近红外法监测标准物质分装及贮存过程中水分的变化

Using NIR technology to monitor the moisture change of drug reference standard in its packaging or storage duration

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：The levocarnitine reference standard （RS） and cromolyn sodium RS were used as examples to study the feasibility of using near-infrared （NIR） technology to monitor the moisture change of drug RS in its packaging or storage duration.Methods：Record the diffuse reflectance spectra of a suitable number of representative samples for one RS immediately after its packaging was finished.First derivate with 17 points smoothing was used as spectral preprocessing method.The correlation coefficients （r） between any two spectra were calculated in the spectral ranges which are sensitive to moisture change.If one of the r is less than 99.00%,the tested RS may Absorb moisture in its packaging duration.Put all the samples with their package into 92% RH （relative humidity） place for 7 days.Then record their NIR spectra and calculate the correlation coefficients between any two spectra under the same condition.If one of the r is less than 99.00%,the package of this RS is not air-tight completely.Results：The NIR identification results of 10 bottles of levocarnitine RS and cromolyn sodium RS were identical to those determined by their official method.Conclusion：It is a good method using NIR technology to monitor the moisture change of drug RS in their packaging or storage duration.