目的 建立枳实薤白桂枝汤HPLC指纹图谱分析方法和复方中10种指标成分（辛弗林、槲皮素、桂皮酸、厚朴酚、柚皮苷、腺苷、香豆素、橙皮苷、和厚朴酚、新橙皮苷）含量测定方法，开展相关评价分析。方法 采用HPLC法建立枳实薤白桂枝汤指纹图谱，开展相似度评价研究；测定复方中10个指标成分，分析复方中药材不同配伍对其量的变化影响；采用聚类分析等化学计量学方法，对获取相关数据进行分析，评价枳实薤白桂枝汤的质量控制相关指标的影响和价值。结果 10批样品的相似度在0.376～0.990，部分批次相似度大于0.9（5批），说明10批样品相似度差异较大。10批样品中S1～S3、S5、S6、S8、S10为一组，S4、S9为一组，S7单独为一组。共标定了30个特征峰，经主成分分析，主成分1～6是影响药材样品质量评价的主要因子；30个特征峰中对样品分组起关键作用的成分为21（新橙皮苷）、26、29（和厚朴酚）、3、23、17、30（厚朴酚）、5、24（香豆素）、28和7。含量测定结果显示，除槲皮素外，其余9种成分在测定的质量浓度范围内线性关系、精密度、稳定性和重复性良好；不同配伍会对药材中相关成分产生增加或抑制溶出的作用。结论 所建立的HPLC方法可用于同时测定枳实薤白桂枝汤中10种化学成分的含量，该方法高效、准确、重复性好，可用于枳实薤白桂枝汤的质量控制和评价。

Objective To establish an HPLC fingerprint analysis method of Zhishi Xiebai Guizhi Decoction (ZXGD) and the content determination method of 10 index components of the decoction, and carry out the relevant evaluation and analysis. Methods HPLC method was used to establish the fingerprint analysis method of ZXGD and then similarity evaluation was carried out. Ten index components of the decoction were determined, the influence of the change of compatibility of medicinal materials on the content of index components was analyzed. Cluster analysis and other chemometrics methods were used to analyze the relevant data and evaluate the impact and value of quality control related indicators of ZXGD. Results The similarity of 10 batches of samples ranged from 0.376 to 0.990, and that of five batches was more than 0.9, which indicated that the similarity of 10 batches of samples was quite different. In 10 batches of samples, S1, S2, S3, S5, S6, S8 and S10 were in one group, S4 and S9 were in one group, S7 was in one group. In this study, 30 characteristic peaks were calibrated, and principal components 1—6 was the main factor affecting the quality evaluation of medicinal materials. Among the 30 characteristic peaks, peak 21 (neohesperidin), 26, 29 (honokiol), 3, 23, 17, 30 (magnolol), 5, 24 (coumarin), 28, and 7 were the key components. The results showed that except quercetin, the other nine components had good linear relationship, precision, stability and repeatability in the range of mass concentration. Different compatibilities could increase or inhibit the dissolution of related components in medicinal materials. Conclusion The HPLC method can be used for the simultaneous determination of ten chemical components in ZXGD. The method is efficient, accurate and reproducible, and can be used for the quality control and evaluation of ZXGD.

R286.02

江苏省高等学校自然科学研究项目资助（18KJB360014）；泰州市科技支撑计划（社会发展）项目资助（TS201721）；泰州职业技术学院科研项目资助（TZYKY-17-25）；泰州职业技术学院博硕基金项目资助（TZYBS-17-7）；江苏省大学生创新计划项目资助（201812106001Y）；江苏省大学生创新计划项目资助（201812106002Y）；江苏省大学生创新计划项目资助（201812106003Y）；泰州职业技术学院创新型科研团队资助项目资助（TZYTD-16-1）