摘要
目的:建立不同波长下同时测定血必净注射液中多种指标成分的质量控制方法。方法:HPLC-DAD法,采用Agilent Eclipse XDB C18(4. 6 mm×150 mm,5#m)色谱柱,以甲醇(A)-0. 3%甲酸水(B)为流动相(梯度洗脱),流速1 m L·min^(-1),柱温35℃,检测波长230、280、390、323 nm,进样量10#L,对丹参素、羟基红花黄色素A、芍药苷、阿魏酸、洋川芎内酯Ⅰ五种指标成分同时进行含量测定。结果:测得血必净注射液中五种指标成分在线性范围内均具有良好的线性关系(r>0. 999 6),精密度(RSD<1. 05%)、重复性(RSD<2. 84%)均符合要求,平均回收率为98. 85%～103. 22%(RSD<1. 27%)。三个批次血必净注射液中丹参素、羟基红花黄色素A、芍药苷、阿魏酸、洋川芎内酯Ⅰ的平均含量分别为14. 2、464. 5、1 489. 2、27. 8、60. 6μg·m L^(-1)。结论:该方法简便、快速、准确,可为血必净注射液全面质量控制标准的建立提供参考。
Objective： To establish a method for quality control of Xuebijing Injection based on the simultaneous determination of various index components. Methods： HPLC-DAD method was used for simultaneous determination of five index components,including danshensu,hydroxysafflor yellow A,paeoniflorin,ferulic acid and senkyunolide I. The separation was carried on an Agilent Eclipse XDB C18（ 4. 6 mm×150 mm,5 mm） with the mobile phase consisting of methanol（ A）-0. 3% formic acid solution（ B） by using gradient elution. The flow rate was 1 m L·min-1 and column temperature was 35 ℃. The detection wavelengths were set at 230,280,390 and 323 nm,and the injection volume was 10 μL. Results： The measured five active index components in Xuebijing Injection exhibited a good linear relationship within the linear range（ r 〉 0. 999 6）,precision（ RSD〈 1. 05%） and repeatability（ RSD 〈 2. 84%） were conform to the requirements,the average recovery was 98. 85%-103. 22%（ RSD 〈 1. 27%）. The average content of danshensu,hydroxysafflor yellow A,paeoniflorin,ferulic acid and senkyunolide I in three batches of Xuebijing Injection were 14. 2,464. 5,1 489. 2,27. 8 and 60. 6 μg·m L-1,respectively.Conclusion： The established method is simple,rapid and accurate,which can provide reference for the establishment of comprehensive quality control standard of Xuebijing Injection.
作者
李娣
曹雪晓
蒲位凌
孙立丽
任晓亮
LI Di;CAO Xue-xiao;PU Wei-ling;SUN Li-li;REN Xiao-liang(College of Traditional Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China)
出处
《中国现代中药》
CAS
2018年第9期1157-1160,共4页
Modern Chinese Medicine
基金
国家自然科学基金面上基金项目(81473543
81774149)
