System and method for detecting N-NO in nadroparin calcium by chemical extraction-thermal energy analysis method

A nadroparin calcium and detection system technology, which is applied in the field of chemical extraction-thermal energy analysis to detect N-NO in nadroparin calcium, can solve the problem that the heating reaction system cannot be oscillated and mixed, the temperature control of the cold trap is troublesome, and the reagents Problems such as complex configuration process, achieve clear detection results, simple reagent configuration process, and improve detection accuracy and stability.

Inactive Publication Date: 2017-11-07
CHANGZHOU QIANHONG BIOPHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The carrier gas of the system is argon, and the reagents used in the bubble trap and the cold trap need to be configured in the traditional device, and the test is carried out after filling the device. Unable to shake and mix the reaction system

Method used

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  • System and method for detecting N-NO in nadroparin calcium by chemical extraction-thermal energy analysis method
  • System and method for detecting N-NO in nadroparin calcium by chemical extraction-thermal energy analysis method
  • System and method for detecting N-NO in nadroparin calcium by chemical extraction-thermal energy analysis method

Examples

Experimental program
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Effect test

Embodiment 1

[0045] A chemical extraction-thermal energy analysis method detects the detection system of N-NO in nadroparin calcium, such as figure 1 As shown, it includes a thermal energy analyzer (TEA analyzer) 6, which is provided with a chemiluminescence detector, and the TEA analyzer 6 is provided with an oxygen source inlet that can provide oxygen for the TEA analyzer 6, 63 and The N-NO mixed gas inlet 61 connected to the chemiluminescence detector and the vacuum pump interface 62, the N-NO mixed gas inlet 61 allows the N-NO gas in the standard or test sample to enter the TEA from the port for chromatography Figure records; the detection system also includes a primary condensing device 3, a secondary condensing device 4, a peristaltic pump 5, a heater 1, a reactor 2, an oxygen source 7, a vacuum pump 8 and a nitrogen source 9.

[0046] The primary condensing device 3 is provided with a condensing medium flow cavity 31 and a first mixed gas flow cavity 32, and the condensing medium fl...

Embodiment 2

[0055] A kind of chemical extraction-thermal analysis method detects the method for N-NO in nadroparin calcium, and this method comprises the following steps:

[0056] S1: According to the structure of the detection system described in Example 1, place and connect the equipment used in the detection reasonably;

[0057] S2: Solution preparation:

[0058] (1) Preparation of formamide solution: Weigh 1 g of sulfamic acid, add 19 ml of formamide and 1 ml of water, shake to form a uniform solution.

[0059] (2) Preparation of the test product solution: Accurately weigh the test product nadroparin calcium, add formamide solution and quantitatively dilute to make a solution containing about 100 mg of nadroparin calcium per 1 ml.

[0060] (3) Preparation of standard product stock solution: Take 100mg of NDPA (N-nitrosodipropylamine) standard product, add 78.62g of absolute ethanol to dissolve and prepare the primary solution, then take an appropriate amount of primary solution, dilu...

Embodiment 3

[0069] A kind of chemical extraction-thermal analysis method detects the method for N-NO in nadroparin calcium, and this method comprises the following steps:

[0070] S1: According to the structure of the detection system described in Example 1, place and connect the equipment used in the detection reasonably;

[0071] S2: Solution preparation:

[0072] (1) Preparation of formamide solution: Weigh 1 g of sulfamic acid, add 19 ml of formamide and 1 ml of water, shake to form a uniform solution.

[0073] (2) Preparation of the test product solution: Accurately weigh the test product nadroparin calcium, add formamide solution and quantitatively dilute to make a solution containing about 100 mg of nadroparin calcium per 1 ml. The actual content of the N-NO group in the pre-established test solution is 0.065ppm;

[0074] (3) Preparation of standard product stock solution: Take 100mg of NDPA (N-nitrosodipropylamine) standard product, add 78.62g of absolute ethanol to dissolve and...

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Abstract

The invention relates to a system and a method for detecting N-NO in nadroparin calcium by a chemical extraction-thermal energy analysis (TEA) method. The system comprises a TEA analyzer, a first-grade condensing device, a second-grade condensing device, a peristaltic pump, a heater, a reactor, an oxygen gas source, a vacuum pump and a nitrogen gas source. The method comprises the following steps: S1: preparing a solution; S2: carrying out instrument regulation preparation and the like; S3: opening two grades of condensing devices to enable the two grades of condensing devices to start condensing medium circulation; S4: adding one part of a reaction system from a sample inlet of the reactor and regulating a nitrogen gas flow speed and the like; S5: adding a standard product solution and a test sample solution and recording a chromatogram; calculating to obtain a result. The system provided by the invention is ingenious and simple and can be completely suitable for the detection of NO in the nadroparin calcium. The method provided by the invention has a more accurate result, lower detection limit and a more rapid detection speed and is simpler. By adopting the method provided by the invention, a procedure is greatly simplified; the method has extremely high sensitivity and high selectivity on a nitrogen-containing compound and is a detection method with extremely strong specificity.

Description

technical field [0001] The invention relates to the field of quantitative detection of chemical components, in particular to a system and method for detecting N-NO in nadroparin calcium by a chemical extraction-thermal energy analysis method. Background technique [0002] Low-molecular-weight heparin is a new generation of heparin antithrombotic drugs developed in recent years. Its antithrombotic effect is better than heparin, but its anticoagulant effect is lower than heparin. The tendency is small and other advantages, has been widely used in clinical practice. Nadroparin calcium is a kind of low-molecular-weight heparin, obtained by degrading heparin with nitrous acid, with a weight-average molecular mass of 3600-5000. It is clinically used to prevent postoperative thromboembolism, prevent deep vein thrombosis, pulmonary embolism, and in vitro during hemodialysis. Circulating anticoagulants, terminal vascular disease, etc. Many studies in recent years have shown that th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N21/76
CPCG01N21/766
Inventor 顾春华徐燕妮王晨光王轲
Owner CHANGZHOU QIANHONG BIOPHARMA
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