右旋佐匹克隆片的制备工艺及质量评价

发布时间：2018-06-27 21:46

本文选题：右佐匹克隆 + 右旋佐匹克隆片　；参考：《黑龙江中医药大学》2014年硕士论文

【摘要】：本文主要是对国内上市的右佐匹克隆片进行仿制,目的是为企业仿制出符合《中国药典》(2010版)标准并能够符合企业大规模生产要求的右佐匹克隆片,为企业创造经济价值。之所以选择片剂是因为片剂在整个药品剂型中是应用最广的,也是在固体制剂剂型中所占比重最大的剂型。出于对企业大规模生产成本以及片剂的优势所带来的广阔市场等因素的考虑而选择片剂的仿制。右旋佐匹克隆(Eszopiclone)为佐匹克隆的右旋单一异构体,是第三代快速短效镇静催眠药物,即非苯二氮卓类镇静催眠药,用于治疗睡眠紊乱。右旋佐匹克隆是由美国Sepracor公司1998年开始研究,并于2005年4月上市,其母体药物佐匹克隆,目前已在世界80多个国家及地区上市销售,属于临床上用于失眠症最多的药物之一。目前国内只有江苏天士力公司生产上市,商品名文飞。在成型工艺研究中,对右旋佐匹克隆片进行处方设计与筛选,通过单因素考察法筛选填充剂的用量、崩解剂的用量、润滑剂的用量和助流剂的用量,以片剂的外观、硬度、脆碎度、崩解时限溶出曲线为指标；包衣工艺,以制得衣膜完整均匀、片面光滑的包衣片为评价指标,选择合适的包衣基本工艺参数。在质量评价研究中,采用UV、GC、HPLC等技术,对所制右旋佐匹克隆片进行含量测定、含量均匀度检查、有关物质、溶出度、光学纯度等项目检查并对右旋佐匹克隆片的质量进行评价。结果表明,所仿制得的右旋佐匹克隆片符合《中国药典》(2010版)中国药典标准,制备工艺合理、方法可行,质量稳定、可控,适合企业大规模生产要求,达到预期目标。
[Abstract]:The aim of this paper is to make a copy of the right Zopi clone which is listed on the domestic market in order to create economic value for the enterprise. The aim is to make the right Zopi clone which meets the standard of "Chinese Pharmacopoeia" (2010 Edition) and can meet the requirements of large-scale production of the enterprise. Tablets are chosen because they are the most widely used and the most important formulations in solid formulations. In order to consider the factors such as the large production cost and the advantage of tablets, the imitation of tablets is chosen. Eszopiclone, a dextral monoisomer of zopiclone, is the third generation fast, short-acting sedative hypnotic drug, namely non-benzodiazepine sedative hypnotic drug, which is used to treat sleep disorder. Dextrorzopicron was studied by Sepracor Company in 1998 and went on sale in April 2005. Its parent drug Zopicron has been sold in more than 80 countries and regions in the world. It is one of the most commonly used drugs in clinical practice. At present, only Jiangsu Tianshili production listed, commodity name Wenfei. In the study of molding technology, the formulation of dextrozopicron tablets was designed and screened. The dosage of filler, disintegrating agent, lubricant and fluid-aid were screened by single factor investigation method, and the appearance and hardness of the tablet were also studied. The brittle degree and disintegration time limit of dissolution curve were taken as the index, and the coating process was selected as the evaluation index, and the suitable basic technological parameters were selected for the coating film with complete and uniform coating film and one-sided smooth coating film as the evaluation index. In the study of quality evaluation, the content, content uniformity, related substances, dissolution and optical purity of dextrozopicron tablets were determined by UVX GCX HPLC and the quality of dextrozopicron tablets was evaluated. The results showed that the copy of Dzopi Clone was in accordance with the standard of Chinese Pharmacopoeia (2010 Edition), the preparation process was reasonable, the method was feasible, the quality was stable and controllable, the product was suitable for large-scale production and the expected goal was achieved.
【学位授予单位】：黑龙江中医药大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R943

【参考文献】