摘要
本文采用热分析方法考查了氨酚待因片中赋形剂与药物之间的物理与化学变化。实验结果表明,赋形剂硬脂酸镁、玉米淀粉、低替代度羟丙基纤维素与药物乙酰氨基酚、磷酸可待因之间不发生物理与化学变化。硫脲(用作抗氧剂)与乙酰氨基酚可形成最低共熔体系,低共熔温度为139.5℃,低共熔混合物组成含乙酰氨基酚72.5%.硫脲与磷酸可待因在较高温度下可能存在化学作用。
In this study the physical and chemical changes of the excipients and chief drugs in TABELLAE PARACETAMOLI ET CODEINE were invesigated by differential thermal analysis method. The results obtained showed that no reaction took place between excipients of magnesium stearate, corn starth and Ls-Hydroxy-propyl and drugs of N-Acethy Aminophenol and codeine phosphate. A eutectic system was formed between sulfocarbamide and N-Acethy Aminophenol, the eutectic temperature being 139.5℃ and N-Acethy Aminophenol accounting for 72.5% in the eutectic mixture. A chemical reaction may be possible between sulfocarbamide and codeine phosphate at highter temperatures.
关键词
热分析方法
氨酚待因片
赋形剂
Method of thermal analysis
Tabellae paracetamoli et codeine
Excipient
Eutectic system
