差示扫描量热法对尼群地平晶型的定量分析研究

发布时间：2018-08-02 17:23

【摘要】：目的:针对尼群地平晶I型与晶IV型,建立其混晶原料药中晶型含量的定量分析方法。方法:采用差示扫描量热法,在分别考察晶I型、晶IV型样品质量与热量线性关系的基础上,通过配制尼群地平晶I型与晶IV型的不同含量混晶样品,建立其吸热峰热焓值与晶型含量间的线性关系,实现尼群地平混晶样品中晶型含量的定量分析。结果:尼群地平晶I型与晶IV型的吸热峰Peak值相差2℃,当混晶样品中晶I型含量小于10%或大于40%时,两种晶型的吸热峰无法区分,当混晶样品中晶I型含量在10%~40%范围内时,其含量与热焓具有良好的线性关系。结论:本方法具有试样微量化、操作简单、快速便捷、图谱易于分析等优势,可作为尼群地平晶型质量控制的限量方法使用。
[Abstract]:Aim: to establish a quantitative analysis method for the content of crystal type I and IV in Nijundipine bulk drug. Methods: differential scanning calorimetry (DSC) was used to investigate the linear relationship between the quality and heat of the samples of crystal type I and type IV, and to prepare mixed crystal samples with different contents of nitrendipine type I and crystal type IV respectively. The linear relationship between the enthalpy of endothermic peak and the content of crystal form was established, and the quantitative analysis of crystal form content in the mixed crystal sample was realized. Results: the endothermic peak Peak of nitrendipine I and IV is 2 鈩，

本文编号：2160142