左旋多巴微囊漂浮片的处方优选

Formula Optimization of Levodopa Microcapsules Floating Tablets

目的:优选左旋多巴微囊漂浮片的处方。方法:高效液相色谱法测定左旋多巴与苄丝肼的含量,以漂浮片释放度得分为指标,采用正交试验优选左旋多巴微囊漂浮片的处方,并对其体外释药特性进行评价。结果:建立的测定左旋多巴胃内漂浮片中左旋多巴与苄丝肼含量的高效液相色谱法,符合方法学要求。优化的微囊漂浮片处方组成为硬脂酸:主药:丙烯酸树脂:HPMC=2∶5∶2∶1,平均片重为550 mg。验证试验结果表明该微囊漂浮片具有漂浮、缓释、可分剂量使用等特性。结论:优选出的复方左旋多巴微囊漂浮片处方合理,生产工艺稳定、可行。

To optimize the formula of levodopa microcapsules floating tablets. Methods：The contents of levodopa and benserazide in the microcapsules floating tablets were determined by HPLC simultaneously. The release rate as the index, an orthogonal design was used to optimize the formula and preparation technology of levodopa microcapsules floating tablets. The release property of the microcapsules floating tablets was evaluated. Results：The HPLC method for the in vitro determination of levodopa and benserazide in the floating tablets met the methodological requirements. The selected formula was as following：the amount ratio of stearic acid, the drugs, acrylic resin and HPMC was 2∶5∶2∶1. The average weight of the tablets was 550 mg. The results of validated tests showed that the microcapsules floating tablets had floating and sustained release property, which could be used by divided dose. Conclusion： The optimized formula of the microcapsules floating tablets is reasonable, and the production process is stable and feasible.