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[目的]建立氨咖黄敏胶囊近红外一致性检验模型.[方法]运用近红外漫反射光谱技术采集氨咖黄敏胶囊的近红外光谱,以一阶导数、17点平滑法和矢量归一化法对光谱进行预处理,选取同一厂家6个批次样品,使用3台仪器共扫描108张光谱作为标准光谱,另取8批其他厂家的氨咖黄敏胶囊样品进行扫描,共扫描144张作为检验光谱.参考光谱的CI值最高为7,利用比对最大CI值方法建立一致性近红外检验模型.[结果]标准样品波谱形态一致,位置集中不偏移.检验样品波谱形态虽然一致,但位置存在偏移.两组之间在9 000~7 500cm~(-1),6 900~5 600cm~(-1)和5 000~4 250cm~(-1) 3个波段表现突出.标准样品CI值较集中,并均在4.5以下,检验样品CI值均高于4.5.[结论]近红外光谱检测同一厂家药品表现出良好的一致性,而检测不同厂家的药品表现出明显的特异性.建立相应药品近红外一致性检验模型可快速、简便、准确地筛查出药品的生产厂家.
[Objective] The research aimed to establish a near-infrared consistency test model of Ammonia Caramel Capsule. [Methods] Near-infrared diffuse reflectance spectroscopy was used to collect the near infrared spectra of Ammonia Caffeine Capsule. The first derivative, 17- France spectrum pretreatment, select the same batch of six batches of samples, the use of three instruments scans a total of 108 spectra as the standard spectrum, the other eight batches of other manufacturers of ammonia Caramel Capsules were scanned, scans a total of 144 As the test spectrum. The CI value of the reference spectrum is up to 7, and the consistent near-infrared test model is established by using the method of comparing the maximum CI value. [Results] The spectral forms of the standard samples are consistent and the positions are not shifted. But there is a shift in the position between the two groups in the band of 9 000-7 500 cm -1, 6 900-5 600 cm -1 and 5 000-4 250 cm -1. The CI value of the samples was more concentrated and both were below 4.5, the CI values of the tested samples were higher than 4.5. [Conclusion] Near-infrared spectroscopy showed a good consistency with the same manufacturer’s drugs, while the drugs from different manufacturers showed obvious specificity The establishment of the corresponding drug near infrared conformance test model can be fast, It accurately screened for drug manufacturers.