摘要
目的 :地塞米松脂质体是本院研究的新剂型 ,本文从质量控制的主要方面 ,对其进行了研究。方法 :通过负染法 ,观察在透射电子显微镜下的形态 ;采用紫外系数倍率法测定地塞米松的含量 ;用MACROSEP首次测定了包封率。结果 :地塞米松脂质体属于胶体分散系范围 ,符合质量控制的要求 ;在 4～ 52 μg/ml浓度范围内线性关系良好 ,回收率在 98.2 8%～ 99.71%之间 ;包封率均在 80 %以上 ,包封效果良好。结论 :本文方法具有准确、快速、重现性好等特点 。
OBJECTIVE:To study the main aspects of quality control of dexamethasone liposomes.METHODS:The structure of liposomes was studied with negative staining method of TEM.K-ratio spectrophotometry was used to determine the content,and the Macrosep was used to seperate the entrapped from free drugs.RESULTS:An excellent linear relationship was obtained with the range of 4～52μg/ml,the average recovery percent was between 98.28%～99.71%.The entrapment efficiency was one of the important parameters of liposomes quality control.It was related with the clinical effect directly,the entrapment efficiency was more than 80%.CONCLUSION:This method is accurate,quick and reproducible.
出处
《药学实践杂志》
CAS
2001年第2期86-88,共3页
Journal of Pharmaceutical Practice
关键词
地塞米松
脂质体
系数倍率法
包封率
质量控制
dexamethasone
liposome
k ratio spectrophotometry
entrapment efficiency
