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以重均分子量50 000聚乳酸(polylactic acid,PLA)为载体,与一定比例的红霉素(erythromycin,EM)和醋酸泼尼松(prednisone acetate,PNA)混合制备复方红霉素延迟起释型缓释片。利用紫外分光光度法检测EM和高效液相法检测PNA在体外介质中的释药量。缓释片持续释放时间约为21天,EM平均含量为99.7 mg/片,RSD为0.82%;PNA平均含量为10.03 mg/片,RSD为0.93%。缓释片从第5天开始缓慢而平稳地释放,在初期的突释现象尤为显著。在21天内EM累积释放量为86.1%,PNA累积释放量为78.3%。结果表明:缓释片制备方法可行,释药性能良好,临床疗效显著。
Polylactic acid (PLA) with a weight average molecular weight of 50 000 was mixed with a certain proportion of erythromycin (EM) and prednisone acetate (PNA) to prepare a compound erythromycin delayed-release Sustained Release Tablets. Using UV spectrophotometry detection of EM and high performance liquid phase detection of PNA in vitro media release. Sustained release sustained release tablets for about 21 days, EM average content of 99.7 mg / tablet, RSD 0.82%; PNA average content of 10.03 mg / tablet, RSD 0.93%. The sustained-release tablets released slowly and steadily from the 5th day, especially in the early burst release. The cumulative release of EM was 86.1% and the cumulative release of PNA was 78.3% in 21 days. The results showed that the preparation method of sustained-release tablets is feasible, the drug release performance is good, and the clinical curative effect is remarkable.