丙酸氯倍他索脂质体的制备和豚鼠湿疹模型药效学研究

Preparation of clobetasol propionate liposome and its pharmacodynamics study on guinea pig eczema model

目的:制备丙酸氯倍他索(CP)脂质体并考察其稳定性,以及对豚鼠湿疹模型的药效学研究。方法:采用旋转薄膜蒸发法制备CP脂质体,考察样品中主药含量,粒径,包封率等指标的初步稳定性。并采用高倍镜下真皮炎症细胞浸润数进行不同制剂对豚鼠湿疹模型的药效学研究。结果:样品主药含量为(100.84±2.0)%,平均粒径(140.5±56.8)nm,包封率为(90.1±2.3)%。初步稳定性考察结果提示在三种不同储存留样条件下,样品含量、粒径、包封率等关键指标均无明显改变。豚鼠湿疹模型药效学研究结果表明:脂质体组与乳膏组在真皮炎症细胞计数上差异有统计学意义。结论:所制制剂包封率较高,稳定性良好,疗效高于上市乳膏。

Objective：To prepare clobetasol propionate liposome, investigate its stability and study its pharmacodynamies on guinea pig eczema model. Methods： Clobetasol propionate liposome was prepared with revolution thin film dispersion. The stability of indices,sueh as the content of the principal agent,grain size,encapsulation efficiency,was investigated. The pharmacodynamies of different preparation on guinea pig eczema model were studied by evaluating cellular infiltrates in dermis. Results：The content of the principal agent,grain size and encapsulation efficiency of liposome were （100.84 ± 2.0）%, （140.5 ± 56.8）nm, （90.1± 2.3 ）%, respectively. No obvious changes were found in all the indices in the stability of liposome under three different storage condition. There was signifleant difference in cellular infiltration in dermis of CP liposome group and commercial CP cream group. Conclution： The preparation was proved to be of high encapsulation efficiency, good stability and better curative effect than cream.