琥珀酰明胶注射液及其明胶原料的特性

Characterization of succinylated gelatin injection and its raw material gelatin

目的为保障琥珀酰明胶注射液临床用药的安全性,研究了该注射液及其明胶原料的特性。方法分别采用紫外可见分光光度法、热失重分析（TGA）和差示扫描量热技术（DSC）测定明胶的含量、含水量与玻璃化温度（θg）。另外,采用流变仪、激光粒度测定仪及凝胶渗透色谱法（GPC）对琥珀酰明胶注射液的流变性质、粒度分布稳定性及相对分子质量与分布进行了测试。结果该明胶含水量的质量分数为14.53%（均为结合水）,在240℃以后发生氧化裂解;DSC测定得到该明胶的θg为50~59℃。琥珀酰明胶注射液属于牛顿流体,黏度为2.266 mPa.s;其相对数均分子质量（M-n）为2.067 3×104,相对重均分子质量（M-w）为4.426 9×104,分布系数（D）为2.141;琥珀酰明胶注射液在输注期间,平均粒径有增长的趋势,但均在1μm以下。结论具有上述热特性的明胶原料制备的琥珀酰明胶注射液具有确定的相对分子质量、稳定的相对分子质量分布指数,且在输注期间,粒度分布稳定,保证了制剂的质量。

Objective To ensure the clinical safety,characterizations of succinylated gelatin injection（Gelofusine）,and study its raw material gelatin.Methods Spectrophotometry,thermal gravimetric analysis（TGA）,differential scanning calorimetry（DSC）were applied forn the determination of water content and glass transition temperature（θg）of gelatin.Moreover,rheometer,laser particle size analyzer and gel permeation chromatography（GPC）were utilized to test the rheological properties,stability and molecular weight distribution of Gelofusine.Results Moisture content of gelatin was 14.53%（only with bond water）,pyrolysis was at 240 ℃;the glass transition temperature of the gelatin（θg）was determined as 50-59 ℃ by differential scanning calorimetry（DSC）.Gelofusine was a Newtonian fluid with viscosity of 2.266 mPa·s;the number average molecular weight M-n was 2.067 3×104,weight average molecular weight M-w was 4.426 9×104,distribution coefficient D was 2.141;during the infusion period,the particle size grew,but all less than 1 μm.Conclusions Gelofusine with such thermal characteristics has certain molecular weight,changeless molecular weight distribution,and in the infusion period,the particle size distribution is stable,ensuring the preparation with fine quality.