结合可视化特征提取的格列齐特缓释片释药行为研究  

Visual feature extraction combining dissolution testing for the study of drug release behavior of gliclazide modified release tablets

作　　者：陈思宇 李泽亚 黎萍 赵欣庆 龚涛[1] 邓黎[1] 张志荣[1] CHEN Si-yu;LI Ze-ya;LI Ping;ZHAO Xin-qing;GONG Tao;DENG Li;ZHANG Zhi-rong(Key Laboratory of Drug-Targeting and Drug Delivery System of the Education Ministry and Sichuan Province,West China School of Pharmacy,Sichuan University,Chengdu 610041,China;Chengdu Institute for Drug Control,Sichuan Medical Products Administration Key Laboratory for Quality Research and Control of Chemical Medicine,Chengdu 610046,China)

机构地区：[1]四川大学华西药学院,靶向药物与释药系统教育部重点实验室,四川成都610041 [2]成都市药品检验研究院,四川省药品监督管理局化学药品质量研究及控制重点实验室,四川成都610046

出　　处：《药学学报》2025年第1期225-231,共7页Acta Pharmaceutica Sinica

基　　金：四川省药品监督管理局化学药品质量研究与控制重点实验室开放课题项目(2023HZKF-04);大学生创新创业计划项目(C2024128841).

摘　　要：口服固体制剂需经过崩解和溶出等过程释放药物才可被机体吸收利用。本文采用可视化技术对国内15家格列齐特缓释片的体外静态释药过程进行连续化表征,并结合传统的体外释放度试验,测定格列齐特缓释片在pH 7.4磷酸盐缓冲液介质中的释放曲线,采用相似因子(f_(2))法评价释放曲线的相似性并根据多种数学模型对释药曲线进行拟合分析。研究结果表明,14家企业生产的格列齐特缓释片为亲水凝胶骨架片,对比仿制制剂与参比制剂,11家企业的仿制制剂与参比制剂的释放曲线相似(f_(2)>50)。其中与参比制剂可视化特征相似的仿制制剂其释放曲线相似。本研究为格列齐特缓释片的体外一致性评价提供了一种全新的思路和方法,旨在更准确、全面地评估仿制制剂的体外释药行为。Oral solid dosage forms require processes such as disintegration and dissolution to release the drug before it can be absorbed and utilized by the body.In this manuscript,imaging technology was used to continuously visualize and characterize the in vitro static drug release process of gliclazide modified release tablets from 15 manufacturers,combined with the traditional method of in vitro dissolution testing,to determine the release profile of gliclazide modified release tablets,to evaluate the similarity of the release profiles by using the similarity factor(f_(2)method and based on the analysis of the release profiles fitted with a variety of mathematical models.The results indicate that the gliclazide modified release tablets produced by 14 companies are hydrophilic gel matrix tablets.Compared to the reference listed drug,the release profiles of formulations from 1l companies show high similarity(f_(2)>50)to the reference.Among these,formulations with visual characteristics similar to the reference exhibit similar release curves.This study provides an alternative method for the in vitro consistency evaluation of gliclazide modified release tablets,aiming to assess the in vitro release behaviour of generic formulations more accurately and comprehensively.

关 键 词：格列齐特缓释片 亲水凝胶骨架片 可视化方法 体外释放度 模型拟合 

分 类 号：R943[医药卫生—药剂学]