复方红霉素延迟起释型缓释片的研制及其体外释放

Compound erythromycin sustained release preparation and its in vitro release

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。

Using the weight-average molecular weight 50 000 polylactic acid（PLA） as a carrier,and a certain proportion of erythromycin（EM） and prednisone acetate（PNA） to mixed prepare the compound erythromycin sustained release preparation（sustained-release tablets）.Using ultraviolet spectrophotometry and high performance liquid chromatography（HPLC） to detect separately the release amount of EM and PNA in vitro medium.The sustained-release tablets release for about 21 days,the average content of EM is 99.7 mg/table,RSD = 0.82%;and the average content of PNA is 10.03 mg/table,RSD = 0.93%.Within 21 days,the cumulative releases of EM and PNA are 86.1% and 78.3%,respectively.The drug release is steady and slow after 5 days,the burst release phenomenon in early stage is more significant.The results showed that the sustained-release tablet preparation method is feasible,the release performance is good and the clinical efficacy is significant.