Studies On Pidotimod Syrup And Sodium Chloride Injection

Pidotimod is a new immunomodulatory agent with a peptide-like structure of synthetic origin. The drug did not show antimicrobial or antifungal activities .It acts as immunostimulant agent by increasing cell-mediates immune response via stimulation of IL-2 andγ-interferon production.We developed Pidotimod Syrup and Pidotimod and Sodium Chloride Injection made thorough study of the prescription, technology, quality, stability and pharmacokinetics of two preparations.First, we investigate the heat-degradation kinetic characteristics of pidotimod in various pH conditions. These could provide reference for the prescription of pidotimod liquid preparations. Then we prepared Pidotimod Syrup and Pidotimod and Sodium Chloride Injection. HPLC method was developed for the quality and the pharmacokinetics characteristic in rabbits. The pharmacokinetics parameters were calculated with statistical moment principal.All results of quality accorded with the criteria in Chinese Pharmacopeias. They had good stability and the expiration could be considered two years temporarily. Injection was safe. All the pharmacokinetics parameters in rabbits after i.v. administration and oral route show that pidotimod is a fastly adsorbed, distributed and quite fastly eliminated drug, does not show autoinduction and accumulation phenomena.Pidotimod Syrup and Pidotimod and Sodium Chloride Injection are simple in preparation technique feasible in quality control, could be used for clinical trial. The analysis methods were accurate, speedy and specific. These findings could provide reference for clinical trial, moreover offer medical data in vivo for studying pidotimod’s correlated dosage forms.