The Studies On Propranolol Hydrochloride Gels

Objective:To determine the optimal prescription matrix proportion of propranolol hydrochloride gel,preferably to promote type and concentration of the best penetration enhancers,preparate excellent propranolol hydrochloride gel and build the quality control standard and preliminary stability study and safety study, intend to provide a safe and effective external drug for superficial infantile hemangioma patients.Method: First inspect single factor affecting gel of excipients, moisturizers and humectants, base on the composite score for evaluation transparency, consistency, spreadability and stability of, with a star design- response surface methodlogy to determine optimal proportion of prescriptions gels; secondly, through the cumulative amount per unit area as an indicator, screening different concentrations of nitrogen ketone, oleic acid, propylene glycol, and a total of six kinds of pairwise with penetration enhancers propranolol hydrochloride transdermal absorption properties, determine the type and concentration of the best accelerators; Finally, press the preparation process for preparing gels, its content wasdetermined by HPLC,establish quality evaluation of propranolol hydrochloride gel methodology according to new drug filing requirements for quality control, and preliminary animal experiments to study its safety.Results: Determine the excipient,moisturizer and humectant of prescription forms. The best formulation matrix proportion is Hypromellose 2.33%, 18.06% glycerin and polyethylene glycol-400 8.06%; by the cumulative amount per unit area through transparency, stability and performance of the coating inspection, to determine the optimal penetration enhancers 2% Azone; propranolol hydrochloride prepared gels quality controlled, stable, safe without stimulating, the establishment of quality standards in line with regulatory submissions.Conclusion: Propranolol hydrochloride transdermal gel preparated has good perform-ance and a higher penetration rate, prescription form stable, controllable quality,safe and without stimulation for further development and lay a foundation of the developpment of propranolol topical formulation...