Method for high sensitivity detection of oversulfated chondroitin sulfate and dermatan sulfate in heparin sodium

A technology for chondroitin polysulfate and dermatan sulfate is applied in the directions of measuring devices, instruments, scientific instruments, etc., and can solve the problems such as the inability to realize simultaneous detection of chondroitin polysulfate and dermatan sulfate, the reduction of detection costs, and the high price of instruments, Achieve the effect of good linear relationship, short detection time and low detection cost

Inactive Publication Date: 2015-12-30
DONGYING TIANDONG PHARM CO LTD
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Problems solved by technology

At present, the domestic heparin sodium industry mainly uses nuclear magnetic resonance and high-efficiency capillary electrophoresis to detect chondroitin polysulfate. However, there are disadvantages such as expensive instruments and complicated operations, which make it difficult to popularize and use them in daily detection.
Chinese invention patent application CN102830150A discloses a highly sensitive detection method of polysulfated chondroitin in heparin sodium by a high-efficiency capillary electrophoresis method (HPCE), but the method equipment price is high and the cost is high; and this method cannot realize polysulfated chondroitin Simultaneous detection of dermatan and dermatan sulfate; therefore, the detection method in the prior art still needs to be improved and improved, and the detection cost also needs to be further reduced

Method used

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  • Method for high sensitivity detection of oversulfated chondroitin sulfate and dermatan sulfate in heparin sodium

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Embodiment 1

[0016] Instruments and reagents: Japan Shimadzu high performance liquid chromatography, using LC-10Ai pump, CBM-20A controller, SPD-20A ultraviolet detector, and LCsolution workstation. Lithium phosphate, dimethylformamide, and ethylene glycol are all chromatographically pure, and water is ultrapure water.

[0017] Preparation of the control solution: Take heparin sodium, chondroitin polysulfate, and dermatan sulfate respectively, weigh them accurately, use ultrapure water as a solvent, and configure them to contain 20.0 mg / mL of heparin sodium and 0.20 mg / mL of chondroitin polysulfate. and a control solution of 0.20 mg / mL dermatan sulfate. Heparin sodium, chondroitin polysulfate and dermatan sulfate in the control solution were USP standard products.

[0018] Preparation of the test solution: take the heparin sodium test product, and prepare a solution containing heparin sodium 20.0 mg / mL with ultrapure water.

[0019] Chromatographic conditions and system suitability test ...

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Abstract

The invention relates to a method for high sensitivity detection of oversulfated chondroitin sulfate and dermatan sulfate in heparin sodium. A gradient elution method is used for elution, a CIM-QA monolithic column with the diameter of 12mm and height of 3mm is used, ultrapure water is used as a mobile phase A, a high-purity water mixed solution is used as a mobile phase B, and the mixed solution comprises lithium phosphate, dimethyl formamide, glycol and high purity water. The method has the characteristics of low equipment investment, low detection cost and simple processes, has high detection sensitivity, short detection time and good reappearance, can be used for tracking detection of oversulfated chondroitin sulfate and dermatan sulfate and is suitable for quality control in large scale production.

Description

technical field [0001] The invention relates to the technical field of drug analysis, more specifically, the invention relates to a highly sensitive detection method for chondroitin polysulfate and dermatan sulfate in heparin sodium. Background technique [0002] Heparin (HP) is an acidic mucopolysaccharide composed of repeating disaccharide units linked by glucuronic acid or iduronic acid and acetylglucosamine with -1,4-glycosidic bonds. It is widely used as an anticoagulant drug clinically. It is used in the treatment of hemodialysis, surgery and cardiovascular diseases. At present, heparin is an important carbohydrate drug that has been clinically used for the longest time and is still widely used. [0003] Heparin is one of the important export varieties of biochemical raw materials in my country, and the export value has exceeded 80 million US dollars. However, in early 2008, the heparin sodium pollution incident occurred in Europe, America and other countries, and my...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 张在忠郭林李荣崔慧斐李加耀陈少鹏
Owner DONGYING TIANDONG PHARM CO LTD
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