阿司匹林丁香酚酯咀嚼片的稳定性试验  

Study on the Stability of Aspirin Eugenol Ester Chewable Tablets

作　　者：白莉霞 刘希望[1] 杨亚军[1] 李世宏[1] 秦哲[1] 葛闻博 许笑 李剑勇[1] BAI Li-xia;LIU Xi-wang;YANG Ya-jun;LI Shi-hong;QIN Zhe;GE Wen-bo;XU Xiao;LI Jian-yong(Key Laboratory of New Animal Drug Project of Gansu Province,Key Laboratory of Veterinary Pharmaceutical Development of Ministry of Agriculture and Rural Affairs,Lanzhou Institute of Animal Husbandry and Pharmaceutical Science,Chinese Academy of Agricultural Sciences,Lanzhou,Gansu,730050,China)

机构地区：[1]中国农业科学院兰州畜牧与兽药研究所,农业农村部兽用药物创制重点实验室,甘肃省新兽药工程重点实验室,甘肃兰州730050

出　　处：《动物医学进展》2024年第2期54-58,共5页Progress In Veterinary Medicine

基　　金：中国农业科技创新工程项目(CAAS-25-LZIHPS-02)。

摘　　要：考察不同因素对阿司匹林丁香酚酯(Aspirin eugenol ester, AEE)咀嚼片稳定性的影响,为制剂临床应用、贮存及运输提供理论依据。按照2020年版《中华人民共和国兽药典》原料药物与制剂稳定性试验指导进行影响因素试验、加速试验和长期试验,考察AEE咀嚼片在不同试验条件下的外观性状、重量差异、脆碎度、有关物质含量及溶出度变化,用高效液相色谱法测定有关物质和主成分含量,紫外可见分光光度法测定溶出度。结果显示,影响因素试验及加速试验条件下,AEE咀嚼片的各项考察指标均无明显变化;长期试验中除AEE咀嚼片的含量与溶出度随时间延长有所降低,但仍符合质量标准要求,其他各项指标均无明显变化。表明AEE咀嚼片制备工艺可靠,24个月内稳定性良好,建议包装应密闭,宜置于干燥阴凉处存放,以保证产品稳定。To investigate the effects of different factors on the stability of aspirin eugenol ester(AEE)chewable tablets,and to provide a theoretical basis for the clinical application,storage,and transportation of the formulation,according to the guidelines of stability test of raw materials and preparations in the 2020 edition of the"Veterinary Pharmacopoeia of the People's Republic of China",the influencing factor test,acceleration test and long-term test were conducted to investigate the appearance,weight difference,fragility,related substances,principal component contents and dissolution changes of AEE chewable tablets under different experimental conditions.The contents and related substances were determined by high performance liquid chromatography,and the dissolution was determined by UV visible spectrophotometry.The results showed that there were no significant changes in the various inspection indicators of AEE chewable tablets under the conditions of influencing factor test and acceleration test.In the long-term test,except for the decrease in the content and dissolution of AEE chewable tablets over time,the quality still meet standard requirements,all other indicators displayed no significant changes.The study indicated that the preparation process of AEE chewable tablets was reliable,and the product had good stability within 24 months.It was recommended that the packaging should be sealed and stored in a dry and cool place to ensure product stability.

关 键 词：阿司匹林丁香酚酯 咀嚼片 稳定性 

分 类 号：S859.79[农业科学—临床兽医学]