阿司匹林丁香酚酯颗粒剂的研制及质量评价  

Preparation and quality evaluation of aspirin eugenol ester granules

作　　者：王志霞 白莉霞 秦哲[1] 刘希望 杨亚军[1] 李世宏[1] 葛闻博 李剑勇[1] WANG Zhi-xia;BAI Li-xia;QIN Zhe;LIU Xi-wang;YANG Ya-jun;LI Shi-hong;GE Wen-bo;LI Jian-yong(Key Laboratory of Veterinary Pharmaceutical Development of the Ministry of Agriculture and Rural Affairs/Key Laboratory of New Animal Drug Project of Gansu Province/Lanzhou Institute of Husbandry and Pharmaceutical Sciences,Chinese Academy of Agricultural Sciences,Lanzhou 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、甘肃省工程重点实验室,甘肃兰州730050

出　　处：《中国兽医科学》2023年第6期780-786,共7页Chinese Veterinary Science

基　　金：中国农业科技创新工程项目(CAAS-25-LZIHPS-02)。

摘　　要：优选阿司匹林丁香酚酯颗粒的成型工艺,建立含量测定方法并进行质量评价。采用单因素试验及正交设计试验,以综合评分为考察指标,确定颗粒剂最佳处方,建立有效成分含量测定方法,并对颗粒剂进行质量评价。结果显示,颗粒剂的最佳处方为:以15 g阿司匹林丁香酚酯计,蔗糖为5 g,甘露醇为5 g,交联羧甲基纤维素钠为1.31 g;建立的含量测定方法准确度高,精密度良好,阿司匹林丁香酚酯在1.0~80μg/mL浓度范围内线性良好,样品平均回收率为98.23%;3批小试样品具有较好的成型性和流动性,阿司匹林丁香酚酯在60 min时溶出度达85%以上。结果表明,本研究制备的阿司匹林丁香酚酯颗粒剂性状符合要求、稳定性良好、质量可控。This study aims at preparing the aspirin eugenol ester granules,determining its content and evaluating the quality.We took the comprehensive score as evaluation indexes and determined the best formula by single factor test and orthogonal design test.Meanwhile,the HPLC method was established to determine the content of main components,and the physicochemical properties of the granules was preliminarily evaluated.The results showed that the optimal formulation of the granules was 5 g of sucrose,5 g of mannitol,1.31 g of croscarmellose sodium based on 15 g of aspirin eugenol ester.The HPLC method we established had high accuracy and good precision,the good linear relationship for aspirin eugenol ester was obtained in the rage of 1.0—80μg/mL,and the average recovery was 98.23%.Three batches of small-scale samples had better formability and fluidity,and the dissolution rate of aspirin eugenol ester was more than 85%in 60 min.In summary,the granules prepared in this study meets the requirements,has good stability and controllable quality.

关 键 词：阿司匹林丁香酚酯 含量测定 溶出度 质量评价 

分 类 号：S859.796[农业科学—临床兽医学]