Somatonorm

Originator

Protropin,Genentech

Uses

Hormone (growth).

Manufacturing Process

Highly purified human growth hormone was isolated from fresh glands by the procedure involving gel filtration of Sephadex. The hormone was oxidized by performing acid. Both the native and the oxidized product were submitted to digestion with trypsin as well as with chymotrypsin, while only native hormone was hydrolyzed with pepsin. These digests were fractionated on ion-exchange resin columns. Some of fraction required further purification by paper chromatography in a system consisting of 1-butanol/acetic acid/water (4:1:5) and by high-voltage electrophoresis on paper in a buffer of pH 2.3. Human growth hormone is contained 188 amino acids. From sedimentation equilibre studies the molecular weight of the hormone was shown to be 21,500.
1000 ml of sterile intramuscular preparation containing 2.5 mg of chymotripsin hydrolyzed bovine growth hormone and 2.5 mg methylprednisolone is prepared from the following types and amounts of materials containing (per ml); 1) 2.5 mg chymotripsin hydrolyzed bovine growth hormone (powder), 2) 2.5 mg methylprednisolone (micronized), 3) 30 mg polyethylene glycol (40 000), 4) 9 mg sodium chloride, 5) 2 mg polysorbate 80, 1.8 mg methylparaben, 0.2 mg propylparaben and watef q.s. to 1000 ml.
The parabens are added to most of the water and dissolved with stirring and heating to 65-70°C. The mixture is cooled to room temperature and ingredient 3, 4 and 5 are added. The resulting solution was made up to 100 ml with water and sterilized by filtration. Ingredient 1 and 2 are sterilized with ethylene oxide and added aseptically. The final preparation is packaged in sterile containers with 1 ml of the final product. This is used advantageously in the treatment of arthritis and to avoid negative nitrogene balance.

brand name

Protropin (Genentech).

Therapeutic Function

Growth stimulant