枳实多元质量控制指标的稳定性研究  

Study on Quality Stability of Aurantii Fructus Immaturus by Multiple Quality Control Indicators

作　　者：邱小燕 王章伟 刘芳芳 刘地发 钟仁清 陈文北 Qiu Xiaoyan;Wang Zhangwei;Liu Fangfang;Liu Difa;Zhong Renqing;Chen Wenbei(Jiangxi Qingfeng Pharmaceutical Co.,Ltd.,Ganzhou 341000,China;Jiangxi Kerui Pharmaceutical Co.,Ltd.,Ganzhou 341000,China)

机构地区：[1]江西青峰药业有限公司,江西赣州341000 [2]江西科睿药业有限公司,江西赣州341000

出　　处：《山东化工》2024年第18期124-129,共6页Shandong Chemical Industry

基　　金：江西省重点研发计划项目(20212BBG73038);江西省重大科技成果熟化与工程化研究项目(20232AEI92004)。

摘　　要：目的:比较性状、水分、浸出物、生物碱和黄酮类成分的变化情况,考察枳实在大生产贮藏条件下的质量稳定性。方法:建立枳实柚皮苷、新橙皮苷的含量测定方法;同时结合《中国药典》2020年版枳实项下关键检测指标对不同贮存期的枳实进行质量评价。结果:高效液相色谱法检测枳实中柚皮苷、新橙皮苷含量,方法简单,准确可靠;枳实采用中药材包装用编织袋包装,在阴凉干燥处贮藏24个月,各关键质控指标均无明显变化。结论:采用多元的质量控制指标可更全面反映枳实稳定性期间的质量变化情况。枳实药材大生产条件下,在阴凉干燥处贮藏的复验期为24个月。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 

分 类 号：O657.72[理学—分析化学] TQ460.72[理学—化学]