提高注射用替考拉宁澄清度和稳定性的探讨

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

关键词:  注射用替考拉宁  澄清度  正交试验  稳定性

Key words:  teicoplanin for injection  clarity  orthogonal test  stability

摘要:

目的 制备含有氯化钠的注射用替考拉宁，并对其澄清度和稳定性进行考察。方法 分别采用含有多羟基的醇类、单糖类和双糖类化合物为赋形剂制备注射用替考拉宁，考察不同辅料对澄清度的影响；利用正交试验设计优化注射用替考拉宁冻干工艺，考察其加速和长期稳定性。结果 处方中加入聚乙二醇400，采用速冻至-50 ℃后保持3 h；5 h内从-50 ℃升至-20 ℃后保持20 h；2 h内从-20 ℃升至40 ℃后保持6 h的冻干工艺能有效提高澄清度。结论 该方法制备的注射用替考拉宁澄清度良好，质量稳定，可以室温保存。

Abstract:

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.