摘要
肠溶片的包衣厚度是关键质量属性,而拉曼光谱法在分析药物制剂微观结构方面具有独特的优势。该研究采用拉曼光谱成像技术测定了不同来源、7个批次的阿司匹林肠溶片的包衣厚度和包衣均匀性,并运用Micro-CT三维成像技术验证阿司匹林肠溶片的包衣均匀性差异。结果显示,包衣厚度依序为:厂家A样品>厂家B样品>参比制剂>厂家C样品>自制片E>厂家D样品;厂家A样品、厂家B样品、厂家D样品和自制片E的包衣层都较为均匀,参比制剂和厂家C样品的包衣均匀性较差,表明拉曼光谱法可以用于测定片剂的包衣层厚度及包衣工艺评价。
Coating thickness of enteric-coated tablets is a critical quality attribute.Raman mapping has unique advantages in analysis of the microstructure of pharmaceutical preparations.In this paper,Raman mapping was used to determine the coating thickness and coating uniformity of 7 batches of aspirin enteric-coated tablets from different sources,and Micro-CT three-dimensional imaging technology was used to verify the difference in coating uniformity of aspirin enteric-coated tablets.The results showed that the coating thickness was in sequence as follows:products from manufacturer A>products from manufacturer B>reference preparation>products from manufacturer C>self-made tablets E>products from manufacturer D.The coating layers of the products from manufacturer A,manufacturer B,manufacturer D and self-made tablets E were relatively uniform,and the coating uniformity of the reference preparations and the products from manufacturer C were poor,indicating that Raman spectroscopy could be used to determine the thickness of tablet coating layers and the evaluation of coating process.
作者
刘伟
张馨月
邹文博
许卉
宁保明
LIU Wei;ZHANG Xinyue;ZOU Wenbo;XU Hui;NING Baoming(School of Pharmacy,Yantai University,Yantai 264005;Key Lab.of Chemical Drug Quality Research and Evaluation,National Medical Products Administration,China National Institute for Food and Drug Control,Beijing 102629;School of Pharmacy,China Pharmaceutical University,Nanjing 211198)
出处
《中国医药工业杂志》
2025年第1期80-88,共9页
Chinese Journal of Pharmaceuticals
关键词
阿司匹林肠溶片
拉曼光谱成像
包衣层厚度
包衣均匀性
质量评价
aspirin enteric-coated tablet
Raman mapping
coating thickness
coating uniformity
quality evaluation
