The raw material of heparin sodium is crude heparin sodium extracted from the mucosa of the small intestine of healthy pigs. Because it contains a large number of proteins, nucleic acids, microorganisms and other impurities, physical and chemical extraction and separation processes are required to obtain heparin with complete structure and then make heparin raw materials. The process of heparin sodium is as follows:
1. Clean the fresh pig's lung (or frozen pig's lung after natural thawing) with clean water to remove internal and external dirt and external skin fat, ground it into chyme, and mix it with the same amount of water and a little preservative with a solubility of.01% under full agitation.
2. Enzymatic extraction: The above raw materials are carefully adjusted to PH value of 8-9 with a small amount of dilute lye under full agitation. Then add the fresh crushed pancreatic pulp as the enzymolysis agent, stir well, and slowly heat up to about 40 degrees.
Keep stirring, and keep the PH of the feed liquid at 7.5-8, keep the temperature of the liquid at 37-40 degrees, and enzymolize for 3-4 hours, then heat up to 47-50 degrees, and maintain the PH value at 8.0-8.5. Add a little pig pancreas syrup as appropriate, and enzymolize for 4-5 hours.
3. Ion exchange adsorption; First, the enzyme-hydrolyzed extraction liquid was cooled to room temperature, and the thin oil layer floating on the liquid surface was removed carefully. The temperature was controlled to 45 degrees, and the heating was stopped. The heparin sodium component in the adsorbent liquid which had been pretreated with D-254 resin was added under stirring.
4, refining: the obtained crude heparin sodium with 2% sodium chloride solution completely dissolved, made of its solubility of about 8% of the solution, in this process can be appropriately heated to help dissolve. The above material was finely adjusted with 5mol/L sodium hydroxide solution at PH=8.0-8.2 and heated to 78-80 degrees.
The precipitate is dehydrated by anhydrous ethanol, ground fine, then dehydrated by acetone, ground fine, then dehydrated by acetone, far infrared vacuum drying (50-60 degrees), then heparin sodium boutique.