盐酸金霉素眼膏粒度及显微拉曼光谱分析研究  

Analysis and research on the particle size and micro Raman spectrum of chlortetracycline hydrochloride eye ointment

作　　者：刘绪平 张银花 陈希 殷彦鹏 王杰 段和祥 LIU Xu-ping;ZHANG Yin-hua;CHEN Xi;YIN Yan-peng;WANG Jie;DUAN He-xiang(Jiangxi Provincial Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang 330029,China)

机构地区：[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,南昌330029

出　　处：《药物分析杂志》2020年第10期1897-1904,共8页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:研究盐酸金霉素眼膏粒度检验方法,应用显微拉曼光谱法快速鉴定粒子,分析粒度超标原因。方法:应用显微镜法检查盐酸金霉素眼膏粒度;采用显微拉曼光谱法对盐酸金霉素粒子进行快速检测和鉴别,测定条件:532 nm激光器,2.5 m W激光功率,0.002 s曝光时间,1 000次累加。结果:部分企业粒度检查结果不符合标准规定,粒度批间差异较大;由显微拉曼光谱表明样品中超过50μm的微粒均为盐酸金霉素粒子。结论:部分企业生产工艺未对粒度进行有效控制,是导致产品粒度超标的根本原因;建议《中华人民共和国药典》2015年版四部粒度检查法对粒径测定标准等方面做出更详细的规定;显微拉曼光谱法在药品显微鉴别结果准确,具有较好的的应用前景。Objective:To study on the particle size inspection method of chlortetracycline hydrochloride eye ointment,using micro Raman spectroscopy to quickly identify particles and analyze the reasons of unqualified particle size inspection. Methods:The particle size of chlortetracycline hydrochloride eye ointment was examined by microscopy. Rapid detection and identification of chlortetracycline hydrochloride particles was proceed by using micro Raman spectroscopy with measurement conditions were as follows:532 nm laser,2.5 m W laser power,0.002 s exposure time and 1 000 accumulations. Results:The particle size of chlortetracycline hydrochloride eye ointment from some manufacturers did not meet the standard requirements and varied between batches. Microscopic Raman spectroscopy showed that the particles larger than 50 μm in chlortetracycline hydrochloride eye ointment were chlortetracycline hydrochloride raw particles. Conclusion:The production process of some enterprises does not effectively control the particle size,which is the root cause of the unqualified product particle size. There is no specific standard for determining the particle size in Chinese Pharmacopoeia 2015 edition,and it is recommended to make more detailed regulations for the particle size limit inspection. The results of micro Raman spectroscopy are accurate and have a good application prospect.

关 键 词：盐酸金霉素眼膏 四环素类广谱抗生素 粒度 显微拉曼光谱法 药品快速检测和鉴别 质量控制 

分 类 号：R917[医药卫生—药物分析学]