痛风方剂颗粒质量标准研究  

Study on Quality Control of Traditional Chinese Medicine Gout Granules

作　　者：姚苑梅[1] 徐玉红[1] 李东[2,3] 万于军[2,3] 

机构地区：[1]广东医学院附属福田人民医院,广东深圳518033 [2]广东省深圳市人民医院 [3]暨南大学第二临床医学院临床药学研究室,广东深圳518020

出　　处：《中国药业》2011年第13期14-16,共3页China Pharmaceuticals

基　　金：深圳市科技计划项目(医疗卫生类);项目编号:200405080

摘　　要：目的建立痛风方剂颗粒的质量控制方法,确保制剂质量稳定可控、安全、有效。方法对展开剂及展开条件进行筛选,采用薄层色谱法定性鉴别制剂中的防己、黄柏、当归;采用高效液相色谱法测定痛风方剂颗粒中粉防己碱的含量。结果分别以正己烷-氯仿-甲醇(7.5∶4∶2)、正丁醇-冰醋酸-水(7∶1∶2)、石油醚-乙酸乙酯(4∶1)为展开剂,可对痛风颗粒制剂中的防己、黄柏、当归进行定性鉴别。采用Kromasil C8柱(250 mm×4.6 mm,5μm)为分析柱,以含0.6%三乙胺的0.01 mol/L磷酸二氢钾缓冲液(用磷酸调pH至3.0)-甲醇-乙腈(50∶20∶30)为流动相,可对痛风颗粒制剂中的粉防己碱含量进行测定。粉防己碱的质量浓度线性范围为4.0～40.0μg/mL(r=0.999 8),平均回收率为99.41%,RSD=1.63%(n=9)。结论所建立的薄层色谱鉴别方法和高效液相色谱法专属性强、重复性好,可分别用于痛风颗粒制剂的质量控制。Objective To establish the quality control methods for traditional Chinese medicine Gout Granules 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 Gout 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 reproducible,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 

分 类 号：R284.1[医药卫生—中药学] R286.0[医药卫生—中医学]