Pharmaceutics Studies On Recombinant Human Epidermal Growth Factor

Pharmaceutics studies on biopharmaceuticals, especially emphasis on its stability and long-term delivery systems, was performed using recombinant human epidermal growth factor(rhEGF) as model drug. Based on studies on the stability of rhEGF, the optimized formulation and preparation technology of rhEGF gel, rhEGF ointment and rhEGF pH sensitive solution were established, and the pharmacodynamics of these preparations were investigated. The different storage condition (physical state, temperature, pH and drug concentration) had significant effect on the stability of rhEGF. Some additives could inhibit activity loss of rhEGF, and could be used as stabilizing agents in rhEGF preparations. Both rhEGF gel and rhEGF ointment could be manufactured easily with reliable quality. They also could be applied conveniently to accelerate wound healing in rats. Intragastric administration of rhEGF pH sensitive solution had significant protective effect on ethanol-induced gastric mucosal injury and marked therapeutic effect on chronic gastric ulcers induced by acetic acid.