摘要
目的:建立高效液相色谱(HPLC)测定香砂养胃丸中辛弗林的方法,以单独控制药品中枳实的质量,弥补现行标准中以橙皮苷的含量同时控制药品中枳实、陈皮质量产生的专属性不强和不同品种枳实影响测定结果的缺陷。方法:岛津LC-20AT高效液相色谱仪,WondaSilC18-WR(250mm×4.6mm,5μm)色谱柱,以甲醇-磷酸二氢钾溶液(取磷酸二氢钾0.6g,十二烷基磺酸钠1.0g,冰醋酸1mL,加水溶解并稀释至1000mL)(50∶50)为流动相,流速为1.0mL·min^-1,检测波长为275nm,柱温为30℃。结果:测定成分在0.01465~2.344μg线性关系良好,精密度、稳定性、重复性RSD均低于2.0%,平均加样回收率为94.64%(RSD=2.72%)。结论:该方法准确、可靠,可用于香砂养胃丸中辛弗林的含量测定,有效改进了现行质量标准。
Objective:To establish an HPLC method of determining synephrine in Xiangshayangwei Pills for quality control of Fructus Aurantii Immaturus,a herb in the formula,and make up the shortcoming of previous method in less specificity and interference in determination. Methods:Shimadzu LC-20AT was used,WondaSil C 18 -WR (250 mm×4.6 mm, 5 μm )chromatographic column was applied with methanol and potassium dihydrogen phosphate solution (50∶ 50 )as mobile phase,the flow rate was 1.0 mL · min^-1 ,the detection wavelength was set at 275 nm,and the column temperature was 30 ℃. Results:The linear relationship of peak area was very good when synephrine was in the range 0.014 65-2.344 μg.The RSD of precision,stability and repeatability were all below 2.0%,sample recovery rate was 94.64%(RSD=2.72%). Conclusion:The established method was accurate and reliable,which can be used for the determination of synephrine in Xiangshayangwei Pills.It improved the current quality standards effectively.
作者
程雅婷
王晓云
王艳博
王健
刘凯娜
王学涛
杨新宇
郑斓
CHENG Ya-ting;WANG Xiao-yun;WANG Yan-bo;WANG Jian;LIU Kai-na;WANG Xue-tao;YANG Xin-yu;ZHENG Lan(Qinhuangdao Food and Drug Inspection Center,Qinhuangdao,Qinhuangdao 066004,China;Zhengda Qingchunbao pharmaceutical limited company,Hangzhou,Hangzhou 310000,China)
出处
《中国现代中药》
CAS
2019年第7期951-955,共5页
Modern Chinese Medicine
关键词
辛弗林
香砂养胃丸
枳实
酸橙
甜橙
标准提高
synephrine
Xiangsha Yangwei Pills
Fructus Aurantii Immaturus
Citrus aurantium
Citrus sinensis
standard improvement
