王昭懿 陈扬 邹秦文 顾念念 赵霞 孟雪丹 冯丹 梁瑞强 林瑞超 高达欣

摘要 目的：针对复方马红散中具有抗炎、收湿止痒功效的两味中药红花和炉甘石，分别建立快速、高效、准确的高效液相色谱法及紫外-可见光分光光度法以测定其中羟基红花黄色素A和ZnO的含量，为复方马红散的质量控制提供保障、为其质量标准的建立提供参考。方法：羟基红花黄色素A的含量测定采用Waters XSelect HSS T3色谱柱（250 mm×4.6 mm，5 μm），柱温设置为30 ℃，以乙腈-0.1%磷酸溶液（23∶77）为流动相等度洗脱，流速1.0 mL/min，进样量为20 μL，在403 nm波长下检测。以锌试剂为显色剂，采用改良的紫外-可见光分光光度法在620 nm下测定ZnO的含量。结果：15批复方马红散样品中羟基红花黄色素A的含量范围为8.61～15.31 mg/g。15批复方马红散样品中ZnO的含量范围为82.67～149.40 mg/g。结论：本文基于2020版《中华人民共和国药典》和相关文献，对羟基红花黄色素A、ZnO的含量测定方法进行了一定的优化，经方法学考察，所建立的含量测定方法能快速、准确地测定复方马红散中羟基红花黄色素A、ZnO的含量，对其质量控制及质量标准的制定有一定的参考意义。

关键词 羟基红花黄色素A;ZnO;高效液相色谱法;紫外-可见光分光光度法;含量测定;复方马红散

Abstract Objective：To establish fast，efficient and accurate high performance liquid chromatography（HPLC）methods and UV-Vis spectrophotometry methods to determine the content of hydroxysafflor yellow A and ZnO of Carthamus tinctorius L.and to provide guarantee for the quality control and reference for the establishment of quality standards of Fufang Mahong Powder，and Calamine in Fufang Mahong Powder，which have anti-inflammatory，removing dampness and antipruritic effects.Methods：A Waters XSelect HSS T3 column（250 mm × 4.6 mm，5 μm）was used for the determination of hydroxysafflor yellow A.The column temperature was 30 ℃.Acetonitrile-0.1% phosphoric acid solution（23∶77）was used as the mobile phase，and the flow rate was 1 mL/min.The injection volume was 20 μL.The detection wavelength was 403 nm.The zinc reagent was used as the chromogenic reagent，and a modified UV-Vis spectrophotometry was used to determine the content of ZnO at 620 nm.Results：The content of hydroxysafflor yellow A was 8.61-15.31 mg/g in 15 batches of Fufang Mahong Powder.The content of ZnO was 82.67-149.40 mg/g in 15 batches of Fufang Mahong Powder.Conclusion：The determination methods of hydroxysafflor yellow A and ZnO have been optimized based on the Chinese Pharmacopoeia（2020 edition）and related literature.Their Hydroxysafflor yellow A; ZnO content of Fufang Mahong Powder can be quickly and accurately determined by the established methods with confirmed methodology.This study has a certain reference significance for the quality control and the establishment of quality standards of Fufang Mahong Powder.

Keywords Hydroxysafflor yellow A; ZnO; High performance liquid chromatography; UV-Vis spectrophotometry; Content determination; Fufang Mahong Powder

中图分类号：R284.1文献标识码：Adoi：10.3969/j.issn.1673-7202.2020.13.010

复方马红散是北京泰康园医学研究院研究并开发的院内制剂，其对于类风湿性关节炎具有较好疗效[1]。其药味组成之一的红花是菊科植物Carthamus tinctorius L.的干燥花[2]，具有通经活络、活血化瘀等功效，红花中所含的羟基红花黄色素A是其活血化瘀的主要有效成分[3]，其可以通过激活BK Ca通道并抑制L型Ca通道来诱导血管舒张[4]，并能制JAK2/STAT1通路从而对心肌缺血再灌注损伤、缺血性脑灌注等产生治疗效果[5-6]。……