拉曼光谱法用于药品注射液标准中鉴别项的探讨  

Investigation on Identification Items of Injections by Raman Spectroscopy in Pharmaceutical Standard

作　　者：赵瑜[1] 尹利辉[1] 曹丽梅[1] 肖新月[1] 

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药品标准》2015年第6期416-420,共5页Drug Standards of China

摘　　要：目的:探讨在药品标准中采用拉曼光谱方法作为注射液鉴别项的科学性、可行性和有效性。方法:采用拉曼光谱法,以相应对照品的水溶液的拉曼光谱作为参考光谱,对《中国药典》2010年版二部中采用红外光谱法鉴别的8个注射液品种进行定性鉴别。结果:拉曼光谱法能够对氨茶碱注射液等8个品种进行鉴别。结论:拉曼光谱法用于注射液品种的定性鉴别,具有不需要复杂的样品前处理,可直接测定,准确度高,不受水分干扰等优点,可作为药品标准中一些注射液及其他溶液制剂定性鉴别的方法之一。Objective： To find out whether the Raman spectroscopy was scientific and effective as an identification method of injectionsin drug standard. Method： Raman spectra of reference substances were used as reference spectra, 8 injection varieties recorded in Chinese Pharmacopeia 2010 Edition Vol. 11 that using IR method were identified. Results： Raman spectroscopy could identify Aminophylline Injection and other 8 varieties. Conclusion： Raman spectroscopy used to the qualitative identification of a variety of injections has some advantages, such as no need complex sample pre-processing, direct determination, high-accuracy and not affected by moisture, etc. It can be one of methods for the qualitative identification of some injections and other solutions in the pharmaceutical standard.

关 键 词：注射液 拉曼光谱法 鉴别 药典方法 

分 类 号：R921.2[医药卫生—药学]