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。 In order to increase the dispersion rate of the dry suspension after addition of water, this experiment attempts to add effervescent agent in the dry suspension formulation. Effervescent drug was used as model drug to prepare effervescent dry suspension. The effects of prescription composition on product dispersion rate, pH value, weight loss on drying and sedimentation volume ratio were investigated. The dissolution performance and stability in vitro were determined. The results showed that the addition of effervescent agent can significantly improve the dispersion rate of the drug after the dry suspension is added with water, but the large amount of effervescent agent will form a lot of foam in the liquid surface; the type and amount of suspending agent significantly affect the retention of the froth time. The preferred effervescent dry suspension has a dispersing time of about 15 s after adding water, with little and easily defoaming. The settling volume ratio is 0.96 ± 0.02 and the drug is rapidly eluted (5 min and greater than 90%). The remaining quality indexes also meet the requirements. Humidity is the main factor affecting the stability of effervescent dry suspensions. Finished products should be moisture-proofed.