复方阿莫西林纳米乳的制备及其稳定性研究

Preparation and stability evaluation of compound amoxicillin nanoemulsion

【目的】制备复方阿莫西林纳米乳(AMX-LH-NE),并考察其稳定性。【方法】绘制伪三元相图,筛选纳米乳处方,制备AMX-LH-NE,并对其结构类型、形态、粒径进行检测,利用HPLC法对其稳定性进行研究。【结果】优选的AMX-LH-NE配方为:冰醋酸10.00%,聚氧乙烯蓖麻油-40 31.65%,肉豆蔻酸异丙酯3.48%,阿莫西林原料药1.58%,盐酸左氧氟沙星原料药1.58%,蒸馏水51.71%(各组分的含量均为质量分数)。所制备的AMX-LH-NE为O/W型,澄明均一,分布均匀,乳滴呈球形,平均粒径为14.30 nm,多分散系数为0.03,约96%粒子的粒径小于18nm,稳定性参数KE较小,加速试验条件下稳定,光照颜色渐深。【结论】AMX-LH-NE的制备工艺简单,切实可行,制备的纳米乳稳定性良好,但需避光保存。

[Objective] The aim of this paper was to study the preparation and stability evaluation of compound amoxicillin and levofloxacin hydrochloride nanoemulsion （AMX-LH-NE）. [Method] The optimal formulation was screened by pseudoternary phase diagrams. AMX-LH-NE was prepared and its structural type, appearance, particle size were detected, and its stability was investigated by HPLC. [Result] The optimized formulation was composed of glacial acetic acid 10.00%, cremophor EL-40 31. 65%, isopropylmyristate 3.48 %, amoxicillin 1.58 %, levofloxacin hydrochloride 1.58 %, distilled water 51.71%（Content of each ingredient was all mass fraction）. The prepared nanoemulsion was the type of oil-in-water,transparent, uniform and well-distributed. The nanoemulsion drop appeared in spherical shape,the drop size aw eraged 14.30 nm with a polydispersity index of 0.03,and the particle diameter of 96% was less than 18 nm. The stability constant（KE）of the nanoemulsion was lower,and it was stable under the condition of accelerated tests, but its color gradually deepened when it was illuminated. [Conclusion] The optimal preparation procedure of AMX-LH-NE is simple and practicable,and the stability of the prepared nanoemulsion is good,but it needs to be stored without light.