葛根黄酮自微乳化软胶囊的制备和溶出度的考察

Preparation of self-microemulsifying soft capsule and investigation of dissolution for pueraria lobata isoflavone

目的:研制葛根黄酮自微乳化软胶囊,并考察其溶出度。方法:通过溶解度实验,三元相图的绘制,体外乳化和稳定性实验确定最佳处方;以市售愈风宁心片为参比制剂测定自微乳化软胶囊(SMESC)的溶出度。结果:该自微乳化软胶囊中的乳化剂为聚山梨酯-80,助乳化剂为1,2-丙二醇,油相为油酸乙酯,其比例为65∶20∶15。SMESC在水、pH6.8缓冲液和0.1mol/L盐酸中,10min的溶出度可达90以上,而愈风宁心片90min的溶出度不足40。结论:葛根黄酮自微乳化软胶囊与市售片剂相比,其在水、人工肠液和人工胃液中的溶出度显著提高。

AIM： In order to prepare the self-microemulsifying soft capsule （SMESC）of pueraria lobata isoflavone and investigate its dissolution property. METHODS： Through solubility experiment, self-microemulsification in vitro, phase diagram and the stability of solution, the optimum formulation was selected for pueraria lobata isoflavone. The dissolution of SMESC was measured taking the commercial tablet as reference. RESULTS ： In the selected formulation, Tween-80, 1,2-Propanediol and ethyl oleate were screened as emulsifier, co-emulsifier and oil phase,respectively. The optimized proportion was 65： 20： 15 . The dissolution of SMESC in the condition of distilled water,pH6.8 phosphate buffer and 0. 1 mol/L HCl were more than 90% in 10 min,while those of the commercial tablet were less than 40% in 90 min. CONCLUSION ： In comparison with the commercial tablet, the dissolution of pueraria lobata isoflavone is sufficiently improved at various conditions.