氟康唑立方液晶凝胶的评价

摘要

目的 对氟康唑立方液晶凝胶进行表征,建立氟康唑含量测定方法. 方法 以甘油单油酸酯( GMO)为液晶材料制备氟康唑立方液晶凝胶,偏光显微镜及小角X衍射仪( SAXS)对氟康唑立方液晶凝胶进行表征;采用高效液相色谱法测定立方液晶凝胶中氟康唑的含量. 结果 立方液晶凝胶在偏光显微镜( PLM)下为暗视野;SAXS显示空白立方液晶凝胶中出现2个信号峰,分别是q1 (0.832 09 nm-1 ) 和q2 (1.017 nm-1 );氟康唑立方液晶凝胶中出现2个信号峰,分别是q1 (0.818 88 nm-1 )和q2 (0.950 95 nm-1 ). 高效液相色谱法测定立方液晶凝胶中氟康唑在20~500 μg/ml范围内线性关系良好. 结论 PLM及SAXS适宜于立方液晶凝胶表征,高效液相测定方法可用于氟康唑立方液晶凝胶的质量控制和评价.%Objective To characterize the internal structures of fluconazole-loaded cubic phase gels and establish a method for determination of fluconazole.Methods Glycerol monooleate( GMO) was used as the liquid crystal material to prepare the fluconazole loaded cubic phase gels.Polarizing light microscopy ( PLM ) and small-angle X-ray scattering ( SAXS) were used to confirm their internal structures and establish an HPLC method for determination of their content. Results Cubic phase gels were the dark field under PLM,SAXS showed that the blank cubic phase gels had two single peaks:q1(0.832 09 nm-1 ) and q2 (1.017 nm-1 ) while the fluconazole-loaded cubic phase gels had two single peaks:q1(0.818 88 nm-1)and q2(0.950 95 nm-1).Under the selected HPLC, the linearity within the range of 20-500 μg/ml was good.Conclusion PLM and SAXS are reliable for characterization of cubic phase gels.The HPLC method can be used in quality control and evaluation of this enema.