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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
【Author】 YANG Xue-feng~(1,2) OUYANG Wu-qing~1 CAO Fa-hao~1 LI Xiang-hui~1 (1.College of Veterinary Medicine,Northwest A & F University,Yangling,Shanxi 712100;2.College of Animal Science,Henan Institute of Science and Technology,Xinxiang 453003,Henan;China)
【机构】 西北农林科技大学动物医学学院; 河南科技学院动物科学学院;
【摘要】 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%的粒子粒径小于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。
【Abstract】 The aim of this paper was to study the preparation and stability evaluation of compound amoxicillin and levofloxacin hydrochloride nanoemulsion(AMX-LH-NE).The optimal formulation was screened by pseudoter- nary phase diagrams.AMX-LH-NE was prepared and its structural type,appearance,particle size were detec- ted,and its stability was investigated by HPLC.The optimized formulation was composed of glacial acetic acid 10.00%,cremophor EL-40 31.65%,isopropylmyristate 3.48%,amoxicillin 1.58%,levofloxacin hydrochlo- ride 1.58%,distilled water 51.71%(Content of each ingredient was all mass fraction).The prepared nanoe- mulsion was the type of oil-in-water,transparent and uniform,well-distributed.The nanoemulsion drop ap- peared in spherical shape,the drop size averaged 14.30 nm with a polydispersity index of 0.03,particle diameter of 96% was less than 18 nm.The stability constant(KE)of the nanoemulsion was lower,it was stable under the condition of accelerated tests,but its color gradually deeped when it was illuminated.The optimal preparation pro- cedure of AMX-LH-NE is simple and practicable,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;
- 【会议录名称】 首届中国兽药大会动物药品学暨中国畜牧兽医学会动物药品学分会2008学术年会论文集
- 【会议名称】首届中国兽药大会动物药品学暨中国畜牧兽医学会动物药品学分会2008学术年会
- 【会议时间】2008-11
- 【会议地点】中国天津
- 【分类号】S859.79
- 【主办单位】中国兽医药品监察所、中国动物保健品协会