【作者】 叶颖雅；

【导师】 瞿海斌；

【作者基本信息】 浙江大学 ， 药物分析学， 2006， 硕士

【摘要】 混合均一化方法是一种中药生产过程质量控制方法。它将中药生产过程中不同批次的中药产品按照一定比例混合,使得到的混合物质量指标与质控要求的指标尽可能地一致,从而保证批次间产品质量的稳定均一。本论文在系统研究混合均一化方法基础上,将其与多元指纹图谱和近红外光谱分析技术相结合,研究提出基于这两种分析技术的混合均一化方法。主要研究工作如下: 1.系统研究混合均一化方法,考察指纹图谱相似度算法和优化算法对混合均一化结果的影响。另外,根据多元指纹图谱原理,提出基于多元指纹图谱的混合均一化方法。 2.以丹参提取物和复方丹参提取物为实例,考察混合均一化方法在中药提取物质量控制中的应用效果,研究结果表明,混合均一化方法能提高中药提取物质量稳定均一性。 3.利用小波变换提取中药近红外光谱分析数据中的特征信息,建立基于该特征信息的混合均一化方法。将此方法用于仿真数据,研究结果表明此方法有效。 4.以丹参药材为实例,验证基于近红外光谱分析技术的混合均一化方法的有效性。与基于色谱指纹图谱的混合均一化方法相比,此方法快速、无损,更适于中药生产过程质量控制。 上述研究工作表明,混合均一化方法是一种适用于中药生产过程的质量控制技术,可保证中药产品质量的稳定均一,具有较好的推广应用前景。更多还原

【Abstract】 The blending homogenization is a quality control method for Traditional Chinese Medicine (TCM) manufacture process. It blends various batches of TCM products together by certain ratios to ensure the mixture as consistent to the quality control index as possible. Based on systematic studies on the blending homogenization method, two new methods which combined with multiple chromatograph fingerprinting and Near Infrared Spectrum(NIR) are proposed in this dissertation. The main researches are as follows:1. Systematic studies on the blending homogenization method. Study on the influence of the similarity arithmetic of fingerprint and the optimized arithmetic to the result of the blending homogenization. In addition, according to the theory of the multiple chromatographic fingerprinting, a new blending homogenization method is discussed.2. The blending homogenization method was applied in Danshen extracts and Compound Danshen extracts respectively. The results show that the method can improve the batch-to-batch replicability of the TCM extracts.3. Using Wavelet Transform (WT) technique to extract the useful information of the TCM and based on the wavelet coefficient, we propose a new blending homogenization method. The result of the simulated data shows that the method is reasonable.4. Take Danshen as an example, to examine the efficiency of the blending homogenization method which based on the NIR spectrum. Compared to the method based on the fingerprint, this new method is speediness and lossless, and more suitable in the quality control of TCM manufacture process.The above researches show that the blending homogenization method is applicable to the quality control of TCM manufacture process, and it can also improve the replicability of TCM. The method has a very bright future in theindustrial application.更多还原