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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: Xiyanping is a traditional Chinese medicine injection of andrographolide obtained through sulfonation reaction. It is the main component of andrographolide sulfonate E, which is also the target component of product quality control. This article studies the establishment of andrographolide sulfonate E reference value of the delivery method. Methods: A calibration curve of andrographolide sulphonate E, a representative reference substance, was prepared by HPLC using andrographolide, a chemically stable and legally standard parent compound, as a reference material. The slope ratio was used to characterize both And as a correction factor, the amount of andrographolide sulfonate E is delivered by combining the magnitude of the reference substance with the correction factor. RESULTS: The calibration factor for the representative reference substance, andrographolide and andrographolide S, was 2.2912 (RSD = 1.8%, n = 6). CONCLUSION: With andrographolide as a reference material, the calibration of andrographolide sulfonate E can be accurately passed through calibration factors.