Studies On The Blending Homogenization Method And Its Application In TCM Quality Control

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.