Development background
Product features
1）About BFGF
2）Mechanism of action
-BFGF can induce stem cell differentiation, promote the division and proliferation of mesoderm and ectoderm-derived cells, and promote tissue repair, angiogenesis, nerve regeneration and bone growth;
-BFGF can promote chemotactic inflammatory cells and tissue repair cells to gather to the wound and promote tissue repair;
-BFGF can promote angiogenesis, improve local blood circulation, provide oxygen and nutrients for tissue repair and promote wound healing;
-BFGF can promote nerve repair and restore motor and sensory functions;
-BFGF can promote restoration, hair growth and perspiration;
-BFGF can regulate collagen balance and prevent scar formation.
Physical, chemical and biological properties
1）Specification:
| Strength of bFGF | Volume of Solvent (Sterile Water for Injection) |
| 70000 IU | 5 ml |
2）Administration method: this product is for external use.
3）Dosage form: lyophilized powder.
4）Appearance: white or off-white crisp cake.
5）Stability
5.1）Stability of lyophilized powder
| Test type | Test condition | Container | Test duration | Results |
| Long-term stability | 2-8°C | Low-borosilicate tubing injection vial with halogenated butyl rubber stopper and aluminum-plastics combined cap | 36 months | All indicators comply with requirements, indicating the product is stable. |
| Accelerated stability | 25±2°C and related humidity of 60%±10% | Low-borosilicate tubing injection vial with halogenated butyl rubber stopper and aluminum-plastics combined cap | 6 months | All indicators comply with requirements, indicating the product is stable. |
5.2）Stability after reconstitution
| Test type | Test condition | Container | Test duration | Results |
| Stability after reconstitution | Store at 2°C-8°C; use at room temperature | Vial assembled with the sprayer | 7 days | No microorganism or bacterium is detected within 7 days |
6）Container
*Low-borosilicate tubing injection vial, containing 70000IU of bFGF
*Polypropylene ampoule, containing 5 ml of sterile water for injection
*Spray pump
*Package insert