摘要
目的:从中成药溶出行为的一致性角度,以标准提取物投料的中成药大宗品种——银杏叶片为例,系统开展与原研药的溶出度对比研究,探讨溶出度检查在中成药质量一致性及中药仿制药开发中应用的可行性。方法:采用流通池闭环系统,以水(150 mL)为溶出介质,设置温度为37℃、流速为8 mL·min^(–1)、脉动频率为0 Hz,预热搅拌为300 r·min^(–1),取样前等待4 min,在规定时间点取样,绘制溶出曲线。共完成4个厂家14批不同规格仿制药银杏叶片的检查,并与原研药进行对比,探讨不同厂家样品之间的质量差异。结果:在该溶出条件下,各批次市售银杏叶片与原研药的溶出曲线均存在不同程度的差异,且不同厂家相同规格的样品间也存在一定程度的差异,表明国内不同厂家之间银杏叶片的溶出行为差异较大,质量一致性有待提升。结论:开展溶出度检查对于银杏叶片的品质控制和临床疗效保障十分必要,对中药仿制药的质量提升具有指导作用。
Objective:From the perspective of consistency in dissolution behaviors of Chinese patent medicines(CPMs),this study systematically compares the dissolution between the generic and original drugs of Ginkgo Folium Tablets(a major CPM formulated with standardized extracts),aiming to explore the feasibility of applying dissolution testing in the evaluation of quality consistency of CPMs and the development of generic CPMs.Methods:A flow-through cell with a closed-loop circulation system was used,with 150 mL water as the dissolution medium,the temperature at 37℃,the pulsation frequency of 0 Hz,preheat stirring at 300 r·min^(–1),and the flow rate of 8 mL·min^(–1).The waiting time was 4 min before sampling,and sampling was conducted at predetermined time points for the establishment of a dissolution curve.A total of 14 batches of Ginkgo Folium Tablets of different specifications from 4 manufacturers were inspected and compared with the original drug to explore the quality differences between samples from different manufacturers.Results:Under the specified dissolution conditions,commercial Ginkgo Folium Tablets of different batches exhibited varying degrees of differences in dissolution curves from the original drug.Moreover,the samples of the same specification from different manufacturers also showed discrepancies.This demonstrated significant variations in dissolution behaviors of Ginkgo Folium Tablets among different domestic manufacturers,revealing that the product consistency required improvement.Conclusion:Conducting dissolution testing is essential for the quality control and clinical efficacy of Ginkgo Folium Tablets,and it provides guidance for quality enhancement of generic CPMs.
作者
崔丽娟
易红
吴哲
李春
高慧敏
刘晓谦
王智民
CUI Lijuan;YI Hong;WU Zhe;LI Chun;GAO Huimin;LIU Xiaoqian;WANG Zhimin(National Engineering Laboratory of Quality Control Technology of Chinese Materia Medica,Institute of Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《中国现代中药》
2025年第7期1347-1353,共7页
Modern Chinese Medicine
基金
国家重点研发计划项目(2023YFC3504000)
中国中医科学院科技创新工程项目(CI2021A04308)。
关键词
银杏叶片
黄酮苷
流通池法
溶出度
中药仿制药
Ginkgo Folium Tablets
flavonoid glycosides
flow-through cell method
dissolution
generic Chinese patent medicines
