotechnology Research and Development Base Co.,Ltd.,Guiyang Guizhou 550002;Guizhou Kehui Pharmaceutical Co.,Ltd.,Qingzhen Guizhou 551400)

机构地区：[1]贵州省生物技术研究开发基地有限公司,贵州贵阳550002 [2]贵州省科晖制药有限公司,贵州清镇551400

出　　处：《中国科技纵横》2022年第8期124-126,共3页China Science & Technology Overview

基　　金：贵州省科技成果转化引导基金计划项目:炎可宁片的GMP产业化(黔科合成转字[2015]5013号)。

摘　　要：为建立炎可宁片中黄柏浸膏的质量标准,采用高效液相色谱法测定黄柏浸膏中盐酸小糜碱的含量,色谱条件:依利特C_(18)柱(250mm×4.6mm,5μm),以乙睛:0.05ml/L磷酸二氢钾:三乙胺(35:65:0.1)为流动相,流速为1.0ml·min^(-1),检测波长为265nm,温度为30℃。采用薄层色谱法鉴别黄柏浸膏中盐酸小麋碱。结果显示:薄层色谱中,盐酸小漿碱与样品中其他组分分离效果较好。盐酸小糜碱在6.28μg/ml-401.92μg/ml范围内具有良好线性关系,回归方程为Y=46558X+29207,相关系数r=0.9999。平均回收率为99.65%,RSD为1.51%(n=9)。得出结论:采用此法测定炎可宁片黄柏浸膏中盐酸小菓碱的含量,准确可靠,可用于该制剂浸膏的质量控制。To establish the quality standard of phellodendri phellodendri extract in Yankening tablets.The content of berberine hydrochloride in cortex phellodendri extract was determined by HPLC.The chromatographic conditions were as follows:Ilite C_(18) column(250mm× 4.6mm,5|im),acetonitrile:0.05ml/L potassium dihydrogen phosphate:Triethylamine(35:65:0.1)was the mobile phase,the flow rate was 1.0ml·min^(-1),the detection wavelength was 265nm,and the temperature was 30℃.TLC was used to identify berberine hydrochloride in phellodendri chinensis extract.The results show that the separation effect of berberine hydrochloride from other components was good in TLC.Berberine hydrochloride had a good linear relationship in the range of 6.28-401.92 μg/ml,the regression equation was Y=46558X+29207,the correlation coefficient was 0.9999.The average recovery was 99.65%with RSD of 1.51%(n=9).We can get onclusion:The method was accurate and reliable for the determination of berberine hydrochloride in the extract of cortex phellodendri yankening tablets,which could be used for the quality control of the extract.

关 键 词：炎可宁片 黄柏浸膏 盐酸小糜碱 高效液相色谱 薄层色谱 

分 类 号：R927.2[医药卫生—药学]