金银花枝叶提取物口腔崩解片的制备及质量评价

Preparation and Quality Evaluation of Honeysuckle Branches and Leaf Extract Orally Disintegrating Tablets

[目的]制备金银花枝叶提取物口腔崩解片并对其品质进行评价和考察。[方法]采用单因素法初步筛选工艺参数,在此基础上,采用响应面优化法确定最佳工艺参数。[结果]最终优化的处方为金银花提取物19.3%、交联聚乙烯吡咯烷酮(PVPP)9.6%、微晶纤维素(MCC)26.6%、低取代羟丙基纤维素5.0%、桔子香精∶甘露醇∶阿司帕坦=1∶4∶1,制得的口腔崩解片在30 s内崩解完全,口感良好。[结论]该处方和工艺制得的金银花枝叶提取物口腔崩解片质量上乘,达到设计要求。

[Objective] The aim was to prepare honeysuckle branches and leaf extract oral disintegrating tablet and evaluate its quality.[Method]Single-factor method was adopted to screen out the process parameters,on the basis of this,response surface methodology was used to optimize the technique parameters.[Result] The optimized formulation was as follows：19.3% honeysuckle extract,9.6% cross-linked polyvinylpyrrolidone,26.6% microcrystalline cellulose and 5.0% L-HPC.Orange flavor：mannitol：aspartame ratio was 1∶ 4∶ 1.The prepared tablets disintegrated totally within 30 s and tasted good.[Conclusion] The honeysuckle extract orally disintegrating tablets obtained by this prescription and process have good qualities and meet the design requirements.