A method for detecting nadroparin calcium products

A technology of heparin calcium and determination method, which is applied in the measurement of color/spectral properties, etc., can solve the problems of inability to apply the production process of heparin drugs, complicated preparation procedures of auxiliary detection reagents, and narrow application range, and achieves production process monitoring, anti-interference and other problems. Powerful, easy-to-use effects

Active Publication Date: 2016-01-20
广东三生制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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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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  • A method for detecting nadroparin calcium products
  • A method for detecting nadroparin calcium products
  • A method for detecting nadroparin calcium products

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0099] (1) Standard working curve of fluorescein detection system for detecting Nadroparin calcium

[0100] Take 9 10mL colorimetric tubes, one of which is used as a blank control system (without fluorescein and nadroparin calcium), one as a fluorescein color system (without nadroparin calcium), and 7 as fluorescein-nadroparin Calcium detection system. First, add 5.0 mL of 0.1 mol / L citric acid-sodium citrate buffer and 1.0 mL of 2.0×10 to all the colorimetric tubes. -2 mol / L sodium sulfate solution. Then, add 0.5mL3.0×10 to the fluorescein color system -4 mol / L fluorescein ethanol solution; add 0.5mL3.0×10 to 7 fluorescein-nadroparin calcium detection system -4 mol / L fluorescein ethanol solution and 1.0 mL of different concentrations (1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0×10 -2 mol / L) Nadroparin calcium solution. Finally, dilute the obtained solution to the mark with water for injection, shake well, and mix well. After standing for 10 minutes, with the blank control system as the ...

Embodiment 2

[0111] Example 2: Fluorescein detection system for the detection of nadroparin calcium preparation products

[0112] On the basis of the experiment of detecting the standard working curve of nadroparin calcium in Example 1, another three 10 mL colorimetric tubes were taken as the actual sample test system, each sample was tested repeatedly three times, and the average value was taken. Take the same batch of 3 nadroparin 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 in Example 1 to prepare nadroparin Calcium preparation sample detection system solution, and UV-visible spectrophotometry 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 are lis...

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PUM

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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 spectrophotometric 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, it is currently the only specific drug available in the treatment of severe hemodialysis. Currently, low molecular weight heparin (LMWH), which is a heparin derivative with an average molecular weight distribution of 3500-6500Da, is dominant in the heparin drug market. Because compared with unfractionated heparin (UFH), LMWH has many obvious clinical application advantages, including clearer pharmacological effects, greatly reduced side effects, long duration of antithrombotic activity, and higher bioavailability. There are mainly 5 kinds of common LMWH preparations, namely Nadro...

Claims

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Application Information

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Patent Type & Authority Patents(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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