清热解毒颗粒质量标准研究  

Investigation on Quality Standard of Qingrejiedu Granules

作　　者：洪挺 许妍 张昆艳 鄢章龙 王栋 杨毅生 HONG Ting;XU Yan;ZHANG Kunyan;YAN Zhanglong;WANG Dong;YANG Yisheng(Jiangxi Pravicial Institute for Drug Control,Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality,Nanchang,Jiangxi 330029,China;Jiangxi University of Traditional Chinese Medicine,Nanchang,Jiangxi 330004,China;Jiangxi Tonggu Renhe Pharmaceutical Co.Ltd,Tonggu,Jiangxi 336200,China;Jiangxi Provicial Institute for Food Control,Jiangxi National Fruit and Vegetable Proudcts and Processed Food Quality Supervision and Inspection Center,Nanchang,Jiangxi 330001,China)

机构地区：[1]江西省药品检验检测研究院,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029 [2]江西中医药大学,江西南昌330004 [3]江西铜鼓仁和制药有限公司,江西铜鼓336200 [4]江西省食品检验检测研究院,江西国家果蔬产品及加工食品质量监督检验中心,江西南昌330001

出　　处：《今日药学》2019年第11期737-741,共5页Pharmacy Today

基　　金：江西省食品药品监督管理局科研项目(2017YX04);国家药典委员会国家药品标准提高项目(2017-488);江西省研究生创新专项资金项目(YC2018-S286)

摘　　要：目的建立清热解毒颗粒的质量标准。方法采用薄层色谱法鉴别清热解毒颗粒中黄连、玄参、大青叶、连翘;采用高效液相色谱法测定连翘酯苷A的含量。结果处方中4味药材均能运用薄层色谱方法检测,且色谱斑点清晰,分离度较好。连翘酯苷A在0.039 4~0.985 1 mg·m L^-1(r=0.999 7)之间呈良好的线性关系,平均回收率为101.3%,RSD为1.3%(n=6)。结论通过研究建立了清热解毒颗粒的质量标准,测定方法操作简便,重现性和分离度好,为保证其临床用药安全性提供依据。OBJECTIVE To establish a quality standard of Qingrejiedu granules. METHODS Coptidis Rhizoma,Scrophulariae Radix,Isatidis Folium,Forsythiae Fructus in Qingrejiedu granules were identified by TLC.The content of Forsythoside A in Qingrejiedu granules were determined by HPLC. RESULTS Four herbs could be detected by TLC,the spots were clear and well-separated. The linear range of Forsythoside A was 0.039 40-0.985 1 mg·m L^-1(r = 0.999 7),the average recovery was 101.3%,RSD = 1.3%(n = 6).CONCLUSION The established method can be used for the quality control of Qingrejiedu granules.

关 键 词：清热解毒颗粒 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R917[医药卫生—药物分析学]