利多卡因脂质体凝胶的制备及质量控制

Preparation and Content Determination of Lidocaine Liposome Gel

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。

OBJECTIVE： To prepare lidocaine liposome gel and to establish its quality control method. METHODS： Lidocaine liposorne was prepared using a film dispersion method and the liposome gels were prepared with carborner 940 as base. The concentration of lidocaine was determined by HPLC and the lipsorne entrapment efficiency was determined by centrifugation. RESULTS： The linear detection concentration range of lidocaine was 2.5～25.0mg/ ml（r = 0.9 996） with average recovery at （99.83 ± 0.53）% and entrapment efficiency at （82.7±1.83）%. CONCLUSION： This liposorne gel is feasible in preparation techniques, stable in quality, convenient and reliable in quality control method.