【作者】 李振宇；

【导师】 匡海学；

【作者基本信息】 黑龙江中医药大学 ， 中药学， 2005， 硕士

【摘要】 瑶宝克癌颗粒剂是由山豆根、金荞麦、功劳木、延胡索、川贝母等17味中药组成的中药复方制剂,主要用于咽喉癌,肺癌,胃癌,肝癌等恶性肿瘤的治疗。瑶宝克癌颗粒剂是以传统中医药理论为指导原则,运用现代制药技术,将传统的汤剂根据方中各味中药有效成分、有效部位理化性质不同,采用不同提取方法,精制而成的颗粒剂。 本课题主要进行了瑶宝克癌颗粒剂制备工艺的研究,实验中运用正交试验法,以多指标综合评价筛选最佳提取工艺、醇沉工艺及制剂成型工艺,提取工艺研究包括水提取工艺技术条件筛选,醇提取工艺技术条件筛选,动物性中药提取工艺技术条件筛选;同时进行了中试放大试验及质量标准的研究,建立了以HPLC法测定该方中君药山豆根中所含抗癌活性成分苦参碱的含量测定方法,建立了相应的含量限度;并对方中山豆根、金荞麦、功劳木、延胡索、川贝母进行了薄层色谱鉴别;在质量标准可控的基础上对该制剂进行了初步稳定性研究。 该研究结果表明制备工艺合理可行,质量标准可控,成品质量稳定。本文研究结果可为研制新的抗癌中药新药奠定坚实基础,其产品具有广阔的应用前景。更多还原

【Abstract】 Compound Yaobao Anti-cancer granule is a new prescription of Traditional Chinese Medicine, which consists of 17 herbs such as herba Radix Sophorae Tokinensis, herba Rhizoma Fagopyri Dibotryis, herba Caulis Mahoniae, herba Rhizoma Curydalis, herba Bulbus Firtillariae Cirrhosae, ect. Therefore it can be chiefly used to treat malignant tumors. With the guidance of the theories of Traditional Chinese Medicine Yaobao Anti-cancer granule was studied with modern pharmaceutical technology. On the basis of effective components and parts as well as the characters of components of the herbs, traditional decoction was transformed into granules by different extractions.This research mainly studied on the preparing technique of Yaobao Anti-cancer granules. The technology of optimum extraction, alcohol-precipitate and preparation moulding were selected by using orthogonal design which used quite a few assessing norms to evaluate them comprehensively. The research of extraction was to select conditioned parameter of water-extract technique, conditioned parameter of alcohol-extract technique and conditioned parameter of animal pharmaceutical-extract technique. Meanwhile middle test enlargement and quality standard were finished. The content of matrine in herba Radix Sophorae Tokinensis was determined by HPLC. Moreover the research used TLC to identify herba Radix Sophorae Tokinensis, herba Rhizoma Fagopyri Dibotryis, herba Caulis Mahoniae, herba Rhizoma Curydalis and herba Bulbus Firtillariae Cirrhosae. Then the preliminary stability was fulfilled on the basis of controllable quality standard.The results indicated that the technique of preparation was reasonable and practical, the standard of quality was controllable and the quality of the sample was steady as well. The results of this study can establish stable foundation for developing new更多还原