妇科九味洗剂高效液相色谱法特征指纹图谱及成分定量研究

The characteristic fingerprint of Fuke Jiuwei lotion and quantitative analysis of its components by HPLC

目的建立妇科九味洗剂的高效液相色谱法(HPLC)特征指纹图谱及多指标成分测定方法。方法该研究于2020年5—8月在芜湖市中医医院制剂室实验室中进行。采用HPLC法,色谱柱Agilent Zorbax SB-C_(18)(4.6 mm×150 mm,5µm),流动相甲醇-0.4%甲酸不同比例梯度洗脱,波长334 nm,柱温30℃;13批妇科九味洗剂样品的特征图谱运用“中药色谱指纹图谱相似度评价系统”(2012版)评价其相似度;同时测定咖啡酸、木犀草苷和蒙花苷的含量。结果13批样品共标定16个共有峰,相似度均在0.91以上;通过对照品比对,识别出咖啡酸、木犀草苷和蒙花苷成分。3个成分分别在5.82~58.20 ng(r=0.9995)、9.44~94.40 ng(r=0.9995)、20.08~200.80 ng(r=0.9996)范围内呈现良好的线性关系。结论所建立的方法简单,准确可靠,可用于妇科九味洗剂的质量控制。

Objective To establish an HPLC characteristic fingerprint and multi-components determination of Fuke Jiuwei lotion.Methods The study was conducted in the Preparation Room of Wuhu Hospital of Traditional Chinese Medicine from May 2020 to Au‐gust 2020.An HPLC method was adopted.The separation was performed on an Agilent ZORBAX SB-C_(18)(4.6 mm×150 mm,5µm)with methanol-0.4%formic acid as the mobile phase with gradient elution.The detection wavelength was 334 nm,and the temperature was 30℃.The characteristic fingerprints of 13 batches of Fuke Jiuwei lotion were determined,and the similarity was evaluated by the"Sim‐ilarity Evaluation System of TCM Chromatographic Fingerprint"(2012 edition).Meanwhile,caffeic acid,luteolin and linarin were deter‐mined.Results Totally 16 common peaks were defined of the 13 batches of Fuke Jiuwei lotion,and the similarity of each batch was above 0.91.The components of caffeic acid,luteolin and linarin were identified by comparison with reference substances.These three constituents showed good linearity at 5.82~58.2 ng(r=0.9995),9.44~94.4 ng(r=0.9995)and 20.08~200.8 ng(r=0.9996).Conclu⁃sion The method was simple,accurate and reliable,which can be used for the quality control of Fuke Jiuwei lotion.