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(xué)》2014年碩士論文

【摘要】：本文主要是對國內(nèi)上市的右佐匹克隆片進(jìn)行仿制,目的是為企業(yè)仿制出符合《中國藥典》(2010版)標(biāo)準(zhǔn)并能夠符合企業(yè)大規(guī)模生產(chǎn)要求的右佐匹克隆片,為企業(yè)創(chuàng)造經(jīng)濟(jì)價值。之所以選擇片劑是因?yàn)槠瑒┰谡麄�藥品劑型中是應(yīng)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(chǎn)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(gòu)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(nèi)只有江蘇天士力公司生產(chǎn)上市,商品名文飛。 在成型工藝研究中,對右旋佐匹克隆片進(jìn)行處方設(shè)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(biāo)；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(biāo),選擇合適的包衣基本工藝參數(shù)。 在質(zhì)量評價研究中,采用UV、GC、HPLC等技術(shù),對所制右旋佐匹克隆片進(jìn)行含量測定、含量均勻度檢查、有關(guān)物質(zhì)、溶出度、光學(xué)純度等項目檢查并對右旋佐匹克隆片的質(zhì)量進(jìn)行評價。 結(jié)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(biāo)準(zhǔn),制備工藝合理、方法可行,質(zhì)量穩(wěn)定、可控,適合企業(yè)大規(guī)模生產(chǎn)要求,達(dá)到預(yù)期目標(biāo)。
[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(xué)位授予單位】：黑龍江中醫(yī)藥大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R943

【參考文獻(xiàn)】

相關(guān)期刊論文 前8條

1 羅景慧,楊迎暴;催眠藥(Zaleplon)[J];國外醫(yī)藥(合成藥 生化藥 制劑分冊);2000年01期

2 胡發(fā)明,王鳴和;藥源性胸膜病變[J];國外醫(yī)藥(合成藥 生化藥 制劑分冊);2000年04期

3 李硯鋒,詹皓,唐桂香,韋四煌,辛益妹,李彤;短效催眠藥三唑侖、唑吡坦和佐匹克隆對人體認(rèn)知能力的影響[J];解放軍預(yù)防醫(yī)學(xué)雜志;2004年01期

4 李積東;新型鎮(zhèn)靜催眠藥[J];青海醫(yī)學(xué)院學(xué)報;2001年03期

5 李積東,韻海霞,車勝榮;鎮(zhèn)靜催眠藥研究新進(jìn)展[J];西北藥學(xué)雜志;2001年05期

6 蔡素華,翁輝廉;苯二氮類藥的臨床現(xiàn)狀[J];廣東藥學(xué);1999年03期

7 張開明,沈惟堂;巴比妥類藥在兒科的臨床應(yīng)用[J];中國實(shí)用兒科雜志;1998年03期

8 司天梅;李森強(qiáng);舒良;;艾司佐匹克隆的臨床研究進(jìn)展及應(yīng)用[J];中國新藥雜志;2006年02期

，

本文編號：2075383