复方辛夷滴鼻液的指纹图谱及7种成分含量测定研究  

Study on fingerprint and content determination of seven components in Compound Xinyi Nasal Drops

作　　者：顾从文 卜超 王学芹 黄保生 韩燕全[1] 洪燕[2] 吴德玲[2] GU Congwen;BU Chao;WANG Xueqin;HUANG Baosheng;HAN Yanquan;HONG Yan;WU Deling(The First Affiliated Hospital of Anhui University of Chinese Medicine,Grade Three-level Laboratory of Traditional Chinese Medicine Preparation/Anhui Province Key Laboratory of Chinese Medicinal Formula/Anhui Engineering Technology Research Center of Modernized Pharmaceutics,Hefei,Anhui 230601,China;Anhui University of Chinese Medicine,Hefei,Anhui 230031,China)

机构地区：[1]安徽中医药大学第一附属医院国家中医药管理局中药制剂三级实验室/中药复方安徽省重点实验室/现代药物制剂安徽省工程技术中心,安徽合肥230601 [2]安徽中医药大学,安徽合肥230031

出　　处：《湖南中医药大学学报》2022年第6期934-940,共7页Journal of Hunan University of Chinese Medicine

基　　金：药物制剂技术与应用安徽省重点实验室开放基金(2021KFKT09);安徽省自然科学基金(2108085MH313)。

摘　　要：目的建立复方辛夷滴鼻液UPLC指纹图谱及7种成分含量测定方法,为其质量评价提供依据。方法采用Waters Acquity UPLC BEH C18色谱柱(2.1 mm×50 mm,1.7μm),乙腈-0.1%磷酸水为流动相,梯度洗脱,流速0.2 mL/min,进样量1μL,检测波长230 nm,柱温30℃;在此条件下建立复方辛夷滴鼻液指纹图谱,同时,测定其木兰花碱、芍药苷、黄芩苷、汉黄芩苷、黄芩素、木兰脂素和短叶老鹳草素A的含量。结果建立了10批复方辛夷滴鼻液的UPLC指纹图谱,确定了16个共有峰,指认了其中7个成分,相似度均大于0.994;聚类分析可将10批样品分为3类;正交偏最小二乘判别分析筛选出对样品分类贡献较大的8个色谱峰;含量测定结果显示,7种成分的平均含量为0.0343~2.0598 mg/mL,RSD值为7.18%~23.52%。结论不同批次复方辛夷滴鼻液整体质量较稳定,但批次间部分成分含量存在一定差异;实验建立的指纹图谱及多成分含量测定方法稳定可行,可为复方辛夷滴鼻液的质量评价提供依据。Objective To establish the UPLC fingerprint and determination method of seven components in Compound Xinyi Nasal Drops,and to provide basis for its quality evaluation.Methods Waters Acquity BEH C18column(2.1 mm×50 mm,1.7μm)was used with acetonitrile-0.1%phosphoric acid water as mobile phase by gradient elution at a flow rate of 0.2 mL/min.The injection volume was 1μL;the detection wavelength was 230 nm;the column temperature was 30℃.Under these conditions,the fingerprint of Compound Xinyi Nasal Drops was established,and the content levels of magnolflorine,paeoniflorin,baicalin,wogonoside,baicalein,magnolin and brevilin A in the samples were determined.Results The UPLC fingerprints of ten batches of Compound Xinyi Nasal Drops were established;sixteen common peaks were identified;seven components were identified,and the similarity of ten batches of samples was greater than 0.994.Hierarchical cluster analysis can divide ten batches of samples into three categories.Eight chromatographic peaks screened by orthogonal partial least squares discrimination analysis and contributed significantly to sample classification.The content determination results showed that the average content of the seven components was 0.0343-2.0598 mg/mL,with RSD values ranging from 7.18%to 23.52%.Conclusion The overall quality of different batches of Compound Xinyi Nasal Drops is stable,but there are some differences in the content levels of some components between batches.The fingerprint and multi-component determination methods established in the experiment are stable and feasible,which can provide a basis for the quality evaluation of Compound Xinyi Nasal Drops.

关 键 词：复方辛夷滴鼻液 UPLC 指纹图谱 含量测定 质量控制 

分 类 号：R284.1[医药卫生—中药学]