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目的葛根素自微乳化释药系统的制备优化及评价。方法通过测定葛根素在各辅料中的溶解度,处方配伍实验,绘制伪三元相图筛选自微乳化释药系统组分;以葛根素在不同自微乳处方中的平衡溶解度和粒径为指标,采用星点设计-效应面优化法,确定较优处方;并用透析袋扩散法对葛根素自微乳的体外释药性质进行考察研究。结果葛根素自微乳较优处方选择ODO为油相,Cremophor RH40为表面活性剂,Transcutol P为助表面活性剂,比例为17.5∶55.0∶27.5,葛根素在最优处方中的溶解度为51.27 mg/g,是其蒸馏水中溶解度的9.22倍,用蒸馏水稀释后平均粒径为21.51 nm;葛根素自微乳化释药系统的体外释放速度较其混悬液更快。结论成功制备了葛根素自微乳,可显著提高葛根素的溶解度;应用星点设计-效应面优化法能够快速方便的得到葛根素自微乳化释药系统的较优处方。
Preparation and Evaluation of Puerarin Self - microemulsifying Drug Delivery System. Methods By measuring the solubility of puerarin in various excipients and the prescription compatibility experiment, the pseudo-ternary phase diagram was drawn from the components of the microemulsified drug delivery system. The equilibrium solubility and particle size of puerarin in different self-microemulsions , The star point design - response surface optimization method to determine the optimal prescription; and dialysis bag diffusion method of puerarin self-microemulsion in vitro release properties were investigated. Results ODO was selected as the oily phase, Cremophor RH40 as surfactant, Transcutol P as co-surfactant, the ratio of 17.5:55.0:27.5, puerarin’s solubility in the optimal prescription was 51.27 mg / g, which is 9.22 times of its solubility in distilled water. The average particle size after being diluted with distilled water is 21.51 nm. The release rate of puerarin self-microemulsifying drug delivery system is faster than that of its suspension. Conclusion The puerarin self-microemulsion was successfully prepared, which can significantly improve the solubility of puerarin. The optimal formulation of puerarin self-microemulsifying drug delivery system can be quickly and conveniently obtained by using the star-dot design-response surface optimization method.