奇丹颗粒质量标准研究  

Quality standard for Qidan Granules

作　　者：李军[1] 虞丽芳[1] 王莉莉[1] 李婷[1] 陆伟根[1] 

机构地区：[1]上海医药工业研究院,上海200437

出　　处：《中成药》2009年第3期405-409,共5页Chinese Traditional Patent Medicine

基　　金：上海市科委资助项目(05DZ19707)

摘　　要：目的：建立奇丹颗粒（丹参,黄芪,没药,莪术,五灵脂）的质量标准。方法：用薄层色谱法对处方中的莪术、没药和五灵脂进行定性鉴别;用高效液相色谱法测定制剂中丹参酮ⅡA的含量;用HPLC-ELSD法测定制剂中黄芪甲苷的含量。结果：在薄层色谱鉴别中均能检出莪术、没药和五灵脂;丹参酮ⅡA在2.98-953.6 ng范围内有良好的线性关系,r=0.9999,平均回收率为100.6%,RSD为0.5%;黄芪甲苷在2.05-40.92μg范围内有良好的线性关系,r=0.9998,平均回收率为102.0%,RSD为1.8%。结论：该方法可用于奇丹颗粒的质量标准制订。AIM ： To establish the quality standard for Qidan Granules （ Radix et Rhizoma Salviae Miltiorrhizae, Radix Astragali, Myrrha, Rhizoma Curcumae; Faeces Togopteri ）. METHODS： Myrrh, Rhizoma Curcumae and Faeces Trogopteri in Qidan Granules were identified by TLC. The content of tanshinone Ⅱ A was determined by HPLC. The astragaloside content was determined by HPLC-ELSD. RESULTS： Myrrh, Rhizoma Curcumae and Faeces Trogopteri could be identified by TLC. There was a good linear relationship between the peak area and quantity of tanshinone ⅡA at the range of 2.98 - 953.6 ng, r = 0. 999 9, and the recovery was 100.6%, RSD was 0.5 %. Also, there was a good natural logarithm linear relationship between the peak area and quantity of astragaloside at the range of 2. 05 -40.92 μg, r =0.999 8, and the recovery was 102.0%, RSD was 1. 8%. CONCLUSION： The method can be used to set up the quality standard for Qidan Granules.

关 键 词：奇丹颗粒 TLC 丹参酮ⅡA 黄芪甲苷 HPLC HPLC-ELSD 

分 类 号：R927.2[医药卫生—药学]