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采用伪三元相图法筛选蒿甲醚纳米结构脂质载体的处方组成,分别采用微乳法和高压乳匀法进行制备,通过单因素试验和正交设计进行工艺及处方优化。结果显示,优化条件下,微乳法所得纳米粒粒径为(30.0±2.3)nm,ζ电位为(-40.9±1.1)m V,包封率为(92.8±2.4)%;高压乳匀法所得纳米粒粒径为(61.5±1.9)nm,ζ电位为(-28.4±0.5)m V,包封率为(83.8±0.2)%。二者体外释放规律均符合一级动力学方程,48 h累积释放率为80.6%和83.9%。两种方法制备的纳米粒粒径均达到预期值(小于80 nm)并显示缓释特性。由于高压乳匀法工艺参数更易控制,适合放大批量生产,将在后续研究中用于蒿甲醚纳米结构脂质载体的制备。
The formulation of artemether nanostructured lipid carrier was screened by pseudo-ternary phase diagram method. The microemulsion method and high-pressure homogenization method were respectively used to prepare the formulation. The optimization of technology and formulation was carried out by single factor experiment and orthogonal design. The results showed that under optimized conditions, the nanoparticle size was (30.0 ± 2.3) nm and the average zeta potential was (-40.9 ± 1.1) mV and the entrapment efficiency was (92.8 ± 2.4)%. The obtained nanoparticle size was (61.5 ± 1.9) nm, the zeta potential was (-28.4 ± 0.5) mV, and the entrapment efficiency was (83.8 ± 0.2)%. Both in vitro release laws are in line with the first-order kinetic equation, 48 h cumulative release rate of 80.6% and 83.9%. The nanoparticles prepared by the two methods all reach the expected value (less than 80 nm) and show the slow release characteristics. As high-pressure milk homogenization process parameters easier to control, suitable for amplification of mass production, will be used in the subsequent study of artemether nanostructured lipid carrier preparation.