【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/m L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。更多还原

【Abstract】 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—80 μg/m L,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.更多还原