临时配制的布洛芬混悬液的稳定性与分剂量研究  

The Stability and Divided Dose Study of Extemporaneous Ibuprofen Suspension

作　　者：刘丽利 石磊 LIU Lili;SHI Lei(Department of Pharmacy,155 Hospital of Kaifeng,Kaifeng 475003,Henan,China)

机构地区：[1]开封一五五医院药剂科,河南开封475003

出　　处：《中国药物滥用防治杂志》2024年第11期2013-2015,2021,共4页Chinese Journal of Drug Abuse Prevention and Treatment

摘　　要：目的:探讨临时配制的布洛芬混悬液的稳定性与分剂量的准确性。方法:将片剂研磨成粉状分别加入到单糖浆和纯化水中配成混悬液,分别开展稳定性试验和分剂量试验,考察其在常温和冰箱(2~10℃)环境下72 h内的药物稳定性与0、4、8、24 h的分剂量准确性。结果:在稳定性试验中,放置72 h后两种混悬剂的浓度均在起始浓度的98.1%~100.7%范围之内;在分剂量试验中,在冰箱(2~10℃)环境下,以单糖浆为溶媒的除了0 h与4 h无显著性差异外,其他各个时段皆有显著性差异。以水为溶媒的大部分时段之间皆有显著性差异。在室温下,以单糖浆为溶媒的在24 h与0 h有显著性差异,其他时段皆无显著性差异,在4、8、24 h的分剂量浓度皆在准确的范围之内;而以水为溶媒的除了0 h与4 h无显著性差异外,其他时段之间皆有显著性差异。结论:在室温和冰箱(2~10℃)条件下,两种混悬液放置72 h后稳定性都较好;而在24 h内的分剂量试验中,只有在室温环境下以单糖浆为溶媒且放置时间至少24 h内分剂量相对准确。Objective:To investigate the stability and the accuracy of divided dose of extemporaneous ibuprofen suspension.Methods:In the experiment,tablets were crushed into powder and added to single syrup and pure water to make suspension respectively.Stability test and divided dose test were carried out respectively to investigate the drug stability and divided dose accuracy at 0,4,8,24 hours at room temperature and refrigerator(2℃-10℃).Results:In the stability test,the concentrations of the two suspensions were both within the range of 98.1%-100.7% of the initial concentration after 72 h.In the divided dose test,at refrigerator(2℃-10℃),there was no significant difference between 0 h and 4 h when single syrup was used as the solvent,and there was significant difference at all other periods.There were significant differences between most periods when purified water was the solvent.At room temperature,there was a significant difference between 24 h and 0 h when single syrup was used as solvent,but no significant difference in other periods.The divide dose concentrations at 4,8 and 24 h were all within the accurate range.Except that there was no significant difference between 0 h and 4 h when in pure water,there were significant differences between other periods.Conclusion:At room temperature and refrigerator(2℃-10℃),the two suspensions have good stability after 72 h.In the 24 h divided dose test,the dose is relatively accurate only when the single syrup is used as the solvent at room temperature and the storage time is at least 24 h.

关 键 词：布洛芬 稳定性 分剂量 单糖浆 

分 类 号：R942[医药卫生—药剂学]