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.
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)
出处
《中南药学》
CAS
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)
关键词
右旋布洛芬
乳膏
透皮实验
质量控制
dexibuprofen
cream
transdermal experiment
quality control
