摘要
目的:研究外用经验方苦黄散制备成O/W型软膏剂的工艺。方法:通过正交设计实验对软膏剂基质配方进行筛选,基质离心稳定性、耐寒性、耐热性、提取物加入量作为评价指标进行考察,优选其最佳制备工艺。结果:苦黄软膏剂的最佳制备工艺为1.8 g凡士林、8 mL液体石蜡、7 g硬脂酸、1.2 g单硬脂酸甘油酯、0.15 g三乙醇胺为油相,置于烧杯中水浴加热至85℃保温;3 mL甘油、1.0 g十八醇、蒸馏水(加至基质配方总量30 g)加热至85℃为水相,再加入0.07 g十二烷基硫酸钠、3 g苦黄散提取物;以细流将油相(O)加入到水相(W)中,同方向快速、充分搅拌均匀至乳化,即得。结论:制备的苦黄软膏性状稳定、耐寒耐热性良好、软硬度适中,为其药用新剂型及临床疗效评价研究奠定了基础。
Objective This study was intended to prepare Kuhuang powder,an empirical prescription for external use in dermatology of our hospital,into O/W type ointment.Method The method of L 9(34)orthogonal experiment design was used to select the formulation of the ointment,the centrifugal stability,cold resistance,heat resistance of the formulation and the amount of extract added were investigated as evaluation indexes.Result The best preparation process of Kuhuang ointment was determined as follows:put 1.8 g vaseline,8 mL liquid paraffin,7 g stearic acid,1.2 g glycerol monostearate and 0.15 g triethanolamine in a beaker(heated to 85℃in water bath)as the oil phase,and 3mL glycerin,1.0 g octadecyl alcohol,distilled water(added to 30 g of the total matrix formula)were heated to 85℃as the water phase.Subsequently,0.07 g sodium dodecyl sulfate and 3 g extract were added.The oil phase was added to the water phase by a small rate,then it was quickly and fully stirred to emulsify and obtain ointment.Conclusion Kuhuang ointment has stable character,favourable cold resistance and heat resistance,moderate softness and hardness,which can provide the foundation for new dosage forms and clinical efficacy evaluation.
作者
李富艳
张洪冰
LI Fuyan;ZHANG Hongbing(Traditional Chinese Medicine Hospital of Zaozhuang,Zaozhuang 277000,China;Zaozhuang hospital of Beijing university of Chinese medicine,Zaozhuang 277000,China)
出处
《中国民族民间医药》
2023年第24期37-40,共4页
Chinese Journal of Ethnomedicine and Ethnopharmacy
基金
山东省中医药科技发展计划项目(编号:2019-0649)
山东省中医药科技面上项目(编号:2021M105)。
关键词
提取物
软膏剂
正交试验
制备工艺
Extract
Ointment
Orthogonal Experiment
Preparation Process
