目的 建立血府逐瘀胶囊(Xuefu Zhuyu Capsules,XZC)HPLC指纹图谱,利用指纹图谱与溶出度测试评价XZC质量一致性。方法 采用中药指纹图谱软件(2012A版)对10批XZC进行相似度分析。以没食子酸、芍药内酯苷、芍药苷、阿魏酸、柚皮苷和新橙皮苷作为质量标志物(quality markers,Q-Marker),使用《中国药典》2020年版通则0931第三法小杯法,考察在不同转速(50、75、100 r/min)与不同pH值介质(纯水、盐酸溶液、醋酸缓冲液、磷酸缓冲液)下各成分的溶出度。结果 10批XZC指纹图谱相似度均大于0.990,没食子酸、芍药内酯苷、芍药苷、阿魏酸、柚皮苷和新橙皮苷在50 r/min和纯水介质中溶出较好,且不同批次的XZC具有相似的溶出行为,6种指标成分最符合Weibull方程,证明溶出具有相似的释药特点。结论 建立的指纹图谱和溶出度方法稳定可行,可用于XZC的批次一致性评价。

Objective To establish HPLC fingerprints of Xuefu Zhuyu Capsules (血府逐瘀胶囊, XZC) and evaluate the capsules quality consistency by fingerprints and dissolution testing. Method The similarity analyses were conducted on 10 batches of XZC through traditional Chinese medicine fingerprints software (2012A). Gallic acid, albiflorin, paeoniflorin, ferulic acid, naringin, and neohesperidin were treated as quality markers (Q-Marker), the dissolution of each component was investigated using the small cup method of General Rule 0931 of the Chinese Pharmacopoeia (2020 edition) at different rotating speeds (50, 75, 100 r/min) and mediums (pure water, hydrochloric acid solution, acetate buffer, phosphate buffer) with different pH values. Results The fingerprints similarities of 10 batches of XZC were greater than 0.990. Gallic acid, albiflorin, paeoniflorin, ferulic acid, naringin, and neohesperidin were well dissolved in a medium of 50 r/min and pure water. Different batches of XZC had similar dissolution behavior, and the six components were most in line with the Weibull equation, proving that the dissolution had similar drug release characteristics. Conclusion The established fingerprints and dissolution method are stable and feasible, which can be used for the batch consistency evaluation of XZC.

现代中医药海河实验室-天津宏仁堂药业有限公司合作项目（XMH2022004）；现代中医药海河实验室科技计划项目（22HHZYSS00004）