恩诺沙星β-环糊精包合物的制备

Preparation of enrofloxacin β-cyclodextrin inclusion complex

目的:探讨恩诺沙星β-环糊精包合物的制备工艺并对制剂进行质量考察。方法:采用饱和水溶液法制备恩诺沙星β-环糊精包合物,通过L9(34)正交试验设计,以药物的包封率为考察指标,综合评定后确定最佳制备工艺。结果:最佳包合条件恩诺沙星与β-环糊精比例为1:3、包合时间为1.5h、包合温度为60℃,平均包封率为50.01%。经差示扫描量热分析表明饱和水溶液法制备的恩诺沙星与β-环糊精形成包合物。结论:饱和水溶液法制备恩诺沙星β-环糊精包合物,方法简单、包封率较高、可操作性强。本课题为进一步研究恩诺沙星β-环糊精包合物提供了依据。

Objective：To investigate the preparation of the inclusion complex of enrofloxacin β-cyclodextrin（ENR-β-CD）and evaluate its quality.Methods：ENRβ-CD was prepared by saturated water solution method,and the formulation was optimized by L9（34） orthogonal experimental design,with drug encapsulation efficiency as index.Results：The optimum preparation conditions for inclusion were established as follows： the weight ratio of enrofloxacin and β-CD was1：3,inclusion temperature was 60℃ and inclusion time was 1.5h.Under the conditions,the average encapsulation efficiency was 50.01%.The formation of inclusion complex of ENR-β-CD was confirmed by DSC.Conclusion：ENR-β-CD is successfully prepared by the saturated solution,with a higher encapsulation efficiency and simplified operation,providing the scientific experimental basis for the further research of ENR-β-CD.