夏枯草配方颗粒质量标准研究  

Study on the quality standard of common selfheal fruit-spike granules

作　　者：巩伟[1] 孙旭[1] 张琨[1] 刘忠良[1] 赵庆华[1] 李兴东[1] 赵梅[1] 张欣欣[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：《国际中医中药杂志》2015年第5期435-438,共4页International Journal of Traditional Chinese Medicine

基　　金：军队医疗机构制剂标准提高专项课题（14ZJZ1-1,14ZJZ1-2）

摘　　要：目的：建立夏枯草配方颗粒的质量标准。方法采用薄层色谱法鉴别夏枯草配方颗粒中的迷迭香酸，采用水溶性浸出物测定法中的热浸法测定夏枯草配方颗粒的浸出物，采用高效液相色谱法测定夏枯草配方颗粒中迷迭香酸的含量。结果薄层色谱斑点清晰，分离度好；浸出物不少于10.0%。含量测定中，迷迭香酸在0.0625～2.0080 mg/ml质量浓度范围内线性关系良好（r＝0.9998），平均回收率为99.50%，RSD为1.21%，并初步确定夏枯草配方颗粒中迷迭香酸的含量应不得少于10.0 mg/袋。结论建立的定性定量方法操作方便、结果准确、专属性强，可用于夏枯草配方颗粒的质量控制。Objective To establish the quality standard of common selfheal fruit-spike granules. Mehtods Rosmarinicacid in the granules were identified by TLC. The extractives were tested by the method for determination of water-soluble extractives. The contents of rosmarinicacid were determined by HPLC. Results TLC had obvious characteristics with the spots clear and well-separated. The extraction limit was no less than 10.0%. Rosmarinicacid showed a good linear relationship at 0.062 5~2.008 0 mg/ml （r=0.999 8,n=6） with average recovery of 99.50% （RSD=1.21%,n=9）. The content limitation of rosmarinicacid was discussed as 10.0 mg per pack according to the experiment data.Conclusion The method is easy-operated and accurate which has a good specificity for the quality control of common selfheal fruit-spike granules.

关 键 词：夏枯草配方颗粒 质量标准 迷迭香酸 

分 类 号：R286.0[医药卫生—中药学]