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葶苈子综合质量评价体系的构建(下)

Construction of Comprehensive Quality Evaluation System of Tinglizi

【作者】 马梅芳

【导师】 石俊英;

【作者基本信息】 山东中医药大学 , 中药学, 2009, 博士

【摘要】 课题在中医药学的整体理念和思维体系的指导下,充分依托先进的现代科学技术与分析实验手段,在对葶苈子本草考证、现代文献整理和实地调研的基础上,从生药学研究、薄层色谱鉴别、检查项目测定、浸出物测定、有效部位含量测定、有效成分含量测定、指纹图谱研究、主要药效学研究几个方面对不同品种、不同产地、不同生长环境的多个葶苈子样品进行多指标、多组分、多角度、多层次的质量控制系统研究。从外部形状、大小、色泽、表面特征、质地、气味几个方面进行性状分析;从黏液层、横切面及粉末特征几个方面进行显微鉴定;通过实验建立以芥子碱硫氰酸盐为对照品的薄层色谱鉴别方法;在膨胀度检查的基础上,增加水分和灰分检查;分别采用冷浸法、热浸法测定水溶性和醇溶性浸出物的含量,并对样品是否需要粉碎进行比较研究;采用重量法测定脂肪油的含量,并通过皂化值、碘值、酸值和过氧化值的测定,对葶苈子脂肪油的性质进行综合分析与评价;采用酸性染料分光光度法,建立葶苈子中总生物碱的含量测定方法;采用三氯化铝显色分光光度法,建立葶苈子中的总黄酮的含量测定方法;采用水提醇沉法提取葶苈子多糖,并用硫酸蒽酮法测定多糖的含量;采用高效液相色谱法建立葶苈子中芥子碱硫氰酸盐、槲皮素、山奈素、异鼠李素的含量测定方法;采用聚丙烯酰胺凝胶电泳法,建立葶苈子的蛋白质、同工酶电泳指纹图谱;采用不同极性的多溶剂系统(包括石油醚、氯仿、无水乙醇、水)的提取液,建立葶苈子的紫外谱线指纹图谱;从镇咳、祛痰、利尿、抗炎、免疫、抗肿瘤、急性毒性实验几个方面对葶苈子的主要药效学进行研究。课题采用化学成分指标与药理活性指标相结合的研究思路与方法,定性分析与定量测定相结合,单一成分定量分析与有效部位总量控制相结合,生物技术、色谱技术与光谱技术相结合,药理有效性指标与毒理安全性指标相结合的质量评价模式,强调葶苈子的整体性、综合性特征,体现了传统中医药理论与现代科学技术的紧密结合。探索建立了符合中药特点的、质一效相关性强的、科学规范的葶苈子的综合质量评价体系。

【Abstract】 Under the guidance wholism conception of traditional Chinese medicine, and fully relying on the advanced modern science and technology and analysis of experimental means, this article giving a systematic study on Tinglizi from different varieties, different regions and different growth environment on the basis of herbal textual research, literature collection and practical survey. The study including pharmacognosy, TLC, examination items determination, extract determination, effective ingredients determination, effective components determination, fingerprint study and main pharmacodynamic study. It is a multi-index, multi-component, multi-angle and multi-level quality control system.Carry on the analysis to character analysis in many respects, such as the external shape, size, color, texture, smell and surface characteristics. Taking microscopical identification from mucus layer, transverse section and powder characteristics. Establishing the TLC method with Sinapine Thiocyanate as reference substance. Adding the moisture and ash content check based on expansion degree examination. Determing water-soluble extracts and ethanol-soluble extracts of hot and cold dip and taking comparative analysis on whether there is a need to crush the samples. Using gravimetric method for determination of fatty oil content and making a comprehensive analysis and evaluation on the nature of fatty oil through saponification value, iodine value, acid value and peroxide value. Establishing the method for determination of total alkaloids and total flavonoids by using acid dye spectrophotometry methods and pectrophotometry colorated with aluminum chloride. Extracting polysaccharide by water and ethanol precipitation method, anthrone-sulfuric acid chromatometry was used to determine the polysaccharide content. Establishing the method for determination of Sinapine Thiocyanate, Quercetin, Kaempferol and Isorhamnetin by HPLC. Establishing the protein and isozyme fingerprint of Tinglizi by using polyacrylamide gel electrophoresis. Establishing the ultraviolet fingerprint spectrums group draft of Tinglizi with the different multi-polar solvent system (including petroleum ether, chloroform, anhydrous alcohol and water) extract. The main pharmacodynamics of Tinglizi were studied on several aspects including cough restrain, phlegm eliminate, diuresis, anti-inflammatory, immunity, antitumor and acute-toxicity.Using the research method of combing chemical index with pharmacodynamic index, by means of evaluation model of combing qualitative analyses with quantitative determination, single-component with total effective ingredients, biological technology, chromatographic technology with spectrum technology, effectiveness of pharmacological index with toxicological safety index. The quality evaluation model emphasizes the integrity and synthetical characteristics of Tinglizi, to combine organically the traditional Chinese medicine theory and modern science and technology. Establishing the comprehensive quality evaluation system of Tinglizi, which not only according with characteristics of traditional Chinese medicine, but also strongly correlating of quality and effect and conforming to the norms of science.

  • 【分类号】R284.1
  • 【下载频次】432
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