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目的:研究苦参碱隐形脂质体的包封率测定方法,考察其体外释放度。方法:采用硫酸铵梯度法制备苦参碱隐形脂质体;用葡聚糖凝胶G-100柱分离脂质体和游离药物,并用反相高效液相色谱法测定脂质体的包封率;用《中国药典》中溶出度第二法测定其体外释放度。结果:制得脂质体的包封率为52.40%;苦参碱检测浓度的线性范围为0.005～0.200mg·mL-1(r=0.999 9);平均回收率为98.36%(RSD=0.95%);脂质体的体外释放规律符合Higuchi方程。结论:本方法简单、快速、准确、重现性好,可用于该脂质体的包封率和体外释放度的测定。
Objective: To study the method of determination of the encapsulation efficiency of matrine liposomes and investigate its in vitro release. METHODS: Matrine Stealth liposomes were prepared by ammonium sulfate gradient method; liposomes and free drugs were separated by Sephadex G-100 column, and the entrapment efficiency of liposomes was measured by RP-HPLC. The dissolution rate was determined in vitro using the second dissolution method in the Chinese Pharmacopoeia. RESULTS: The entrapment efficiency of liposomes was 52.40%, and the linear range of matrine was 0.005-0.200 mg·mL-1 (r=0.999 9). The average recovery was 98.36% (RSD=0.95%). The in vitro release of liposomes conforms to the Higuchi equation. Conclusion: This method is simple, rapid, accurate and reproducible. It can be used for the determination of the entrapment efficiency and in vitro release of the liposomes.