Objectives: In this study, the acute toxicity of pidotimod synthesized in Vietnam have been evaluated. Materials are synthetic pidotimod offered by Hanoi University of Pharmacy. Equipments and chemicals used for the study was calibrated according to ISO/IEC 17025. | Journal of military pharmaco-medicine n09-2018 EVALUATION OF ACUTE TOXICITY OF PIDOTIMOD SYNTHESIZED IN VIETNAM Quach Thi Ha Van1; Nguyen Hong Hai1; Nguyen Thi Thu Hang2 Nguyen Hai Nam2; Tran Viet Hung3 SUMMARY Objectives: In this study, the acute toxicity of pidotimod synthesized in Vietnam have been evaluated. Materials are synthetic pidotimod offered by Hanoi University of Pharmacy. Equipments and chemicals used for the study was calibrated according to ISO/IEC 17025. Method: Acute toxicity was evaluated according to the acute toxicity determination method (Medical Publishing House 1996) and the OECD guidelines (OECD guidelines for testing of chemicals. Acute oral toxicity - fixed dose procedure OECD 420, 2001). Results: Acute toxicity of pidotimod by oral administration in mice, LD50 was ± g/kg. Conclusion: The synthesized pidotimod sample (P120513) belongs to the class of non-toxic substances. * Keywords: Pidotimod; Acute toxicity. INTRODUCTION Pidotimod is an immunostimulant that has been synthesized since the late 1980s. Pidotimod increases 100% of T lymphocytes and 133% of NK cell activity in immune deficiency individuals. On some volunteers, pidotimod also increases the number of white blood cells and macrophages [5]. In addition to effects on the immune system, studies have shown that pidotimod has no effect on other organ systems in laboratory animals, safe for infants even after long periods of treatment [5]. Pidotimod has been used extensively in foreign countries, but in Vietnam market, axil (400 mg/7 mL) is the only circulation of pidotimod, but is imported at high prices. Step by step self-sufficiency of pharmaceutical raw materials for domestic drug production is one of the key tasks of the pharmaceutical industry in Vietnam. Hanoi University of Pharmacy has built the process of synthesizing and purifying. Pidotimod reached purity of . In order to make the appropriate dosage forms, therapeutic and safety results, we have .
