Thymosin ¦Á1 Gel Developed

OBJECT To prepare thymosinα1 gel for the treatment of I°and shallow II°burns. METHOD Thymosinα1 in solution was determined both qualitatively and quantitatively by using the method of High Performance Liquid Chromatography (HPLC), and its biological activity was measured by E-rosste test in order to choose suitable dose for application. The effects of pH, temperature and protectants on the stability of the thymosinα1 solution were studied. The influences of received media , pH and different period of cold storage on the percutaneous permeation of thymosinα1 were investigated by modified Valia-Chien diffusion cell. Optimum permeation enhancers were selected to improve the permeated behaviour of thymosinα1 across rat skin without stratum corneum (SC). The prescription and technological process were optimized by the criterion of accumulated amounts of permeating and releasing. Animal experiments were established to investigate pharmacodynamics, irritation, sensitivity of thymosinα1 gel.RESULT The method of HPLC was proved to be effective, correct and convenient. The stability study showed that the best storage conditions were : 4℃, pH 4 and using 5%-10% mannitol as protectant. The results of permeation test indicated that phosphate buffer solution (pH 8.0), 0.2mg·mL^-1 thymosinα1, and skin stored no longer than 1 weeks after excised from live rats were preferable. Coenhancers were found to be superior to monoenhancers. Pharmacologicdynamic study indicated that, when compared with the controlled, thymosinα1 gel may decreased the area of scab and healing time apparently.CONCLUSION Thymosinα1 gel was safe, stable and effective; the procedure of preparation was simple and could be repeated fluently.