复方板蓝根颗粒物质基础研究及其整体质量评价  

Substance basis and overall quality evaluation of Compound Banlangen Granules

作　　者：胡青 程益清 曹帅 孙健 季申 HU Qing;CHENG Yi-qing;CAO Shuai;SUN Jian;JI Shen(China State Institute of Pharmaceutical Industry,Shanghai 201203,China;National Medical Products Administration Key Laboratory for Quality Control of Traditional Chinese Medicine,Shanghai Municipal Institute for Food and Drug Control,Shanghai 201203,China)

机构地区：[1]中国医药工业研究总院,上海201203 [2]上海市食品药品检验研究院,国家药品监督管理局中药质量控制重点实验室,上海201203

出　　处：《中成药》2023年第10期3194-3199,共6页Chinese Traditional Patent Medicine

基　　金：上海市科委研发平台专项(18DZ2292200);上海市科委技术标准专项(18DZ2200900)。

摘　　要：目的 研究复方板蓝根颗粒物质基础,并对其进行整体质量评价。方法 该药物甲醇提取液的UPLC-Q-TOF-MS分析采用Waters HSS T3色谱柱(2.1 mm×100 mm, 1.8μm);流动相乙腈-0.1%甲酸,梯度洗脱;体积流量0.5 mL/min;柱温40℃;电喷雾离子源;负离子扫描。根据精确分子质量、质谱裂解规律结合相关对照品、文献,对所得成分进行鉴定和归属。聚类分析、偏最小二乘法-判别分析评价3家生产企业33批样品质量,HPLC法测定尿苷、腺苷、鸟苷、(R,S)-告依春含量。结果 共鉴定出37种成分,包括8种生物碱、7种苯丙素、3种核苷、2种氨基酸、6种有机酸、4种黄酮、1种含硫成分、6种其他成分。各批样品聚为3类,同一生产企业样品质量一致性较好,不同生产企业样品质量差异明显。尿苷、鸟苷、腺苷、柠檬酸、酪氨酸是主要质量差异标志物。结论 该方法稳定可靠,可为复方板蓝根颗粒质量标准提高提供科学依据、数据支撑。AIM To study the substance basis of Compound Banlangen Granules and to make overall quality evaluation.METHODS The UPLC-Q-TOF-MS analysis of methanol extract of this drug was performed on a 40℃thermostatic Waters HSS T3 column(2.1 mm×100 mm,1.8μm),with the mobile phase comprising of acetonitrile-0.1%phosphoric acid flowing at 0.5 mL/min in a gradient elution manner,and electron spray ionization source was adopted in negative ion scanning.According to accurate molecular weights and mass spectrometry fragmentation laws combined with related reference substances and literatures,the obtained components were identified and assigned.Cluster analysis and partial least square discriminant analysis were adopted in the quality evaluation of thirty-three batches of samples from three production enterprises,and HPLC was used for the content determination of uridine,adenosine,guanosine,(R,S)-goitrin.RESULTS Total thrity-seven constituents were identified,including eight alkaloids,seven phenylpropanoids,three nucleosides,two amino acids,six organic acids,four flavonoids,one sulfur-containing component and six other components.Various batches of samples were clustered into three categories,the quality consistency of samples from same production enterprises was good,while the quality difference of samples from different production enterprises was obvious.Uridine,guanosine,adenosine,citric acid and tyrosine were main quality difference markers.CONCLUSION This stable and reliable method can provide scientific basis and data support for the enhancement of quality stardard for Compound Banlangen Granules.

关 键 词：复方板蓝根颗粒 物质基础 整体质量评价 UPLC-Q-TOF-MS 聚类分析 偏最小二乘法-判别分析 

分 类 号：R284.1[医药卫生—中药学]