摘要
目的:提升知百安神口服液的质量标准。方法:采用薄层色谱法分别对知母和百合进行定性鉴别,采用高效液相色谱法对知母新芒果苷、芒果苷进行定量检测。色谱柱为Agilent Eclipse XDB-C_(18)(4.6 mm×250 mm,5μm),流动相为乙腈-0.2%甲酸水溶液,采用梯度洗脱,流速为1 ml/min,检测波长为246 nm,柱温为30℃,进样量为20μl。结果:薄层鉴别色谱中斑点特征明显、专属性好。新芒果苷、芒果苷的质量浓度线性范围分别为10.5~210.0、10.4~208.0μg/ml(r^2均≥0.999 9),精密度、重复性、稳定性试验的RSD均<2.00%。平均加样回收率分别为103.49%(RSD=0.86%)、98.81%(RSD=1.26%)(n=6)。结论:该方法简便可靠,可用于提升知百安神口服液的质量控制。
OBJECTIVE： To improve the quality standard of Zhibaianshen oral lquid. METHODS： Anemarrhenae rhizoma and lilii bulbus were identified by TLC method,and the concentration of neomangiferin and mangiferin were determined by HPLC method. Separation was carried out on a Agilent Eclipse XDB- C_（18）（ 4. 6 mm ×250 mm,5 μm） column with the mobile phase of acetonitrile and 0. 2% formic acid in gradient elution at a flow rate of 1 ml / min. The detection wavelength was set at 246 nm,the column temperature was 30 ℃,and the injection volume was 20 μl. RESULTS： The characteristics of spots in TLC were quite clear with strong specificity. As for neomangiferin and mangiferin,the linear range of the calibration curve was 10. 5-210. 0 and 10. 4-208. 0 μg / ml,respectively（ r^2≥0. 999 9）,and the results of precision,accuracy and stability were satisfactory with RSD less than 2. 00%. The average recovery rate turned out to be 103. 49%（ RSD = 0. 86%） and 98. 81%（ RSD = 1. 26%）（ n = 6）. CONCLUSIONS： The established method is simple and reliable,which can be used for the quality control of Zhibaianshen oral liquid.
出处
《中国医院用药评价与分析》
2016年第7期880-883,共4页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
"重大新药创制"科技重大专项(No.2013ZX09507005)
