埃索美拉唑镁肠溶胶囊的制备

发布时间：2018-02-25 17:39

本文关键词： 埃索美拉唑镁肠溶微丸流化床离心造粒微丸胶囊　出处：《河北科技大学》2017年硕士论文　论文类型：学位论文

【摘要】：埃索美拉唑(现用名:艾司奥美拉唑)是一种新型的质子泵抑制剂,它是奥美拉唑的S-型异构体,用于治疗胃酸分泌过多的相关性疾病。埃索美拉唑镁肠溶胶囊为微丸胶囊,本课题对其处方和工艺进行了系统研究。本课题的目的在于使用不同的包衣技术制备埃索美拉唑镁肠溶微丸胶囊并采用相应的体外分析方法对所制得的肠溶微丸胶囊进行质量研究和稳定性考察。实验首先介绍埃索美啦唑肠溶微丸胶囊体外分析方法并进行处方前研究和原研剖析;其次采用流化床和离心造粒两种工艺制备埃索美拉唑镁肠溶微丸,使用空白丸芯上药并包衣的方法制备肠溶微丸,综合包衣效率和包衣过程的可控性等因素确定工艺参数。添加隔离层以保证药物稳定性。以稳定性、耐酸力以及溶出为考察指标,采用单因素考察法对处方进行筛选,确定隔离层和肠溶层的处方及增重;最后采用相应的体外分析方法进行质量研究和稳定性考察。采用两种工艺制备的肠溶微丸圆整度好,大小均一,批间差异小且处方重现性好;对制备的埃索美拉唑镁肠溶微丸胶囊进行质量研究,其含量、有关物质、对映异构体等均符合要求。在稳定性实验中,原研样品与自制样品的性状、含量、有关物质、溶出度变化趋势基本一致,具有较好的稳定性。实验结果表明所制备的肠溶微丸胶囊质量可靠、稳定性良好,与原研制剂质量相当,为埃索美拉唑镁肠溶胶囊的工业化提供了参考依据。
[Abstract]:Esomeprazole (now used: esomeprazole) is a new type of proton pump inhibitor, the S-type isomer of omeprazole, which is used to treat stomach acid-secreting related diseases. The purpose of this paper is to prepare esomeprazolium enteric-coated pellets with different coating techniques and to use the corresponding analytical methods in vitro to prepare the enteric pellets. The method of in vitro analysis of esomeprazole enteric-coated pellets was introduced, and the pre-prescription study and original analysis were carried out. Secondly, esomeprazolium enteric-coated pellets were prepared by fluidized bed and centrifugal granulation. The process parameters were determined by synthesizing the coating efficiency and controllability of coating process, the stability of the drug was ensured by adding an isolation layer, and the single factor method was used to screen the prescription with stability, acid resistance and dissolution as the indexes. The formulation and weight gain of the separation layer and enteric layer were determined. Finally, the quality and stability of the pellets were studied by using the corresponding analytical methods in vitro. The enteric pellets prepared by two kinds of processes were of good roundness and uniform size. The contents, related substances and enantiomers of esomeprazolium enteric-coated pellets were all in accordance with the requirements. The changes of properties, contents, related substances and dissolution of the original sample and the self-made sample are basically the same and have good stability. The results show that the prepared enteric pellets capsule is reliable in quality and good in stability. The quality of esomeprazole magnesium enteric capsule is equivalent to that of the original preparation, which provides a reference for the industrialization of esomeprazole magnesium enteric capsule.
【学位授予单位】：河北科技大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R943

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