清火片质量标准研究  

Quality standards for Qinghuo Tablets

作　　者：金阳[1] 

机构地区：[1]安徽省芜湖市药品检验所,安徽芜湖241000

出　　处：《中成药》2008年第4期533-536,共4页Chinese Traditional Patent Medicine

摘　　要：目的：建立清火片（大青叶、大黄、石膏等）质量标准。方法：采用TLC法对清火片中大青叶、大黄、薄荷脑进行定性鉴别；用HPLC法同时测定清火片中靛玉红和大黄素的含量。色谱柱为Agilent-ODS-3（5 μm，4．6mm×250mm），柱温为25℃，甲醇-0．1％磷酸溶液（75：25）为流动相，检测波长为289nm，流速为1．0mL／min。结果：在TLC色谱中均能检出大青叶、大黄、薄荷脑；靛玉红在0．0714～0．714 μg范围内呈良好的线性关系，r=0．9997，平均回收率为98．95％，RSD=0．57％。大黄素在0．204～2．04 μg范围内呈良好的线性关系，r=0．9998，平均回收率为99．01％，RSD=0．79％。结论：所建立的方法快速正确，重现性好，专属性强。AIM： To establish the quality standards for Qinghuo Tablets （Folium Isatidis, Radix et Rhizoma Rhei, Gypsum Fibrosum, etc. ）. METHODS： Folium Isatidis, Radix et Rhizoma Rhei, menthol in Qinghuo Tablets were identified by TLC. Indirubin and emodin were determined by HPLC. Agilent-ODS-3 （5 μm,4.6 mm × 250 mm） column was used. The column temperature was at 25 ℃. Methanol-0.5% H3PO4（75： 25） Was used as a mobile phase. The detection wavelength was at 289 nm. The flow rate was 1.0 mL/min. RESULTS ： Folium Isatidis, Radix et Rhizoma Rhei, menthol could be detected by TLC. Indirubin showed a good linear relationship at the range of 0. 071 4 -0. 714 μg, r =0. 999 7. The average recovery was 98.95%, and RSD was 0.57%. Emodin showed a good linear relationship at the range of 0. 204 - 2.04 μg, r = 0. 999 8. The average recovery was 99.01% , and RSD was 0.79%. CONCLUSION： The established method is rapid, accurate, reproducible with a strong specificify.

关 键 词：清火片 靛玉红 大黄素 TLC HPLC 质量标准 

分 类 号：R927.2[医药卫生—药学]