复方米诺地尔凝胶剂的制备及质量控制研究  

Preparation and quality control of compound monoxide gel

作　　者：要辉 纪万里[1] 白育庭[1] 

机构地区：[1]湖北科技学院药学院,湖北咸宁437000

出　　处：《中南药学》2016年第3期270-273,共4页Central South Pharmacy

基　　金：湖北省自然科学基金(No.2011CDA064)

摘　　要：目的制备复方米诺地尔凝胶剂并初步建立质量控制标准。方法在单因素试验基础上选取甘油、丁二醇、氮酮的用量为考察因素,采用正交试验法,以12 h药物累计渗透量为指标,优选凝胶剂制备处方;并采用HPLC法控制有关物质及进行含量测定。结果最佳处方配伍为甘油10%,丁二醇25%,氮酮1.2%;复方凝胶中2种药物米诺地尔和维A酸在浓度分别为4~320、0.05~4.00μg·m L-1与各自峰面积呈良好的线性关系（r=0.9996、0.9993）。结论该凝胶剂的处方简单,工艺制备可行;建立的质量标准可以用来控制产品质量。Objective To prepare the compound minoxidil gel and establish the quality control standard. Methods Based on the single factor analysis, orthogonal design was used to optimize the prescription of the compound gel, the 24 h accumulative permeation was evaluated as the index, and the amount of glycerinum, butanediol and azone as the factors. The related substances and the content of compound gel were determined by HPLC. Results The optimum formulation contained 10% glycerinum, 25% butanediol, and 1.2% azone. The linear ranges were 4- 320 μg·m L- 1 for minoxidil and 0.05- 4.00 μg·m L- 1 for tretionin. Conclusion The formulation is reasonable and the qulity of the compound monoxide gel is co ntrollable.

关 键 词：米诺地尔 维A酸 凝胶 质量控制 

分 类 号：R94[医药卫生—药剂学]