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

作　　者：肖佳佳 王隽 施崇精 李萍[1] XIAO Jiajia;WANG Jun;SHI Chongjing;LI Ping(Chengdu Integrated TCM&Western Medicine Hospital·Chengdu First People's Hospital,Chengdu,Sichuan,China 611141)

机构地区：[1]四川省成都市中西医结合医院·四川省成都市第一人民医院,四川成都611141

出　　处：《中国药业》2025年第9期40-45,共6页China Pharmaceuticals

基　　金：成都中医药大学“杏林学者”学科人才科研提升计划项目[YYZX2021011]。

摘　　要：目的优选石芒清热软膏制备工艺,并评价其安全性。方法以样品外观、涂抹延展性、离心稳定性、耐寒性试验、耐热性试验的综合评分为评价指标,以聚乙二醇400用量、水用量、甘油用量为考察因素,在单因素试验基础上,采用Box-Behnken Design响应面法筛选最优制备工艺,并进行验证试验。采用日本大耳白兔完整皮肤和破损皮肤进行刺激性试验和急性毒性试验,采用豚鼠进行皮肤过敏试验,以验证石芒清热软膏的安全性。结果最优工艺为聚乙二醇400用量56 g,水用量2.8 g,甘油用量3.2 g,此条件下3次试验的综合评分为(88±2)分。石芒清热软膏及相应赋形剂对局部完整皮肤无刺激性,对破损皮肤有轻度刺激性;致敏率均为10%,未见严重过敏反应;对完整及破损皮肤均无急性毒性反应。结论优选的石芒清热软膏制备工艺科学合理,稳定可行,安全有效。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 

分 类 号：R932[医药卫生—生药学] R283[医药卫生—药学]