摘要
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.
作者
陈土荣
周艳
吴雪茹
袁伟彬
赵毛香
范俊锋
张丽芳
CHEN Turong;ZHOU Yan;WU Xueru;YUAN Weibin;ZHAO Maoxiang;FAN Junfeng;ZHANG Lifang
出处
《新中医》
CAS
2022年第15期1-5,共5页
New Chinese Medicine
基金
广州中医药大学第三附属医院科研创新基金项目(Sy2020008)。
关键词
清热祛湿外洗液
苦参
黄柏
冰片
薄层色谱法
稳定性
Qingre Qudu lotion
Radix Sophorae Flavescentis
Cortex Phellodendri Chinensis
Borneolum Syntheticum
Thin-layer chromatography method
Stability
