清热祛湿外洗液的薄层鉴别及稳定性研究

Thin-Layer Identification and Stability Study of Qingre Qushi Lotion

目的:建立清热祛湿外洗液中苦参、黄柏、冰片的薄层鉴别方法,并考察其质量稳定性。方法:通过薄层色谱法对清热祛湿外洗液处方中的苦参、黄柏、冰片进行鉴别,采用影响因素试验、加速试验和长期试验考察清热祛湿外洗液的稳定性。结果:苦参、黄柏、冰片薄层色谱图中的斑点清晰、特征明显且阴性对照样品没有干扰。3批产品在长期试验和加速试验中均具有较好的稳定性,制剂稳定性重点考察项目均符合标准规定。结论:清热祛湿外洗液制剂质量稳定且可控,薄层色谱法重复性好、专属性高,可作为清热祛湿外洗液的质量控制方法。

Objective:To establish a thin-layer identification method for Radix Sophorae Flavescentis,Cortex Phellodendri Chinensis and Borneolum Syntheticum in Qingre Qushi lotion,and to investigate its quality stability.Methods:The Radix Sophorae Flavescentis,Cortex Phellodendri Chinensis and Borneolum Syntheticum in the prescription of Qingre Qushi lotion were identified by the method of thin-layer chromatography.The stability of Qingre Qushi lotion was investigated by influencing factors tests,accelerated tests and long-term tests.Results:The spots of Radix Sophorae Flavescentis,Cortex Phellodendri Chinensis and Borneolum Syntheticum in the thin-layer chromatograms were clear,with obvious characteristics and no interference from the negative control sample.Three batches of products showed good stability during long-term tests and accelerated tests,and the key inspection items of preparation stability met the standard.Conclusion:The preparation quality of Qingre Qushi lotion is stable and controllable,and the thin-layer chromatography method has good repeatability and high specificity,which can be used as the quality control method of Qingre Qudu lotion.