往复筒法测定阿司匹林肠溶片的溶出曲线  

Characterization of Dissolution Profiles for Aspirin Enteric Coated Tablets by Reciprocating Cylinder Apparatus

作　　者：张馨月 邹文博[2] 刘伟[2,3] 孙春萌[1] 史继锋[4] 宁保明 ZHANG Xinyue;ZOU Wenbo;LIU Wei;SUN Chunmeng;SHI Jifeng;NING Baoming(School of Pharmacy,China Pharmaceutical University,Nanjing 211198;Key Lab.of Research and Evaluation of Chemical Drug Quality,Key Lab.of National Medical Products Administration,National Institutes for Food and Drug Control,Beijing 102629;Yantai University,Yantai 264005;Beijing Kawin Technology Share-Holding Co.,Ltd.,Beijing 102199)

机构地区：[1]中国药科大学药学院,江苏南京211198 [2]中国食品药品检定研究院,国家药品监督管理局重点实验室,化学药品质量研究与评价重点实验室,北京102629 [3]烟台大学,山东烟台264005 [4]北京凯因科技股份有限公司,北京102199

出　　处：《中国医药工业杂志》2024年第5期698-703,共6页Chinese Journal of Pharmaceuticals

摘　　要：考察往复频率、上下筛网孔径等因素在往复筒法溶出条件下对阿司匹林肠溶片溶出行为的影响,建立了用往复筒法测定阿司匹林肠溶片溶出度的方法,测定不同处方制剂的体外溶出曲线。用f_(2)-bootstrap法评价参比制剂和其他处方制剂的溶出曲线,得到处方A、处方B、处方C和处方D的制剂与参比制剂溶出曲线的相似因子(f_(2))分别是81.4、33.5、20.9、17.9。证明处方A制剂与参比制剂的溶出曲线相似,处方B、处方C和处方D制剂与参比制剂溶出曲线不相似。将往复筒法测得的溶出评价结果与篮法进行比较,说明采用往复筒法测定阿司匹林肠溶片溶出行为具有良好的区分力和耐用性,为往复筒法在药品质量评价中的应用提供参考。Investigating the impacts of reciprocating frequency and screen aperture on the dissolution behavior of aspirin enteric-coated tablets.Establishing a reciprocating cylinder method for determining the dissolution of aspirin enteric coated tablets,to figure out the in vitro dissolution profiles for different formulations.The dissolution behavior of reference listed drugs and 4 test formulations was evaluated by f_(2)-bootstrap method,the similarity factor(f_(2))of the dissolution profiles between formulations A,B,C,D and reference listed drugs was 81.4,33.5,20.9 and 17.9.The dissolution profiles of formulation A and reference listed drugs were similar,however,the dissolution profiles of formulation B,C and D were different.Compared with basket apparatus,using reciprocating cylinder is a discriminative and durable method for dissolution behavior characterization of aspirin enteric-coated tablets,providing reference for the application of reciprocating cylinder method in drug quality evaluation.

关 键 词：阿司匹林肠溶片 往复筒法 体外溶出曲线 

分 类 号：R944.4[医药卫生—药剂学] R917[医药卫生—药学]