| 蔡蕊,王世盛,孟昱,孟庆刚,赵伟杰.近红外光谱结合第一范围标定法鉴定化学降糖原料药[J].,2012,(2):162-166 |
| 近红外光谱结合第一范围标定法鉴定化学降糖原料药 |
| Identification of oral hypoglycemic APIs by NIR spectroscopy with scaling to the first range method |
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| DOI：10.7511/dllgxb201202002 |
| 中文关键词: 近红外光谱 降糖原料药 定性分析 第一范围标定法 过程分析技术 |
| 英文关键词: near infrared spectroscopy oral hypoglycemic APIs qualitative analysis scaling to the first range method process analytical technology |
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| 摘要点击次数: 1894 |
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| 中文摘要: |
| 以建立一种快速、准确、无需样品预处理的鉴定8种降糖原料药(固态和液态)的近红外分析方法为目标,分别取64个不同批次的样品为校正集,另取32个样品用于定性模型的验证,使用一阶导数进行光谱预处理,结合第一范围标定法,在12 072.3~4 000.0 cm -1 ,建立了NIR 8种降糖原料药固态定性分析模型,结果显示每种原料药均可被成功鉴定,无一错判．说明所建立的模型可对8种降糖原料药进行快速准确的定性分析,适用于制药企业对降糖原料药进货验收和投料前的品种鉴别． |
| 英文摘要: |
| The aim of this research is to develop a rapid, accurate and no sample preparation required method to identify 8 kinds of oral hypoglycemic active pharmaceutical ingredient (API) (solid and liquid) by using near infrared (NIR) spectroscopy. 64 NIR spectra are utilized to establish the calibration model and rest 32 spectra are utilized to validate the performance of the model. On the original data, the first derivative combined with scaling to the first range method is conducted as the optimum pre processing method at 12 072.3-4 000.0 cm -1 , and 8 oral hypoglycemic APIs can be well identified by this model. With this approach, no ″error determinations″ are assigned to a wrong class, which indicates that the NIR method is appropriate for fast identification of oral hypoglycemic APIs in the inspection and acceptance before manufacture and warehousing of drug products in the pharmaceutical industry. |
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