千里光配方颗粒特征图谱及含量测定方法研究  

Research on characteristic fingerprint and content determination methods of Senecionis Scandentis Herba Formula Granules

作　　者：王金圆 王煜 王子樱 唐莹莹 张紫佳[1,2] 杨莉 熊爱珍[1,2] 王峥涛 WANG Jinyuan;WANG Yu;WANG Ziying;TANG Yingying;ZHANG Zija;YANG Li;XIONG Aizhen;WANG Zhengtao(The MOE Key Laboratory for Standardization of Chinese Medicines and the SATCM Key Laboratory for New Resources and Quality Evaluation of Chinese Medicines,Institute of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Shanghai R&D Center for Standardization of Traditional Chinese Medicines,Shanghai,201203,China)

机构地区：[1]上海中医药大学中药研究所中药标准化教育部重点实验室暨国家中医药管理局中药新资源与质量评价重点实验室,上海201203 [2]上海中药标准化研究中心,上海201203

出　　处：《上海中医药大学学报》2023年第1期45-53,共9页Academic Journal of Shanghai University of Traditional Chinese Medicine

基　　金：上海市人才发展资金资助项目(2020099);上海中医药大学“杏林学者”项目(B1-GY21-409-04-06)。

摘　　要：目的:建立千里光配方颗粒的特征图谱及含量测定方法,为其质量评价提供参考。方法:采用CAPCELL PAK C18AQ色谱柱(4.6 mm×250 mm, 5.0μm),以乙腈-0.2%磷酸溶液为流动相进行梯度洗脱,流速为1 mL/min,柱温为30℃,检测波长为360 nm,建立千里光配方颗粒特征图谱。采用CAPCELL PAK C18MGⅡ(4.6 mm×250 mm,5.0μm)色谱柱,以乙腈-0.2%乙酸溶液(16∶84)为流动相进行等度洗脱,流速为1 mL/min,柱温为30℃,进样量为5μL,检测波长为360 nm,测定千里光配方颗粒中活性成分金丝桃苷的含量。结果:建立了千里光配方颗粒的高效液相色谱(HPLC)特征图谱以及含量测定方法。从特征图谱中指认了6个特征峰(新绿原酸、绿原酸、隐绿原酸、芦丁、金丝桃苷、异槲皮苷),10批样品的HPLC特征图谱的相似度在0.997~1.000之间,各样品与对照特征图谱间的相似度在0.998~1.000之间。以金丝桃苷作为指标成分建立千里光配方颗粒含量测定方法,10批千里光配方颗粒中金丝桃苷含量在0.484~0.549 mg/g之间,平均含量为0.514 mg/g。结论:建立的特征图谱以及含量测定方法简便、准确,重复性好,能有效评价千里光配方颗粒的质量,为保障千里光配方颗粒临床应用的有效性提供参考。Objective: To establish the characteristic fingerprint and content determination methods of Senecionis Scandentis Herba Formula Granules(SSHFG), thus to provide reference for its quality evaluation. Methods: The characteristic fingerprint of SSHFG was developed by using a CAPCELL PAK C18AQ column(4.6 mm × 250 mm, 5.0 μm) with gradient elution of acetonitrile-0.2 % phosphoric acid aqueous solution at a flow rate of 1 mL/min;the column temperature was 30 ℃;the detection wavelength was 360 nm. The content of hyperoside, an active ingredient in SSHFG, was determined by a CAPCELL PAK C18MGⅡ(4.6 mm × 250 mm, 5.0 μm) column with isocratic elution of acetonitrile-0.2% acetic acid aqueous solution(16∶84) at a flow rate of 1 mL/min;the column temperature was 30 ℃;the injection volume was 5 μL;the detection wavelength was 360 nm. Results: The characteristic fingerprint and content determination methods of SSHFG were developed based on high-performance liquid chromatography(HPLC). Six characteristic peaks, including neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, rutin, hyperoside and isoquercitrin, were identified in the characteristic fingerprint chromatogram of SSHFG. The similarity of HPLC characteris fingerprints among 10 batches of SSHFG samples was between 0.997 and 1.000, while the similarity between each batch and the control chromatogram was between 0.998 and 1.000. The content determination method of SSHFG was established using hyperoside as index ingredient. The content of hyperoside in 10 batches ranged from 0.484 mg/g to 0.549 mg/g, with an average content of 0.514 mg/g. Conclusion: The characteristic fingerprint and content determination methods established in present study are simple, accurate and reproducible, which can effectively evaluate the quality of SSHFG, and provide a reference to ensure the effectiveness of SSHFG in the clinical application.

关 键 词：千里光配方颗粒 特征图谱 含量测定 金丝桃苷 质量标准 

分 类 号：R286.0[医药卫生—中药学]