吲哚美辛乳膏的制备及体外释放度考察.docxVIP

赵晓军，赵文明*(辽宁医学院药学院，辽宁 锦州 121000)摘要：目的 赵晓军，赵文明*(辽宁医学院药学院，辽宁 锦州 121000) 摘要：目的 制备吲哚美辛乳膏，并考察其体外释放度。方法 以吐温 80、单硬脂酸甘油酯、液体石蜡、凡士林的用量 为考察对象，以乳膏的外观性状及离心、耐热及耐寒试验是否分层为指标，采用 L9(34)正交设计法优化乳膏处方，并采 用高效液相色谱法测定乳膏在释放介质中的累积渗透量，通过小鼠热板法镇痛试验来观察乳膏的镇痛作用。结果 最佳 处方：吐温 80 为 0.45 g，单硬脂酸甘油酯为 0.9 g，液体石蜡为 0.9 g，凡士林为 0.6 g。吲哚美辛乳膏的累积渗透量几乎 随时间呈等速率增加，且乳膏有明显的镇痛作用。结论 正交试验法优选的吲哚美辛乳膏色泽均匀、质地细腻、渗透性 良好、便于涂布，处方稳定。吲哚美辛乳膏的累积渗透量与时间呈良好的线性关系，方法简单可靠。 关键词：吲哚美辛；乳膏；体外释放 中图分类号：R944.1+7 文献标志码：B 文章编号：1007-7693(2014)11-1362-05 DOI: 10.13748/ki.issn1007-7693.2014.11.016 Preparation and Investigation of in Vitro Release of Indomethacin Cream ZHAO Xiaojun, ZHAO Wenming*(College of Pharmacy, Liaoning Medical University, Jinzhou 121000, China) ABSTRACT: OBJECTIVE To prepare an O/W type indomethacin cream and to investigate of its in vitro release. METHODS With the mass of tween 80, glycerol monostearate, liquid paraffin, petroleum jelly as the research object, centrifugal, heat-resisting and cold-resisting tests whether stratified and cream appearance as an indicator, the L9(34) orthogonal design was used to select cream prescription. Then the cumulative permeation amount of cream was determined by HPLC in the release medium. The analgesic effect of cream was observed by the method of hot plate in mice analgesic experiment. RESULTS The best prescription was Tween-80 0.45 g, glycerin monostearate 0.9 g, liquid paraffin 0.9 g, petrolatum jelly 0.6 g. Cumulative permeation amount of indomethacin cream almost equal velocity increased with time. And cream had obvious analgesic effects. CONCLUSION The cream is uniform in color, homogeneous, exquisite and easy to spread. The prescription is stable. Cumulative permeation amount of indomethacin cream has a good linear relationship with time. The method is simple and reliable. KEY WORDS: indomethacin; cream; in vitro release 乳膏剂作为一种外用剂型[1-2]，因其具备药物 的释放与穿透性能好、不妨碍皮肤的正常功能、 易洗除、不污染衣物、可避免口服药物造成的胃 肠道及神经中枢的不良反应等优点，且可以提高 局部药物浓度，降低血药浓度，提高疗效，而为