银黄充液胶囊制剂工艺研究

Study on preparation process of Yin Huang liquid capsule

目的:筛选中药银黄充液胶囊的最佳处方并开展相关质量研究。方法:通过考察调配处方外观、分散试验、沉降试验等项目确定最佳处方组成,考察不同稀释剂、助悬剂及其用量对制剂分散效果的影响,优选最佳处方。结果:优选处方以75%聚乙二醇400为分散基质,以1.6%聚山梨酯80为助溶剂,将金银花、黄芩提取物与各辅料在50℃混匀灌装封口,混合物混悬性能好。结论:该处方工艺优选合理,质量检查及稳定性试验均符合要求,体外溶出试验表明中药银黄充液胶囊溶出效率优于普通银黄胶囊。

[Objective] To screen the best prescription of Chinese herbal medicine Yin Huang liquid caspsule. [Method]To determine the best prescription composition w ith the investigation of the distribution of the prescription,the dispersion and the settlement test. To optimize the best prescription composition by investagatingthe effect of different diluent,the suspending agent and the dosage of the suspension. [Result]Optimized prescription consisted of 75% PEG 400 as base material,1. 6% polysorbate 80 ascosolvent,and honeysuckle,scutellaria root extract mixed w ith the filling. All compositions w ere mixed uniformly and sealed at 50 C,w hich have a good suspension performance. [Conclusion]The optimized formulation process is reasonable,as quality inspection and stability w ere eligible. The result of in vitro dissolution test show ed that the dissolution efficient of medicine Yin Huang filled is superior compared w ith ordinary Yin Huang capsule.