摘要
目的:采用往复架法对双氯芬酸钠贴体外释放度进行研究,测定溶出曲线并对溶出数据进行模型拟合。方法:采用往复架法对双氯芬酸钠贴在不同介质[磷酸盐缓冲液(pH 6.8,7.0,7.4)以及生理盐水]、不同往复频率(15,30,45 dip·min^(-1))和不同材质双面胶(3M-VHB材质、3M-PET材质、3M-无纺布材质)的24 h体外释放进行考察。以HPLC法测定,采用DDsolver软件对溶出数据分别进行零级模型、一级模型、Weibull模型、Korsmeyer-Peppas模型、Higuchi模型拟合,确定最优释放模型。结果:双氯芬酸钠贴在圆筒样品架、3M-无纺布材质双面胶固定、往复频率30 dip·min^(-1)、振幅2 cm、溶出介质磷酸盐缓冲液(pH 7.4)体积800 mL条件下,释放度测定方法最佳。3批样品24 h累积释放量分别为(55.44±1.74)%,(52.34±1.04)%和(65.39±1.38)%,释放最优模型均为Weibull模型,释放方程分别为F=100×{1-Exp[-((t+0.130)0.739)/13.158]},F=100×{1-Exp[-((t+1.021)0.720)/13.791]}和F=100×{1-Exp[-((t-0.481)0.629)/6.911]},相关系数r 2分别为0.9993,0.9991和0.9977。结论:往复架法可用于双氯芬酸钠贴释放度测定,其操作简单,结果准确可靠,可为相关贴剂采用往复架法开展质量研究提供参考。
Objective:To determine the dissolution profile of diclofenac sodium patches using the reciprocating holder method and fit a model to the dissolution data.Methods:The 24 h in vitro release of diclofenac sodium patches were investigated by the reciprocating holder method with different media(phosphate buffer pH 6.8,7.0,7.4 and saline),different reciprocating frequencies(15,30 and 45 dip·min^(-1)),and different materials of double-sided adhesive tape(3M-VHB material,3M-PET material,and 3M-nonwoven material).The drug content was determined by HPLC,and the Zero order,First order,Weibull,Korsmeyer-Peppas and Higuchi models were fitted to the dissolution data by DDsolver software to identify the optimal release model.Results:The optimal release test condition of diclofenac sodium patches were as follows:the patches were fixed with cylinder sample rack and 3M non-woven double-sided tape,the reciprocating frequency was 30 dip·min^(-1),the amplitude was 2 cm,and the dissolution medium was phosphate buffer(pH 7.4)with a volume of 800 mL.The cumulative release amount(%)of the three batches within 24 h were(55.44±1.74)%,(52.34±1.04)%,(65.39±1.38)%,respectively.The optimal release model was Weibull model,the release equations were F=100×{1-Exp[-((t+0.130)0.739)/13.158]},F=100×{1-Exp[-((t+1.021)0.720)/13.791]},F=100×{1-Exp[-((t-0.481)0.629)/6.911]},and the correlation coefficients r 2 were 0.9993,0.9991 and 0.9977,respectively.Conclusion:The reciprocating holder method can be used for the determination of the release degree of diclofenac sodium patches,which is simple to operate,and the results are accurate and reliable,providing a reference for the quality study of related patches using the reciprocating holder method.
作者
项梦茹
李显庆
堵伟锋
吴虹
谢子立
XIANG Meng-ru;LI Xian-qing;DU Wei-feng;WU Hong;XIE Zi-li(Anhui University of Chinese Medicine,Hefei 230012,China;Anhui Institute for Food and Drug Control,Hefei 230051,China)
出处
《中国新药杂志》
北大核心
2025年第14期1548-1553,共6页
Chinese Journal of New Drugs
基金
安徽省药品监督管理局科技创新资助项目(AHYJ-KJ-202316)
经皮给药制剂的体外释放、渗透过程及评价技术研究资助项目(2023SKLDRS0106)。
关键词
双氯芬酸钠
贴剂
往复架法
圆筒样品架
溶出曲线
体外释放度
diclofenac sodium
patch
reciprocating holder method
cylinder sample rack
dissolution curve
in vitro release
