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目的:建立清炎滴丸的质量控制标准。方法:采用薄层色谱法鉴别本品中的肿节风、苦玄参等成分;以高效液相色谱法测定本品中有效成分异嗪皮啶的含量;并建立其他相关质控指标。结果:薄层色谱斑点清晰,重复性好,专属性强。含量测定方法准确可靠,线性范围为0.042~0.839μg,线性关系良好(R~2=0.999 4),平均回收率为98.28%(RSD=1.02%),精密度良好。结论:建立的质量控制方法可靠、准确、全面,可用于本品的质量控制。
Objective: To establish the quality control standard of Qing Yan drop pills. Methods: Thin layer chromatography was used to identify swollenose, bitter figwort and other components in this product. The content of isoxapide in this product was determined by high performance liquid chromatography. Other relevant quality control indexes were established. Results: Thin-layer chromatography spots clear, reproducible, and highly specific. The method was accurate and reliable, with a linear range of 0.042-0.839 μg and a good linearity (R ~ 2 = 0.999 4). The average recovery was 98.28% (RSD = 1.02%) with good precision. Conclusion: The established quality control method is reliable, accurate and comprehensive and can be used for the quality control of this product.