【摘要】：目的:針對尼群地平晶I型與晶IV型,建立其混晶原料藥中晶型含量的定量分析方法。方法:采用差示掃描量熱法,在分別考察晶I型、晶IV型樣品質(zhì)量與熱量線性關(guān)系的基礎(chǔ)上,通過配制尼群地平晶I型與晶IV型的不同含量混晶樣品,建立其吸熱峰熱焓值與晶型含量間的線性關(guān)系,實現(xiàn)尼群地平混晶樣品中晶型含量的定量分析。結(jié)果:尼群地平晶I型與晶IV型的吸熱峰Peak值相差2℃,當(dāng)混晶樣品中晶I型含量小于10%或大于40%時,兩種晶型的吸熱峰無法區(qū)分,當(dāng)混晶樣品中晶I型含量在10%~40%范圍內(nèi)時,其含量與熱焓具有良好的線性關(guān)系。結(jié)論:本方法具有試樣微量化、操作簡單、快速便捷、圖譜易于分析等優(yōu)勢,可作為尼群地平晶型質(zhì)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，

本文編號：2160142