High sensitivity detection method of oversulfated chondroitin sulfate in liquaemin

Abstract

The invention relates to a high sensitivity detection method of oversulfated chondroitin sulfate in liquaemin. The high sensitivity detection method comprises the following steps of 1) preparing a sample liquid and weighting a liquaemin sample; 2) preparing a standard substance solution and using purification water to dissolve a system suitability standard substance, a liquaemin identification standard substance and an oversulfated chondroitin sulfate standard substance into a solution; 3) preparing a buffered solution and preparing a phosphate buffer or a lithium phosphate buffer in a volumetric flask; and 4) selecting a fused quartz capillary, conducting sample introduction analysis on the liquaemin system suitability standard substance and the liquaemin identification standard substance in the phosphate buffer, and enabling a liquaemin peak of the liquaemin system suitability standard substance and a peak of the oversulfated chondroitin sulfate to be completely separated. The high sensitivity detection method has the advantages of being high in detection sensitivity, short in detection time, simple and convenient to operate, good in reproducibility, capability of effectively controlling the oversulfated chondroitin sulfate in the liquaemin, being favorable for further promoting the quality of liquaemin products and avoiding occurrence of liquaemin contamination accidents again.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a highly sensitive detection method for chondroitin polysulfate in heparin sodium. Background technique [0002] Heparin is a sulfated glycosaminoglycan derived from porcine intestinal mucosa, which has anticoagulant activity and is widely used in the prevention and treatment of cardiovascular diseases. According to the report of China Medicine Information Network, the annual sales of heparin drugs in 2006 were more than 3 billion US dollars. Heparin is one of the most important export varieties of biochemical raw materials in my country. According to the statistics of China Chamber of Commerce for Import and Export of Medicines and Health Products, my country exported 96.97 tons of heparin and heparin products in 2005, a year-on-year increase of 49%, and the export value was 75.2732 million US dollars. A year-on-year increase of 54%. my country's heparin has been exported ...

AI Technical Summary

Problems solved by technology

[0003] At present, the domestic heparin sodium industry mainly detects chondroitin polysulfate by nuclear magnetic resonance and cellulose acetate film electrophoresis. The above two methods have the problem of low detection sensitivity and cannot fundamentally eliminate the pollution of chondroitin polysulfate.

The agarose gel electrophoresis detection method reported by the patent CN101825607 has a detection limit of about 0.5% for OSCS, and has the disadvantages of cumbersome operation, uneven quality of electrophoresis plates, and poor reproducibility, which is still unfavorable for quality control of chondroitin polysulfate

The United States Pharmacopoeia uses strong anion-exchange high-performance liquid chromatography (SAX-HPLC) to control chondroitin polysulfate. The detection limit reaches 0.1%, and the detection sensitivity still needs to be improved.

Images