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Method for detecting nadroparin calcium product

A technology of heparin calcium and its products, which is applied in the direction of color/spectral characteristic measurement, etc. It can solve the problems that the production process of heparin drugs cannot be applied, the preparation procedure of auxiliary detection reagents is complicated, and the detection cost is high, so as to achieve production process monitoring and strong anti-interference ability , good selective effect

Active Publication Date: 2013-11-20
广东三生制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although these detection techniques help to improve the sensitivity and selectivity of detection, there are still many limitations, such as complex preparation procedures of auxiliary detection reagents, high detection costs, narrow application range, etc.
In particular, these final detection methods are difficult to standardize and popularize in accordance with the requirements and regulations of the Good Manufacturing Practice (GMP), so they cannot be applied to the actual production process of heparin drugs

Method used

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  • Method for detecting nadroparin calcium product
  • Method for detecting nadroparin calcium product
  • Method for detecting nadroparin calcium product

Examples

Experimental program
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Effect test

Embodiment 1

[0099] (1) The standard working curve for the detection of nadroparin calcium by the fluorescein detection system

[0100] Take nine 10mL colorimetric tubes, one of which is used as the blank control system (without adding fluorescein and nadroparin calcium), one is used as the fluorescein color development system (without adding nadrixarparin calcium), and 7 is used as the fluorescein-nadroparin calcium Calcium detection system. First, add 5.0mL of 0.1mol / L pH6.6 citric acid-sodium citrate buffer and 1.0mL of 2.0×10 -2 mol / L sodium sulfate solution. Then, add 0.5 mL of 3.0×10 to the fluorescein chromogenic system -4 mol / L fluorescein ethanol solution; add 0.5mL3.0×10 -4 mol / L ethanol solution of fluorescein and 1.0mL different concentrations (1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0×10 -2 mol / L) nadrixarin calcium solution. Finally, dilute the obtained solution to the mark with water for injection, shake well, and mix well. After standing for 10 minutes, use the blank control ...

Embodiment 2

[0111] Example 2: Detection of Nadroparin Calcium Preparation Products by Fluorescein Detection System

[0112] On the basis of the experiment of the standard working curve for detecting nadroparin calcium in Example 1, another 3 10mL colorimetric tubes were taken as the actual sample test system, and each sample was repeatedly tested three times, and the average value was obtained. Take the same batch of 3 nadrixarparin calcium preparation products (specification: 5000IU / 0.5mL) as samples, first add 0.5mL water for injection to dilute it to 1.0mL, and then directly follow the test method of Example 1 to prepare nadroparin Calcium preparation sample detection system solution, and UV-visible spectrophotometric detection. Finally, the obtained relative decrease in absorbance of the 490nm absorption peak was substituted into the standard working curve equation of the 490nm absorption peak obtained in Example 1 to calculate the solution concentration. The test results obtained ar...

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Abstract

The invention relates to the technical field of ultraviolet-visible spectrophotometric method detection and particularly relates to a method for rapidly detecting a nadroparin calcium product. The method comprises the step of detecting the concentration of nadroparin calcium in a solution through detecting the absorbance of a mixed solution in a range of 200nm-800nm by a spectrophotometric method, wherein the mixed solution contains fluorescein, the nadroparin calcium and a buffering solution; preferably, the mixed solution is formed by mixing an ethanol solution of the fluorescein, a nadroparin calcium solution, a sodium sulfate solution and the buffering solution. According to the method disclosed by the invention, an applied instrument is simple and the operation is simple and convenient; the concentration of the nadroparin calcium solution can be rapidly determined. The detection method provided by the invention is strong in anti-interference capability and strong in selectivity, and can be used for monitoring whether the contents of nitrite ions and calcium ions in the nadroparin calcium solution seriously exceed the standard or not. According to the detection method provided by the invention, a linear range is 3.0*10<-3>mol / L-4.5*10<-2>mol / L and a detection limit is 1.0*10<-3>mol / L; the detection method is completely applicable to the detection of a nadroparin calcium middle product and a nadroparin calcium final product and can be used for effectively monitoring a medicine production process of the nadroparin calcium.

Description

technical field [0001] The invention relates to the technical field of ultraviolet-visible spectrophotometry detection, in particular to a method for rapidly detecting nadroparin calcium products. Background technique [0002] Heparin drugs are highly sulfated mucopolysaccharide sulfates, which are widely used in the treatment of cardiovascular and cerebrovascular diseases and hemodialysis. Among them, in the treatment of severe hemodialysis, they are currently the only specific drugs available. At present, low molecular weight heparin (Low Molecular Weight Heparin, LMWH) is dominant in the heparin drug market, that is, heparin derivatives with an average molecular weight distribution of 3500-6500Da. Because compared with unfractionated heparin (UFH), LMWH has many obvious advantages in clinical application, including clearer pharmacological effects, greatly reduced side effects, longer duration of antithrombotic activity, and higher bioavailability. There are five common L...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/31G01N21/33
Inventor 陈贤光郑华淦吴园园张涤平盛光阳
Owner 广东三生制药有限公司
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