祛斑凝胶剂质量标准  

Quality Standards Control of Quban Gels

作　　者：郭红叶[1] 匡颖[1] 闫小平[1] 刘宇[1] 

机构地区：[1]中国中医科学院西苑医院,北京100091

出　　处：《中国实验方剂学杂志》2014年第14期45-47,共3页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：中国中医科学院优势病种项目(CACMS08Y0034)

摘　　要：目的：建立祛斑凝胶剂的质量标准。方法：采用TLC鉴别祛斑凝胶剂中当归、人参、佚苓，检测波长365nm；运用HPLC测定祛斑凝胶剂中阿魏酸含量，流动相乙腈-0．085％磷酸（17：83），柱温35℃，检测波长316nm。结果：定性鉴别中检出当归、人参、茯苓，分离度好、专属性强且阴性无干扰。，阿魏酸线性范同0．024～0．144μg，精密度RSD0．86％，平均加样回收率100．24％（RSD2．93％）；祛斑凝胶剂中阿魏酸平均提取量0．022mg·g，RSD1．46％。结论：建立的HPLC操作简单、重复性好，可较好地控制祛斑凝胶剂的质量，为该制剂的工业化生产提供参考。Objective： To establish quality standards of Quban gels. Method： TLC was adopted to identify Angelicae Sinensis Radix, Ginseng Radix et Rhizoma and Poria with detection wavelength at 365 nm. The content of ferulie acid was determined by HPLC with mobile phase consisted of acetonitrile-0. 085% phosphoric acid （17： 83）, column temperature was set at 35 ℃ and detection wavelength was 316 nm. Result： Angelicae Sinensis Radix, Ginseng Radix et Rhizoma and Poria were identified by TLC, characteristic identification had a good separation, strong specificity and no negative interference. Ferulie acid showed a good linear relationship in the range of 0. 024-0. 144 μg with an average recovery of 100.2% （RSD 2.93% ） and precision RSD of 0. 86%. Average extracting amount of ferulic acid in Quban gels was 0. 022 mg ·g^-1 with RSD of 1.46%. Conclusion： This method could be adopted as a standard for quality control of Quban gels and provide a reference for industrial production of this preparation.

关 键 词：祛斑凝胶剂 当归 人参 茯苓 阿魏酸 高效液相色谱法 卡波姆 人参皂苷RG1 人参皂苷RE 

分 类 号：R284.1[医药卫生—中药学]