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目的制备多西他赛微乳并考察其稳定性。方法利用伪三元相图法确定微乳区域,通过对微乳的含量、粒径考察筛选最优处方,根据含量、粒径、电导率及折光率等理化性质考察微乳的稳定性。结果最佳微乳处方组成为Docetaxel/Miglyol 812/SbPC/HS-15/PEG400/Ethanol/Water(6.4/9.6/6/6/8.4/3.6/60g),最大载药量为64 mg/mL,该微乳体系稳定性良好。结论多西他赛微乳制剂工艺合理,稳定性好。
Objective To prepare docetaxel microemulsion and investigate its stability. Methods The pseudo-ternary phase diagram method was used to determine the microemulsion region. The optimum formulation was screened for the content and particle size of the microemulsion. The stability of the microemulsion was investigated according to physicochemical properties such as content, particle size, conductivity and refractive index. Results The best microemulsion formulation consisted of Docetaxel / Miglyol 812 / SbPC / HS-15 / PEG400 / Ethanol / Water with a maximum loading of 64 mg / mL, The microemulsion system has good stability. Conclusion Docetaxel microemulsion has a reasonable process and good stability.