中国药房2016，Vol.27Issue(3)：375-378,4.DOI:10.6039/j.issn.1001-0408.2016.03.30
舒痛安Ⅰ号胶囊的质量标准研究
Research on the Improvement of Quality Standard for ShutonganⅠGranule
摘要
Abstract
OBJECTIVE:To establish the quality standard for ShutonganⅠgranule.METHODS:TLC was conducted for the qual-itative identification of Citrus aurantium and Forsythia suspensa. HPLC was conducted for the content determination of naringin in the preparation;the column was Agilent C18 with mobile phase of acetonitrile-water(20:80,V/V)at a flow rate of 1.0 ml/min,the detection wavelength was 283 nm,the column temperature was 30 ℃,and the injection volume was 10 μl. HPLC was also used for the content determination of phillyrin;the column was Agilent TC-C18 with mobile phase of acetonitrile- water(23:77,V/V)at a flow rate of 1.0 ml/min,the detection wavelength was 277 nm,the column temperature was 30 ℃,and the injection volume was 10 μl. RESULTS:The C. aurantium and F. suspensa of TLC showed clear spots and good separation. The linear range was 57.843-289.214 μg/ml for naringin(r=0.999 9)and 37.434-187.169 μg/ml for phillyrin(r=0.999 6);RSDs of precision,stability and reproducibility tests were less than 2%;recoveries were 97.20%-102.04%(RSD=1.7%,n=9)and 97.14%-102.27%(RSD=2.0%,n=9),respectively. CONCLUSIONS:The standard can be used for the quality control of ShutonganⅠgranule.关键词
舒痛安Ⅰ号胶囊/薄层色谱法/柚皮苷/连翘苷/高效液相色谱法Key words
ShutonganⅠgranules/TLC/Naringin/Phillyrin/HPLC分类
医药卫生引用本文复制引用
李腾霞,黄木土,谢新民,晏明,李冬,邹学军,米海鹏..舒痛安Ⅰ号胶囊的质量标准研究[J].中国药房,2016,27(3):375-378,4.基金项目
军队医疗机构制剂标准单品种研究项目(No.14TG0186) （No.14TG0186）
广州市科技计划项目(No.201509010012) （No.201509010012）
