文档介绍：中文摘要地塞米松磷酸钠是?种重要的肾上腺糖皮质激素类药物,在临床_Jj仃十分』“泛的应用。目前,国内生产的地塞米松磷酸钠与国外同类产品相比,在粒度、纯度及结晶过程的收率等方面都存在着1定的差距。本论文对地塞米松磷酸钠晶体结构tj晶习、结晶热力学和动力学及生产规模的反应一溶析耦合结品工艺进行了研究与分析,并在此基础}:完成了年产60吨地塞米松磷酸钠的耦合结晶过程的设计与生产实施。利};ljx-射线粉未衍射仪搜集了地塞米松磷酸钠晶体的衍射数掘,j1] TREOR90指标化程序计算得到了地塞米松磷酸钠晶体的品胞参数及其所属品系; 应用扫描电子显微镜(SEM)观察的方法分析考察了结晶疗法、溶剂类型及温度对地塞米松磷酸钠产品晶习的影响。采用激光法测定了地塞米松磷酸钠在各种溶剂中的溶解度并考察了温度和溶剂配比对溶解度的影响情况;测定了地塞米松磷酸钠在甲醇一丙酮一水体系中的结晶介稳区;运用最小二乘法回归得到了溶解度与介稳区曲经验数学模型:刘地塞米松磷酸钠反应及溶析结品动力学进行了分析。结合晶体生产习性、热力学和动力学特性以及对实验室研究结果的分析,建萨了地塞米松磷酸钠耦合结晶过程优化操作时问表,并成功完成了生产过程的设计放大与实施,产晶的各项指标均达到。本论文所做的有关地摩米松磷酸钠晶体结构、结晶生产新工艺的研究与应用在国内外的文献中尚未见到过任何报道。关键词:地塞米松磷酸钠;晶体结构;溶解度;介稳区; 耦合结晶;设计放大生产规模 ABSTRACT Dexamethasone sodium phosphate is oue kind ofimportant drugs ofardrenal cortex itiSwidely used tonow;home-made dexamethasone sodium phosphate iS not asgood asthose overseas products interms of itspurity andsize ,the crystal structure,crystal habit,crystallization reaction—dilutioncoupled crystallization technics of dexamethasone sodium phosphate was manufacturing process with output of 60 ton/year for dexamethasone sodium phosphate wasdesigned and setup. The diffractiondata fordexamethasone sodium phosphate crystal was collectedby X-ray theindexing program named unit cellparameters and space group fordexamethasone sodium phosphate were obtained by theindexing effectofcrystallization method,solvent and temperature on crystal habitofdexamethasone sodium phosphate were investigated by SEM(scanning electronicsmicroscope)analysis. The soluKlitv ofdexamethasone sodium phosphate indifferentsolvents was determined by 1asermonitor effectoftemperature and solvent on solubility was metastable zone ofdexamethasone sodium phosphate inmethanol— system empirical model for solubility andmetastabel zone ofdexamethasone