复方黄芩片HPLC指纹图谱的研究及6种成分的测定  

Study on the fingerprint of Fufang Huangqin tablets by HPLC and determination of six components

作　　者：黄玉普 吴大章[1,3] 王森 冯建安 王玉 HUANG Yupu;WU Dazhang;WANG Sen;FENG Jianan;WANG Yu(Zunyi Medical University,Zunyi,Guizhou,563003 P.R.China;Sichuan Second Hospital of TCM,Chengdu,Sichuan,610031 P.R.China;Chongqing Tong Junge Pharmaceutical Co.,Ltd.,Taji Group,Chongqing,401366 P.R.China)

机构地区：[1]遵义医科大学,贵州遵义563003 [2]四川省第二中医医院,四川成都610031 [3]太极集团重庆桐君阁药厂有限公司,重庆401366

出　　处：《华西药学杂志》2022年第5期531-535,共5页West China Journal of Pharmaceutical Sciences

基　　金：中央引导地方科技发展专项(编号:2018TZYD0003)。

摘　　要：目的 建立复方黄芩片的HPLC指纹图谱及6种成分的含量测定方法。方法 采用Agilent Zorbax SB-C色谱柱(250 mm×4.6 mm, 5μm),流动相为甲醇(A)-0.1%磷酸溶液(B),梯度洗脱,流速1 mL·min,柱温25℃,检测波长280 nm。结果 16批样品标定出23个共有峰,指认出其中6个峰,相似度均大于0.976。聚类分析将16批样品分为2类,投料批次不同所得制剂的质量也存在差异。筛选出3个主成分,累计方差贡献率为85.12%,表明前3个主成分可代表样品的大部分信息内容。6种成分在各自范围内的线性关系良好(r>0.9995),加样回收率为99.53%~103.12%,RSD为2.19%~3.44%。结论 所用方法简便,重复性好、稳定性好、准确度高,可用于复方黄芩片的质量控制。OBJECTIVE To establish HPLC fingerprint of Fufang Huangqin tablets and content determination method of 6 components.METHODS Agilent Zorbax SB-Ccolumn(250 mm×4.6 mm, 5 μm) was used.The mobile phase composed of methanol(A)-0.1% phosphoric acid solution(B) in gradient elution manner with a flow rate of 1.0 mL·min,temperature of 25 ℃ and the detection wave length of 280 nm.RESULTS 16 batches of Fufang Huangqin tablets were calibrated with 23 common peaks, of which 6 common peaks were identified, and the similarity was greater than 0.976.In cluster analysis, 16 batches of Fufang Huangqin tablets were divided into 2 categories, and the results showed that there were differences in the quality of the preparations obtained from different feeding batches.Principal component analysis screened out 3 principal components.The cumulative contribution rate of the three components reached 85.12%.It showed that the first three principal components could reflect the most information of Fufang Huangqin tablets.The content determination results showed that the six components had good linear relationship in their respective ranges(r>0.9995),the sample addition recovery was 99.53%-103.12%,and the RSDs was 2.19%-3.44%.CONCLUSION The method is simple and reliable, with good repeatability, good stability and high accuracy, and can be used for the quality control of Fufang Huangqin tablets.

关 键 词：复方黄芩片 高效液相色谱 指纹图谱 含量测定 共有峰 聚类分析 主成分分析 黄芩苷 

分 类 号：R917[医药卫生—药物分析学]