异硫蓝的制备及其质量标准的研究

发布时间：2018-03-15 09:17

本文选题：异硫蓝　切入点：淋巴示踪剂　出处：《沈阳化工大学》2017年硕士论文　论文类型：学位论文

【摘要】：异硫蓝作为一种新型的淋巴示踪剂,对淋巴定位有很好的效果,染色快且作用持久,可明显提高单独采用染料型乳腺癌前哨淋巴结活性检查(SLNB)的准确率和灵敏度,在癌症的治疗当中有广泛的应用。异硫蓝目前在我国并未上市,原研厂家是美国的COVIDINE公司,异硫蓝是美国FDA批准的第一个也是唯一一个用于淋巴示踪术的染料,在临床已经使用多年,许多研究表明异硫蓝在临床上具有很大的价值。在持续的淋巴癌治疗术中,异硫蓝可以用来识别并帮助结扎淋巴管。本文参考大量文献,设计异硫蓝的合成路线是以2-氯苯甲醛为起始原料,经磺化、缩合、盐化及还原反应制备了异硫蓝,高效液相检测纯度大于99.3%,总收率40.76%。该合成路线路线较短、工艺简单、便于操作。我们用自制的异硫蓝建立其原料药的质量标准并对该标准进行了方法学验证,采用高效液相色谱法,验证内容包括准确度、线性、精密度、检测限、定量限、耐用性、系统适用性。结果显示均满足各方法验证下的标准要求。采用高效液相色谱法灵敏度高、专属性强,得到的结果准确,适用于异硫蓝原料药的含量测定。
[Abstract]:As a new type of lymphatic tracer, isothiocyanate has a good effect on lymphatic localization. It can improve the accuracy and sensitivity of sentinel lymph node activity examination of dyestuff breast cancer alone. It is widely used in the treatment of cancer. Isosulfide blue is not listed in China at present. The original manufacturer is COVIDINE Company of the United States. Isothiocyanin is the first and only dye approved by FDA for lymphatic tracer. In clinical use for many years, many studies have shown that isothiocyanin has great clinical value. Isothiocyanin can be used to identify and help ligate lymphatic vessels during continuous lymphatic cancer treatment. The synthetic route of isothionyl blue was designed as the starting material of 2-chlorobenzaldehyde, which was prepared by sulfonation, condensation, salinization and reduction reaction. The purity of high performance liquid phase detection was greater than 99.3 and the total yield was 40.76.The synthetic route was short and the process was simple. The quality standard of its raw material was established and the method was validated by HPLC. The content of verification included accuracy, linearity, precision, detection limit and quantitative limit. The results show that the method has high sensitivity and specificity, and the results are accurate and suitable for the determination of isosulfide raw materials.
【学位授予单位】：沈阳化工大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R943

【参考文献】