Objective:The critical quality stability of Zhishi(Aurantii Fructus Immaturus)under large-scale production was studied by comparing the changes of property,moisture,extracts,alkaloids,and flavonoid components.Methods:Quantitative identification of Aurantii fructus immaturus by determination of naringin and neohesperidin by High Performance Liquid Chromatography.According to key detection indicators of Aurantii fructus immaturus in Chinese Pharmacopoeia(2020 Edition),the quality of different storage period were evaluated and compared.Results:The established HPLC method of content determination was simple,accurate and repeatable.The quality was stable during storage period of 24 months under the condition of cool and dry place.Conclusion:The quality changes were reflected more comprehensively by multiple quality control indicators.The retest period of Aurantii fructus immaturus was 24 months.
关键词
枳实/关键质量属性/稳定性/复验期
Key words
aurantii fructus immaturus/critical quality attributes/stability/retest period
维普
万方数据