灯盏花素泡腾干混悬剂的研制及体外评价  

Preparation and in vitro Evaluation of Breviscapine Effervescent Dry Suspensions

作　　者：陆静[1,2] 黄建明[3] 沈腾[3] 翁伟宇[1] 

机构地区：[1]华东理工大学药学院,上海200237 [2]葛兰素史克日用保健品中国有限公司,上海200001 [3]复旦大学药学院,上海201203

出　　处：《中国医药工业杂志》2017年第2期195-199,共5页Chinese Journal of Pharmaceuticals

摘　　要：为提高干混悬剂加水后的分散速率,本试验尝试在干混悬剂处方中加入泡腾剂。以灯盏花素为模型药物制备泡腾干混悬剂,考察了处方组成对制品分散速率、pH值、干燥失重和沉降体积比的影响,并测定了体外溶出性能和稳定性。结果表明,加入泡腾剂可显著提高干混悬剂加水后药物的分散速率,但泡腾剂用量大时会在液面形成大量浮沫;助悬剂的种类和用量显著影响浮沫的存留时间。优选的泡腾干混悬剂加水后分散时间约15 s,浮沫少且易消退,沉降体积比为0.96±0.02,药物溶出迅速(5 min大于90%),其余质量指标亦均符合规定。湿度是影响泡腾干混悬剂稳定性的主要因素,成品须防潮包装。The aim of this study was to investigate the feasibility of adopting the effervescent agent to increase the dispersion rate of dry suspensions in water. Formulations of effervescent dry suspensions （EDS） were developed with breviscapine as the model drug, and the influences of formulation compositions on dispersion rate, pH value, loss on drying, and sedimentation volume ratio of EDS were investigated. The in vitro dissolution profiles and stability were also evaluated. The results showed that the dispersion rate was increased significantly when effervescent agents were adopted. However, excessive amount of effervescent agent would result in a thick layer of foams on suspension surface. The type and amount of suspending agents greatly influenced the lasting time of formed foams. The optimized EDS would be dispersed uniformly within 15 s after water addition, and produced little fragile foams. The sedimentation volume ratio was 0.96±0.02. The dissolution of breviscapine from EDS was very rapid （〉90 % within 5 min）. Other quality control parameters were within acceptable ranges. Humidity was the major factor affecting the stability of EDS, which suggested that EDS should be substantially enclosed in a moisture proof package.

关 键 词：干混悬剂 泡腾 灯盏花素 分散 溶出 稳定性 

分 类 号：R944.9[医药卫生—药剂学]