广藿香油-β-环糊精包合物胶囊的制备及稳定性研究

采用饱和水溶液法制备广藿香油(Oleum Pogostemonis)-β-环糊精包合物,并进一步制备胶囊.设计单因素试验和正交试验考察广藿香油与β-环糊精的比例、包合时间、包合温度对包合物指标的影响,优化包合条件.结果表明,广藿香油与β-环糊精质量比为1∶7、包合温度为50℃、包合时间为3h时,包合物收率为90.84％、包合物含油率为14.93％、广藿香油收率为92.63％,综合评分结果最高.对包合物用薄层色谱法(TLC)进行验证,表明包合物已经形成.每50g包合物中添加0.5 g硬脂酸镁,所得胶囊休止角最小,水分、装量差异和崩解时限均符合《药典》规定.稳定性检测结果表明广藿香油-β-环糊精包合物胶囊对光、热、湿的稳定性明显高于广藿香油与β-环糊精的物理混合物.

Study on the Preparation and Stability of Oleum Pogostemonis-β-Cyclodextrin Inclusion Compound Capsule

Oleum Pogostemonis-β-cyclodextrin(β-CD) inclusion compound was prepared by saturated water solution method,and then was used for production of capsules.The effects of Oleum Pogostemonis to β-CD mass ratio,inclusion time and temperature on the indices of compound were studied by single tests and orthogonal design.The optimum compound preparation conditions were as follows,Oleum Pogostemonis to β-CD mass ratio,1∶7;inclusion temperature,50 ℃;and inclusion time,3 h.The yield of inclusion compound,oil content in compound and recovery rate of oil in the inclusion obtained under these conditions was 90.84%,14.93% and 92.63% respectively,of which the comprehensive scores was the highest.Thin-layer chromatography(TLC) test proved the formation of inclusion compound.Angle of repose(θ) was the smallest when 0.5 g magnesium stearate was added in every 50 g inclusion compound to make capsules.The moisture content,gross deviation and disintegration of capsule conformed to the Pharmacopoeia.And the stability of capsules to lights,heat and humidity was obviously higher than its physical mixture.