目的 比較阿托伐他汀鈣原料的國內(nèi)仿制品與進(jìn)口產(chǎn)品在溶解度方面的區(qū)別，并分析其原因。方法 以進(jìn)口阿托伐他汀鈣為原料，通過國內(nèi)的重結(jié)晶的方法，重新制備了兩種晶型的阿托伐他汀鈣，測(cè)定其在不同pH溶劑中的溶解度，并與進(jìn)口產(chǎn)品、國產(chǎn)產(chǎn)品進(jìn)行比較。通過X衍射實(shí)驗(yàn)和熱重分析實(shí)驗(yàn)對(duì)這四種阿托伐他汀鈣進(jìn)行了固相表征。結(jié)果 結(jié)果表明進(jìn)口阿托伐他汀鈣所含有的一分子結(jié)晶水，是其晶型略不同于國產(chǎn)原料的原因，也是其溶解度良好的原因。結(jié)論 國內(nèi)的重結(jié)晶工藝是造成國產(chǎn)阿托伐他汀鈣在溶解度方面有別于進(jìn)口產(chǎn)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 pH 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.