聚桂醇尿素乳膏的处方工艺考察  

Study on the Formulation and Process of Poly(Cinnamic Alcohol Urea)Cream

作　　者：周琴琴[1] 李怡平 姚风艳 朱国理 王立兴 徐伟[1] Zhou Qinqin(Colleges of Pharmacy,Fujian University of Traditional Chinese Medicine,Fuzhou Fujian 350122)

机构地区：[1]福建中医药大学药学院,福建福州350122 [2]福建长富星生物医药科技有限公司,福建福州350025

出　　处：《黑龙江医药》2023年第4期771-777,共7页Heilongjiang Medicine journal

基　　金：高校产学合作项目(编号:2020Y4013),课题名称:国家化学药品三类新药聚桂醇尿素乳膏的研制。

摘　　要：目的:采用正交设计考察聚桂醇尿素乳膏的处方工艺。方法:采用正交试验表L 18(37)考察不同的辅料组成比例(二甲硅油、苯基聚二甲基硅氧烷、液状石蜡、鲸蜡醇棕榈酸酯、硬脂酸、聚山梨酯40、卡波姆)对处方的影响,建立高效液相色谱法测定聚桂醇体外释放曲线、尿素体外释放曲线,外观性状,乳膏稳定性,乳膏黏度等为考察指标,对乳膏处方的辅料组成比例进行筛选,分步确定各辅料含量。结果:通过实验结果分析,得出聚桂醇尿素乳膏的处方工艺。每100g乳膏中聚桂醇3g,尿素5g,二甲硅油2g,苯基聚二甲基硅氧烷5g,液状石蜡1.5g,鲸蜡醇棕榈酸酯0.5g,硬脂酸1.5g,聚山梨酯403g,辛基十二醇10g,甘油1.7g,苯甲醇1g,卡波姆1.3g,氨丁三醇1.2g,纯化水,调整乳膏总量至100g。结论:正交设计试验法可用于聚桂醇尿素乳膏的处方工艺考察,优选处方稳定可行,为后期聚桂醇尿素乳膏的新药开发奠定良好的基础。Objective:To investigate the formulation and process of polycinnamic alcohol urea cream using orthogonal design.Methods:Orthogonal test table L 18(37)was used to investigate the influence of different proportion of excipients(dimethicone,phenyl polydimethylsiloxane,liquid paraffin,Cetyl alcohol palmitate,stearic acid,polysorbate 40,carbomer)on the prescription.High-performance liquid chromatography was established to determine the in vitro release curve of polycinnamol,urea,appearance,stability of cream,viscosity of cream,etc,Screen the proportion of excipients in the cream prescription and determine the content of each excipient step by step.Result:Through the analysis of experimental results,the prescription process of polycinnamic alcohol urea cream was obtained.Every 100g of cream contains 3g of cinnamyl alcohol,5g of urea,2g of dimethicone oil,5g of phenyl polydimethylsiloxane,1.5g of liquid paraffin,0.5g of Cetyl alcohol palmitate,1.5g of stearic acid,403g of polysorbate,10g of octyl dodecanol,1.7g of glycerol,1g of Benzyl alcohol,1.3g of carbomer,1.2g of trometamol,purified water,and the total amount of cream is adjusted to 100g.Conclusion:The orthogonal design experimental method can be used to investigate the formulation and process of poly(cinnamic alcohol urea)cream,and the optimized formula is stable and feasible,laying a good foundation for the later development of new drugs of poly(cinnamic alcohol urea)cream.

关 键 词：聚桂醇尿素乳膏 处方工艺 正交试验 

分 类 号：TQ46[化学工程—制药化工]