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摘要：近年来，社会进步的脚步正以越来越快的速度发展，而随着人们的生活也发生很大的改变，在生活节奏方面逐渐显得更加的快速，在这种社会现状的影响下，人们在感染消化道疾病的发病率也呈上升趋势。与消化道相关的疾病需要及时并且合适的治疗，否则会对人们的生活质量造成严重的影响，更严重的情况是导致消化道疾病的恶化，发生消化道穿孔或癌症等疑难杂症。兰索拉唑作为奥美拉唑后研发的新一代质子泵抑制剂，其具备治愈成功率高，有较高的生物利用度、在对疾病的减轻方面速度更快、花费比较低、服用后毒副作用少等优势。此类胃肠疾病的药物市场需求也在稳步增长。在全世界药品销售量的排行榜排在前两百的胃肠疾病类的药物中，在21世纪初兰索拉唑就已经高居胃肠疾病类药物的畅销榜第6名，所以开发注射用右兰索拉唑不仅有经济效益，而且有着重要的社会意义。本文通过处方前研究对右兰索拉唑进行理化性质和药理学方面的研究和评价，侧重于对注射用右兰索拉唑的规格与处方工艺、工艺流程等工艺过程进行研究，旨在设计生产出右兰索拉唑的注射剂。48994
本文通过对原料药的理化性质的评价和测定，对药物性质的了解，以右兰索拉唑的溶解度和冻干效果为指标得出了处方，并根据共晶点确定了冻干曲线。根据《中国药典》确定主要考察性状，溶液澄清度，细胞内毒素，含量测定，pH值，有关物质等对处方制品进行影响因素试验和稳定性试验，其中有关物质检查和含量测定均使用HPLC。经40℃下加速考察2个月，本品质量稳定性，药品质量能够达到中国药典的注射液项下的相关要求。由于时间所限，本处方工艺尚未经中试研究和放大生产验证。
毕业论文关键词： 注射用右兰索拉唑; 注射剂; 质子泵抑制剂；工艺研究
Injection dexlansoprazole prescription technology research
Abstract：In recent years, the pace of social progress at an increasingly rapid pace, and with the people's life has undergone great changes in terms of the pace of life gradually becomes more rapid, under the influence of this social situation, people the incidence of infection in the digestive tract diseases is also on the rise.Associated with the gastrointestinal diseases need for timely and appropriate treatment, otherwise it would be the quality of life of severely affected, more severe cases lead to the deterioration of digestive diseases, the occurrence of gastrointestinal perforation or cancer and other incurable diseases.Lansoprazole is a new generation of proton pump inhibitors following omeprazole , which have the cure success rate, a higher bioavailability, in terms of speed to reduce the disease faster, cheap,few side effects. Such gastrointestinal disease drug market is also growing demand for the market. In twenty-first Century , the world's top 200 gastrointestinal disease drugs,lansoprazole is the sixth.Therefore, the development of injection dexlansoprazole is not only economic, but also has important social significance.This paper through the study of right before the prescription lansoprazole study and evaluate the physical and chemical properties and pharmacology. This paper focuses on the right lansoprazole injection process such as specifications, prescription ,process,technological.Aimed at the design and production of injection of r-lansoprazole.
Based on the physicochemical properties of the drug were measured and evaluated to understand the nature of the drug, in order to effect the solubility and lyophilized dexlansoprazole as an indicator derived prescription, and the freeze-drying curve is determined based on the eutectic point. Mainly on the characters, the clarity of the solution, intracellular toxins, determination, pH, and other related substances on prescription products for stress testing and stability testing according to "Chinese Pharmacopoeia" ,inspection and determination of the related substances were using HPLC. At 40 ℃ by accelerated study two months, the product quality and stability, the quality of drugs to achieve the requirements of the Chinese Pharmacopoeia injection under item. Due to time constraints, this process has not been prescribed by the pilot study and enlarge production verification.