摘要
目的:对《中国药典》2015年版收载测定熔点的三种方法(传温液法、熔点自动测定仪法、热分析法)适用性进行比较。方法:采用熔点自动测定仪法结合传统传温液法以及热分析法对熔点标准品及复杂代表性药品的熔点进行测定。结果:传温液法和熔点自动测定仪法重复性、中间精密度结果良好,适用于测定均匀、物化性质稳定样品的熔点;热分析法适用于难以直观判断终点的熔融同时分解样品以及多晶型样品的熔点测定。结论:三种熔点测定方法各有优势,在日常药品熔点测定中可结合样品物化性质选择合适的方法测定其熔点。
Objective： To compare three methods for determining melting point in Chinese Pharmacopoeia 2015. Methods： The melting points of standard materials and complex representative drugs were detected by automatic melting point determinator, traditional transmission fluid and thermal-analysis methods. Results： The transmission fluid and automatic melting point determinator methods had good repeatability and intermediate precision, could be applied to detect uniform and stable samples. Thermal-analysis method could be used to the hardly intuitive judgment and polymorphism samples. Conclusion： Three methods for determining melting point have advantages separately.
出处
《中国药品标准》
CAS
2015年第6期412-416,共5页
Drug Standards of China
