葛根素固体自微乳制剂的制备及其质量评价

Preparation of Puerarin Solid Self-microemulsifying Drug Delivery System and Quality Evaluation of It

目的:制备葛根素固体自微乳制剂,并评价其质量。方法:通过改变处方组成、稀释倍数、介质、温度等考察影响自微乳化效率和粒径大小的因素,采用激光粒度分析仪测定成乳后粒径,并通过透射电镜对成乳后的微乳进行形态学观察;通过3个月的加速试验考察葛根素固体自微乳的稳定性。结果:处方组成、温度等因素对自微乳化效率和粒径大小都有影响;稀释倍数、分散介质等在一定范围内影响不大。葛根素固体自微乳成乳后为圆球形,平均粒径为30nm。结论:葛根素固体自微乳粒径小,稳定性好。

OBJECTIVE： To prepare Puerarin solid self-microemulsifying drug delivery system （SMEDDS）, and to evaluate its quality. METHODS： The influencing factors of the efficiency of self-emulsifying and the particle size were investigated by changing the formulation composition, dilution,medium, temperature etc. The particle size was determined by the laser particle size analyzer, and the morphology was investigated by TEM. Besides, the stability of Puerarin solid SMEDDS was studied by 3 months of accelerated test. RESULTS ： The composition, temperature, etc. had some impactions to the efficiency of self-emulsifying and particle size, but the dilution, dispersion, etc. had little effect in a certain range. Puerarin solid SMEDDS was round after it was dissolved into ME and the average diameter was 30 nm. CONCLUSION： Puerarin solid SMEDDS are stable with small particle size.