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目的:使用左卡尼汀和色甘酸钠对照品研究应用近红外方法监测标准物质分装及存储过程中水分变化的可行性。方法:对照品分装完毕后,立即抽取一定量代表性样品,使用积分球方法采集近红外漫反射光谱,谱图经一阶导数和17点平滑处理,采用相关系数法,在水分敏感谱段计算各瓶对照品近红外光谱彼此间的相关系数,与事先设定的阈值(99.00%)相比较,如果出现小于阈值的结果,则认为该对照品在分装过程中吸潮使样品分装不均匀。随后将所有样品带包装放入密闭高湿的环境,7d后测定其近红外光谱,同样计算彼此间的相关系数,如果出现小于阈值的结果,则说明对照品包装密闭性存在问题。结果:通过对左卡尼汀和色甘酸钠各10瓶对照品的研究,发现2种对照品分装均匀但是前者的包装密闭性存在问题,与实际情况一致。结论:近红外是值得推荐的监测药品标准物质水分变化的好方法。
OBJECTIVE: To investigate the feasibility of using near-infrared spectroscopy to monitor the change of moisture content during standard packing and storage of standard materials by using levocarnitine and cromolyn sodium reference substance. Methods: After the reference substance was packed, a certain amount of representative samples were taken immediately. The near-infrared diffuse reflectance spectra were acquired by integrating sphere method. The first derivative and 17-point smoothing spectra were obtained. Correlation coefficient method The correlation coefficients between the near-infrared spectra of each bottle of reference products were calculated and compared to a pre-set threshold value (99.00%), if less than the threshold value was present, the reference substance was considered moisture up during the dispensing process to dispense the sample Inhomogeneous. Afterwards, all the samples were packaged in a sealed, high-humidity environment. After 7 days, their near-infrared spectra were measured and the correlation coefficients were also calculated. If the results were less than the threshold, there was a problem with the airtightness of the reference product packaging. Results: Through the study of 10 bottles of reference substance of L-carnitine and cromolyn sodium, it was found that the two kinds of reference substance were evenly packed but the former had a problem of packaging airtightness, which was consistent with the actual situation. Conclusion: NIR is a good way to monitor changes in the moisture of a standard reference substance.