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目的:建立复方阿司匹林控释片的释放度测定方法,以控制该控释片的质量。方法:模拟人体胃肠道的情况,先以盐酸液作溶出介质,经120min后,加入磷酸钠液调节介质pH值为6.8,以双波长紫外分光光度法测定在284nm和268nm两波长下的△A,从而测定其释放度。结果:回收率为(98.8±0.96)％,3个批号样品在24h时释放均较完全。结论:本文为复方阿司匹林控释片提供了简便、快速、准确的释放度检测方法。
OBJECTIVE: To establish a method for the determination of release of compound aspirin controlled release tablets in order to control the quality of the controlled release tablets. Methods: To simulate the situation of human gastrointestinal tract, hydrochloric acid was used as the dissolution medium first. After 120 minutes, the pH of the medium was adjusted to 6.8 by sodium phosphate solution and the difference between the two wavelengths at 284 nm and 268 nm was determined by dual-wavelength UV spectrophotometry A, to determine its release. Results: The recovery rate was (98.8 ± 0.96)%. The three lot samples were completely released at 24h. Conclusion: This paper provides a simple, rapid and accurate method for the determination of release of compound aspirin.