白桦脂醇纳米乳处方筛选及制备工艺优化研究

Formulation screening and preparation process optimization of betulin nanoemulsion

关键词:  白桦脂醇  纳米乳  处方筛选  制备工艺

Key words:  betulin  nanoemulsion  formulation screening  preparation process

摘要:

[目的] 确定白桦脂醇纳米乳的制备工艺处方。[方法] 采用伪三元相图法筛选纳米乳处方。采用单因素筛选和效应面法（Box-Behnken）优化制备工艺参数。[结果] 白桦脂醇纳米乳的最优处方为：m（肉豆蔻酸异丙酯）∶m（吐温80）∶m（丙三醇）∶m（蒸馏水）= 15.38%∶20.51%∶41.03%∶23.08%。最优处方工艺为：搅拌温度53 ℃，搅拌速度1 050 r/min，搅拌时间6.2 min。[结论] 确定的处方工艺稳定简便，重复性好，制得的纳米乳载药量较高。

Abstract:

[Objective] To determine the process prescription for the preparation of Betulinol nano-emulsion. [Methods] Pseudo-ternary phase diagram method was used to screen the nano-emulsion prescription. The preparation process parameters were optimized using one-factor screening and effect surface method（Box-Behnken）. [Results] The optimal prescription of betulinol nano-emulsion was：m（isopropyl myristate）∶m（tween 80）∶m（glycerol）∶m（distilled water）=15.38%∶20.51%∶41.03%∶23.08%. The optimum prescription process was：stirring temperature 53 ℃，stirring speed 1 050 r/min，stirring time 6.2 min. [Conclusion] The determined prescription process was stable and simple，reproducible，and produced nanoemulsions with high drug loading capacity.