中国药房2025，Vol.36Issue(4)：447-453,7.DOI:10.6039/j.issn.1001-0408.2025.04.10
鸡内金当归褥疮软膏的制备工艺优化及质量标准研究
Study on preparation technology and quality standard of Jineijin danggui ruchuang ointment
摘要
Abstract
OBJECTIVE To optimize the preparation technology of Jineijin danggui ruchuang ointment and to establish its quality standard.METHODS Using oil phase dosage,emulsifier dosage and emulsification temperature as the indicators,the preparation technology of Jineijin danggui ruchuang ointment was optimized by response surface method.Gallus gallus domesticus and Angelica sinensis in the ointment were identified by TLC.The property of the ointment was observed,and its particle size and deliverable volume were inspected according to Chinese Pharmacopoeia.The contents of uridine,ferulic acid and ligustilide in the ointment were determined by high-performance liquid chromatography.RESULTS The optimal preparation technology of Jineijin danggui ruchuang ointment was as follows:4.0 g of white vaseline,7.0 g of liquid paraffin,5.0 g of lanolin(oil phase),0.44 g of triethanolamine as the emulsifier,and emulsification temperature of 78℃.Jineijin danggui ruchuang ointment prepared according to the optimal preparation method was a beige paste,and its particle size and deliverable volume inspection all met the requirements of the Chinese Pharmacopoeia.The identification of TLC for G.gallus domesticus and A.sinensis obtained satisfactory results.The linear ranges of uridine,ferulic acid and ligustilide were 1.6-25.6 μg/mL,0.003 15-0.100 8 mg/mL,0.006-0.192 mg/mL(all r＞0.999).RSD for the inspection,stability,reproducibility and recovery tests were all less than 2%(n=6).The average contents of uridine,ferulic acid and ligustilide were 0.081 2,0.100 0 and 0.396 9 mg/g,respectively.CONCLUSIONS The optimal preparation technology can be used for the production of the in-hospital preparation of Jineijin danggui ruchuang ointment;the content determination method can be used for the quality control of the ointment.关键词
鸡内金当归褥疮软膏/制备工艺/质量标准/响应面法/薄层色谱法/高效液相色谱法Key words
Jineijin danggui ruchuang ointment/preparation technology/quality standard/response surface method/thin layer chromatography/high-performance liquid chromatography分类
医药卫生引用本文复制引用
庞晓军,谢颜,陈杏..鸡内金当归褥疮软膏的制备工艺优化及质量标准研究[J].中国药房,2025,36(4):447-453,7.基金项目
广西中医药适宜技术开发与推广项目(No.GZSY22-91) （No.GZSY22-91）
钦州市科学研究与技术开发计划项目(No.202116621) （No.202116621）
