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目的筛选及优化莫匹罗星微乳经皮给药系统。方法采用HPLC方法测定莫匹罗星在各辅料中的饱和溶解度和绘制伪三元相图,确定微乳处方所用辅料及K_m值。以粒径、稳定性及皮肤滞留量为考察指标,通过星点设计-效应面法优化微乳制剂处方。结果经过处方筛选及优化,确定莫匹罗星微乳最优处方为:20.3%MAISINE 35-1、13.23%吐温80、13.23%LABRASOL、26.46%TRANSCUTOLP和26.78%水。微乳粒径均匀,稳定性较好,皮肤滞留量为(45.07±2.03)mg·g~(-1),符合透皮微乳要求。结论本实验制得了符合要求的莫匹罗星微乳,为进一步研究奠定了良好的基础。
Objective To screen and optimize mupirocin microemulsion transdermal delivery system. Methods HPLC method was used to determine the saturation solubility of mupirocin in all excipients and the pseudo-ternary phase diagram was drawn to determine the excipients and K_m values of the microemulsion prescription. Taking particle size, stability and retention of skin as indexes, the formulation of microemulsion was optimized by the method of star point design-response surface. Results After prescription screening and optimization, the optimal formulation of mupirocin microemulsion was determined to be 20.3% MAISINE 35-1, 13.23% Tween 80, 13.23% LABRASOL, 26.46% TRANSCUTOLP and 26.78% water. The microemulsion size is uniform and the stability is good. The retention of skin is (45.07 ± 2.03) mg · g ~ (-1), which meets the requirements of transdermal microemulsion. Conclusion Mupirocin microemulsion that meets the requirements was obtained in this experiment, which laid a good foundation for further study.