小儿推拿退热凝胶制备工艺及质量标准研究  

Preparation process and quality standard for Xiao’er Tuina Tuire Ningjiao(小儿推拿退热凝胶)

作　　者：万力生[1] 陈争光[1] 张辉 闫志翻 WAN Lisheng;CHEN Zhengguang;ZHANG Hui;YAN Zhifan(Department of TCM,Shenzhen Children's Hospital,Shenzhen,Guangdong,518000,China;Business Division of Composition Prescription and Granules,China Resources Sanjiu Medical&Pharmaceutical Co.,Ltd.,Shenzhen,Guangdong,518000,China)

机构地区：[1]深圳市儿童医院中医科,广东深圳518000 [2]华润三九医药股份有限公司配方颗粒事业部,广东深圳518000

出　　处：《中医儿科杂志》2020年第3期31-36,共6页Journal of Pediatrics of Traditional Chinese Medicine

基　　金：广东省中医药局科研项目(20173030)。

摘　　要：目的建立小儿推拿退热凝胶的制备工艺及质量控制方法。方法以萃取量作为考察指标,评价萃取釜温度、萃取釜压力、萃取时间等;以凝胶剂的均匀性、涂展性、稳定性为评价指标,确定小儿推拿退热凝胶剂的最佳处方配比。结果小儿推拿退热凝胶的最佳萃取工艺参数为萃取温度35℃,萃取压力25 MPa,萃取时间1.5 h;制备工艺处方为0.1%氮酮、16%吐温-80,10%丙二醇。结论本研究初步建立了小儿推拿退热凝胶的最佳萃取工艺及凝胶制备工艺,凝胶剂在均匀性、涂展性、耐热和耐寒稳定性方面均良好,且该方法稳定、可行。Objective To establish preparation process and quality control method for Xiao’er Tuina Tuire Ningjiao(小儿推拿退热凝胶).Methods Taking the amount of the extract as an index of investigation,the temperature,the pressure of the extraction kettle and the extraction time were evaluated.The uniformity, smearing and stretchability as well as stability of Ningjiao were taken as the evaluation indexes to determine the optimal prescription ratio of Xiao’er Tuina Tuire Ningjiao.Results The optimal extraction parameters of Xiao’er Tuina Tuire Ningjiao was determined: the extraction temperature 35 ℃, extraction pressure 25 MPa, extraction time 1.5 hours;the preparation process prescription was 0.1% azone, 16% tween-80, and 10% propylene glycol.Conclusion Through this research,the optimal extraction process and preparation process of Xiao’er Tuina Tuire Ningjiao were established preliminarily.The ningjiao has good uniformity,smearing and stretchability,stability of heat resistance and cold resistance,moreover,the method is stable and feasible.

关 键 词：小儿推拿退热凝胶 制备工艺 质量标准 

分 类 号：TQ460.72[医药卫生—药物分析学]