正交试验优选α-细辛脑明胶微球制备工艺

Preparation Technology of α-Asarone Gelatin Microspheres by Orthogonal Test

目的:优选α-细辛脑明胶微球的制备工艺。方法:采用乳化缩聚法制备α-细辛脑明胶微球,以明胶浓度、乳化剂用量、搅拌速度、投料比为考察因素,以载药量和包封率的综合评分为评价指标,采用正交试验优化工艺,并观察微球形态、粒径分布。结果:最优工艺为明胶浓度20%、乳化剂用量3.0mL、搅拌速度800r·min-1、投料比1∶2;所制得的微球球形圆整,平均载药量为3.98%,平均包封率为24.25%。结论:所选工艺稳定,各项质量指标良好。

OBJECTIVE ： To optimize the preparation process of a-asarone gelatin microspheres. METHODS ： α-asarone gelatin microspheres were prepared by emulsion polymerization methods. Preparation process was optimized by orthogonal test using the concentration of gelatin, amount of emulsifier, mixing speed and material ratio as factors with drug-loading amount and encapsula- tion efficiency ad index. Microspheres morphology was observed and particle size distribution of microspheres was plotted. RE- SULTS： The optimal technology was gelatin of 20%, emulsifier of 3.0 mL, mixing speed of 800 r. min-1, material ratio 1 ： 2. a-asarne gelatin microspheres were regular round in its morphology. The average drug-loading amount was 3.98%, and average encapsulation efficiency was 24.25%. CONCLUSION：Selected technology is stable with good quality index.