正交试验法优化布洛芬乳膏处方工艺

Prescription and Technology Optimization of Ibuprofen Cream by Orthogonal Experimental Method

目的优化布洛芬乳膏的处方工艺。方法采用乳化法制备布洛芬乳膏,以鱼鳔为半透膜,利用立式Franz扩散池进行体外透皮扩散试验,以6 h累积渗透量为指标,采用正交试验法优化其处方工艺。结果三乙醇胺的含量对布洛芬乳膏处方影响最大,蓖麻油和硬脂酸的含量影响次之,氮酮的含量也有影响。最佳布洛芬乳膏处方为布洛芬5%,单硬脂酸甘油酯4%,甘油10%,硬脂酸20%,三乙醇胺1%,蓖麻油30%,氮酮3%,蒸馏水27%。6 h平均累积渗透量为4.096 mg。结论研制的布洛芬乳膏成型性好、工艺可行。

Objective To optimize the prescription and technology of Ibuprofen Cream. Methods lbuprofen Cream was prepared by the emulsion method. With the swim bladder as the semi- permeable membrane, the vertical Franz diffusion cell was adopted to conduct the in vitro transdermal diffusion test. With the 6 h cumulative infiltration volume as the index,the orthogonal test was used to optimize its prescription and technology. Results The content of triethanolamine affected the prescription of Ibuprofen Cream most, followed by the content of castor oil and stearic acid, the azone content also had an effect on the cream prescription. The optimal prescription of Ibuprofen Cream was 5% of ibuprofen,4% of glycerol monostearate, 10% of glycerol,20% of stearic acid, 1% of tfiethanolamine,30% of castor oil,3% of azone and 27% of distilled water. The average cumulative permeation amount of ibuprofen was 4.096 mg in 6 h. Conclusion Researched and prepared Ibuprofen Cream has good formability and the technology is feasible.