分子光谱法在微生物鉴别和生物制品及生化药品质量控制中的应用  

Application of molecular spectroscopy on microbiological identification and quality control of biological products and biochemical drugs

作　　者：秦晓东 赵瑜[1] 杭太俊[2] 尹利辉[1] 宋敏[2] QIN Xiaodong;ZHAO Yu;HANG Taijun;YIN Lihui;SONG Min(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629,China;China Pharmaceutical University,Nanjing 210009,China)

机构地区：[1]中国食品药品检定研究院,化学药品质量研究与评价重点实验室,北京102629 [2]中国药科大学,南京210009

出　　处：《中国药品标准》2021年第4期324-329,共6页Drug Standards of China

摘　　要：《中国药典》中涉及的生物制品和生化药品的生物检查是保障药效和安全性的重要方面。本文综述了红外光谱(IR)、近红外光谱(NIR)、拉曼光谱(Raman)、荧光光谱(MFS)和紫外光谱(UV)等分子光谱法在微生物鉴别及生物制品和生化药品生物检查中的应用,例如生物制品和生化药品快速质量筛查中的应用;工艺杂质控制中的应用;蛋白质聚合物分析中的应用;生物活性和效价测定中的应用以及生物制品过程分析技术中的应用。分子光谱法快速、绿色、高效的特点,使其在生物制品和生化药品质量控制方面具有巨大的潜力和广泛的应用空间。The biological inspection of biological products and biochemical drugs in the Chinese Pharmacopoeia can guarantee the efficacy and safety of drugs.The review summarizes the application of molecular spectroscopy methods such as infrared spectroscopy(IR),near infrared spectroscopy(NIR),Raman spectroscopy,fluorescence spectroscopy(MFS),ultraviolet-visible(UV)in the microbiology identification and biological inspection of biological products and biochemical drugs,such as rapid quality screening of biological products and biochemical drugs;process impurity control;activity/potency determination and process analytical technology.The rapid,green and high-efficiency characteristics of molecular spectroscopy make it have a huge potential and a wide range of applications in the quality control of biological products and biochemical drugs.

关 键 词：分子光谱法 生物制品 生化药品 生物检查 过程分析技术 

分 类 号：R921.2[医药卫生—药学]