卡巴他赛原料及其注射液的质量评价及方法研究

发布时间：2018-03-28 06:06

本文选题：卡巴他赛　切入点：卡巴他赛注射液　出处：《南京师范大学》2017年硕士论文

【摘要】：卡巴他赛是一种化学半合成紫杉烷类小分子化合物,属于紫衫烷类抗肿瘤药物,由法国赛诺菲-安万特公司(Sanofi-aventis)研发,用于前列腺癌的二线治疗。卡巴他赛与泼尼松联合使用,可治疗既往用含多西他赛治疗方案的激素难治性转移性前列腺癌患者。具有巨大的市场潜力,可以很好地为患者服务。本研究按照2015年版中国药典指导原则,利用了高效液相色谱法(HPLC)、X-射线粉末衍射法(PXRD)、差示扫描量热法(DSC)等分析手段对卡巴他赛原料药进行了定性鉴别和表征。参考欧洲药典8.0中多西他赛质量标准,对卡巴他赛原料药进行质量研究,考察了性状、鉴别、无机检查等项目,对有关物质、含量测定方法进行了系统研究,建立了卡巴他赛有关物质及含量测定的高效液相色谱,为注射用卡巴他赛质量标准提供理论依据。以卡巴他赛的质量研究的基础,对注射用卡巴他赛同样进行了质量标准研究,通过对色谱条件的考察,确定注射用卡巴他赛有关物质测定的高效液相色谱法,并且通过系统适用性试验、专属性试验、溶液稳定性等方法进行验证,确保了该方法可行性和准确性,符合试验的要求。对注射用卡巴他赛进行影响因素实验,考察注射用卡巴他赛的性状、有关物质及主成分含量,确保注射用卡巴他赛质量稳定、有效、可控。本文为卡巴他赛的进一步研究提供了参考数据。
[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.
【学位授予单位】：南京师范大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R927.1

【参考文献】