甘草次酸脂化乳的质量评价指标探讨  

Quality Evaluation and Index Exploration of the Glycyrrhetinic Acid Lipo-emul

作　　者：金粟 李士远[1] 张秀荣[1] 陈芳宁 王秀丽[1] 

机构地区：[1]北京中医药大学中药学院,北京100102

出　　处：《中国药房》2017年第6期800-803,共4页China Pharmacy

基　　金：国家自然科学基金资助项目(No.81202928)

摘　　要：目的:为甘草次酸脂化乳的质量评价提供参考指标。方法:采用冷冻透射电子显微镜检测甘草次酸脂化乳粒子形态,激光纳米粒度仪测定其粒径、多分散系数(PDI)及电位情况;采用超高效液相色谱法测定其中有效成分甘草次酸的载药量;在30℃下放置10 d考察该制剂的稳定性。结果:制备的甘草次酸脂化乳轮廓清晰、结构完整、呈类圆形、排列紧密;平均粒径为(245.2±4.29)nm,PDI为(0.054±0.01),平均电位为(-6.25±0.54)m V;甘草次酸的载药量平均值为(1.25±0.09)mg/m L;质量浓度为0.82 mg/m L的样品在10 d内稳定性良好。结论:粒径、电位、载药量、稳定性可作为甘草次酸脂化乳的评价指标。OBJECTIVE：To provide reference indexs for the quality evaluation of Glycyrrhetinic acid lipo-emul. METHODS：Croy-TEM was used to detect the morphology of Glycyrrhetinic acid lipo-emul,laser nano-particle size analyzer was used to determine the particle size,polydispersity index（PDI）and the zeta potential;UPLC was used to determine the drug loading of its active ingredient glycyrrhetinic acid;placing 10 d in 30 ℃,then stability was detected. RESULTS：Prepared Glycyrrhetinic acid lipo-emul was clear outline,structural integrity,roundlike and arranged closely;the mean particle size was（245.2±4.29）nm,PDI was（0.054 ± 0.01） and the mean zeta potential was（-6.25 ± 0.54） m V;the average drug loading of glycyrrhetinic acid was（1.25±0.09）mg/m L;the sample with mass concentration of 0.82 mg/m L showed good stability in within 10 d. CONCLUSIONS：Particle size,zeta potential,drug loading and stability can be used as the evaluation index of Glycyrrhetinic acid lipo-emul.

关 键 词：甘草次酸脂化乳 质量评价 指标 载药量 

分 类 号：R943[医药卫生—药剂学]