右旋布洛芬乳膏的制备及质量控制研究  

Preparation and quality control of dexibuprofen cream

作　　者：张恩景 潘静 肖静 刘小龙 罗才奎 ZHANG En-jing;PAN Jing;XIAO Jing;LIU Xiao-long;LUO Cai-kui(Tongren Hospital of Wuhan University (Wuhan Third Hospital), Wuhan 430060)

机构地区：[1]武汉大学同仁医院(武汉市第三医院),武汉430060

出　　处：《中南药学》2018年第11期1552-1555,共4页Central South Pharmacy

基　　金：武汉市卫生与计划生育委员会临床医学科研项目(编号:WX15CI3)

摘　　要：目的制备右旋布洛芬乳膏并进行质量控制研究。方法采用体外透皮实验,以24 h药物累计透过量为指标,优化促渗剂氮酮的用量,并采用HPLC法进行有关物质检查及含量测定。结果在处方中通过体外透皮实验优选促渗剂氮酮的用量为3.0%;乳膏中右旋布洛芬在0.3024～0.7056 mg·mL^(-1)与峰面积呈良好的线性关系,线性方程为:y=1519.9x+0.0169,r=0.9995,通过强制降解实验验证有关物质检查方法,各杂质均能很好分离;在加速、长期稳定性实验考察中总杂质略有增加,但远低于自身对照(1%),标示量无明显变化。结论该右旋布洛芬乳膏处方简单,工艺制备可行,建立的方法可控制产品质量。右旋布洛芬软膏具有经皮渗透性能,为其透皮吸收给药途径提供了依据。Objective To prepare and control the quality of dexibuprofen cream.Methods In vitro transdermal test was conducted to optimize the dosage of azone by using 24 h drug accumulation.HPLC method was used to determine substance and content.Results The optimal dosage of azone was 3.0%.The concentration of dexibuprofen in the cream was at 0.3024-0.7056 mg·mL^-1.The reationship between the concentration and the peak area was linear.The linear equation was y =1519.9x + 0.0169, r =0.9995.The results of degradation test showed that the impurities could be separated well, and the total impurities increased slightly in the accelerated and long-term stability test, but were far lower than the self-control(1%).The dosage of azone was 3.0% in the prescription.Conclusion The dexibuprofen cream is a simple to prescription.The process is feasible, and the quality method can be established to control the quality of the product.Dexibuprofen cream exhibits transdermal penetration and absorption properties.

关 键 词：右旋布洛芬 乳膏 透皮实验 质量控制 

分 类 号：R943[医药卫生—药剂学]