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目的:研制丹皮酚高效快速的自乳化给药系统,提高起效时间和生物利用度。方法:选择适宜油相、乳化剂、助乳化剂,并在此基础上绘制伪三元相图。通过对各处方比例的筛选,结合各处方载药量以及所形成微乳的稳定性,确定最佳处方并制备片剂,考察其乳化后微乳的粒径、形态和体外溶出情况。结果:以油相为三辛酸/癸酸甘油酯,乳化剂为Cremophor EL,助乳化剂为丙二醇,丹皮酚在助乳化剂中的质量百分数为30%的处方为最佳处方;自乳化片在20 min之内溶出达到80%左右。结论:所研制的自乳片具有粒径小、载药量高、性质稳定的优势,并能显著提高其体外溶出。
OBJECTIVE: To develop a rapid and efficient self-emulsifying drug delivery system for paeonol to improve its onset time and bioavailability. Methods: Select the appropriate oil phase, emulsifier, co-emulsifier, and on this basis to draw pseudo-ternary phase diagram. Through the screening of the proportion of each prescription, combined with the prescription drug loading and the stability of the formed microemulsion, to determine the best prescription and prepare tablets to investigate the emulsified microemulsion size, morphology and in vitro dissolution. Results: The prescription of Cremophor EL with emulsifier as emulsifier and propylene glycol as emulsifier and 30% mass percentage of paeonol as co-emulsifier was the best prescription. The self-emulsifying tablets Within 20 min dissolution reached about 80%. Conclusion: The developed self-milk tablets have the advantages of small particle size, high drug loading and stable properties, and can significantly improve their dissolution in vitro.