今日药学

2020, v.30(08) 544-547

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近红外光谱法快速鉴别不同厂家的头孢克肟制剂
A Raped Test Model for Cefixime Preparation from Different Manufacturers by Near Infrared Spectroscopy

朱丹丹;阮玮婷;曾文珊;
ZHU Dandan;RUAN Weiting;ZENG Wenshan;Guangzhou Institute for Drug Control;

摘要(Abstract):

目的建立头孢克肟分散片、头孢克肟胶囊的近红外快速定性分析方法,为鉴别不同厂家产品提供依据。方法选取8 956.2~7 494.3 cm~(-1)、6 892.6~5 592.8 cm~(-1)及4 979.5~4 258.2 cm~(-1)谱段,对11个厂家的28批样品进行扫描,采用近红外漫反射光谱法,运用OPUS软件通过预处理方法对图谱进行分析,建立一致性定性检验模型。结果建立的一致性定性检验模型能够区分出不同厂家生产的头孢克肟分散片和头孢克肟胶囊,达到模型对样品的正确判断。结论所建立的一致性检验模型能准确快速地对不同厂家的样品进行快速筛查检验。
OBJECTIVE To establish a rapid qualitative analysis method for cefixime tablets and capsules from different factories by near infrared spectroscopy. METHODS 28 batches of samples from 11 manufacturers were scaned and analyzed by Near infrared diffuse reflectance spectroscopy at frequency range of 8 956.2 to 7 494.3 cm~(-1),6 892.6 to 5 592.8 cm~(-1) and 4 979.5 to 4 258.2 cm~(-1) with OPUS software,for establishing the qualitative test model for consistency. RESULTS The established qualitative test model could distinguish cefixime preparation from different manufacturers. CONCLUSION The established consistency test model can screen samples from different manufacturers accurately and quickly.

关键词(KeyWords): 近红外光谱;头孢克肟分散片;头孢克肟胶囊;不同剂型;定性;一致性检验模型
near infrared spectroscopy;cefixime dispersible tablets;cefixime capsules;different dosage forms;qualitative analysis;consistency test model

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作者(Author): 朱丹丹;阮玮婷;曾文珊;
ZHU Dandan;RUAN Weiting;ZENG Wenshan;Guangzhou Institute for Drug Control;

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