红砂软膏剂的制备工艺研究  

Study on the Preparation Process of Reaumuria Soongorica Ointment

作　　者：钮树芳[1] 白万富 段姝廷 王新伟 丁玲 Niu Shufang;Bai Wanfu;Duan Shuting;Wang Xinwei;Ding Ling(Baotou Medical College,Baotou 014040,China)

机构地区：[1]包头医学院,内蒙古包头014040

出　　处：《广东化工》2024年第15期59-61,共3页Guangdong Chemical Industry

基　　金：自治区教育厅基金项目2022年大学生创新创业训练项目(202210130008);内蒙古自然科学基金项目(2021LHMS08013);包头医学院博士科研启动基金(BSJJ201815);包头医学院科学研究基金项目(BYJJ-ZRQM 202312)。

摘　　要：目的:研究红砂软膏剂的制备方法,确定最佳制备工艺。方法:首先通过超声提取法提取红砂中的有效成分,并将提取液浓缩;然后以外观均一性、涂抹延展性、耐热耐寒性、离心稳定性为评价指标,进行油相、水相、油水两相最佳配比及最佳乳化温度的单因素考察,并在此基础上通过L9(3^(4))正交实验选出最佳软膏基质配比和乳化温度;最后以5%载药量制备红砂软膏,并再次通过L9(3^(4))正交实验及配方优化确定红砂软膏剂的最佳制备工艺;结果:红砂软膏剂的最佳制备工艺是载药量为5%;油水比为1∶2.5;油相:硬脂酸(9.40%)、白凡士林(7.00%)、司盘-80(3.50%)、羊毛脂(4.70%)、液体石蜡(4.70%)、尼泊金乙酯(0.15%);水相:三乙醇胺(3.60%)、甘油(10.70%)、红砂水提物浓缩液和蒸馏水(57.10%)。两相分别水浴加热到80℃,然后将水相缓慢加入油相中,快速搅拌即得O/W型红砂软膏剂。结论:研究制备出了一种理化性质稳定、耐热耐寒、外观细腻均匀、肤感较好的红砂软膏剂,为红砂软膏剂后期进一步应用于皮炎湿疹的治疗奠定了基础。Objective:To study the optimal preparation method of Reaumuria Soongorica ointment and determine the best preparation process.Method:Firstly,the active ingredients of Reaumuria Soongorica were extracted by ultrasonic extraction method,and the extract was concentrated.Then,the evaluation indicators such as appearance uniformity,spreadability,heat and cold resistance,and centrifugal stability were used to investigate the optimal ratios of oil,water and oil-water phase,as well as the best emulsification temperature,through single-factor experiments.On this basis,the optimal ointment matrix ratio and emulsification temperature were selected by L9(3^(4))orthogonal experiment.Finally,the Reaumuria soongorica ointment with 5%drug load was prepared,and the optimal preparation process of red sand ointment was determined by L9(3^(4))orthogonal experiment and formulation optimization.Results:The best preparation process of Reaumuria soongorica ointment was as follows:drug-loading amount of 5%;oil-water ratio of 1∶2.5;oil phase:stearic acid(9.40%),white petroleum(7.00%),Span-80(3.50%),lanolin(4.70%),liquid paraffin(4.70%),ethylparaben(0.15%);water phase:triethanolamine(3.60%),glycerol(10.70%),concentrated aqueous extract of red sand and distilled water(57.10%).The two phases were separately heated to 80℃in a water bath,and then the water phase was slowly added to the oil phase with rapid stirring to obtain an O/W type Reaumuria soongorica ointment.Conclusions:The Reaumuria soongorica ointment with stable physicochemical properties,good heat and cold resistance,uniform appearance and pleasant skin feeling was prepared,which laid the foundation for further application of Reaumuria soongorica ointment in the treatment of dermatitis and eczema.

关 键 词：红砂 软膏剂 制备工艺 

分 类 号：R944.2[医药卫生—药剂学]