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作 者:邹燕 欧贝丽 施文禧 龚秋翼 ZOU Yan;OU Beili;SHI Wenxi;GONG Qiuyi(Laboratory of Chemical Drugs,Jiaxing Institute of Food,Drug and Product Inspection,Zhejiang Jiaxing 314000,China)
机构地区:[1]嘉兴市食品药品与产品质量检验检测研究院化学药品检验室,浙江嘉兴314000
出 处:《中国医药导刊》2024年第7期704-708,共5页Chinese Journal of Medicinal Guide
基 金:浙江省药品监管系统科技计划项目(2022012)。
摘 要:目的:建立肤痒颗粒的高效液相色谱(HPLC)指纹图谱。方法:选择C18色谱柱,流动相为甲醇-0.4%磷酸水溶液,梯度洗脱,总流速1.0 mL·min^(-1),检测波长327 nm,柱温35℃,进样量为10μL。采用“中药色谱指纹图谱相似度评价系统”(2.0版)对19批次的肤痒颗粒进行相似度分析。结果:HPLC指纹图谱共发现9个共有峰,其中4个为已知特征峰,分别为新绿原酸、绿原酸、隐绿原酸、阿魏酸。19批次肤痒颗粒与对照图谱相似度为0.767~0.995,相对保留时间范围为0.189~1.587,相对峰面积范围0.032~11.220。19批样品可聚为3类,特征图谱比较显示,14家公司中A公司的2批次、B公司的1批次样品相似度均低于0.9,E、G公司样品及L公司的一批次样品相似度大于0.98。结论:建立的该肤痒颗粒HPLC方法稳定性、重复性良好,可作为肤痒颗粒的质量评价指标,为肤痒颗粒质量控制提供参考。Objective:To establish the HPLC fingerprint of fuyang granule.Methods:A C18 column was used for separation,with a column temperature at 35℃,a flow rate of 1.0 mL·min^(-1).The detection wavelength was set at 327 nm.The mobile phase consisted of methanol-0.4%phosphoric acid solution by gradient elution.The injection volume was 10μL.The similarity evaluation of 19 batches of fuyang granule was carried out by using Similarity Evaluation System of TCM Chromatographic Fingerprint(2012 edition).Results:9 common peaks were found in HPLC fingerprints,4 of them were neochlorogenic acid,chlorogenic acid,cryptochlorogenic acid and feru⁃lic acid.Compared with the control fingerprint,the similarity of 19 batches of fuyang granule was 0.767-0.995,the relative retention time range was 0.189-1.587,and the relative peak area ratio was 0.032-11.220.The 19 batches of samples can be clustered into 3 cat⁃egories.By Comparing with the characteristic fingerprint,it shows the similarities of 2 batches of Company A and 1 batch of Company B were below 0.9,while the similarities of Company E,G,and L(one batch)were all higher than 0.98.Conclusion:The established HPLC method showed good stability and repeatability.It can be used as a quality evaluation method for fuyang granule,and provides a reference for the quality control.
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