药学研究2026，Vol.45Issue(8)：875-878,931,5.DOI:10.13506/j.cnki.jpr.2026.08.005
吡拉西坦片近红外快速检验模型的建立与应用
Establishment and application of rapid testing model for piracetam tablets by near-infrared spectroscopy
丁大中 1毕传林 1裴琳 1杨龙华1
作者信息
- 1. 青岛市食品药品检验研究院,山东 青岛 266071
- 折叠
摘要
Abstract
Objective To establish a near-infrared(NIR)rapid testing model for piracetam tablets and apply it to qualitative and quantitative analysis.Methods The original NIR spectra of 393 batches of piracetam tablets from 38 manufacturers were collected.The modeling spectral ranges of 9 000～7 500 cm-1,6 900～5 600 cm-1,and 5 000～4 250 cm-1 were optimized,and the first derivative combined with vector normalization(FD+VN)was selected as the spectral preprocessing method to establish a consistency rapid qualitative model.For the quantitative model,gradient simulation samples with piracetam content ranging from 0.493 1 to 1.000 0 g·g-1 were prepared as the calibration set.The spectral ranges of 6 600～6 000 cm-1 and 5 000～4 500 cm-1 were optimized,and FD+VN was applied to develop the model using the reference values of piracetam content determined by HPLC.Results Consistency models for four manufacturers were established and validated.For the manufacturer with the largest sample size,the quantitative model achieved a determination coefficient(R2)of 0.992 9 for the calibration set,with a root mean square error of cross-validation(RMSECV)of 0.013 9.The root mean square error of prediction(RMSEP)for the validation set was 0.010 5.The deviation between predicted and reference values was less than 0.032 5 g·g-1,with an average deviation of 0.008 3 g·g-1.Conclusion The established models are accurate,reliable,and efficient for rapid screening,suitable for quality control in production and regulatory surveillance against counterfeit or substandard piracetam tablets.关键词
近红外光谱/吡拉西坦片/快速检验模型Key words
Near-infrared spectroscopy/Piracetam tablet/Rapid testing model分类
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丁大中,毕传林,裴琳,杨龙华..吡拉西坦片近红外快速检验模型的建立与应用[J].药学研究,2026,45(8):875-878,931,5.
