清心解瘀方标准汤剂多指标成分含量测定及UPLC指纹图谱研究

  目的  制备18批清心解瘀方标准汤剂，对其物质基准进行研究。   方法  以标准汤剂丹酚酸B、阿魏酸、总生物碱和黄芪甲苷的含量、转移率，出膏率、含油量、指纹图谱相似度等为评价指标，建立清心解瘀方标准汤剂相关表征参数允许范围。利用中药指纹图谱相似度评价系统软件(2012版)进行指纹图谱分析，采用聚类分析(CA)、主成分分析(PCA)和正交偏最小二乘法-判别分析(OPLS-DA)对指纹图谱共有峰进行评价。   结果  共确定了18个共有峰，共有峰相似度均大于0.90。18批样品聚为2类，结合相似度结果，分析可能与不同产地饮片配伍有关。根据OPLS-DA VIP值结合载荷图，共筛选出3个影响批间样品质量的色谱峰，依次为丹酚酸B(14号峰)、盐酸黄连碱(10号峰)和阿魏酸(7号峰)。为减小批间样品的质量差异，保证制剂质量的一致性，在后续制剂生产中应尽量选择同一道地产区药材。   结论  清心解瘀方标准汤剂制备方法稳定，多指标含量测定方法简便、快捷，指纹图谱方法稳定、相似度高，可为该方后续制剂质量控制提供参考。 

Study on Determination of Multi-Index Components and UPLC Fingerprint of Standard Decoction of Qingxin Jieyu Formula

  OBJECTIVE  To prepare 18 batches of standard decoction of Qingxin Jieyu Formula and study its substance benchmarks.   METHODS  The contents and transfer rates of salvianolic acid B, ferulic acid, total alkaloids, astragaloside Ⅳ, as well as extraction rate, oil content and fingerprint similarity of standard decoction were used as evaluation indexes to establish the allowable range of characterization parameters of standard decoction of Qingxin Jieyu Formula. The fingerprint similarity evaluation system software (2012 version) was used for fingerprint analysis, and cluster analysis (CA), principal component analysis (PCA) and orthogonal partial least squares discriminant analysis (OPLS-DA) were used to evaluate the fingerprint common peak.   RESULTS  A total of 18 common peaks were determined, with the common peak similarity greater than 0.90. It was found that 18 batches of samples were grouped into two groups, and combined with the results of similarity, this difference may be related to the slices compatibility of different producing areas. According to the OPLS-DA VIP value combined with the load diagram, three peaks affecting the quality of the batch samples were selected, which were salvianolic acid B (peak 14), copithine hydrochloride (peak 10) and ferulic acid (peak 7) in turn. In order to reduce the quality difference between batches of samples and ensure the consistency of preparation quality, the medicinal materials from the same production area should be selected as far as possible in the subsequent preparation production.   CONCLUSION  The preparation method of standard decoction of Qingxin Jieyu Formula is stable, the multi-index content determination method is simple and fast, the fingerprint method is stable and the similarity is high, which can provide reference for the quality control of the subsequent preparation of Qingxin Jieyu Formula.