Difference between crude heparin and finished heparin sodium

Details:

In the eyes of most people, heparin is a drug. In fact, in addition to medicine, it has many uses, such as in vitro diagnosis, biochemical testing, blood collection and storage or cosmetics. These heparins are purified and processed from crude heparin before they are made into finished heparin sodium products.

Source of heparin

Heparin is called heparin because it was first found in the liver. It is a natural anticoagulant substance in many organs of mammals, in which the content of lung and intestinal mucosa is the highest. Unfractionated heparin is an aminoglucan sulfate extracted and refined from pig intestinal mucosa or bovine lung. It is a mixture with a molecular weight ranging from 3000-30000 KD and an average of about 15000 KD. Aminoglucan sulfate fragments after unfractionated heparin cracking, i.e. low molecular weight heparin, heparin calcium, enoxaparin, dalteparin, etc., with an average molecular weight range of 3000-8000kd.

Preparation of crude heparin

The fresh pig intestines (or frozen pig intestines after natural thawing) are carefully cleaned with clean water before enzymatic hydrolysis: the raw materials are finely adjusted to pH value of 8-9 with a small amount of dilute alkali solution under full stirring, and the solution temperature is maintained at 37-40 ℃ for enzymatic hydrolysis for 3-4 hours. Add refined salt of 5% of the total weight of the feed solution (containing NaCl ≥ 95%, calcium magnesium calcium salt < 0.5%), make it miscible evenly, then raise the temperature by 90 ℃, keep the temperature for 30 minutes, fine filter, and the filtrate will be returned to the range of pH = 9.0-9.5 for ion exchange adsorption treatment. Elute, filter, combine the clear solution and filtrate, fine adjust the pH = 6.0-6.5, add 1.5 times the amount of 95% ethanol for precipitation overnight, carefully bake and suck out the upper clear solution the next day, and collect the lower precipitate The sediment is pumped and filtered to dryness (the mother liquor can be used in the eluent before adjusting the pH value). After vacuum drying, crude heparin is prepared.

Refined heparin sodium

The crude heparin is completely dissolved with 2% sodium chloride solution to make a solution with a solubility of about 8%. In this process, it can be heated appropriately to facilitate dissolution. Finely adjust pH = 8.0-8.2 with 5mol / L sodium hydroxide solution at night, raise temperature to 78-80 ℃, add 0.15-0.2mol/l potassium permanganate solution for oxidation, fine filtration, filter the material solution with "sterilization filter", add 3-4 times of 95% ethanol for precipitation, dehydrate and grind with acetone, and vacuum dry with far-infrared ray (50-60 ℃), so as to obtain the high-quality heparin sodium.

It can be seen from the above that crude heparin is the raw material, and the finished product of heparin sodium can be obtained through further refining. Desheng currently provides heparin raw materials such as vascular heparin, enoxaparin, cosmetic heparin, etc.