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Zopiclone tablet rapid identification method based on near infrared spectrum

A technology of near-infrared spectroscopy and near-infrared spectrometer, applied in the field of rapid identification of zopiclone tablets based on near-infrared spectroscopy, to achieve the effect of saving analysis time and cost

Inactive Publication Date: 2015-05-06
SHANDONG INST FOR FOOD & DRUG CONTROL
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The invention provides a rapid identification method for zopiclone tablets based on near-infrared spectroscopy, which effectively solves the problem of accurate, rapid and non-destructive identification of fake and inferior drugs

Method used

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  • Zopiclone tablet rapid identification method based on near infrared spectrum
  • Zopiclone tablet rapid identification method based on near infrared spectrum
  • Zopiclone tablet rapid identification method based on near infrared spectrum

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Experimental program
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Effect test

Embodiment

[0028] 1. Sample information

[0029] (1) The sample passed the qualification test

[0030] Drug Name: Zopiclone Tablets

[0031] Dosage form and packaging: tablet, aluminum composite panel

[0032] Manufacturer: Qilu Pharmaceutical Co., Ltd.

[0033] Specification: 7.5mg

[0034] Lot number: 4040051KN, 4070111KN, 4080171KN, 4030021KN, 4060081KN, 4080151KN

[0035] (2) Samples that failed the qualification test

[0036] Drug Name: Carvedilol Tablets

[0037] Source: Provided by Qilu Pharmaceutical Co., Ltd.

[0038] 2. Spectroscopic measurement conditions

[0039] Instrument model: Matrix-F Fourier transform near-infrared spectrometer, the instrument numbers are 2I106606, 1001, and 0266, respectively.

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Abstract

The invention provides a zopiclone tablet rapid identification method based on a near infrared spectrum. The zopiclone tablet rapid identification method comprises the following steps: firstly, acquiring an original graph and pre-processing the original graph; modeling by adopting two instruments, and identifying by one instrument, thus realizing modeling and identifying a spectrum by using the instruments; and carrying out a qualification test on near infrared diffuse reflection spectrums of a plurality of batches of dynamic production samples by using a model so as to judge whether medicines are counterfeited or not. After the model is established, a negative sample and a positive sample are used for testing the stability of the model respectively; and when the result is that the passing rate of the positive sample is 100% and the negative sample does not pass, the false positive rate and the false negative rate of the model are relatively low, the method is suitable for market rapid checking and the result is reliable. A rapid quality identification and evaluation method for zopiclone tablets which are produced by Qilu Pharmaceutical Co.,Ltd. and are packaged by an aluminum-plastic plate is established, the detected sample does not need to be subjected to complicated pre-treatment, and the sample is not damaged and polluted; and a lot of analysis time and cost can be saved, and the method is a convenient, rapid and lossless green analysis technology.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for rapid identification of zopiclone tablets based on near-infrared spectroscopy. Background technique [0002] Zopiclone was first listed in France in 1987, and is currently produced and sold in more than 80 countries in the world. It is one of the most clinically used drugs for insomnia. Zopiclone is a representative of the third-generation sedative-hypnotic drugs. Animal experiments have shown that the drug has sedative, anxiolytic, anticonvulsant and muscle-relaxing effects. It is an ideal sedative-hypnotic drug with definite curative effect and fewer adverse reactions. Zopiclone is similar to long-acting benzodiazepines in improving sleep quality, similar to short-acting benzodiazepines in shortening sleep onset time, and has less residual effect than benzodiazepines after taking the drug. Unlike benzodiazepines, long-term use of this drug has no obvious dru...

Claims

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Application Information

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IPC IPC(8): G01N21/3563G01N21/359
Inventor 谭会洁张中湖石峰巩丽萍李军
Owner SHANDONG INST FOR FOOD & DRUG CONTROL
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