CAJ | 학술논문

目的：研究聚乙二醇6000对间尼索地平溶解度和体外溶出度的影响,为间尼索地平剂型的选择提供参考。方法以聚乙二醇(PEG)6000为载体,采用溶剂-熔融法制备间尼索地平固体分散体。应用差示扫描量热分析法( DSC)、X射线粉末衍射光谱( XRD)对固体分散体进行鉴定,紫外分光光度法测定固体分散体的溶解度和体外溶出度。结果固体分散体的DSC、XRD图谱与原料药及其物理混合物均不同,不同比例的间尼索地平-聚乙二醇固体分散体的溶解度及体外溶出度均高于原料药,2 h的溶出百分率：原料药26.80%,固体分散体(13,15,17)分别为35.31%,38.71%,41.48%,比例相同的固体分散体的溶出率高于其物理混合物。结论间尼索地平与聚乙二醇6000形成了低共熔物,聚乙二醇6000作为间尼索地平的载体,可加速其体外溶出。
목적：연구취을이순6000대간니색지평용해도화체외용출도적영향,위간니색지평제형적선택제공삼고。방법이취을이순(PEG)6000위재체,채용용제-용융법제비간니색지평고체분산체。응용차시소묘량열분석법( DSC)、X사선분말연사광보( XRD)대고체분산체진행감정,자외분광광도법측정고체분산체적용해도화체외용출도。결과고체분산체적DSC、XRD도보여원료약급기물리혼합물균불동,불동비례적간니색지평-취을이순고체분산체적용해도급체외용출도균고우원료약,2 h적용출백분솔：원료약26.80%,고체분산체(13,15,17)분별위35.31%,38.71%,41.48%,비례상동적고체분산체적용출솔고우기물리혼합물。결론간니색지평여취을이순6000형성료저공용물,취을이순6000작위간니색지평적재체,가가속기체외용출。
Objective To investigate the influences of polyethylene glycol on the solubility and in vitro dissolution of m-nisoldipine,which could provide guidance for chosing formulations of m-nisoldipine. Methods Solid dispersions of m-nisoldipine were prepared by solvent-melting method with polyethylene glycol6000 matrix. DSC and XRD spectroscopy were applied to identify the solid dispersions. The solubility and in vitro dissolution were detected by UV spectroscopy. Results The DSC and XRD map were different from the crude drug and their physical mixtures. The dissolution rates(13,15,17) were faster(35. 31%,38. 71%,41. 48%) than that of the crude drug(26. 80%),and the dissolution rates of the solid dispersions in the same ratio were higher than the physical mixtures. Conclusion DSC analysis indicated that eutectic compounds were produced by the m-nisoldipine and polyethylene glycol,in which polyethylene glycol6000 acts as a carrier. The solubility and in vitro dissolution of m-nisoldipine can be increased.