NIRS法分析复方磺胺甲噁唑片的均匀性

目的：建立复方磺胺甲噁唑片厂间、批间及批内均匀性的近红外光谱无损快速分析方法。方法：测量4个厂家13批共258片复方磺胺甲噁唑片的近红外漫反射光谱，结合化学计量学技术，建立该片厂间、批间及批内的均匀性分析方法。结果：所建NIRS法能够准确、无损、快速地分析复方磺胺甲噁唑片厂间、批间及批内的均匀性。结论：所建NIRS法可用于复方磺胺甲噁唑片质量监督管理及生产过程控制中的均匀性分析。

Objective: To establish a nondestructive and rapid analytical method for the uniformities of compound sulfamethoxazole tablets between manufacturers,between batches,and within one batch with near infrared spectroscopy. Methods: The near infrared diffuse reflectance spectra for 13 batches of compound sulfamethoxazole tablets from 4 manufacturers (258 tablets in total) were measured.The strategies were built using the spectra and chemometric techniques to analyze the uniformities of compound sulfamethoxazole tablets between manufacturers,between batches,and within one batch. Results: The uniformities of compound sulfamethoxazole tablets between manufacturers,between batches,and within one batch could be analyzed by the NIRS strategies accurately,nondestructively and rapidly. Conclusion: The proposed strategies can be used in the uniformity control of compound sulfamethoxazole tablets in supervision management and in manufacture process.

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