盐酸阿比朵尔微乳的制备及其质量评价

目的:研制阿比朵尔微乳并对其质量进行评价。方法:选用肉豆蔻酸异丙酯作为油相,蓖麻油聚氧乙烯醚-40、聚山梨酯-20和聚山梨酯80-司班20(质量比为49∶51)分别作为表面活性剂,乙醇、正丁醇和异丙醇作为助表面活性剂。再通过滴定法制备伪三元相图的基础上,根据相图优选处方,分别考察微乳制剂的稳定性、形态粒径;用高效液相色谱(HPLC)法测定微乳中阿比朵尔的含量。结果:以蓖麻油聚氧乙烯醚-40为表面活性剂和乙醇作为助表面活性剂形成微乳系统。阿比朵尔微乳稳定,透射电镜下呈圆球形,分布均匀,平均粒径为28.4nm,呈Gauss分布。用RP-HPLC法测定回收率为100.18%,RSD为0.51%(n=6)。结论:采用微乳作为药物载体制备口服阿比朵尔微乳,为开发阿比朵尔微乳新型口服制剂提供了依据;HPLC检测方法可靠,重复性好。

Preparation of arbidol microemulsion and its quality evaluation

OBJECTIVE To study the preparation of Arbidol microemulsion and its quality evaluation.METHODS Arbidol microemulsion was prepared by using the methods titration to prepare the pseudotertiary diagram,the effect of various elements on the formation of the microemulsion was investigated.Stability,size distribution of Arbidol microemulsion were tested.The contents of Arbidol in microemulsion was determined by HPLC method.RESULTS In the microemulsion of EL-40 and ethanol system,Arbidol microemulsion was very stable after three months storage.Arbidol microemulsion in electron microscopy were small spherical drops with a mean diameter of 28.4 nm.The methodological average was 100.18%,with RSD of 0.51%.CONCLUSION The Arbidol microemulsion delivery could be prepared using EL-40/Ethanol /IPM/Water.A new formulation for Arbidol is developed.The method to determine the contents of Arbidol is accurate and reliable.