他克莫司软膏体外释放评价方法的研究  

Investigation of An Evaluation Method of in vitro Release Test for Tacrolimus Ointment

作　　者：凌霞 宋诗颖 叶晓霞 张叶 许旭 乐健 LING Xia;SONG Shiying;YE Xiaoxia;ZHANG Ye;XU Xu;LE Jian(NMPA Key Lab.for Quality Analysis of Chemical Drug Preparations,Shanghai Institute for Food and Drug Control,Shanghai 201203;Shanghai Institute of Technology,Shanghai 201418)

机构地区：[1]上海市食品药品检验研究院,国家药品监督管理局化学药品制剂质量分析重点实验室,上海201203 [2]上海应用技术大学,上海201418

出　　处：《中国医药工业杂志》2025年第2期232-238,共7页Chinese Journal of Pharmaceuticals

摘　　要：采用改良Franz扩散池建立了他克莫司(1)软膏体外释放的测定方法,评价同规格、不同处方工艺1软膏体外释放的一致性。首先计算了原研制剂0.1% 1软膏和0.03% 1软膏的中位体外释放率比值。结果显示,90%置信区间均落在FDA一致性规定的75.00%~133.33%限度内。然后计算6家生产企业的0.1% 1软膏仿制药与原研制剂的中位体外释放率比值,结果显示,样品C和样品F的90%置信区间均落在规定限度内,而样品D、样品E、样品G、样品H没有落在规定限度内。该研究建立的方法符合1软膏体外释放评价的要求,评价方法能有效区分不同企业的生产工艺。A method for determining the in vitro release of tacrolimus(1) ointment was established using an improved Franz diffusion cell,and the consistency of in vitro release of 1 ointments with the same specifications but different prescription processes was evaluated.Firstly,the median in vitro release rate ratio of the original formulations,1 0.1% and 0.03% ointment,was calculated.The results showed that the 90% confidence intervals were within the limit range of 75.00% to 133.33% specified by the FDA for consistency.Then,the median in vitro release rate ratios of 1 0.1% ointment generic drugs from 6 manufacturers to original reference formulation were calculated.The results showed that the 90% confidence intervals of samples C and F were within the specified limits,while samples D,E,G,and H did not fall within the specified limits.The established method met the requirements for in vitro release evaluation of 1 ointment,and the evaluation method could effectively distinguish different production processes of manufacturers.

关 键 词：他克莫司软膏 免疫抑制剂 特应性皮炎 体外释放 仿制药 一致性评价 改良Franz扩散池 高效液相色谱 

分 类 号：R917[医药卫生—药物分析学] R979.5[医药卫生—药学]