利多卡因脂质体凝胶的制备及质量控制

目的:制备利多卡因脂质体凝胶,并建立其质量控制方法。方法:用薄膜分散法制备利多卡因脂质体,以卡波姆940为凝胶基质,制备利多卡因脂质体凝胶。以高效液相色谱法测定利多卡因含量,以离心法测定脂质体的包封率。结果:利多卡因检测浓度线性范围为2.5~25.0mg/ml(r=0.9996),平均回收率为(99.83±0.53)%;包封率为(82.7±1.83)%。结论:该脂质体凝胶制备工艺可行,性质稳定,质量控制方法简便、可靠。

Preparation and Content Determination of Lidocaine Liposome Gel

OBJECTIVE:To prepare lidocaine liposome gel and to establish its quality control method.METHODS:Li-docaine liposome was prepared using a film dispersion method and the liposome gels were prepared with carbomer-940as base.The concentration of lidocaine was determined by HPLC and the lipsome entrapment efficiency was determined by centrifuga-tion.RESULTS:The linear detection concentration range of lidocaine was2.5～25.0mg/ml(r=0.9996)with average re-covery at(99.83±0.53)%and entrapment efficiency at(82.7±1.83)%.CONCLUSION:This liposome gel is feasible in preparation techniques,stable in quality,convenient and reliable in quality control method.