奥沙利铂-姜黄素脂质体复合物的制备及质量评价

目的：制备共载奥沙利铂-姜黄素脂质体复合物，并对其质控方法进行评价。方法：采用薄膜分散-被动载药技术制备脂质复合物，建立高效液相色谱法测定脂质体复合物含量及包封率，采用Malvern粒度仪测定Zeta电位、动态光散射技术测定粒度与粒度分布。结果：奥沙利铂-姜黄素脂质体复合物的包封率分别为99.02%、97.97%，Zeta电位为（-8.36±1.8） mV；平均粒径为（134.6±1.9） nm，D10（99.2±2.2） nm，D50（137±1.7） nm，D90（189±1.1） nm，D100（248±1.6） nm；脂质体复合物于5℃±3℃稳定性考察6个月，各项考察指标均在标准规定范围内。结论：该技术适合奥沙利铂-姜黄素脂质体复合体的制备，建立的质控方法简单、准确，适合对该脂质体复合物的性质进行评价。

Preparation and Quality Evaluation of Liposome Complex of Oxaliplatin and Curcumin

ABSTRAC T Objective: To prepare liposome complex loading oxaliplatin and curcumin, and evaluate its pharmaceutical properties. Methods: A film dispersion-passive drug-loading technology was used to entrap oxaliplatin and curcumin for preparing liposome complex. An HPLC method was established for determining oxaliplatin and curcumin. The mean diameter of liposome complex was determined by dynamic light scatter-ing (DLS) techniques. Results: The entrapment efficiency of oxaliplatin and curcumin was 99.02% and 97.97%, respectively. The Zeta potential was (-8.36±1.8) mV, and the mean diameter was (134.6±1.9) nm with D10 at (99.2±2.2) nm, D50 at (137±1.7) nm, D90 (189±1.1) nm and D100 at (248±1.6) nm. The inspection indexes of the liposome complex met the specification of stability test for 6 months at (5℃±3℃). Conclu-sion: The technology is fit to prepare the liposome complex of oxaliplatin and curcumin. The analysis method is simple and accurate which can be used to evaluate the property of the liposome complex.