温性经筋通贴膏醇提和制剂工艺优化研究

Study on Optimization of Alcohol Extraction Technology and Preparation Formula of Wenxing Jingjintong Cataplasm(温性经筋通贴膏)

目的优化温性经筋通贴膏的醇提工艺和制剂配方工艺,使其发挥更好的临床疗效。方法采用L_(9)(3^(4))正交试验法,以乙醇浓度,乙醇倍量,提取时间,提取次数为考察因素,以干膏得率为评价指标,优选最佳提取工艺条件;采用混合型骨架,用L_(9)(3^(4))正交试验法,以NP-700、高岭土、甘羟铝、酒石酸为考察因素,以成型凝胶贴膏的初黏力、持黏力、剥离强度、综合感官为评价指标,优选出制剂最佳配方。结果温性经筋通贴膏最佳醇提工艺是以6倍量的70%乙醇提取2次,每次2 h;优化的制剂配方是NP-700∶高岭土∶甘羟铝∶酒石酸=100∶80∶8∶0.8。结论优选出的工艺稳定可行,适合制剂生产操作,可作为温性经筋通贴膏的提取工艺和制剂配方工艺。

Objective To optimize the alcohol extraction process and formulation process of Wenxing Jingjintong Cataplasm(温性经筋通贴膏)so as to make it play a better clinical effect.Methods L_(9)(3^(4))orthogonal test method was used to optimize the best extraction conditions with the concentration of ethanol,ethanol times,extraction time and extraction times as the factors,and the yield of dry paste as the evaluation index.The mixed skeleton was used.The orthogonal test of L_(9)(3^(4))was used.Taking NP-700,kaolin,glycinate and tartaric acid as the investigation factors,the best formulation was optimized by taking the initial viscosity,adhesion,peel strength and comprehensive sensory evaluation of the cataplasm as the comprehensive evaluation index.Results The best alcohol extraction process of Wenxing Jingjintong Cataplasm was as follows:extract twice with 6 times of 70%ethanol,2 hours for each time.The optimized formulation was as Np-700∶Kaolin∶Galal∶tartaric acid=100∶80∶8∶0.8.Conclusion The optimized process is stable and feasible,which is suitable for the preparation production and operation.It can be used as the extraction process and formulation process of Wenxing Jingjintong Cataplasm.