| 摘要: |
| 摘要：目的 建立常通舒颗粒的HPLC指纹图谱及多指标成分含量测定方法。方法 采用HPLC方法建立常通舒颗粒指纹图谱，通过中药指纹图谱相似度评价系统软件对3家企业22批样品进行相似度评价；采用Agilent ZORBAX SB-C18色谱柱(5 μm，250 mm×4.6 mm)，柱温35 ℃，流速1 mL·min-1，乙腈-0.2%磷酸水梯度洗脱，测定常通舒颗粒中没食子酸、原儿茶酸、芍药苷、二苯乙烯苷、苯甲酸、大黄素的含量；以聚类分析和正交-偏最小二乘法判别分析对样品质量进行评价。结果 标示了12个共有峰，指认了7个成分，与对照图谱相比，3个企业22批样品中，只有3批样品相似度在0.96以上，1批样品相似度＞0.87，其余样品相似度在0.627~0.859之间；CA分析将A企业聚为一类，B企业聚为一类，C企业聚为另一类；OPLS-DA筛选出没食子酸、原儿茶酸、芍药苷、二苯乙烯苷、苯甲酸、大黄素6个差异性成分。结论 本实验建立的方法准确，简单，重复性好，可用于常通舒颗粒的质量控制与评价。 |
| 关键词: 常通舒颗粒 高效液相色谱法 指纹图谱 多指标成分含量测定 |
| DOI： |
| 分类号:R284.1 |
| 基金项目:江西省药品监督管理局科研项目(2020JS03) |
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| Study on Fingerprint and Multiple Index Components Determination of Changtongshu Granules |
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Lang Shuqin, Fu Huizheng
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Jiangxi University of Traditional Chinese Midicine
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| Abstract: |
| ABSTRACT: OBJECTIVE To establish the fingerprint of Changtongshu granules, and determine the contents of multi-index component. METHODS HPLC was used to create the fingerprint of Changtongshu granules, and to evaluate the similarity of 22 batches of samples from 3 companies by the similarity evaluation system software for traditional Chinese medicine fingerprint. With Agilent ZORBAX SB-C18 chromatographic column(5 μm, 250 mm×4.6 mm), acetonitrile-0.2%phosphoric acid as mobile phase of gradient elution, column temperature of 35 °C, flow rate of 1 mL·min-1. To determine the contents of gallic acid, protocatechin acid, paeoniflorin, 2,3,5,4’-tetrahydroxy stilbene-2-O-β-D-glucoside, benzoic acid and emodin. The quality of sample was evaluated using cluster analysis and orthogonal partial least squares method-discriminant analysis. RESULTS A total of 12 common peaks were identified, and 7 components were identified. Comparing the 22 batches of samples from 3 different companies with the reference fingerprint, only 3 batches of samples had a similarity above 0.96, 1 sample greater than 0.87, while the similarity of the remaining samples ranged from 0.627 to 0.859. Though cluster analysis, the sample from manufacturer A were clustered into group Ⅰ, the sample from manufacturer B were clustered into group Ⅱ, and the sample from manufacturer C was clustered into group Ⅲ. Based on orthogonal partial least squares method-discriminant analysis identified, 6 components with large differences, such as gallic acid, protocatechin acid, paeoniflorin, 2,3,5,4’-tetrahydroxy stilbene-2-O-β-D-glucoside, benzoic acid, and emodin, were screened out. CONCLUSION The established method is accurate, simple and good repeatability, and it can be used for Chuantongshu granules quality control and evaluation. |
| Key words: Changtongshu granules high performance liquid chromatography fingerprint determination of multiple index components |
