中国药业2011，Vol.20Issue(13)：14-16,3.
痛风方剂颗粒质量标准研究
Study on Quality Control of Traditional Chinese Medicine Gout Granules
摘要
Abstract
Objective To establish the quality control methods for traditional Chinese medicine Cout Cranules and assure its clinical efficacy and patient safety. Methods TLC was adopted for qualitative identification of Radix stephaniae tetrandrae,Cortex phellodendri chinensis and Radix angelicae sinensis in Cout Granules,and the developer systems were optimized respectively. HPLC was used to determine the tetrandrine content. Results The optimized developer systems were as follows: cyclohexane,trichloromethane and methanol (7. 5 ∶ 4 ∶ 2) for Radix stephaniae tetrandrae,n - Butanol, Glacial acetic acid and water (7 ∶ 1 ∶ 2) for Cortex phellodendri chinensis,petroleum ether and ethyl acetate (4 ∶ 1) for Radix angelicae sinensis. For the determination of tetrandrine in Gout Granules,the Kromasil C8 analytical column was used and mobile phase was composed of 0. 01 mol/L KH2PO4 (containing 0. 6％ triethylamine, adjusted pH to 3.0): methanol: acetonitrile ( 50 ∶ 20 ∶ 30). The linear range of tetrandrine was 4. 0 - 40. 0 μg/mL( r = 0. 999 8 ),and the average recovery rate was 99. 41％ , RSD = 1. 63％ ( n =9). Conclusion The established TLC and HPLC methods are specified and reproducihle, and can be used for qualitative identification and quantitative determination of traditional Chinese medicine Gout Granules.关键词
痛风方剂颗粒/薄层色谱法/高效液相色谱法/质量控制Key words
Gout Granules/ TLC/ HPLC/ quality control分类
医药卫生引用本文复制引用
姚苑梅,徐玉红,李东,万于军..痛风方剂颗粒质量标准研究[J].中国药业,2011,20(13):14-16,3.基金项目
深圳市科技计划项目(医疗卫生类),项目编号:200405080. （医疗卫生类）
