中国药业2025，Vol.34Issue(9)：40-45,6.DOI:10.3969/j.issn.1006-4931.2025.09.009
石芒清热软膏制备工艺优选及其安全性评价
Preparation Process Optimization and Safety Evaluation of Shimang Qingre Ointment
摘要
Abstract
Objective To optimize the preparation process of Shimang Qingre Ointment,and to evaluate its safety.Methods The comprehensive scores of sample appearance,coating ductility,centrifugal stability,cold resistance test,and heat resistance test were taken as evaluation indexes,and the dosage of polyethylene glycol 400,water,and glycerol were taken as evaluation factors,the Box-Behnken Design(BBD)response surface methodology was used to screen the optimal preparation process based on the single factor test,and the validation test was conducted.The irritation test and acute toxicity test were conducted on intact and damaged skin of Japanese white rabbits,and the skin allergy test was conducted on guinea pigs to verify the safety of Shimang Qingre Ointment.Results The optimal process was as follows:the dosage of polyethylene glycol 400 was 56 g,the dosage of water was 2.8 g,and the dosage of glycerol was 3.2 g.Under these conditions,the comprehensive score of the three experiments was(88±2)points.Shimang Qingre Ointment and corresponding excipients had no local irritant reaction on intact skin,but have a mild irritant effect on damaged skin;the sensitization rate was 10%,and no severe allergic reactions were observed;there were no acute toxic reactions to intact or damaged skin.Conclusion The optimal preparation process of Shimang Qingre Ointment is scientific,reasonable,stable,feasible,safe,and effective.关键词
石芒清热软膏/Box-Behnken Design响应面法/工艺优选/安全性Key words
Shimang Qingre Ointment/Box-Behnken response surface design method/process optimization/safety分类
药学引用本文复制引用
肖佳佳,王隽,施崇精,李萍..石芒清热软膏制备工艺优选及其安全性评价[J].中国药业,2025,34(9):40-45,6.基金项目
成都中医药大学"杏林学者"学科人才科研提升计划项目[YYZX2021011]. （）
