喜炎平中穿心莲内酯磺化物E含量测定对照品量值传递方法研究

Study of a potency value transmission method for reference standard of andrographolide sulfonate E in Xiyanping injection

目的:喜炎平是穿心莲内酯通过磺化反应制得的一种中药注射液,穿心莲内酯磺化物E是其中的主要成分,也是产品质量控制的目标成分。本文研究建立穿心莲内酯磺化物E对照品的量值传递方法。方法:选用化学性质稳定且具有法定标准的母体化合物穿心莲内酯作为表征性参比物质,通过HPLC测定表征性参比物质与穿心莲内酯磺化物E的标准曲线,以其斜率的比值表征两者的摩尔紫外吸收系数比值,并作为校正因子,通过表征性参比物质的量值结合校正因子来传递穿心莲内酯磺化物E的量值。结果:表征性参比物质穿心莲内酯与穿心莲内酯磺化物E的校正因子为2.2912(RSD=1.8%,n=6)。结论:以穿心莲内酯为表征性参比物质,通过校正因子,可实现穿心莲内酯磺化物E对照品量值的准确传递。

Objective： Andrographolide sulfonate E is one of the main constituents in Xiyanping,an injection made from andrographolide through sulfonating reaction.A potency value transmission method for reference standard of andrographolide sulfonate E was established. Methods：The parent compound,andrographolide,was selected as a deputy reference substance.Calibration curves of andrographolide and andrographolide sulfonate E were determined by HPLC-UV and the slope ratio was defined as a calibration factor representing the mole ultraviolet absorption coefficients ratio of the two substances.Thus the potency value of sulfonate E reference standard could be transmitted by the value of deputy reference substance combining with the calibration factor.Results：The calibration factor is 2.2912 with RSD 1.8%（n=6）Conclusion：The potency value of andrographolide sulfonate E reference standard can be transmitted accurately to keep constant continuously.