氨基比林咖啡因片有区分力的溶出度方法的建立及溶出曲线相似性评价  

Establishment of a Discriminatory Dissolution Method for Aminopyrine Caffeine Tablets and Evaluation of the Similarity of Dissolution Curves

作　　者：王建强 曹洪杰 夏方亮 王建功 WANG Jianqiang;CAO Hongjie;XIA Fangliang;WANG Jiangong(Binzhou Municipal Testing Center,Binzhou 256600;Binzhou Municipal Key Lab.for Chemical Drug Research and Development and Quality Control(Preparation),Binzhou 256600;The Hospital Affiliated to Binzhou Medical College,Binzhou 256600)

机构地区：[1]滨州市检验检测中心,山东滨州256600 [2]滨州市化学药物研发与质量控制重点实验室(筹),山东滨州256600 [3]滨州医学院附属医院,山东滨州256600

出　　处：《中国医药工业杂志》2025年第3期396-402,共7页Chinese Journal of Pharmaceuticals

基　　金：滨州市农社领域科技创新政策引导计划项目(2023SHFZ005)。

摘　　要：建立了氨基比林咖啡因片中氨基比林和咖啡因的溶出度测定方法,以反映不同厂家制剂的处方及生产工艺的差异,评价不同厂家生产的产品质量。溶出度方法为采用篮法,以pH 6.8磷酸缓冲液900 mL为溶出介质,转速为50 r/min,于30 min时取样,用HPLC法进行测定。对不同厂家的多批次产品通过相似等效限法和相似因子(ƒ_(2))法进行评价。结果显示,各厂家产品中氨基比林溶出行为的批内均一性和批间重现性较差,且不同厂家产品中氨基比林的溶出行为存在明显的差异,提示各厂家应改进处方及提高生产工艺的稳定性,以保证产品安全、有效。A dissolution determination method for aminopyrine and caffeine in aminopyrine caffeine tablets was established,in order to reflect the differences in formulation and production processes of different manufacturers,and evaluate the quality of products produced by different manufacturers.The basket method was adopted,with 900 mL of pH 6.8 phosphate buffer solution as the dissolution medium and a rotation speed of 50 r/min.Samples were taken at 30 min and determined by HPLC.Evaluate multiple batches of products from different manufacturers using the similarity equivalent limit method and similarity factor method(ƒ_(2)).The results showed that the intra-batch uniformity and inter-batch reproducibility of the dissolution behavior of aminopyrine from the products manufactured by various companies were poor,and there were significant differences in the dissolution behavior of aminopyrine products from different manufacturers,which indicated that manufacturers should improve their formulations and enhance the stability of their production processes to ensure product safety and effectiveness.

关 键 词：氨基比林咖啡因片 解热镇痛药 氨基比林 溶出度 等效限 相似因子 

分 类 号：R917[医药卫生—药物分析学] R971.1[医药卫生—药学]