摘要
建立麻黄-杏仁药对配方颗粒的HPLC指纹图谱及指标性成分含量测定方法。采用Zorbax SB-C18(4.6 mm×150.0 mm,5μm)色谱柱,以乙腈-0.02 mol/L磷酸二氢钾(0.1%磷酸+0.1%三乙胺)溶液为流动相,梯度洗脱,流速为1 mL/min,检测波长为210 nm,柱温为25℃。采用“中药色谱指纹图谱相似度评价系统(2012版)”建立10批样品的HPLC指纹图谱,并进行相似度评价及4个指标性成分的含量测定。结果显示,建立的指纹图谱及多指标成分含量测定方法符合方法学考察要求。指纹图谱共标定了9个色谱峰,指认了其中4种成分;10批麻黄-杏仁药对配方颗粒与对照图谱的相似度均大于0.900,其中盐酸麻黄碱、盐酸伪麻黄碱、盐酸甲基麻黄碱和苦杏仁苷4种成分的平均含量分别为56.09μg/g、44.28μg/g、51.69μg/g及5.96μg/g。本研究建立的HPLC指纹图谱及4种成分同时测定的方法稳定可靠、重现性好,可用于麻黄-杏仁药对配方颗粒的质量控制。
To establishment a HPLC fingerprint and content determination method for multiple index components of herb pair formula granules of Herba Ephedrae and Semen Armeniacae Amarum.Agilent Zorbax SB-C18 column(4.6 mm×150.0 mm,5μm)was used with gradient elution of acetonitrile-0.02 mol/L potassium dihydrogen phosphate(0.1%phosphoric acid solution and 0.1%triethylamine)at a flow rate of 1.0 mL/min.The detection wavelength was 210 nm and the column temperature was 25℃.The HPLC fingerprint of 10 batches of samples were established and evaluated by using the software of“TCM chromatographic fingerprint similarity evaluation system(2012 Edition)”,and similarity evaluation and content determination of four index components were conducted.The results showed that fingerprint and multi-index component content determination method met the requirements of methodology investigation.A total of 9 chromatographic peaks were identified and 4 components were specified.The similarity of 10 batches of the formula granules and the control fingerprint was greater than 0.900,and the average content of ephedrine hydrochloride,pseudoephedrine hydrochloride,methylephedrine hydrochloride and bitter amygdalin was 56.09μg/g,44.28μg/g,51.69μg/g and 5.96μg/g,respectively.The method is efficient,accurate and reproducible,and can be used for the quality control and evaluation of herb pair formula granules of Herba Ephedrae and Semen Armeniacae Amarum.
作者
公硕
郭愿生
葛朝晖
GONG Shuo;GUO Yuansheng;GE Zhaohui(Medical College of Linyi University,Linyi Shandong 276000,China)
出处
《中兽医医药杂志》
CAS
2023年第5期63-67,共5页
Journal of Traditional Chinese Veterinary Medicine
基金
大学生创新创业训练计划项目(X202010452063)。
关键词
麻黄-杏仁药对
中药配方颗粒
指纹图谱
含量测定
herb pair of Herba Ephedrae and Semen Armeniacae Amarum
TCM formula granules
fingerprint
content determination
