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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 ,便于药厂和医院的快检
OBJECTIVE: Dexamethasone liposomes are the new formulations studied in this hospital. In this paper, the main aspects of quality control were studied. Methods: The morphology of the dexamethasone was observed by negative staining method under the transmission electron microscope. The content of dexamethasone was determined by the ultraviolet ratio magnification method. The entrapment efficiency was determined by MACROSEP for the first time. Results: The dexamethasone liposomes belonged to the range of colloidal dispersion, which met the requirements of quality control. The linearity ranged from 98.2 8% to 99.71% at the concentration range of 4 ~ 52 μg / ml. The encapsulation efficiency At more than 80%, the encapsulation effect is good. Conclusion: This method is accurate, rapid, reproducible and easy, so it is convenient for the rapid inspection of pharmaceutical factories and hospitals