摘要
目的推动复方芒果叶蛇油霜临床应用和产业化,探讨复方芒果叶蛇油霜的制备工艺、皮肤刺激性和稳定性等。方法 (1)采用水包油型乳化剂乳化法制备该药;(2)以肤宝乳霜为对照品,将实验兔8只分为完整皮肤试验组和破损皮肤试验组,采用左右侧自身对比,观察该药对实验兔皮肤刺激性;(3)常温观察期12个月,指标包括性状、色泽、气味、鉴别、有效成分含量等。结果获得的合格样品,对完整皮肤无刺激性,对破损皮肤有轻度刺激性;常温观察期内质量无明显变化。结论该制备工艺可行,对皮肤无异常作用,质量稳定良好,安全性高,为今后规模化生产和临床应用等提供有利参考。
Objective The study aims to promote the clinical application and industrialization of compound mango leaf snake oil creamand to discuss the preparation process,skin irritation and stability of the cream.Methods (1)The medicine was prepared by the oil-in-water emulsifier emulsification method.(2) The Skin Cream was used as the reference product,and 8 rabbits were randomly divided into the integrity skin test group and the damaged skin test group,using the left and right sides to contrast and observe the drug's irritation to the experimental rabbit skin.(3)The normal temperature observation period is 12 months.The indicators include traits,color,odor,identification,and active ingredient content.Results Qualified samples were obtained;it has no irritation on intact skin,only mild irritation on damaged skin,neither significant change of quality during normal temperature observation period.Conclusion The preparation process is feasible without abnormal effect on the skin,and it has stable quality and high safety,and provides a favorable reference for large-scale production and clinical application in the future.
作者
王捷
王羽中
何成章
张宏亮
陈圣杰
杨春兰
刘丽敏
叶勇
WANG Jie;WANG Yu-zhong;HE Cheng-zhang;ZHANG Hong-liang;CHEN Sheng-jie;YANG Chun-lan;LIU Li-min;YE Yong(Phamaceutical Factory of Guangxi Medical University,Nanning City,Guangxi Zhuang Autonomous Region,530021,China;Guangxi Medical University,Nanning City,Guangxi Zhuang Autonomous Region,530021,China;First Affiliated Hospital of Guangxi Medical University,Nanning City,Guangxi Zhuang Autonomous Region,530021,China)
出处
《蛇志》
2019年第1期13-15,共3页
Journal of Snake
基金
广西南宁市青秀区科学研究与技术开发计划项目(编号:2017028)
广西南宁市青秀区科学研究与技术开发计划项目(编号:2015Z01)
关键词
复方芒果叶蛇油霜
制备工艺
皮肤刺激性
稳定性
芒果苷
Compound mango leaf snake oil cream
Preparation process
Skin irritation
Stability
Mangiferin
