芙蓉方乳膏剂处方优化及流变学研究  

Formulation optimization and rheological study of Furong ointment

作　　者：王灵敏 邓莉莉 王昕怡 李婷婷 郝逗逗 李鑫 梅凯 刘葭[1] 吴清[1] WANG Lingmin;DENG Lili;WANG Xinyi;LI Tingting;HAO Doudou;LI Xin;MEI Kai;LIU Jia;WU Qing(School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China)

机构地区：[1]北京中医药大学中药学院,102488

出　　处：《环球中医药》2022年第7期1112-1120,共9页Global Traditional Chinese Medicine

摘　　要：目的将芙蓉膏改为乳剂型软膏,选出最优处方,并对其进行流变学研究。方法采用Plackett-Burman实验筛选出具显著性影响的辅料,结合D-最优混料设计进行处方优化制备芙蓉膏,并对其进行流变学评价,建立流变参数物理指纹图谱。结果(1)确定芙蓉膏基质处方:3.14 g硬脂酸、1.30 g单硬脂酸甘油酯、4.00 g白凡士林、8.00 g十八醇、12.00 g甘油、3.67 g Tween-80、0.52 g Span-80、37.37 g提取液(0.8 g生药/g)、0.07 g尼泊金乙酯。(2)流变学测试说明芙蓉膏属于假塑性流体,具有剪切变稀特性、抗高温能力、较好的存储稳定性和极强的触变性。(3)构建了10批芙蓉膏的物理指纹图谱,通过SPSS软件计算结果表明10批芙蓉膏的相似度均大于0.950,证明芙蓉膏制备工艺稳定。结论将芙蓉膏改为乳剂型软膏,并引入流变学评价,建立了流变参数物理指纹图谱,为中药乳膏剂的处方优化及质量评价提供了新的研究思路和方法。Objective To change the Furong ointment to an emulsion type ointment,select the optimal formulation and carry out the rheological study.Methods Plackett-Burman experiment was used to screen out the excipients with significant influence,and combined with D-optimal mixture design to optimize the formulation to prepare Furong ointment,and rheological method was carried out to establish the physical fingerprint of rheological parameters.Results(1)Determined Furong ointment base formula:3.14 g stearic acid,1.30 g glycerol monostearate,4.00 g white vaseline,8.00 g octadecyl alcohol,12.00 g glycerol,3.67 g Tween-80,0.52 g Span-80,37.37 g extract(0.8 g crude drug/g)and 0.07 g Nipagin ethyl ester.(2)Furong ointment is a pseudoplastic fluid with shear thinning properties,suitable storage stability,high temperature resistance and strong thixotropy.(3)By establishing the physical fingerprint of rheological parameters,the stability of the preparation process of the Furong ointment was proved.Conclusion This paper has changed the Furong ointment into emulsion ointment,including the rheological evaluation and establishing the physical fingerprint of the rheological parameters,which would provide new research guidelines and methods for the formulation optimization and quality evaluation of traditional Chinese medicine ointment.

关 键 词：芙蓉膏 流变学 物理指纹图谱 处方优化 质量评价 

分 类 号：R285.5[医药卫生—中药学]