今日药学

2019, v.29(11) 737-741

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清热解毒颗粒质量标准研究
Investigation on Quality Standard of Qingrejiedu Granules

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 Provicial Institute for Drug Control,Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality;Jiangxi University of Traditional Chinese Medicine;Jiangxi Tonggu Renhe Pharmaceutical Co.Ltd;Jiangxi Provicial Institute for Food Control,Jiangxi National Fruit and Vegetable Proudcts and Processed Food Quality Supervision and Inspection Center;

摘要(Abstract):

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)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(KeyWords): 清热解毒颗粒;质量标准;薄层色谱法;高效液相色谱法
Qingrejiedu granules;quality standard;TLC;HPLC

Abstract:

Keywords:

基金项目(Foundation): 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)

作者(Authors): 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 Provicial Institute for Drug Control,Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality;Jiangxi University of Traditional Chinese Medicine;Jiangxi Tonggu Renhe Pharmaceutical Co.Ltd;Jiangxi Provicial Institute for Food Control,Jiangxi National Fruit and Vegetable Proudcts and Processed Food Quality Supervision and Inspection Center;

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