复方乙酰水杨酸片溶出度方法研究  

Study on Dissolution Method of Compound Acetylsalicylic Acid Tablets

作　　者：陈承贵 刘敏 陈颜清 杨雅贤 庞发根 李玉兰 王铁杰 CHEN Cheng-gui;LIU Min;CHEN Yan-qing;YANG Ya-xian;PANG Fa-gen;LI Yu-lan;WANG Tie-jie(Shenzhen Institute for Drug Control,Shenzhen Key Laboratory of Drug Quality Standard Research,Guangdong Shenzhen 518057,China)

机构地区：[1]深圳市药品检验研究院,深圳市药品质量标准研究重点实验室,广东深圳518057

出　　处：《中国药物评价》2023年第3期244-248,共5页Chinese Journal of Drug Evaluation

基　　金：2016年国家药典委员会药品标准提高课题(项目编号:309,项目名称:复方乙酰水杨酸片)。

摘　　要：目的:建立复方乙酰水杨酸片溶出度测定方法。方法:采用桨法,以盐酸溶液(取稀盐酸24 mL加水稀释至1000 mL)为溶出介质,转速为75 r·min^(-1),采用HPLC法测定复方乙酰水杨酸片的溶出度。结果:乙酰水杨酸、咖啡因和非那西丁3组分线性方程r值均为1.000,重复性、稳定性(24 h)、耐用性试验的RSD均<2.0%,平均回收率分别为99.5%、100.2%、100.2%(RSD<1.0%,n=6)。溶出仪管路系统和取样系统、滤膜对样品检测结果均无干扰。在9家企业产品中,有1家企业的产品检测不符合规定。结论:该溶出度方法能较好地反映不同企业复方乙酰水杨酸片溶出行为差异,为企业工艺优化提供参考。Objective:To establish a method for dissolution determination of compound acetylsalicylic acid tablets.Methods:The HPLC method was used to investigate the dissolution rate of compound acetylsalicylic acid tablets,using the hydrochloric acid solution(24 mL of dilute hydrochloric acid was diluted with water to a final volume of 1000 mL)as the dissolution medium at the speed of 75 r·min^(-1).Results:R-values of the three linear equation for acetylsalicylic acid,caffeine and phenacetin were all 1.000.Relative standard deviation(RSD)values for reproducibility,stability(24 h)and durability tests were all lower than 2.0%.The average recovery of these three tests was 99.5%,100.2%and 100.2%(RSD<1.0%,n=6),respectively.The stripping system,sampling system and filter membrane didn′t have interference on the test.Among products from 9 manufactures,only one batch from one manufacture didn′t meet the regulation.Conclusion:The newly established method for dissolution determination of compound acetylsalicylic acid tablets can detect the difference between manufactures,thus supports the optimization of the product.

关 键 词：复方乙酰水杨酸片 溶出度 溶出曲线 高效液相色谱 

分 类 号：R927[医药卫生—药学]