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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。
Combined with the pre-test results, the prescription composition of alprostadil microemulsion was determined. The optimal dosage of each component of the alprostadil microemulsion prescription was determined by the method of star-point design-response surface and the plot of conductivity-water content. Finally, the particle size and drug content as an indicator to optimize the microemulsion preparation of the stirring speed, time and temperature and other process parameters. The results showed that the optimum formulation of alprostadil microemulsion was Solutol HS 15 8%, egg yolk lecithin 2%, medium chain triglyceride 4%, glycerol 6% and water 80%. The speed, temperature and time Respectively 300 r / min, 30 ℃ and 0.5 h. The three batches of alprostadil microemulsions prepared according to the optimized prescriptions were about 23-25 nm in diameter with good centrifugal stability.