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目的:研制尼美舒利(NIM)乳胶剂。方法:用剪切-高压均质法制备NIM亚微乳,并对其体外透皮扩散进行考察,再与凝胶基质混合制成NIM乳胶剂。对其处方及制备工艺进行了正交筛选,对其粒径、稳定性及体外透皮效果进行了考察。结果:用最佳处方及制备工艺制备的NIM亚微乳平均粒径为182.8nm,不耐强光及高温,体外透皮效果与NIM凝胶相比有明显改善,累积透过量Q有显著性差异(P<0.05),稳态透皮速率J有非常显著性差异(P<0.01)。结论:NIM乳胶剂具有较好的促进NIM透皮扩散作用,值得进一步研发。
Objective: To develop nimesulide (NIM) latex. METHODS: NIM submicroemulsions were prepared by shear-high pressure homogenization and investigated in vitro transdermal diffusion. The NIM latex was then mixed with the gel matrix. The prescriptions and the preparation process of the orthogonal screening, its particle size, stability and in vitro transdermal effect were investigated. Results: The average particle size of NIM submicroemulsion prepared by the best prescription and preparation process was 182.8nm, which was not resistant to strong light and high temperature. The in vitro transdermal effect of NIM submicroemulsion was significantly improved compared with that of NIM gel. The cumulative permeation Q was significant (P <0.05), steady-state transdermal rate J had a very significant difference (P <0.01). Conclusion: NIM latex has a good effect of promoting NIM transdermal diffusion and deserves further research.