西南医科大学学报2025，Vol.48Issue(3)：262-268,7.DOI:10.3969/j.issn.2096-3351.2025.03.006
甲瘤消颗粒提取工艺的优选及质量标准和安全性研究
Optimization of Extraction Process,Quality Standardization,and Safety Study of Jia Liuxiao Granules
摘要
Abstract
Objective To optimize the extraction process conditions for Jia Liuxiao Granules,and study their quality standards and safety to provide a basis for the development of this formulation.Methods Using the orthogonal experimental design method,we primarily investigated the effects of three factors—amount of water added,extraction time,and number of extractions—on the extrac-tion process of Jia Liuxiao Granules,with ferulic acid,habuxin,hydroxy safflower yellow A,hesperidin,and dry extract yield as evalu-ation indicators.Finally,we screened out the optimal extraction process and conducted quality standards and safety studies on Jia Liux-iaoGranules.Results The optimal aqueous extraction process for Jia Liuxiao was to add 12 times the amount of water,extract twice,each time for 1 hour.The determination of hydroxysafflower A content in Jia Liuxiao granules had no negative interference,high accu-racy and good separation under liquid chromatography conditions,and could be preliminarily used as a content determination indicator for Jia Liuxiao granules.In the thin layer chromatography identification of Chaihu,Xuanshen,Qingpi,and Danggui in Jia Liuxiao gran-ules,each spot showed clear color,good separation effect,negative without interference,and could be used as a thin layer identifica-tion method for Chaihu,Xuanshen,Qingpi,and Danggui in Jia Liuxiao granules.The maximum tolerated dose of Jia Liuxiao granules in mice was 84 g/kg,which is equivalent to 140 times the clinical dosage for humans.This suggests that Jia Liuxiao granules have a relatively high safety margin.Conclusion The optimized extraction process is stable and feasible,and the study of safety and quality standards ensures the safety and stability of Jia Liuxiao granules.关键词
正交设计/提取工艺/甲瘤消颗粒/质量标准研究/安全性评价Key words
Orthogonal design/Extraction process/Jia Liuxiao granules/Quality standards/Safety evaluation分类
中医学引用本文复制引用
靳永文,王利军,魏玉辉..甲瘤消颗粒提取工艺的优选及质量标准和安全性研究[J].西南医科大学学报,2025,48(3):262-268,7.基金项目
甘肃省重点研发计划-社会发展类项目(20YF3FA030) （20YF3FA030）
甘肃省医院中药制剂产业技术创新联盟资助项目(202001) （202001）
