Deer and melon polypeptide injection

Deer melon polypeptide injection, its properties and dosage form are light yellow transparent liquid. Indications: Used for rheumatism, rheumatoid arthritis, ankylosing spondylitis, various fractures, wound repair and low back and leg pain. Specification: 4ml: 8mg Dosage and Administration: Intramuscular injection. 2 to 4 ml each time, 4 to 8 ml per day. Intravenous drip. 8-12 ml daily, intravenous injection of 250-500 ml of 5% glucose injection or 0.9% sodium chloride injection. A course of treatment is 10 to 15 days or under the guidance of a doctor, should be reduced for children.

1. Pharmacological action

The bone-inducing polypeptide biological factors in this product can effectively promote the synthesis of bone-derived growth factors that affect bone formation and absorption in the body, including bone morphogenetic proteins (BMPs), β-transforming growth factor (TGF-β), fibroblast growth factor (FGF), etc., thus having multiple biological activities. Its main pharmacological effects include: promoting cell mitosis, differentiation, chemotaxis and osteolytic activity. Among them, BMPs is a group of acidic low molecular weight glycoproteins. As a highly effective bone inducing substance, BMPs are the initial signal molecules for the differentiation of mesenchymal cells into bone cells. They can induce mesenchymal cells swimming around blood vessels to transform into irreversible bone cells, namely chondrocytes and osteoblasts, thereby promoting callus formation, inducing new bone formation, and promoting fracture repair; in addition, BMPs can also regulate changes in extracellular matrix components, and better induce new bone formation through coordinated effects with TGF-β and FGF, making bone tissue more mature. TGF-β is a family of protein polypeptides with multiple functions. It has a dual regulatory effect on osteoblasts and chondrocytes, either promoting differentiation or reducing differentiation. It synergizes with multiple factors such as extracellular matrix and other differentiation-regulating growth factors to regulate cell differentiation. TGF-β can promote the synthesis of extracellular matrix, directly stimulate the synthesis of extracellular matrix of fibroblasts, and significantly inhibit the degradation of newly synthesized matrix. For osteoblasts, TGF-β can promote their synthesis of type I collagen, osteonectin and osteopontin. At the same time, the effect of TGF-β on lymphocytes and macrophages shows that it can both alleviate the destructiveness of inflammatory responses and assist certain cytokines derived from macrophages to play a role in tissue repair. FGF is a group of heparin-binding polypeptides that can stimulate cell migration, proliferation and differentiation, increase the number of collagen-synthesizing cells, promote the synthesis of collagen and non-collagen proteins, and increase the synthesis of osteocalcin.

Muskmelon seed extract is extracted from the mature and dried seeds of the Cucurbitaceae plant Cucumis melo L. through a special process. It can reduce the permeability of local capillaries in the fracture area, reduce inflammatory exudation, and promote the recovery of local blood circulation disorders; at the same time, it can also reduce whole blood viscosity and red blood cell aggregation, improve local blood circulation in the callus, and provide a good blood supply environment for bone cells. In addition, it can inhibit the release of prostaglandins to achieve analgesic effects; in promoting early fracture healing, melon seed extract has a synergistic effect with supplemented bone-inducing polypeptide biological factors to promote the synthesis of bone-derived growth factors.

This product is rich in a variety of free amino acids, which provide raw materials for bone cells to synthesize bone-derived biological factors such as BMPs, TGF-β, FGF, etc., and promote the synthesis of bone-derived biological factors. Organic calcium and phosphorus ions can participate in calcium-phosphorus metabolism and maintain bone volume.

2. Toxicology studies

Acute toxicity test: The maximum intravenous injection dose of 800 mg/kg in rats did not cause obvious poisoning symptoms in animals, and its LD50>800 mg/kg; the maximum single intravenous drip of cervus and melon polypeptide in Beagle dogs did not cause poisoning symptoms in animals at a maximum dose of 800 mg/kg (1664 to 2496 times the clinical dose).

Long-term toxicity test: Rats were intraperitoneally injected with cervus and melon peptide for 13 weeks. Except for the foreign body irritation reaction of the peritoneum caused by the intraperitoneal administration, no other toxic reactions related to the test product were found. The dose level at which no adverse reactions were observed in Beagle dogs after repeated intravenous infusion of deer melon polypeptide for 13 weeks was 100 mg/kg (208 to 312 times the clinical dose). The possibility that a high dose of 400 mg/kg (832 to 1248 times the clinical dose) could cause mild, reversible hepatocyte degeneration cannot be ruled out.