本文選題：卡巴他賽　切入點：卡巴他賽注射液　出處：《南京師范大學》2017年碩士論文

【摘要】：卡巴他賽是一種化學半合成紫杉烷類小分子化合物,屬于紫衫烷類抗腫瘤藥物,由法國賽諾菲-安萬特公司(Sanofi-aventis)研發(fā),用于前列腺癌的二線治療。卡巴他賽與潑尼松聯(lián)合使用,可治療既往用含多西他賽治療方案的激素難治性轉(zhuǎn)移性前列腺癌患者。具有巨大的市場潛力,可以很好地為患者服務。本研究按照2015年版中國藥典指導原則,利用了高效液相色譜法(HPLC)、X-射線粉末衍射法(PXRD)、差示掃描量熱法(DSC)等分析手段對卡巴他賽原料藥進行了定性鑒別和表征。參考歐洲藥典8.0中多西他賽質(zhì)量標準,對卡巴他賽原料藥進行質(zhì)量研究,考察了性狀、鑒別、無機檢查等項目,對有關(guān)物質(zhì)、含量測定方法進行了系統(tǒng)研究,建立了卡巴他賽有關(guān)物質(zhì)及含量測定的高效液相色譜,為注射用卡巴他賽質(zhì)量標準提供理論依據(jù)。以卡巴他賽的質(zhì)量研究的基礎,對注射用卡巴他賽同樣進行了質(zhì)量標準研究,通過對色譜條件的考察,確定注射用卡巴他賽有關(guān)物質(zhì)測定的高效液相色譜法,并且通過系統(tǒng)適用性試驗、專屬性試驗、溶液穩(wěn)定性等方法進行驗證,確保了該方法可行性和準確性,符合試驗的要求。對注射用卡巴他賽進行影響因素實驗,考察注射用卡巴他賽的性狀、有關(guān)物質(zhì)及主成分含量,確保注射用卡巴他賽質(zhì)量穩(wěn)定、有效、可控。本文為卡巴他賽的進一步研究提供了參考數(shù)據(jù)。
[Abstract]:Carbataxel is a chemically semisynthetic taxane small molecular compound developed by Sanofi-aventisof Sanofi-aventisof Sanofi-aventis, a chemosynthetic, semi-synthetic taxane antitumor drug developed by Sanofi-aventis, a French company, for the second line treatment of prostate cancer. Carbataxel is used in combination with prednisone. This study is based on the 2015 Chinese Pharmacopoeia guidelines, which can treat patients with steroid refractory metastatic prostate cancer with docetaxel regimen. High performance liquid chromatography (HPLC) and differential scanning calorimetry (DSCC) were used to identify and characterize carbataxel. The quality standard of docetaxel in the European Pharmacopoeia 8.0 was used to identify and characterize carbataxel by means of high performance liquid chromatography (HPLC) and differential scanning calorimetry (DSCS). In this paper, the quality of carbataxel raw material was studied, the properties, identification, inorganic examination and other items were investigated. The methods for the determination of related substances and contents were systematically studied, and the HPLC for the determination of the related substances and the content of carbataxel was established. To provide the theoretical basis for the quality standard of carbataxel for injection. Based on the study of the quality of carbataxel for injection, the quality standard of carbataxel for injection was also studied, and the chromatographic conditions were investigated. To determine the HPLC method for the determination of carbatin related substances for injection, and to verify the feasibility and accuracy of the method by systematic applicability test, specificity test, solution stability, etc. In order to ensure the stability and effectiveness of carbataxel for injection, the effect factors of carbataxel for injection were tested, and the characters, related substances and principal components of carbactasel for injection were investigated to ensure that the quality of carbataxel for injection was stable and effective. This paper provides reference data for further study of Kabatasai.
【學位授予單位】：南京師范大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R927.1

【參考文獻】

相關(guān)期刊論文 前10條

1 張濤;楊芳;;某院2013—2015年抗腫瘤藥物利用研究[J];中國藥物與臨床;2016年09期

2 陳萬青;鄭榮壽;張思維;曾紅梅;左婷婷;賈漫漫;夏昌發(fā);鄒小農(nóng);赫捷;;2012年中國惡性腫瘤發(fā)病和死亡分析[J];中國腫瘤;2016年01期

3 葉定偉;朱耀;;中國前列腺癌的流行病學概述和啟示[J];中華外科雜志;2015年04期

4 張夏蘭;韓峗;沈夕坤;;我院抗腫瘤藥物醫(yī)囑點評分析[J];臨床合理用藥雜志;2015年09期

5 田宇楠;祝慧鳳;萬東;;肝肺腫瘤臨床聯(lián)合用藥的研究進展[J];實用臨床醫(yī)藥雜志;2014年11期

6 陳東寧;祝宇;;去勢抵抗性前列腺癌治療進展[J];現(xiàn)代泌尿外科雜志;2014年05期

7 李東鋒;王鈺博;楊梅英;王建華;;我院2010-2012年抗腫瘤藥應用分析[J];中國藥房;2014年06期

8 周愛萍;房虹;李長嶺;孫燕;;去勢抗拒前列腺癌治療新藥卡巴他賽[J];中國新藥雜志;2013年19期

9 曹希亮;高江平;;晚期前列腺癌藥物治療研究進展[J];解放軍醫(yī)藥雜志;2013年02期

10 周鑫莉;;糖皮質(zhì)激素在腫瘤治療中的合理應用[J];上海醫(yī)藥;2011年12期

，

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