多西他赛微乳制剂的研究

Study on Docetaxel Microemulsion Formulation

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 formulation for injection and investigate the stability. Methods Pseudo-ternary phase diagram was used to prepare microemulsion phase diagrams and the optimized formulation was chosen. The stability of the system is well by evaluating the content, size, viscosity, conductivity,refractivity. Results The best prescription composition to be determined was Docetaxel/Miglyol 812/SbPC/HS-15/PEG400/Ethanol/Water （6.4/9.6/6/6/8.4/3.6/60g）. The solubility of IEE in the optimized microemulsion formulation was 64mg/ml. Conclusion Processing of Docetaxel microemulsion is reasonable with perfect stability.