氢溴酸高乌甲素分散片的处方优化及制备

目的:制备氢溴酸高乌甲素分散片,并对其处方进行优化。方法:湿法制粒压片法制备氢溴酸高乌甲素分散片。以崩解时限、口感、片面光洁度为指标进行处方筛选,并采用正交实验设计优化处方。结果:最佳处方为氢溴酸高乌甲素-阿司帕坦-薄荷香精5∶5∶1;交联聚维酮6%;乳糖:微晶纤维素2∶1;硬度5 kg。所制片剂片面光洁,口感良好,崩解分散快,分散均匀性符合药典相关要求,释药速度较普通片快,10 min内溶出即达80%以上。结论:优化后的氢溴酸高乌甲素分散片制备方法简单,崩解迅速,分散均匀,溶出速度快,达到了设计要求。

Preparation of lappaconitine hydrobromide dispersible tablets

OBJECTIVE To prepare lappaconitine hydrobromide dispersible tablets.METHODS Lappaconitine hydrobromide dispersible tablets were prepared with wet granulation method.The formulation was optimized with taste,disintegration time and appearance of tablets as reference parameters by an orthogonal design.RESULTS The optimized formulation was as follows:the ratio of lappaconitine hydrobromide,aspartame and peppermint essence was 5∶5∶1,PVPP 6%,lactose:MCC was 2∶1 and the hardness of tablets was about 5 kg.The dispersible tablets were integrity and smooth with desirable taste,and disintegrated rapidly.The dissolved amount of lappaconitine hydrobromide dispersible tablets was more than 80% within 10 min.CONCLUSION The preparation method was simple and the dispersible tablets dissolved faster than the marketed lappaconitine hydrobromide tablets.