复方木香丸质量标准的提高  

Improvement of quality standard for Compound Muxiang Pills

作　　者：赵军[1] 徐媛[1] 王庆伟[1] 刘梅[1] ZHAO Jun XU Yuan WANG Qingwei LIU Mei(Department of Pharmacy, Tangdu Hospital, the Fourth Military Medical University, Shaanxi Province, Xi＇an 710038, China)

机构地区：[1]第四军医大学唐都医院药剂科,陕西西安710038

出　　处：《中国医药导报》2017年第6期146-150,共5页China Medical Herald

基　　金：军队医疗机构制剂标准提高科研专项课题(14ZJZ14-1)

摘　　要：目的提高并完善复方木香丸的质量标准。方法采用薄层色谱法分别对青皮、莱菔子、姜黄、草豆蔻、香附进行定性鉴别;以高效液相色谱法测定橙皮苷的含量。分析采用C18色谱柱(250 mm×4.6 mm,5μm);流动相甲醇-水(48∶52),体积流量1.0 m L/min;柱温30℃;检测波长284 nm。结果各药材在相应的薄层色谱条件下斑点清晰,分离度好,阴性无干扰。橙皮苷在17.5~350μg范围内线性关系良好(R2=0.9995),平均加样回收率为102.88%,RSD为1.22%(n=6),3批样品含量测定结果均值为12.41 mg/g。结论该鉴别方法专属性强、灵敏度高;定量方法简便快速、结果准确且重复性好,可用于控制复方木香丸的质量。Objective To improve the quality standard for Compound Muxiang Pills. Methods Citrus reticulata Blanco, Raphanus sativus L., Curcuma Ionga L., Alpinia katsumadai Hayata, Cyperus rotundus were identified by TLC. The content of Hesperidin was determined by HPLC. The analysis was performed on 30℃ thermostatic C18 column （250 mm × 4.6 mm, 5 μm）, with the mobile phase comprising of methanol-water （48：52） at a flow rate of 1.0 mL/min, and detection Wavelength was set at 284 nm. Results TLC spots were clear and well-separated without negative interference. Hes- peridin showed a good linear relationship within the range of 17.5-350 μg/mL （R2 = 0.9995）. The average recovery was 102.88%, RSD = 1.22% （n = 6）, the average contents of the three batches of samples was 12.41 mg/g. Conclusion This identification method is selective and sensitive. The quantitative method is simple, rapid, accurate and reproducible, and canbe used to control the quality of Compound Muxiang Pills.

关 键 词：复方木香丸 青皮 莱菔子 姜黄 草豆蔻 香附 橙皮苷 薄层色谱 高效液相色谱 

分 类 号：R284[医药卫生—中药学]