6种市售阿司匹林肠溶片的体外溶出试验比较  

Comparison of dissolution tests among 6 kinds of commercialized enteric- coated tablets of aspirin

作　　者：吕剑[1] 卢恩先[1] 江志强[2] 

机构地区：[1]复旦大学药学院药剂学 [2]复旦大学药学院药剂学教研室,上海200032

出　　处：《中国临床药学杂志》2001年第5期296-298,共3页Chinese Journal of Clinical Pharmacy

摘　　要：目的：考察６种市售阿司匹林肠溶片的体外溶出，以评价其内在质量。方法：采用转篮法进行体外溶出试验，用紫外分光光度法检测溶出液中药物浓度，计算累积释放量。以威布尔分布拟合溶出参数，由双侧ｔ检验对组间溶出参数进行统计学分析。结果：６种阿司匹林肠溶片在酸性介质（０．１ｍｏｌ／Ｌ盐酸）及ｐＨ ６．８磷酸盐缓冲液中的溶出均符合中国药典要求；拜阿司匹灵与其他５种阿司匹林肠溶片的体外释放速度具有显著性差异（Ｐ＜０．０５），前者慢于后者。结论：６种制剂的体外溶出均符合中国药典的要求，但制剂间体外释放速度存在显著差异。AIM: To investigate if the dissolution results in vitro of 6 kinds of the commercialized en- teric-coated tablets of aspirin are fitted in with the requirements of Pharmacopoeia of People's Republic of China, and if there are differences among 6 kinds of the enteric-coated tablets. METHODS: The dissolu- tion tests were carried out in dissolution test system with the rotating basket. The ultraviolet chro- matograph assay was used to determine the concentration of aspirin in different dissolution media. The cu- mulative dissolution percent of the labelled amount was calculated and the Weibubll's equation was used to model the main dissolution parameters according to the dissolution data. The differences between different groups were statistically evaluated by a two-tails student's t-test. RESULTS: The dissolution results of 6 kinds of aspirin tablets all were fitted in with the requirements of the Pharmacopoeia during dissolution testing either in acidic medium (0.1mol/L HCl)or in pH 6. 8 phosphate buffer solution. The dissolution rates of other 5 preparations were remarkably rapid than that of preparation 1. CONCLUSION: The disso- lution difference among 6 kinds of enteric-coated tablets of aspirin will induce different effects on their pre- vention or therapeutic use during long-term use of low-dose aspirin for cardiovascular prophylaxis.

关 键 词：阿司匹林 肠溶片 小剂量 体外溶出 转篮法 

分 类 号：R944[医药卫生—药剂学]