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Method for quickly detecting tablet weight of medicine tablets through near infrared spectroscopy

A technology of near-infrared spectroscopy and near-infrared spectroscopy, which is applied in the field of quality control of pharmaceutical preparations and can solve problems such as cumbersome and time-consuming

Inactive Publication Date: 2014-11-05
CHONGQING MEDICAL UNIVERSITY
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Problems solved by technology

The method is cumbersome and time-consuming

Method used

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  • Method for quickly detecting tablet weight of medicine tablets through near infrared spectroscopy
  • Method for quickly detecting tablet weight of medicine tablets through near infrared spectroscopy
  • Method for quickly detecting tablet weight of medicine tablets through near infrared spectroscopy

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Embodiment

[0034] 1. Sample information

[0035] Samples of Compound Sulfamethoxazole Tablets were collected from 13 batches of 257 tablets from 4 manufacturers, and the sample information is shown in Table 1.

[0036] Table 1 Sample information of Compound Sulfamethoxazole Tablets

[0037]

[0038]

[0039] 2. Determination of tablet weight reference value

[0040] The tablet weight of each tablet sample was accurately weighed with an analytical balance. As a result, the tablet weight of the 257 samples of compound sulfamethoxazole tablets measured ranged from 0.4999 to 0.5897g.

[0041] 3. Measurement of Near Infrared Diffuse Reflectance Spectrum of Tablet Samples

[0042] Instrument: Antaris II Fourier transform near-infrared spectrometer from Thermo Fisher Scientific in the United States, equipped with a tablet diffuse transmission sampling accessory and an integrating sphere accessory, and the signal acquisition software is Results 3.0.

[0043] Spectral measurement conditi...

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Abstract

The invention relates to a method for quickly detecting the tablet weight of medicine tablets through near infrared spectroscopy, and belongs to the field of medicinal preparation mass control. The method includes the following steps that firstly, medicine tablet samples are collected, and the tablet weight reference value of each tablet sample is measured; secondly, optimal spectral measurement parameters are screened out, and a Fourier transformation near infrared diffuse reflection spectrum of each tablet sample is measured through a Fourier transformation near infrared spectrometer; thirdly, calibration set samples and prediction set samples are selected; fourthly, an optimal spectral data pretreatment method is selected; fifthly, an optimal modeling spectral range is screened out; sixthly, abnormal spectrums or samples are diagnosed and removed; seventhly, calibration set spectrums of the tablet samples are related with the tablet weight reference values through chemometrics technology, and a tablet weight calibration model is established; eighthly, the performance of the tablet weight calibration model is evaluated through verification set samples; ninthly, the established calibration model is applied to predicting the tablet weight of the unknown tablet samples. The method is quick, accurate and capable of being used for mass control over the tablet weight of the medicine tablets and online detection of the tablet weight of the medicine tablets.

Description

technical field [0001] The invention relates to a method for rapidly and non-destructively detecting the weight of pharmaceutical tablets, in particular to a method for rapidly detecting the weight of pharmaceutical tablets by using near-infrared spectroscopy combined with chemometrics technology, and belongs to the field of quality control of pharmaceutical preparations. Background technique [0002] To ensure the continuous and stable production of drugs that meet the intended use and registration requirements is one of the main purposes of my country's implementation of the 2010 version of "Good Manufacturing Practice for Drugs". The weight difference of drug tablets is a test item stipulated by multinational pharmacopoeias. Currently, the legal method used to check for differences in the weight of pharmaceutical tablets is the gravimetric method. This method is cumbersome and time-consuming. The dosage of drug tablets is often calculated in units of "tablets". The vari...

Claims

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Application Information

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IPC IPC(8): G01G17/02
Inventor 范琦董艳虹李娟
Owner CHONGQING MEDICAL UNIVERSITY
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