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目的制备连翘种子油自乳化释药系统,并进行体外评价。方法通过溶解度试验、正交筛选和相图绘制,以体外乳化效果、乳化平衡时间、乳剂粒径大小及分布为指标,筛选最佳处方并找出自乳化区域。通过考察该制剂的乳滴形态、粒径大小、分布、ξ电位、自乳化速度以及稳定性来进行体外评价。结果最佳处方组成为连翘种子油-聚山梨酯80-乙醇(45∶41∶14),乳化后乳滴呈规则的圆形,分布均匀,有效粒径90.9 nm,自乳化速度快,5 min之内达到平衡,强光,低温,冷热交替放置10 d以及长时间室温放置3个月条件下稳定性良好。结论连翘种子油自乳化释药系统制备工艺简单,性质稳定,方便吸收,易于生产。
Objective To prepare the self-emulsifying drug delivery system of Forsythia suspensa seed oil and evaluate its in vitro. Methods Solubility test, orthogonal screen and phase diagram were used to screen the best prescription and find out the self-emulsifying area based on the emulsifying effect in vitro, the equilibration time of emulsifying time, the size and distribution of the emulsion size. The formulation was evaluated in vitro by examining droplet morphology, particle size, distribution, zeta potential, self-emulsifying rate, and stability. Results The optimal prescription was composed of Forsythia suspense seed oil-polysorbate 80-ethanol (45:41:14). The emulsified milk droplets showed a regular circular shape with a uniform distribution and an effective particle size of 90.9 nm. The self-emulsifying rate was 5 min to achieve the balance, glare, low temperature, hot and cold alternately placed 10 d and long time at room temperature for 3 months under the conditions of good stability. Conclusion Forsythia seed oil self-emulsifying drug delivery system preparation process is simple, stable, easy to absorb, easy to produce.