大青叶配方颗粒质量标准研究  

Study on Quality Standard for Isatidis Folium Dispensing Granules

作　　者：巩伟[1] 赵庆华[1] 赵梅[1] 孙旭[1] 刘忠良[1] 李兴东[1] 张欣欣[1] 张琨[1] 

机构地区：[1]济南军区联勤部药品仪器检验所,济南250022

出　　处：《中国药师》2014年第12期2021-2023,共3页China Pharmacist

基　　金：军队医疗机构制剂标准提高专项课题(编号:13ZJZ21-2)

摘　　要：目的：建立大青叶配方颗粒的质量标准。方法：采用薄层色谱法鉴别配方颗粒中的靛蓝、靛玉红,采用醇溶性浸出物测定法中的热浸法测定浸出物的含量,采用高效液相色谱法测定靛玉红的含量。结果：薄层色谱斑点清晰,分离度好;浸出物的含量限度初步拟定为应不少于12.0%;含量测定中,靛玉红在0.50-8.04μg·ml^-1质量浓度范围内线性关系良好（r=0.999 9）,平均回收率为99.41%,RSD为1.21%（n=9）,并初步确定靛玉红的含量应不得少于50.0μg/袋。结论：建立的定性定量方法操作方便、结果准确、专属性强,可用于大青叶配方颗粒的质量控制。Objective： To establish the quality standard for Isatidis folium dispensing granules. Methods： Indigo and indirubin in the granules were identified by TLC. The extract content was determined by a hot dipping method for the determination of alcohol-soluble extract. The content of indirubin was determined by HPLC. Results： The spots in TLC were clear and well-separated. The extraction limit no less than 12. 0% was preliminarily drawn up. Indirubin showed a good linear relationship within the range of 0. 50-8. 04μg·ml^-1（ r = 0. 999 9） with the average recovery of 99. 41%（ RSD = 1. 21%,n = 9）. The content limit no less than 50. 0 μg per pack was preliminarily drawn up for indirubin. Conclusion： The method is easy-operated and accurate with good specificity for the quality control of Isatidis folium dispensing granules.

关 键 词：大青叶配方颗粒 质量标准 薄层色谱法 浸出物 高效液相色谱法 靛玉红 

分 类 号：TQ460.72[医药卫生—药物分析学]