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目的:利用近红外漫反射光谱(NIRDRS)分析技术对头孢氨苄胶囊进行快速定量分析。方法:以22个企业的98批头孢氨苄胶囊为分析对象,用光纤探头测定近红外漫反射光谱;定量模型的预处理方法为一阶导数与矢量归一化,波长范围11995.6～6098.1cm~(-1),回归方法为偏最小二乘法(PLS)。结果:80个样品经内部交叉验证建立预测模型,浓度范围为42.46%～92.32%,内部交叉验证均方差(RMSECV)为1.53%,相关系数为0.9871。用18个样品进行外部验证,外部验证均方差(RMSEP)为1.18%,平均回收率为100.1%,RSD为1.79%。结论:该法快速、准确、简便、无损,可用于药品的快速检验。
Objective: The rapid quantitative analysis of cephalexin capsules by near infrared diffuse reflectance spectroscopy (NIRDRS) analysis. Methods: Ninety-eight cefalexone capsules of 22 enterprises were used as the analysis objects, and the near-infrared diffuse reflectance spectra were measured by fiber optic probe. The pretreatment method of the quantitative model was first derivative and vector normalization with the wavelength range of 11995.6 ~ 6098.1cm ~ -1), and the regression method is partial least squares (PLS). Results: Eighty samples were identified by internal cross-validation. The concentration ranged from 42.46% to 92.32%. The internal cross-validation mean square error (RMSECV) was 1.53% and the correlation coefficient was 0.9871. External validation was performed with 18 samples, with an RMSEP of 1.18%, an average recovery of 100.1% and a RSD of 1.79%. Conclusion: The method is rapid, accurate, simple, nondestructive and can be used for the rapid test of drugs.