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Method for distinguishing coating quality of medicine preparation

A pharmaceutical preparation and coating technology, applied in the identification of the coating quality of pharmaceutical preparations and the identification of coating quality, can solve the problems of labor and time-consuming, increasing errors, inability to comprehensively evaluate the coating quality, etc., and achieves good prediction ability, The effect of reducing interference, ensuring effectiveness and rationality

Active Publication Date: 2010-05-26
河北鑫民和质检技术服务有限公司
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  • Description
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  • Application Information

AI Technical Summary

Problems solved by technology

However, in practical applications, the establishment of quantitative models requires the use of classical methods to measure the actual thickness of a large number of coated tablets, which is labor-intensive and time-consuming, and there is a risk of increasing errors
In addition, the quantitative model can only express the correlation between the thickness of the coating and the near-infrared spectrum, but fails to reflect the influence of the integrity of the coating on its near-infrared spectrum, and cannot comprehensively evaluate the coating quality

Method used

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  • Method for distinguishing coating quality of medicine preparation
  • Method for distinguishing coating quality of medicine preparation
  • Method for distinguishing coating quality of medicine preparation

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] 1 instrument

[0033] Antaris Fourier transform near-infrared spectrometer (manufactured by Thermo Nicolet, USA) is equipped with an InGaAs detector, an integrating sphere diffuse reflectance sampling system, Result operating software and TQ Analyst V6 spectral analysis software.

[0034] 2NIR scanning conditions

[0035] Integrating sphere diffuse reflectance sampling system, NIR spectral scanning range 4000cm -1 ~10000cm -1 ; Scan times 32; Resolution 8cm -1 ;Reference the built-in background.

[0036] 3 Data processing and software

[0037] In this embodiment, the iPCA method is used to select the band, the SPXY method is used to select the training set and the test set, and the spectrum is properly preprocessed, the SVM method is used to establish the identification model of the near-infrared spectrum, and the k-fold cross-validation (k-fold) of the training set is used. cross-validation) accuracy to determine the parameter γ and penalty factor C of the RBF Ker...

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Abstract

The invention belongs to the field of medicine preparations, which in particular relates to a method for distinguishing the coating quality. More concretely, the invention relates to a method for distinguishing the coating quality of a medicine preparation. In the method provided by the invention, a qualitative distinguishing model of the coating quality is quickly constructed by combining the methods of a near-infrared spectrum method, an interval principal component analysis method, a support vector machine method and the like, the comprehensive evaluation of the coating quality of the medicine preparation is realized, and the distinguishing accuracy basically reaches the requirement of industrial production. Relative to a traditional method or experiential judgment, the distinguishing method provided by the invention can quickly, nondestructively, reliably and accurately distinguish the coating quality of the medicine preparation in a coating process in an on-line way.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a method for identifying coating quality. More specifically, the present invention relates to a method for identifying the coating quality of pharmaceutical preparations. Background technique [0002] Tablets made by direct compression, if the properties of the drug are unstable, have bad smell, irritate the stomach, or are easily damaged by gastric juice, etc., it is usually necessary to wrap a layer of excipients on the surface to isolate the drug in the tablet from the outside world , so as to further ensure the quality of the tablet. The quality of the coating layer directly affects the coating effect. If the coating layer is too thin, it cannot meet the requirements of protecting the tablet core, while if it is too thick, it will not be conducive to the disintegration of the coated tablet, and at the same time lead to an increase in cost. [0003] In ...

Claims

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Application Information

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IPC IPC(8): G01N21/35G06N99/00G01N21/359
Inventor 乔延江史新元宰宝禅艾路
Owner 河北鑫民和质检技术服务有限公司
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