本文關鍵詞： 埃索美拉唑鎂 腸溶微丸 流化床 離心造粒 微丸膠囊　出處：《河北科技大學》2017年碩士論文　論文類型：學位論文

【摘要】：埃索美拉唑(現(xiàn)用名:艾司奧美拉唑)是一種新型的質子泵抑制劑,它是奧美拉唑的S-型異構體,用于治療胃酸分泌過多的相關性疾病。埃索美拉唑鎂腸溶膠囊為微丸膠囊,本課題對其處方和工藝進行了系統(tǒng)研究。本課題的目的在于使用不同的包衣技術制備埃索美拉唑鎂腸溶微丸膠囊并采用相應的體外分析方法對所制得的腸溶微丸膠囊進行質量研究和穩(wěn)定性考察。實驗首先介紹埃索美啦唑腸溶微丸膠囊體外分析方法并進行處方前研究和原研剖析;其次采用流化床和離心造粒兩種工藝制備埃索美拉唑鎂腸溶微丸,使用空白丸芯上藥并包衣的方法制備腸溶微丸,綜合包衣效率和包衣過程的可控性等因素確定工藝參數(shù)。添加隔離層以保證藥物穩(wěn)定性。以穩(wěn)定性、耐酸力以及溶出為考察指標,采用單因素考察法對處方進行篩選,確定隔離層和腸溶層的處方及增重;最后采用相應的體外分析方法進行質量研究和穩(wěn)定性考察。采用兩種工藝制備的腸溶微丸圓整度好,大小均一,批間差異小且處方重現(xiàn)性好;對制備的埃索美拉唑鎂腸溶微丸膠囊進行質量研究,其含量、有關物質、對映異構體等均符合要求。在穩(wěn)定性實驗中,原研樣品與自制樣品的性狀、含量、有關物質、溶出度變化趨勢基本一致,具有較好的穩(wěn)定性。實驗結果表明所制備的腸溶微丸膠囊質量可靠、穩(wěn)定性良好,與原研制劑質量相當,為埃索美拉唑鎂腸溶膠囊的工業(yè)化提供了參考依據(jù)。
[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.
【學位授予單位】：河北科技大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R943

【參考文獻】

相關期刊論文 前10條

1 張歡;胡艇;于培明;;埃索美拉唑專利現(xiàn)狀分析[J];中國藥事;2015年08期

2 劉浩;;世界暢銷藥埃索美拉唑的開發(fā)應用進展[J];黑龍江醫(yī)藥;2015年04期

3 高子彬;陳小龍;張麗男;王曉君;齊獻利;谷艷玲;;離心造粒法制備醋氯芬酸微丸[J];河北科技大學學報;2015年01期

4 尹江燕;陳道榮;;消化性潰瘍藥物治療的進展[J];醫(yī)學綜述;2013年11期

5 門樂;鮮潔晨;洪燕龍;馮怡;王玲;;4種輔料空白丸芯制備工藝的優(yōu)選及差異性分析[J];中國實驗方劑學雜志;2013年10期

6 曹筱琛;賈飛;陶巧鳳;;藥物與輔料相容性研究進展[J];中國現(xiàn)代應用藥學;2013年02期

7 嚴華;涂海華;田麗麗;卞志家;何瑜;何奕秋;;埃索美拉唑的全球專利申請狀況分析[J];中國發(fā)明與專利;2012年11期

8 崔傳耀;;消化性潰瘍臨床研究進展[J];首都醫(yī)藥;2012年20期

9 胡士高;孫備;;口服固體制劑原輔料相容性研究進展[J];中國現(xiàn)代應用藥學;2012年09期

10 張生雄;;埃索美拉唑研究進展[J];青海醫(yī)藥雜志;2012年03期

，

本文編號：1534524