阿托伐他汀钙的溶解度测定及差异分析

Determination and Difference Analysis of Solubility of Atorvastain Calcium

目的比较阿托伐他汀钙原料的国内仿制品与进口产品在溶解度方面的区别,并分析其原因。方法以进口阿托伐他汀钙为原料,通过国内的重结晶的方法,重新制备了两种晶型的阿托伐他汀钙,测定其在不同p H溶剂中的溶解度,并与进口产品、国产产品进行比较。通过X衍射实验和热重分析实验对这四种阿托伐他汀钙进行了固相表征。结果结果表明进口阿托伐他汀钙所含有的一分子结晶水,是其晶型略不同于国产原料的原因,也是其溶解度良好的原因。结论国内的重结晶工艺是造成国产阿托伐他汀钙在溶解度方面有别于进口产品的主要因素。

Objective To find the differences of the solubilities of atorvastain calcium between the imported and the domestic,and analyse the reason.Methods In this paper,two kinds of different crystalline of atorvastain calcium were prepared from imported atorvastain calcium by domestic recrystallization.The solubilities of the above mentioned products were measured with different p H values,and to compare their solubilities with the imported and the domestic.These four kinds of atorvastain calcium were further characterized by powder X-ray diffractometry and thermogravimetric analysis.Results The results show that the imported contained one isolated site water in its crystal lattice and this was why it had stronger solubility and different crystal form from the domestic.Conclusion This study proved that the recrystallization was a major cause for the different solubility between the domestic and the imported.