基于指纹图谱与化学计量学的藿香正气软胶囊质量控制方法研究  

Quality Control Method of Huoxiang Zhengqi Soft Capsules Based on Fingerprint and Chemometrics

作　　者：马宿杉 苏建 李舒琪 苏紫藤 王常顺 刘永利 MA Su-shan;SU Jian;LI Shu-qi;SU Zi-teng;WANG Chang-shun;LIU Yong-li(Hebei University of Science and Technology,Shijiazhuang 050000,China;Hebei Institute for Drug and Medical Device Control/Hebei Provincial Key Laboratory of Quality Evaluation and Standard Research of Chinese Medicine,Shijiazhuang 050000,China;Hebei University of Chinese Medicine,Shijiazhuang 050000,China)

机构地区：[1]河北科技大学,河北石家庄050000 [2]河北省药品医疗器械检验研究院/河北省中药质量评价与标准研究重点实验室,河北石家庄050000 [3]河北中医学院,河北石家庄050000

出　　处：《中国现代中药》2024年第2期378-386,共9页Modern Chinese Medicine

基　　金：河北省重点研发计划项目(21372502D)。

摘　　要：目的:建立藿香正气软胶囊的高效液相色谱法(HPLC)指纹图谱及多指标成分测定方法,结合化学计量学方法评价藿香正气软胶囊的质量。方法:采用HPLC,SHIMADZU VP-ODSC18色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.1%磷酸水溶液为流动相,梯度洗脱,流速为1.0 mL·min^(–1),梯度波长为254、283 nm,柱温为30℃,进样量为10μL,建立指纹图谱及多指标成分测定方法,结合化学计量学方法对不同批次藿香正气软胶囊质量进行分析和评价。结果:建立了藿香正气软胶囊的HPLC指纹图谱,共标定了22个共有峰,15批藿香正气软胶囊指纹图谱的相似度均在0.8以上;对甘草苷、柚皮芸香苷、橙皮苷、水合氧化前胡素、白当归脑、欧前胡素、和厚朴酚、珊瑚菜素、异欧前胡素、厚朴酚10个成分进行了含量测定;化学计量学分析表明,不同企业生产的藿香正气软胶囊质量存在一定差异,区分各样品的质量差异标志物为水合氧化前胡素、和厚朴酚、异欧前胡素、珊瑚菜素、厚朴酚和甘草苷。结论:建立的HPLC指纹图谱及多指标成分测定方法准确、简便,结合化学计量学方法可用于评价藿香正气软胶囊的质量。Objective:To establish a high performance liquid chromatography(HPLC)fingerprint and multi-index component determination method for Huoxiang Zhengqi Soft Capsules,and to evaluate the quality of the prescription by chemometrics.Methods:HPLC was performed using a SHIMADZU VP-ODS C18 column(250 mm×4.6 mm,5μm)with acetonitrile-0.1%phosphoric acid aqueous solution as mobile phase in gradient elution.The flow rate was 1.0 mL·min–1,and the gradient wavelength was 254 nm and 283 nm.The column temperature was 30°C and the injection volume was 10μL.Then the fingerprint and multi-index component determination method were established for analyzing and evaluating the quality of different batches of Huoxiang Zhengqi Soft Capsules in combination with chemometrics.Results:The HPLC fingerprint of Huoxiang Zhengqi Soft Capsules was established,and 22 common peaks were calibrated.The similarity of the fingerprints of 15 batches of samples was above 0.8.Liquiritin,narirutin,hesperidin,oxypeucedanin hydrate,byakangelicol,imperatorin,honokiol,phellopterin,isoimperatorin and magnolol were determined.Chemometrics showed that there were some differences in the quality of Huoxiang Zhengqi Soft Capsules produced by different enterprises,and the quality markers were oxypeucedanin hydrate,honokiol,isoimperatorin,phellopterin,magnolol and liquiritin.Conclusion:The established HPLC fingerprint and multi-index component determination method were accurate and simple,and could be used to evaluate the quality of Huoxiang Zhengqi Soft Capsules in combination with chemometrics.

关 键 词：藿香正气软胶囊 指纹图谱 化学计量学 聚类分析 主成分分析 正交偏最小二乘法-判别分析 质量评价 

分 类 号：R286[医药卫生—中药学]