金莲花口服液高效液相色谱指纹图谱建立及指标成分含量测定

Establishment of HPLC Fingerprint and Content Determination of Indicator Components of Jinlianhua Oral Liquid

目的 建立金莲花口服液的高效液相色谱(HPLC)指纹图谱和多成分定量方法。方法 以荭草苷峰为参照,建立18批金莲花口服液的HPLC指纹图谱,确定共有峰,采用中药色谱指纹图谱相似度评价系统(2012版)评价相似度。采用HPLC法,测定荭草素-2″-O-β-L-半乳糖苷、荭草苷、牡荆苷、槲皮素的含量。结果 18批样品有22个共有峰,相似度均不低于0.988;指认2号峰为荭草素-2″-O-β-L-半乳糖苷,4号峰为荭草苷,8号峰为牡荆苷,17号峰为槲皮素。18批样品中,荭草素-2’’-O-β-L-半乳糖苷、荭草苷、牡荆苷、槲皮素的含量分别为(2.54±0.22)mg/mL、(3.12±0.37)mg/mL、(0.79±0.06)mg/mL、(0.28±0.04)mg/mL。结论 所建立的HPLC指纹图谱和多成分定量方法快速简便,可用于金莲花口服液的质量控制。

Objective To establish a high-performance liquid chromatography(HPLC) fingerprint and multi-component quantitative method for Jinlianhua Oral Liquid.Methods orientin peak as a reference.The common peaks were identified and the similarity was evaluated by the Similarity Evaluation System of Chromatographic Fingerprint of Traditional Chinese Medicine(Version 2012).HPLC was used to determine the contents of 2″-O-β-L-galactopyanosylorientin,orientin,vitexin,and quercetin.Results A total of 22 common peaks were identified from the fingerprints of 18 batches of samples,with a similarity of no less than 0.988.It was identified that peak 2 was 2″-O-β-L-galactopyanosylorientin,peak 4 was orientin,peak 8 was vitexin,peak 17 was quercetin.Among 18 batches of samples,the contents of 2″-O-β-L-galactopyanosylorientin,orientin,vitexin,and quercetin were(2.54 ± 0.22) mg/mL,(3.12 ± 0.37)mg/mL,(0.79 ± 0.06)mg/mL,and(0.28 ± 0.04)mg/mL,respectively.Conclusion component quantitative method for Jinlianhua Oral Liquid were fast and simple,which can be used for the quality control of Jinlianhua Oral Liquid.