Study on the Improvement of Clarity and Stability for Teicoplanin for Injection

OBJECTIVE To prepare the teicoplanin for injection containing sodium chloride, study the clarity and stability. METHODS The teicoplanin for injection including hydroxyl alcohols, monosaccharide and disaccharides compounds were prepared separately and their clarity were tested, the influence of clarity from different materials were compared. The optimization freeze-drying process were selected by orthogonal experimental design. The stability study were conducted in an accelerated testing and long-time testing. RESULTS The best formulation was that containing PEG400, the optimization freeze-drying process were fast frozen to –50 ℃ and keep 3 h; 5 h from -50 ℃ to -20 ℃ and keep 20 h; 2 h from -20 ℃ to 40 ℃ and keep 6 h. CONCLUSION The teicoplanin for injection produced with this method has good clarity, stable quality and could be kept in room temperature.