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自然铜水凝胶的制备及质量标准研究

Preparation and Quality Standardization of Pyritum Hydrogels
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摘要 优化自然铜水凝胶的制备工艺,并进行质量评价。以自然铜水凝胶的外观、气味、均匀度、涂展性、pH值的综合评分为考察指标,以凝胶中基质卡波姆940含量、三乙醇胺含量、甘油含量为因素,采用单因素实验结合响应面试验法,同时根据2020版《中国药典》四部通则对自然铜水凝胶的理化性质进行评价,并在510 nm处测定自然铜水凝胶中Fe^(2+)含量。筛选出自然铜水凝胶的最佳制备工艺为:卡波姆-940含量1%,三乙醇胺含量1.6%、甘油含量6%,同时制得自然铜水凝胶外观、粒度、pH、黏度等均符合2020版《中国药典》相关规定,且凝胶中铁离子的平均含量为0.57 mg/g。该方法制备所得自然铜水凝胶剂稳定,为后续制剂研究提供指导意义。 The preparation process of Pyritum hydrogel was optimized and evaluated for quality.The comprehensive scores of appearance,odor,homogeneity,spreadability and pH of the Pyritum hydrogel were used as the investigation indexes,the matrix carbomer 940 content,triethanolamine content and glycerol content of the gel were used as the factors,and the one-way experiment combined with the response surface test method was used,while the physicochemical properties of the Pyritum hydrogel were evaluated according to the four general rules of the 2020 edition of the Chinese Pharmacopoeia,and Fe^(2+)content in Pyritum hydrogel were determined at 510 nm.The optimal preparation process of Pyritum hydrogel was screened as 1% carbomer-940,1.6% triethanolamine and 6% glycerol,and the appearance,particle size,pH and viscosity of the Pyritum hydrogel met the requirements of 2020 edition of Chinese Pharmacopoeia,and the average content of Fe2+in the gel was 0.57 mg/g.This method is stable,and provides a guidance for the subsequent formulation research.guidance for subsequent formulation studies.
作者 马佳卉 王争 兰青 谢辉 郁红礼 张庆明 刘佳新 王婉婷 韩佩佩 余浩婷 李海龙 张兴德 MA Jiahui;WANG Zheng;LAN Qing;XIE Hui;YU Hongli;ZHANG Qingming;LIU Jiaxin;WANG Wanting;HAN Peipei;YU Haoting;LI Hailong;ZHANG Xingde(College of Traditional Chinese Medicine,Yunnan University of Chinese Medicine,Yunan Kunming 650000;Pharmacy Department of Eastern Theater General Hospital,Jiangsu Nanjing 210000;School of Pharmacy,Nanjing University of Chinese Medicine,Jiangsu Nanjing 210000;Jiangsu Key Laboratory of Chinese Medicine Processing,Jiangsu Nanjing 210000,China)
出处 《广州化工》 2026年第5期63-67,共5页 GuangZhou Chemical Industry
基金 教育部产学合作协同育人项目(2022年度)(011062004014)。
关键词 自然铜 水凝胶 响应面 质量评价 pyritum hydrogel response surface quality evaluation

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