用近红外光谱相似系数法监测市场药品的质量

Using Near-infrared Spectroscopy Correlation Coefficient Method Monitoring Drug Quality in the Circulation Field

目的用近红外相关系数法,通过药品检测车对药品在流通领域中的变化进行跟踪,对药品的真伪进行快速筛查。方法将真品近红外光谱图作参照光谱,选择7 240～7 140 cm-1,6 200～5 500 cm-1及5 000～4 700 cm-1波长范围,光谱预处理方法为二阶导数(13点平滑),测定待测样品光谱与参照光谱的相似系数,相似系数的阈值为95.0%,小于此值判为伪品。结果以14种真品药品为参照光谱,检测市场上收集到的相应伪品,相似系数均低于95.0%。结论该法简便、易行,通过药品检测车可对流通链中药品进行快速全程跟踪。

OBJECTIVE To track the drug movement and monitor drug quality in market.METHODS The spectra of the genuine drugs were used as reference spectra.The ranges of 7 240-7 140 cm-1,6 200-5 500 cm-1 and 5 000-4 700 cm-1 were selected as the spectra ranges and second derivate with 13 points smoothing was used as preprocessing method.The initial threshold was set as 95% of experimental statistical results.When using the model to identify a sample,the correlation coefficient of the tested spectra and the reference was calculated.If the calculated correlation coefficient was below 95%,the tested sample was identified as counterfeit.RESULTS The identification of 14 batches counterfeit drugs were all correct.CONCLUSION This model is not only accurate,but also easy to set up and to use.The model can be used to rapid monitor the drug quality in market of China.