摘要
目的:建立骨疏康胶囊的分析方法,测定丹酚酸B、淫羊藿苷、隐丹参酮、丹参酮I、丹参酮ⅡA的含量。方法:采用HPLC分析方法,使用Symmetry C_(18)色谱柱(4.6 mm×250 mm,5μm),流速为1.0 mL·min^(-1),柱温为25℃,检测波长为270 nm,以乙腈(A)-0.2%甲酸(B)为流动相,梯度洗脱。结果:5种成分在各自范围内线性关系良好(r≧0.999);精密度良好,RSD为1.46%~2.61%;重复性良好,RSD为1.18%~2.51%;供试品溶液在48 h内稳定性良好,RSD为1.35%~2.87%;加样回收率98.24%~101.04%,RSD为0.01%~0.68%。测定样品10批:5种成分的含量范围分别为8.018~11.064、11.939~17.329、0.559~1.568、0.533~1.020、1.155~2.834 mg·g^(-1),其中淫羊藿苷含量符合《中国药典》2020年版规定。结论:该方法具有较好的稳定性和重复性,可用于骨疏康胶囊的质量分析。
Objective:To establish the analytical methods for the determination of salvianolic acid B,icariin,cryptotanshinone,tanshinone I,and tanshinoneⅡA in Gushukang capsule.Methods:HPLC analysis was performed on a Symmetry C_(18) column(4.6 mm×250 mm,5μm)with flow rate of 1.0 mL·min^(-1),column temperature of 25℃,and the detection wavelength of 270 nm.Acetonitrile(A)-0.2%formic acid(B)in a gradient mode were used as the mobile phases.Results:The five components showed a good linear relationship in their respective ranges(r≥0.999).The precisions for these five components were good and RSD were between 1.46%and 2.61%.The repeatabilities for these five components were good and RSD were between 1.18%and 2.51%.The stability for these five components was good within 48 hours and RSD were between 1.35%and 2.87%.The average recovery rates for these five components were between 98.24%and 101.04%,with RSD ranged from 0.01%to 0.68%.Ten batches of samples were determined:the content ranges of five components were 8.018-11.064,11.939-17.329,0.559-1.568,0.533-1.020,1.155-2.834 mg·g^(-1),respectively,and the content of icariin met the requirements of the Chinese Pharmacopoeia 2020.Conclusion:This method has good stability and repeatability,and can be used for the quality analysis of Gushukang Capsules.
作者
于金倩
王晓
周万辉
孙成龙
李丽丽
刘伟
YU Jinqian;WANG Xiao;ZHOU Wanhui;SUN Chenglong;LI Lili;LIU Wei(Qilu University of Technology(Shandong Academy of Sciences),Shandong Analysis and Test Center,Jinan 250014,China;Qilu University of Technology(Shandong Academy of Sciences),School of Pharmaceutical Sciences,Jinan 250014,China;Shandong Wohua Pharmaceutical Technology Co.,Ltd.,Weifang 261041,China)
出处
《中国药品标准》
CAS
2023年第5期476-480,共5页
Drug Standards of China
基金
中央本级重大增减支项目(2060302)
“泰山学者”建设工程(tsqn202103096)。
