地塞米松脂质体质量控制方面的研究
Studies on quality control of dexamethasone liposomes
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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4～52μg/ml浓度范围内线性关系良好,回收率在98.28%～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Abstract: 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.
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Key words:
- dexamethasone /
- liposome /
- k-ratio spectrophotometry /
- entrapment efficiency
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