齐多夫定薄膜衣片一致性检验模型建立及验证

Construction and validation of conformity test model for zidovudine filmcoated tablets by near infrared reflectance spectroscopy

目的分别建立齐多夫定带铝塑包装和去铝塑包装薄膜衣片的近红外一致性检验模型。方法采用一阶导数+矢量归一化法在12 000~4000 cm^(-1)范围内分别对齐多夫定带铝塑包装和去铝塑包装薄膜衣片的采集光谱进行预处理,选择最佳建模谱段为:9000~7500 cm^(-1)、6900~5600 cm^(-1)和5000~4250 cm^(-1),平滑点设为17,CI限度为7,分别建立一致性检验模型,并进行验证。结果分别使用一致性检验模型区分了正品和伪品齐多夫定带铝塑包装和去铝塑包装薄膜衣片,并通过了不同人员采集光谱以及不同仪器采集光谱的验证,实现了精确有效的模型传递,提高了近红外校正模型的通用性。结论该方法准确、简便、可行,适用于药品快检车对齐多夫定薄膜衣片一致性快速筛查。

Objective To establish a conformity test model for inspecting aluminum-plastic package and removed aluminum- plastic package zidovudine film-coated tablets by near infrared reflectanee（NIR） spectroscopy respectively. Methods The method of first derivative and vector normalization was employed respeetively to pretreat the corresponding NIR speetra of aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets with the spectral ranges of 12000-4000 cm^-1. The optimum modeling band were 9000-7500cm^-1, 6900-5600 cm^-1 and 5000-4250 cm^-1, respectively, and the smoothing point was set as 17 and CI limit was 7. The conformity test model was constructed on the basis of the above parameters and validated respectively. Results The authentic aluminum-plastic package and removed aluminum-plastic package zidovudine film-coated tablets were distinguished from inauthentie ones using the conformity test model validated by spectra collected by different inspectors and different near infrared instruments, realizing the model transfer accurately and effectively and improving the universality of NIR calibration model. Conclusion The conformity test model is accurate, simple, feasible, and suitable for the drug examination of zidovudine film-coated tablets.