目的 优化脂质体包封率测定的方法,提高脂质体包封率测定结果的准确性.方法 以积雪草苷为模型药,建立HPLC法测定积雪草苷的含量;采用薄膜分散法分别制备空白脂质体与载药脂质体,利用微柱离心法分离脂质体与游离药物.分别将空白脂质体与纯化后的载药脂质体以及两者的稀释液过微柱,比较脂质体的过柱回收率.最终采用纯化脂质体的过柱回收率对所得包封率进行修正.结果 在所选定的分离条件下,空白脂质体的过柱回收率为95％,纯化后的载药脂质体的过柱回收率为88％,二者存在显著性差异(P＜0.05);脂质体稀释后,空白脂质体的过柱回收率无明显变化,而载药脂质体的过柱回收率则降至72.80％.结论 两种方法测定脂质体的过柱回收率差异较大.采用过柱回收率修正包封率,可使测得结果更为准确.%Objective To optimize the conditions for determination of the encapsulation efficiency of liposomes,and to improve the accuracy of determination.Methods An HPLC method was established to determine the contents of asiaticoside,which was used as an active pharmaceutical ingredient.Liposomes were prepared by the thin film dispersion method and separated from free drugs by micro-column centrifugation method.The recovery rates through the micro-column of blank liposomes and purified liposomes were compared,so were the diluted suspensions.The recovery rate of purified liposomes was used to correct the encapsulation efficiency.Results Under these separation conditions,the recovery rate of blank liposomes was 95％ and that of purified liposomes was only 88％.There was significant difference (P ＜0.05).When the two kinds of liposomes were diluted,the recovery rate of blank liposomes did not change,but that of purified liposomes decreased to 72.80％.Conclusion The two methods for determinnation can lead to quite different recovery rates of liposomes.The encapsulation efficiency can be made more accurate when corrected by the recovery rate.
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