| 摘要: |
| 【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18 nm,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。 |
| 关键词: 阿莫两林 盐酸左氧氟沙星 复方阿莫两林纳米乳 稳定性 |
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| 基金项目:国家科技支撑计划项目（2006BAD04A11） |
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| Preparation and stability evaluation of compound amoxicillin nanoemulsion |
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| Abstract: |
| 【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 averaged 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. |
| Key words: Amoxicillin levofloxacin hydrochloride compound amoxicillin nanoemulsion stability |
