妇科十味片质量标准研究  

Study on the Quality Specification of Fuke Shiwei Tablets

作　　者：荀艳 秦亚东[2] 吴剑[2] XUN Yan;QIN Ya-dong;WU Jian(The Second People＇s Hospital ofWuhu,Wuhu 241000,China;Anhui College of Traditional Chinese Medicine,Wuhu 241002,China)

机构地区：[1]安徽省芜湖市第二人民医院药剂科,安徽芜湖241000 [2]安徽中医药高等专科学校,安徽芜湖241002

出　　处：《现代中药研究与实践》2018年第3期45-48,共4页Research and Practice on Chinese Medicines

摘　　要：目的建立妇科十味片的质量控制方法,加强对该药的质量控制,维护用药安全。方法通过薄层色谱法鉴别方中当归、川芎、赤芍、白芍,采用超高效液相色谱法双波长同时测定妇科十味片中芍药苷、阿魏酸的含量。结果薄层色谱特征斑点清晰,分离度良好。芍药苷在0.150 4～1.805 4μg(r=0.999 9)、阿魏酸在0.082 5～0.990 0μg(r=0.999 4)的范围内有良好的线性关系,芍药苷的平均加样回收率为100.5%(RSD=1.1%,n=6),阿魏酸的平均加样回收率为103.6%(RSD=1.4%,n=6)。结论所建立的薄层鉴别和含量测定方法简便、准确、重复性好,分析时间短,对妇科十味片的质量可以有效监控,为临床用药的安全、有效起促进作用。Objective To establish a method for the quality control of compound Fuke Shiwei tablets. Methods Radix Angelicae Sinensis, Ligusticum chuanxiong and Paeonia lactiflora are identified by TLC. The contents of paeoniflorin and ferulic acid in Fuke Shiwei tablets are simultaneous determined by double wavelength UPLC. Results The linear range of peoniflorin and ferulic acid are 0.150 4～1.805 4 μg and 0.082 5～0.990 0 μg. The average recoveries are 100.5 % and 103.6 %, RSD〈1.5 %. Conclusion The developed TLC and UPLC methods are simple, accurate and reproductive. They can be used for the quality control of compound Fuke Shiwei tablets.

关 键 词：妇科十味片 芍药苷 阿魏酸 质量标准 

分 类 号：R284.1[医药卫生—中药学]