参仙升脉口服液HPLC指纹图谱研究及多指标成分定量分析  

Study on HPLC fingerprint and multi-index determination of Shenxian-Shengmai Oral Liquid

作　　者：宗时宇 张红[1] 李晔[1] 孙婷婷[1] 陈衍斌 刘峰 刘洋[1] ZONG Shiyu;ZHANG Hong;LI Ye;SUN Tingting;CHEN Yanbin;LIU Feng;LIU Yang(Shaanxi Academy of Traditional Chinese Medicine,Xi'an 710003,China;Shaanxi Buchang Pharmaceutical Co.,Ltd.,Xi'an 710075,China)

机构地区：[1]陕西省中医药研究院,陕西西安710003 [2]陕西步长制药有限公司,陕西西安710075

出　　处：《药物评价研究》2024年第2期353-359,共7页Drug Evaluation Research

基　　金：陕西省重点研发计划项目(2021ZDLSF04-06,2022ZDXM-SF-06);陕西省“秦药”研发重点实验室项目(2021-QYPT-001);秦创园中医药创新研发转化项目(2022-QCYZH-006);陕西省中医药管理局“秦药”开发重点科学研究项目(2021-02-ZZ-019);陕西中医药大学中医体质与疾病防治省级重点实验室开放课题(KF2210)。

摘　　要：目的 建立参仙升脉口服液的特征指纹图谱及多指标成分定量测定方法。方法 采用Ultimate LP-C_(18)(250 mm×4.6mm,5μm)色谱柱,以乙腈和0.2%磷酸水溶液为流动相梯度洗脱,检测波长为270nm(0~16min,24~38min)、210 nm(16~24 min,38~100min),体积流量为1.0mL·min^(-1),柱温为30°C,进样量为10μL。应用中药色谱指纹图谱相似度评价软件(2012版)对10批参仙升脉口服液进行分析,建立HPLC指纹图谱,并测定10个指标成分的含量。结果 建立的指纹图谱确定共有峰28个,指认了其中12个,10批样品间相似度均在0.934以上。定量分析的10个成分分别为丹参素、盐酸伪麻黄碱、补骨脂苷、异补骨脂苷、迷迭香酸、丹酚酸B、补骨脂素、异补骨脂素、朝藿定C和淫羊藿苷,质量浓度分别为1.218~2.781、 0.333~0.702、 2.391~4.120、 2.083~3.486、 0.151~0.203、 0.158~1.046、 0.189~0.286、0.196~0.305、0.231~0.403和0.323~0.512 mg·mL^(-1)。结论 所建立的指纹图谱与多指标成分定量方法准确可靠,可用于参仙升脉口服液较全面的质量控制。Objective To establish the characteristic fingerprint of Shenxian-Shengmai Oral Liquid and the quantitative method of multi-index components.Methods The Ultimate LP-C_(18)(250 mm × 4.6 mm,5 μm) column was used with acetonitrile and 0.2%phosphoric acid aqueous solution as mobile phase gradient elution.The flow rate was 1.0 mL·min^(-1).The column temperature was 30 °C,and the detection wavelength was 270 nm(0—16 min,24—38 min) and 210 nm(16—24 min,38—100 min).Ten batches of Shenxian-Shengmai Oral Liquid were analyzed by using traditional Chinese medicine chromatographic fingerprint similarity evaluation software(2012 edition),HPLC fingerprints were established,and the contents of 10 index components were determined.Results A total of 28 common peaks were calibrated,of which 12 common peaks were identified,and the similarity of the fingerprints between 10 batches of samples was above 0.934.The 10 components of quantitative analysis were danshensu,pseudoephedrine hydrochloride,psoralenoside,isopsoralenoside,rosmarinic acid,salvianolic acid B,psoralen,isopsoralen,epmedin C,icariin,respectively.The contents were 1.218—2.781 mg·mL^(-1),0.333—0.702 mg·mL^(-1),2.391—4.120 mg·mL^(-1),2.083 —3.486 mg·mL^(-1),0.151—0.203 mg·mL^(-1),0.158—1.046 mg·mL^(-1),0.189—0.286 mg·mL^(-1),0.196—0.305 mg·mL^(-1),0.231 —0.403 mg·mL-1 and 0.323—0.512 mg·mL-1,respectively.Conclusion The established fingerprint and multi-index component quantitative method are accurate and reliable,and can be used for comprehensive quality control of Shenxian-Shengmai Oral Liquid.

关 键 词：参仙升脉口服液 高效液相色谱法 指纹图谱 含量测定 质量控制 丹参素 盐酸伪麻黄碱 补骨脂苷 异补骨脂苷 迷迭香酸 丹酚酸B 补骨脂素 异补骨脂素 朝藿定C 淫羊藿苷 

分 类 号：R284.1[医药卫生—中药学]