Method for determining content of water in Salvianolic acid for injection through near-infrared diffuse reflection spectrometry

A salvianolic acid and near-infrared technology, which is applied in color/spectral characteristic measurement, measuring devices, and material analysis through optical means, can solve the problems of large differences in detection results, low accuracy and sensitivity, and complicated operations. To achieve the effect of rapid quantitative analysis

Active Publication Date: 2013-05-08
TIANJIN TASLY ZHIJIAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the current quality standard of salvianolic acid for injection, the water content is measured, and the first method (drying method) of appendix IX H of the 2010 edition of "Chinese Pharma

Method used

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  • Method for determining content of water in Salvianolic acid for injection through near-infrared diffuse reflection spectrometry
  • Method for determining content of water in Salvianolic acid for injection through near-infrared diffuse reflection spectrometry
  • Method for determining content of water in Salvianolic acid for injection through near-infrared diffuse reflection spectrometry

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Step 1, establish a near-infrared quantitative calibration model:

[0053] a Take 30 samples of salvianolic acid for injection as a calibration set, and wipe the bottom of the vial with a cloth;

[0054] b After turning on the spectrometer and preheating the spectrometer for 1 hour, the scanning parameters are: measurement temperature: 21-25°C, humidity: 51-58%, diffuse reflection detection, and the scanning wavelength range is 4000-12000cm -1 , resolution 8cm -1 , using air as a blank control to scan the background, and then scan from the bottom of the vial with a near-infrared diffuse reflectance spectrometer. Each sample is scanned 3 times, and the average spectrum is taken to obtain the calibration set sample spectrum.

[0055] c With 30 parts of salvianolic acid correction set samples for injection in step a, obtain the moisture content in each sample according to the first method (drying method) of appendix IX H of the 2010 edition " Chinese Pharmacopoeia ", see ...

Embodiment 2

[0064] Step 1, establishing a near-infrared quantitative calibration model: the same as in Example 1;

[0065] Step 2, measure the moisture content in the sample:

[0066] a Take 3 samples of salvianolic acid for injection with batch number 20100302, and wipe the bottom of the vial with a cloth;

[0067] b using the same method in step 1b to obtain the spectrogram of the sample to be tested;

[0068] c According to the near-infrared quantitative calibration model established in step 1, the moisture content of the sample to be tested is measured, which are 4.662%, 4.544% and 4.044%, respectively. In order to further verify this test, the actual moisture content in the sample measured by the drying method in the Pharmacopoeia is 4.790%, 4.644% and 4.282%, respectively, and the errors of the two are within the allowable range.

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Abstract

The invention relates to a method for determining the content of water in Salvianolic acid for injection through near-infrared diffuse reflection spectrometry. The method comprises a step of establishing a near-infrared quantitative correction model, and a step of determining the content of water in a sample.

Description

Technical field: [0001] The invention relates to a method for measuring the water content in salvianolic acid for injection by near-infrared diffuse reflectance spectroscopy. Background technique: [0002] The near infrared (near infrared spectroscopy, NIR) spectrum is between the visible spectral region and the mid-infrared spectral region, with a wavelength range of 780-2500nm (12820-4000cm -1 ) molecular spectrum, its main spectrum peaks reflect the double frequency and combined frequency absorption of hydrogen-containing groups such as C-H, N-H, O-H in the molecule. Due to the spectral bandwidth in this interval, the spectral overlap is serious, the absorption signal is weak, and the information contained is complex, so the analysis and application value of near-infrared has not been paid attention to. In recent years, with the rapid development of near-infrared (NIR) spectroscopic analysis technology, and with the characteristics of fast, non-destructive and accurate, ...

Claims

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Application Information

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IPC IPC(8): G01N21/35G01N21/3577G01N21/359
Inventor 叶正良刘君动李德坤周大铮
Owner TIANJIN TASLY ZHIJIAO PHARMA
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