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目的:利用近红外光谱(NIR)建立通用型多烯酸乙酯软胶囊的一致性检验模型,并对不同厂家的样品进行一致性检验。方法:使用3台同一型号的近红外光谱仪在12 000~4 000 cm-1范围内采集了8个厂家73批次样品的近红外光谱。通过聚类分析和二阶导数化和矢量归一化进行预处理,一致性指数限度设置为6,平滑点数13个,建立一致性检验模型。结果:通用模型选定的特征谱段为9 000~7 895、6 500~5 950、5 262~4 752 cm-1;在通用模型谱段和处理方法基础上,得到的细化特征谱段5 930~5 620、4 750~4 520 cm-1使得不同厂家模型的专属性更强。结论:所建立的一致性检验模型方法能够对多烯酸乙酯软胶囊进行快速鉴别。
OBJECTIVE: To establish the consistency test model of universal ethyl polyacrylate soft capsule by near infrared spectroscopy (NIR) and to test the consistency of samples from different manufacturers. Methods: NIR spectra of 73 batches of samples from 8 factories were collected in the range of 12 000 ~ 4 000 cm-1 using 3 sets of NIR spectrometers of the same type. Through cluster analysis and second-order derivative and vector normalization, the consistency index is set to 6, and the number of smoothing points is set to 13, and a consistency test model is established. Results: The general spectral characteristics of the model were 9 000 ~ 7 895, 6500 ~ 5 950, 5262 ~ 4 752 cm-1. Based on the generalized model spectrum and treatment method, 5 930 ~ 5 620,4 750 ~ 4 520 cm-1 makes the model more exclusive to different manufacturers. CONCLUSION: The established conformational test model method can rapidly identify ethyl polyacrylate soft capsules.