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

作　　者：庞晓军[1,2] 谢颜 陈杏 PANG Xiaojun;XIE Yan;CHEN Xing(Dept.of Clinical Pharmacy,the Second People’s Hospital of Qinzhou,Guangxi Qinzhou 535000,China;College of Pharmacy,Guangxi Medical University,Nanning 530021,China)

机构地区：[1]钦州市第二人民医院临床药学科,广西钦州535000 [2]广西医科大学药学院,南宁530021

出　　处：《中国药房》2025年第4期447-453,共7页China Pharmacy

基　　金：广西中医药适宜技术开发与推广项目(No.GZSY22-91);钦州市科学研究与技术开发计划项目(No.202116621)。

摘　　要：目的优化鸡内金当归褥疮软膏的制备工艺,并建立其质量标准。方法以油相、乳化剂用量和乳化温度为指标,采用响应面法优化鸡内金当归褥疮软膏的制备工艺。采用薄层色谱法鉴别该软膏中的鸡内金和当归,观察该软膏的性状,按照《中国药典》方法对该软膏进行粒度和装量检查,采用高效液相色谱法测定该软膏中尿苷、阿魏酸和藁本内酯的含量。结果鸡内金当归褥疮软膏的最优制备工艺为:油相白凡士林4.0 g、液体石蜡7.0 g、羊毛脂5.0 g,乳化剂三乙醇胺0.44 g,乳化温度78℃。按最优工艺制备所得鸡内金当归褥疮软膏为米白色膏状,其粒度和装量检查均符合《中国药典》要求。鸡内金和当归的薄层色谱鉴别结果良好。尿苷、阿魏酸、藁本内酯的线性范围分别为1.6~25.6μg/mL、0.00315~0.1008 mg/mL、0.006~0.192 mg/mL(r均大于0.999);精密度、稳定性、重复性、加样回收率试验的RSD均小于2%(n=6);平均含量分别为0.0812、0.1000、0.3969 mg/g。结论所得最优制备工艺可用于鸡内金当归褥疮软膏的院内制剂生产;所建含量测定方法可用于该软膏的质量控制。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 1.6-25.6μg/mL,0.00315-0.1008 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 0.0812,0.1000 and 0.3969 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 

分 类 号：R917[医药卫生—药物分析学] R283.6[医药卫生—药学]