甘肃医药2026，Vol.45Issue(7)：616-620,5.DOI:10.15975/j.cnki.1004-2725.2026.07.010
安乳消痛丸的质量标准提升研究
Quality standard improvement for Anru Xiaotong Pills
摘要
Abstract
Objective:This study aimed to improve the quality standard of Anru Xiaotong Pills.Methods:Qualitative identification of nine herbal components was performed using microscopic identification.Thin-layer chromatography(TLC)was added to qualitatively identify Angelica sinensis(Danggui)and Paeonia lactiflora(Baishao).The content of paeoniflorin was determined by high-performance liquid chro matography(HPLC),and long-term stability was investigated through accelerated stability testing.Results:TLC spots for Angelica sinensis and Paeonia lactiflora were clear without interference from negative controls.The established HPLC method demonstrated excellent linearity(R2=0.9992)and consistent recovery rates for paeoniflorin quantification.During 24-month stability testing,paeoniflorin content consistently exceed-ed labeled specifications,with all quality parameters complying with pharmacopoeial requirements.Conclusions:The methodologies established in this study are simple,accurate,specific,and reproducible,providing a robust framework for enhancing the quality control of Anru Xiaotong Pills.关键词
安乳消痛丸/显微鉴别/薄层鉴别/含量测定/质量标准Key words
Anru Xiaotong Pills/microscopic identification/thin layer identification/content determination/quality standard分类
医药卫生引用本文复制引用
刘璐,刘东彦,张宇轩,沈薇,雷旭东,戴晓雁..安乳消痛丸的质量标准提升研究[J].甘肃医药,2026,45(7):616-620,5.基金项目
1.国家中医药管理局高水平重点学科建设项目(甘财社[2022]48号) （甘财社[2022]48号）
2.甘肃省药品监管科学研究项目(编号:2026GSMPA130) （编号:2026GSMPA130）
