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作 者:魏文静 朱梨梨 潘娇娇 郝自强 陈卫东 杨瑞 王淑君[2] WEI Wen-jing;ZHU Li-li;PAN Jiao-jiao;HAO Zi-qiang;CHEN Wei-dong;YANG Rui;WANG Shu-jun(School of Pharmacy,Anhui University of Traditional Chinese Medicine,Hefei 230012;School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016;Jiangsu Aidi Nano Biomedical Co.,Ltd.,Nantong Jiangsu 226100;Yangtze Delta Drug Advanced Research Institute,Nantong Jiangsu 226133;The Second Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110034)
机构地区:[1]安徽中医药大学药学院,合肥230012 [2]沈阳药科大学药学院,沈阳110016 [3]江苏艾迪纳米生物医药有限公司,江苏南通226100 [4]南通长三角药物高等研究院,江苏南通226133 [5]辽宁中医药大学附属第二医院,沈阳110034
出 处:《中南药学》2023年第4期876-881,共6页Central South Pharmacy
基 金:国家自然科学基金项目(No.81973494)。
摘 要:目的基于“药辅合一”的理念,优化甘草次酸-蓖麻油亚微乳的处方及制备工艺,并对其质量进行评价。方法通过单因素实验筛选油相和乳化剂,以浊度和粒径为考察指标,采用响应面法优化甘草次酸-蓖麻油乳剂处方,并考察其制备工艺。通过测定粒径、稳定性、pH、体外释放等指标综合评价亚微乳质量。结果优选的处方中,蓖麻油为10%、聚山梨酯-80为2.5%、三油酸山梨坦为0.9%,磷酸盐为0.24%,含药量为(2.94±0.02)mg·mL^(-1),平均粒径为(197.3±2.5)nm,多分散指数(PDI)为(0.19±0.01),且离心稳定性良好。结论此方法构建“药辅合一”的甘草次酸-蓖麻油亚微乳较稳定,有利于进一步开发。Objective To optimize the formulation and preparation technology of glycyrrhetinic acidcastor oil submicron emulsion based on the concept of unification of medicine and adjuvant,and to evaluate its stability.Methods The oil phase and emulsifier were screened by single factor experiment.The formulation of glycyrrhetinic acid-castor oil emulsion was optimized by response surface method with the turbidity and particle size as indexes.Its particle size,stability and pH were determined.The in vitro drug release behavior was investigated,based on which the quality of the as-prepared submicron emulsion was evaluated comprehensively.Results The optimal formulation was composed of 10%castor oil,2.5%polysorbide-80,0.9%sorbitan trioleate,and 0.24%phosphate,which showed a concentration of(2.94±0.02)mg·mL^(-1),mean particle size of(197.3±2.5)nm and PDI of(0.19±0.01),with good stability.Conclusion The method of combining a medicine and adjuvant submicron emulsion of glycyrrhetinic acid-castor oil is relatively stable,which is conducive to further development.
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