富马酸替诺福韦二吡呋酯片近红外一致性检验模型的建立与验证

Construction and validation of conformity test model for tenofovir disoproxil fumarate tablets by near-infrared reflectance spectroscopy

目的探讨建立富马酸替诺福韦二吡呋酯片的近红外一致性检验模型的可行性。方法采用一阶导数+矢量归一化法在12 000~4 000 cm^(-1)范围内对富马酸替诺福韦二吡呋酯片光谱进行预处理,选择最佳建模谱段为9 000~7 500 cm^(-1)、6 900~5 600 cm^(-1)、5 000~4 250 cm^(-1),平滑点为17,CI限度设置为7,建立一致性检验模型并进行验证。结果使用一致性检验模型可区分正品和伪品富马酸替诺福韦二吡呋酯片,并通过了不同人员采集光谱与不同仪器采集光谱验证。结论该方法简便、准确、可行,适用于药品快检车对富马酸替诺福韦二吡呋酯片一致性的快速筛查。

Objective To establish a conformity test model for inspecting tenofovir disoproxil fumarate tablets by near-infrared reflectance spectroscopy（ NIRS）. Methods The method of first derivative（ FD） and vector normalization（ SNV） was employed to pretreat the corresponding near spectroscopy spectral of tenofovir disoproxil fumarate tablets with the spectral ranges of 12 000 - 4 000 cm^-1,the optimum modeling band of 9 000 -7 500 cm^-1,6 900 -5 600 cm^-1and 5 000 - 4 250 cm^-1,the smoothing point of 17 and CI being 7. The conformity test model was constructed on the basis of the above parameters and was validated. Results Using the conformity test model can distinguish the authentic from the inauthentic tenofovir disoproxil fumarate tablets by different inspectors and near-infrared instruments. Conclusion The conformity test model is simple,accurate,feasible and suitable for the drug examination of tenofovir disoproxil fumarate tablets.