摘要
目的筛选独一味黄酮类有效部位充液胶囊的最佳处方。方法通过测定相对湿度60%环境下囊壳水分平衡后内容物中含水量,考察含水量不同的聚乙二醇400(PEG400)对胶囊壳脆性的影响;考察不同稀释剂、助悬剂及其用量对制剂分散效果的影响,确定最佳处方;采用放置观察法考察封口乙醇的体积分数对封口效果的影响;采用紫外分光光度法测定独一味黄酮类有效部位充液胶囊在60min内的溶出度。结果最优处方选用含水量10%的PEG400为稀释剂;PEG400、PMC-K15M、独一味干粉膏质量比为48:2:6,抑菌剂为质量分数0.15%的尼泊金乙酯;选用50%的乙醇封口;45min内累积溶出度达到85%以上。结论该处方设计合理,溶出度符合要求,可用于充液胶囊的制备。
Objective To optimize the formulation of liquid hard capsules containing the active fraction of flavonoids in herba lamiophlomis.Methods A series of experiments were carried out for the choice of diluents、suspending agents.The dissolution rate of the active from the capsules was determined by ultraviolet spectrophotometry.Results The optimized formulation used PEG400(containing 10 % water) as the solvent, and the herba lamiophlomis loaded liquid hard capsules were prepared with the weight ratio of PEG400, HPMC-K15M and drug 48:2:6.More than 85 % of the drug can be released from the capsule in 45 min.Conclusion The herba lamiophlomis liquid hard capsules fit the requirement of the Chinese pharmacopoeia.
出处
《中国药剂学杂志（网络版）》
2009年第3期108-114,共7页
Chinese Journal of Pharmaceutics：Online Edition
关键词
药剂学
充液胶囊
紫外分光光度法
独一味
处方
pharmaceutics
liquid hard capsules
ultraviolet spectrophotometry
herba lamiophlomis
formulation
