依诺沙星片剂及胶囊剂近红外光谱模型的研究  

Investigation of near infrared spectral model of enoxacin tablets and capsules

作　　者：黄婧 HUANG Jing(Xiamen Institute for Food and Drug Quality Control,Xiamen 361012,China)

机构地区：[1]厦门市食品药品质量检验研究院,福建厦门361012

出　　处：《中国药品标准》2022年第2期190-197,共8页Drug Standards of China

摘　　要：目的:建立依诺沙星片剂及胶囊剂的近红外光谱模型。方法:通过对7家生产企业的依诺沙星片和7家生产企业的依诺沙星胶囊进行近红外扫描,对两种依诺沙星制剂分别建立了各企业近红外一致性检验模型和近红外通用型定量模型。结果:一致性检验模型可对各企业产品进行较好的区分,定量模型的验证异常点数在可接受范围内。结论:依诺沙星片剂及胶囊剂的一致性检验模型和定量模型均可达到快速分析的要求。为依诺沙星片剂及胶囊剂的快速分析提供了参考。Objective:To establish a near-infrared spectral model of enoxacin tablets and capsules.Methods:By scanning the near-infrared spectra of enoxacin tablets and capsules from 7 manufacturers,the near-infrared consistency test model of each manufacturer and the near-infrared common quantitative model were established for two enoxacin preparations.Results:The consistency test model can better distinguish the products of various enterprises,and the verification exception points of the quantitative model are within the acceptable range.Conclusion:The consistency test model and quantitative model of enoxacin tablets and capsules can meet the requirements of rapid analysis,which provide a reference for the rapid analysis of enoxacin tablets and capsules.

关 键 词：近红外 依诺沙星 快速分析 

分 类 号：R921.2[医药卫生—药学]