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以熔点、融变时间、外观与硬度为指标,考察了聚乙二醇(PEG)的种类(PEG 400、PEG 600和PEG 1000)和组成比例对空白栓剂基质的影响。结果表明,以PEG 400和PEG 1000(25∶75)为混合基质的空白栓剂熔点和融变时间为30.3℃和19.3 min,外观呈均匀白色,硬度适宜。在此基础上,采用直接加入原料药粉末的方式,制备了空腔直径3 mm、距栓尾深度为1.8或2.3 cm的载布洛芬50 mg的两种小儿用中空栓。结果所得载药中空栓外观和硬度与空白栓剂相似,融变时间为18.4 min。以市售小儿布洛芬栓为对照,考察自制中空栓的体外溶出情况。结果显示,两种中空栓在20 min内均达到溶出平衡,溶出率大于90%;而市售品70 min时溶出率为79%,提示中空栓能达到快速释药的目的。
Melting point, melting time, appearance and hardness were taken as indexes to study the effect of PEG (PEG 400, PEG 600 and PEG 1000) and composition ratio on the blank suppository matrix. The results showed that the melting point and melting time of the blank suppository with PEG 400 and PEG 1000 (25:75) were 30.3 ℃ and 19.3 min, respectively. The appearance of the suppositories was uniform and the hardness was suitable. On this basis, hollow suppositories of two kinds for children with 50 mg of ibuprofen with a cavity diameter of 3 mm and a depth of the tail of 1.8 or 2.3 cm were prepared by directly adding powdered raw materials. Results The appearance and hardness of the drug-loaded hollow suppository were similar to those of blank suppository, and the thawing time was 18.4 min. Commercially available pediatric ibuprofen suppository was used as control to investigate the in vitro dissolution of homemade hollow suppository. The results showed that the two kinds of hollow suppository reached the equilibrium of dissolution in 20 min, the dissolution rate was more than 90%. The dissolution rate of the commercial product at 70 min was 79%, suggesting that the hollow suppository can achieve the purpose of rapid release.