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Near infrared spectrum nondestructive analysis method for mezlocillin sodium powder injections

A technology of mezlocillin sodium powder and near-infrared spectroscopy, which is applied to the measurement of scattering characteristics, can solve the problems of non-destructive analysis and research of mezlocillin sodium powder injection near-infrared spectroscopy, and has no related reports, and achieves simple operation and rapid analysis. Effect

Inactive Publication Date: 2011-06-15
SHANDONG UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] So far, there are no relevant reports on the non-destructive analysis of near-infrared spectroscopy of mezlocillin sodium powder injection

Method used

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  • Near infrared spectrum nondestructive analysis method for mezlocillin sodium powder injections
  • Near infrared spectrum nondestructive analysis method for mezlocillin sodium powder injections

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] 1) Select commercially available 40 batches of mezlocillin sodium powder injections with a mezlocillin sodium content between 91.71% and 94.37%, and measure each The average value of mezlocillin sodium content in each batch of mezlocillin sodium powder injection, specifically see table 1.

[0023] The mean value of the mezlocillin sodium content of table 140 batches

[0024]

[0025] 2) Randomly select 6 bottles of mezlocillin sodium powder injection from each batch of samples obtained in step 1), press the bottom of the glass injection bottle of the powder injection on the diffuse reflectance optical fiber probe to collect near-infrared diffuse reflectance spectra, and the wave number range is 4000~10000cm -1 , the number of scans is 64 times, and the resolution is 8cm -1 , to obtain the near-infrared diffuse reflectance spectrum of each bottle of mezlocillin sodium powder injection.

[0026] 3) Perform spectral preprocessing on the 240 near-infrared diffuse refl...

Embodiment 2

[0034] 1) Select commercially available 40 batches of mezlocillin sodium powder injections with a mezlocillin sodium content between 91.71% and 94.30%, and measure each The average value of mezlocillin sodium content in each batch of mezlocillin sodium powder injection, specifically see table 3.

[0035] The average value of the content of mezlocillin sodium in 48 batches of table 3

[0036]

[0037] 2) Randomly select 6 bottles of mezlocillin sodium powder injection from each batch of samples obtained in step 1), press the bottom of the glass injection bottle of the powder injection on the diffuse reflectance optical fiber probe to collect near-infrared diffuse reflectance spectra, and the wave number range is 4000~10000cm -1 , the number of scans is 64 times, and the resolution is 8cm -1 , to obtain the near-infrared diffuse reflectance spectrum of each bottle of mezlocillin sodium powder injection.

[0038] 3) The 288 near-infrared diffuse reflectance spectra obtained...

Embodiment 3

[0045] The steps are the same as in Example 1, except that the second derivative spectra obtained in step 3) in step 4) are 40 average spectra of 240 second derivative spectra. The content data of the 10 batches of mezlocillin sodium obtained according to this embodiment are specifically shown in Table 5.

[0046] Table 5 Comparison of actual content and predicted content of 10 batches of mezlocillin sodium

[0047] sample number

[0048] The actual content data in Table 5 is measured according to step 1), the predicted content data is measured according to step 5), and the relative error data is ((predicted content data-actual content data) / actual content data)×100. The analysis results showed that the relative error of the method was between -0.45% and 0.40%, which had good content prediction ability and could meet the analysis requirements of mezlocillin sodium content.

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Abstract

The invention relates to a near infrared spectrum nondestructive analysis method for mezlocillin sodium powder injections, which is characterized by comprising the following steps of: 1, selecting n batches of mezlocillin sodium powder injections with mezlocillin sodium content of 91.71 to 94.37 percent and measuring an average value of the mezlocillin sodium content in each batch; 2, nondestructively collecting a near infrared diffuse reflection spectrum of mezlocillin sodium of each batch of mezlocillin sodium powder injection by a diffuse reflection fiber-optical probe; 3, carrying out spectrum pretreatment on the near infrared diffuse reflection spectrums to obtain a second derivative spectrum; 4, carrying out data association on the obtained average value of the mezlocillin sodium content in the step 1 and the obtained second derivative spectrum in the step 3 so as to obtain a mathematical model of the mezlocillin sodium content; and 5, according to the step 2, collecting a near infrared diffuse reflection spectrum of a mezlocillin sodium powder injection with the content to be measured and substituting the near infrared diffuse reflection spectrum into the mathematical model obtained in the step 4 to obtain the mezlocillin sodium content. In the method, a glass injection bottle is not needed to be removed. Analysis can be performed rapidly, easily and conveniently and the result is accurate.

Description

technical field [0001] The invention belongs to the technical field of analysis of pharmaceutical preparations, and in particular relates to a near-infrared spectrum non-destructive analysis method of mezlocillin sodium powder injection. Background technique [0002] The determination method of mezlocillin sodium powder for injection stipulated in the Pharmacopoeia is as follows: take about 50 mg of this product, accurately weigh it, place it in a 100 ml measuring bottle, add water to dissolve and dilute to the mark, shake well, take 20 μl and inject it into the liquid chromatograph Instrument, record the chromatogram; take another appropriate amount of mezlocillin sodium reference substance, and measure it with the same method. According to the external standard method, calculate the C in the test sample with the peak area 21 h 24 N 5 NaO 8 S 2 content. The chromatographic conditions and system suitability test are as follows: use octadecylsilane bond and silica gel a...

Claims

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Application Information

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IPC IPC(8): G01N21/49
Inventor 牛金叶司维江陈志伟连传宝于风平魏晓兵徐鸿志
Owner SHANDONG UNIV OF TECH
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