复方肤清洗剂质量标准研究

Study on Quality Standard for Fufang Fuqing Lotion

关键词:  复方肤清洗剂  薄层色谱法  高效液相色谱法  芍药苷  异绿原酸A  咖啡酸  质量标准

Key words:  Fufang Fuqing lotion  TLC  HPLC  peaoniflorin  isochlorogenic acid A  caffeic acid  quality standard

摘要:

目的 建立复方肤清洗剂内控标准，使临床用药更合理安全。方法 采用薄层色谱法（TLC）对方中的蒲公英、赤芍进行定性鉴别；采用高效液相色谱法同时测定复方肤清洗剂中芍药苷、异绿原酸A、咖啡酸的含量。色谱条件：Inertsil ODS-SP色谱柱（4.6 mm×250 mm，5 μm），流动相为乙腈-0.02%磷酸水溶液（11∶89），流速为1.2 ml·min^-1，检测波长为230，323 nm。结果 在TLC中能检出赤芍、蒲公英的特征斑点；芍药苷、异绿原酸A和咖啡酸分别在14.06~225，7.5~120，2.5~40 μg·ml^-1内与峰面积线性关系较好，相关系数分别为0.999 9，0.999 8，0.999 7，加样回收率的平均值分别为94.5%，98.6%，99.2%，RSD分别为0.98%，1.66%，0.65%（n=6）。结论 所建立的TLC鉴别方法简单、准确，且HPLC含量测定方法专属性强，可用于复方肤清洗剂的质量控制。

Abstract:

OBJECTIVE To establish the internal control standard of Fufang Fuqing lotion, which makes the clinical medicine more reasonable and safe. METHODS dandelion and paeoniae rubra were identificated by TLC. Simultaneous determination of paeoniflorin, isochlorogeni acid A and caffeic acid in Fufang Fuqing lotion by HPLC. The samples of Fufang Fuqing lotion were separated on Inertsil ODS-SP column(4.6 mm×250 mm, 5 μm). The mobile phase was set as acetonitrile-0.02% phosphoric acid(11:89), and the flow rate was 1.0 mL·min^-1. The detection wavelength were set at 230 and 323 nm. RESULTS In TLC could be detected paeoniae rubra radix and dandelion characteristics of the spots. The calibration curves of peaoniflorin, isochlorogenic acid A and caffeic acid showed a good linear relationship over the range of 14.06-225 μg·ml^-1(r=0.999 9), 7.5-120 μg·ml^-1(r=0.999 8) and 2.5-40 μg·ml^-1(r=0.999 7). The average recovery rate were 94.5%, 98.6%, 99.2% with RSD 0.98%, 1.66%, 0.65%. CONCLUSION The established TLC identification method is simple, accurate, and the content of HPLC method is specific, which can be used for quality control of Fufang Fuqing lotion.