摘要
目的:改进乙肝清热解毒片的质量标准。方法:增加茜草的薄层色谱,修订虎杖的含量测定方法为HPLC法测定虎杖苷的含量。HPLC色谱条件:采用SUNTEK Kromasil C18(4.6 mm×250 mm,5μm)色谱柱,流动相为乙腈-水(18∶82),流速1.0mL.min-1,柱温30℃,检测波长306 nm。结果:茜草的薄层色谱斑点分离良好;虎杖苷的含量测定方法专属性高,虎杖苷峰与其他峰分离良好,0.0615~0.6152μg范围内呈良好的线性关系,加样回收率为98.4%(RSD=1.8%)。结论:通过对乙肝清热解毒片质量标准的改进,使标准更具有专属性,更有利于该产品的质量控制。
Objective:To improve the quality standard of Yigan Qingre Jiedu tablets.Methods:TLC method for identification of Rubiae Radix et Rhizoma was increased,and HPLC method for the content determination of polydatin in Polygoni Cuspidati Rhizoma was revised.HPLC conditions:SUNTEK Kromasil C18(4.6 mm×250 mm,5 μm) column was adopted;The mobile phase was acetonitrile-water(18∶82),at the flow rate of 1.0 mL·min^-1;The column temperature was 30 ℃,and the detection wavelength was 306 nm.Results:The madder spots were separated by TLC.The content of polydatin was determined by HPLC with the average recovery of 98.36%(RSD=1.8%) in the range of 0.0615-0.6152 μg.Conclusion:The improved standard has more specificity and more advantageous to the product's quality control.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2011年第10期1970-1972,共3页
Chinese Journal of Pharmaceutical Analysis
关键词
中成药
乙肝清热解毒片
薄层色谱
茜草
高效液相色谱法
虎杖苷
标准提高
Chinese patent medicine
Yigan Qingre Jiedu tablets
TLC
Rubiae Radix et Rhizoma
HPLC
polydatin
standard advance