前列地尔微乳处方及制备工艺的优化

发布时间：2018-04-14 08:26

  本文选题：前列地尔 + 微乳　； 参考：《中国医药工业杂志》2015年06期

【摘要】：结合预试验结果,首先确定前列地尔微乳的处方组成,再通过星点设计-效应面法和绘制电导率-含水量曲线,确定了前列地尔微乳处方中各组分的优化用量;最后以粒径和药物含量为指标,优化了微乳制备时的搅拌速度、时间和温度等工艺参数。结果表明,前列地尔微乳优化处方为:Solutol HS 15 8%、蛋黄卵磷脂2%、中链甘油三酸酯4%、甘油6%和水80%;制备时搅拌的速度、温度和时间分别为300 r/min、30℃和0.5 h。照上述优化处方制备的3批前列地尔微乳粒径均约23~25 nm,且离心稳定性好。
[Abstract]:Based on the results of pre-test, the prescription composition of alprostadil microemulsion was first determined, and then the optimum dosage of each component in the formulation was determined by the method of star design-effect surface and drawing the curve of conductivity and water content.Finally, the stirring speed, time and temperature of the microemulsion were optimized according to the particle size and drug content.The results showed that the optimized formulation of alprostadil microemulsion was: 1 Solutol HS 158, egg yolk lecithin 2, medium chain triglyceride 4, glycerol 6% and water 80%, and the stirring speed, temperature and time were 300 r / min 30 鈩，

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