本文選題：右佐匹克隆 + 右旋佐匹克隆片��； 參考：《黑龍江中醫(yī)藥大學》2014年碩士論文

【摘要】：本文主要是對國內上市的右佐匹克隆片進行仿制,目的是為企業(yè)仿制出符合《中國藥典》(2010版)標準并能夠符合企業(yè)大規(guī)模生產要求的右佐匹克隆片,為企業(yè)創(chuàng)造經濟價值。之所以選擇片劑是因為片劑在整個藥品劑型中是應用最廣的,也是在固體制劑劑型中所占比重最大的劑型。出于對企業(yè)大規(guī)模生產成本以及片劑的優(yōu)勢所帶來的廣闊市場等因素的考慮而選擇片劑的仿制。 右旋佐匹克隆(Eszopiclone)為佐匹克隆的右旋單一異構體,是第三代快速短效鎮(zhèn)靜催眠藥物,即非苯二氮卓類鎮(zhèn)靜催眠藥,用于治療睡眠紊亂。右旋佐匹克隆是由美國Sepracor公司1998年開始研究,并于2005年4月上市,其母體藥物佐匹克隆,目前已在世界80多個國家及地區(qū)上市銷售,屬于臨床上用于失眠癥最多的藥物之一。目前國內只有江蘇天士力公司生產上市,商品名文飛。 在成型工藝研究中,對右旋佐匹克隆片進行處方設計與篩選,通過單因素考察法篩選填充劑的用量、崩解劑的用量、潤滑劑的用量和助流劑的用量,以片劑的外觀、硬度、脆碎度、崩解時限溶出曲線為指標；包衣工藝,以制得衣膜完整均勻、片面光滑的包衣片為評價指標,選擇合適的包衣基本工藝參數。 在質量評價研究中,采用UV、GC、HPLC等技術,對所制右旋佐匹克隆片進行含量測定、含量均勻度檢查、有關物質、溶出度、光學純度等項目檢查并對右旋佐匹克隆片的質量進行評價。 結果表明,所仿制得的右旋佐匹克隆片符合《中國藥典》(2010版)中國藥典標準,制備工藝合理、方法可行,質量穩(wěn)定、可控,適合企業(yè)大規(guī)模生產要求,達到預期目標。
[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.
【學位授予單位】：黑龍江中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2014
【分類號】：R943

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