湿疹喷雾剂制备工艺及质量标准研究

Preparation Technology and Quality Standard of Eczema Spray

目的优化湿疹喷雾剂的制备工艺并建立湿疹喷雾剂质量标准。方法通过正交试验优化湿疹喷雾剂提取液的提取工艺,分析吐温-80、壳聚糖溶液对湿疹喷雾剂的影响。采用薄层色谱法对处方中的黄柏、苦参、地榆进行定性鉴别;采用高效液相色谱法测定黄柏中小檗碱的含量。结果湿疹喷雾剂制备工艺为:取处方量药材,加10倍量的水,提取2次,每次1 h,以0.2%山梨酸钾作防腐剂、3%吐温-80作增溶剂,絮凝剂壳聚糖用量为1 g·L^(-1)。薄层色谱法可鉴别处方中黄柏、苦参、地榆药材;高效液相色谱法精密度、重复性、稳定性良好,小檗碱在4~80μg·ml^(-1)范围内呈良好线性关系,相关系数为0.9998,平均加样回收率为105.60%。结论湿疹喷雾剂制备工艺合理,定性、定量方法准确可靠,可作为质量控制标准。

Objective To optimize the preparation process of eczema spray and establish a quality standard for it.Methods The extraction process of eczema spray was optimized by orthogonal experiments,while the effects of Tween 80 and chitosan solution on eczema spray were analyzed.The thin layer chromatography(TLC)method was used for qualitative identification of Phellodendri Chinrnsis Cortex,Sophorae Flavescentis Radix,Sanguisorbae Radix.The content of berberine in this spray was determined via high performance liquid chromatography(HPLC).Results The optimum processing technology for eczema spray involved taking the prescribed amount of medicine,adding 10 times the amount of water,extracting it for 1.0 h twice,with 0.2%potassium sorbate as the preservative,3%Tween-80 as the solubilizer,and chitosan as the flocculant at the dosage of 1 g·L^(-1).TLC could be used to identify Phellodendri Cortex,Sophorae Flavescentis Radix and Sanguisorbae Radix.Berberine hydrochloride showed a good linearity in the concentration range of 4-80μg·ml^(-1)(r=0.9998).The average recovery of berberine was 105.6%(RSD 0.83%).Conclusion This preparation process of eczema spray is simple and well-designed.The quality method can be used as the quality control standard for the preparation.