运用近红外光谱法建立盐酸二甲双胍肠溶片一致性检验模型

Establishment of the Near Infrared Conformity Test Model of Metformin Hydrochloride Enteric-Coated Tablets

目的运用近红外光谱法建立盐酸二甲双胍肠溶片一致性检验模型。方法在12000cm-1~4000cm-1区间对盐酸二甲双胍肠溶片进行图谱扫描,选择二阶导数化和矢量归一化预处理方法建立一致性检验模型。结果利用该模型可以快速准确的区分贵州天安药业股份有限公司与其他厂家的盐酸二甲双胍肠溶片。结论本文建立的检验模型快速、简便、准确、有效,是药品监督部门快速筛查假冒品牌药品的有效手段。

OBJECTIVE To establish a convenient quick identification method of Metformin Hydrochloride Enteric-Coated Tablets by near infrared spectrum. METHODS Metformin hydrochloride enteric coated tablets were scanned in the range of 12000cm- 1 to 4000cm-1, the second derivative followed by vector normalization method was used for establishment of conformity test model. RESULTS The model of Metformin hydrochloride enteric coated tablets can be used to quickly and accurately distinguish Guizhou Tianan Pharmaceutical Co. Ltd and other manufacturers. CONCLUSION The method is simple, fast, accurate and effective. It can be used for this kind of drugs on the market for a rapid screening judging whether these are fake brand drugs or not.