| The plant extracts, as raw materials for pharmaceutical and healthy food, have been widely used in China. But the compositions of the plants extracts are very complex, and the origin, growth environment, harvest, processing, and other sectors will change the chemical compositions of the bioactive components and pesticide residues, heavy metal pollution,etc. All of these will affect the safety, effectiveness, stability and controllability of the terminal products. With the rapid development of science and technology, modern high-tech method has been gradually applied in the quality control and identification research of plant extracts, which promotes the healthy development of related industries to a safe, effective states.In this work, the tea extracts (including the terminal products of xinnaojian Capsule and xinnaojian Tablets) and maka extracts have been used as examples for the introduction of the application of modern chromatography technology in the quality control of the index components. It aims to ensure the security and stability of the plant extracts quality and provides the research mentality and the technical support for the solid and sustainable development of related plant extracts industries. In addition, the thermodynamic properties of epigallocatechin gallate (EGCG) in quasi-life body fluid, which is an important bioactive component and widely exists in a variety of plant extracts, are also discussed in this paper. It is mainly for a better understanding of the intermolecular interaction, and providing new ideas and theoretical basis for the development of more effective drugs and drug carriers.The main contents are as follows:The first chapter was the introduction part. It was mainly about the research and the domestic and foreign development of plant extract industry, focusing on analyzing and discussing the relevant quality control of Chinese plant extracts, which were famous for botanical extracts. The quality control and supervision of plant extracts should be strengthened and the establishment of standards such as Pharmacopoeia Standard was very essential. Besides, it also introduced the modern technology, especially the development and application of modern chromatographic technology in the quality evaluation of plant extracts. The three key technologies including QAMS (Quantitative analysis of multi-components by single marker) technology, Feature/ Fingerprint technology and Control technology were mainly discussed in the application of plants extracts. At last, the main research significance and research contents were stated.The second to fourth chapters were based on the existing quality standard, which mainly introduced the improvement of quality standard of the tea extract as well as its terminal products of xinnaojian Capsule and xinnaojian Tablets. In view of the limitations and shortcomings in application and other aspects, the current relevant quality standard was improved and enhanced by modern chromatographic techniques and it promoted the healthy development of other related industries. Combined with the technology research on several major domestic manufacturers with this experiment research, a standard of tea extract as well as its terminal products of xinnaojian Capsule and xinnaojian Tablets was established and enhanced on preparation process, TLC identification, Character/Fingerprint identification, multiple index content determination, pesticide residue, solvent residue and so on. In addition, the durability, applicability and feasibility of identification methods were analyzed and proposed. A total of 26 batches tea extracts from some major domestic manufacturers were obtained, and 8 kinds of characteristics components and 14 kinds of organic-chlorine pesticide residues were mainly researched, Besides, the acidity, moisture, residue on ignition, heavy metals, arsenic salt, ethyl acetate solvent residues, caffeine and gallic acid and other indicators were examined. The stability of the catechins in the column was first explored. The research provided a technical support for the wide application of tea extracts as well as one way of research of the quality control and healthy development for plant extracts industry related.Because of the diversity and complexity of chemical compositions in plant extracts, it's difficult to separate and prepare bioactive ingredients standards, and the cost of preparation and detection was high when establishing quality standard on some plant extracts. The fifth chapter established a new strategy of QAMS technology on quality control of the tea extracts by using the relative corrected factors of tea extracts. It allowed simultaneous determination of multiple components by only one reference marker more comprehensively, accurately, simply and rapidly. It was mainly about the establishment of QAMS method in durability, applicability, feasibility, peak accurate positioning and other aspects of the exploration. Central composite design and response surface design were used to decide whether EGCG can accurately locate the other nine bioactive ingredients of tea extracts or not. Taguchi-static design, intuitive analysis, analysis of variance, the correlation analysis of the QAMS method were also introduced for the stability research when used in different laboratories. The main influencing factors were about the different analysts, HPLC instruments and columns. The linear regression model (Sig.) was built to compare the contents results of QAMS method and traditional external standard method (ESM). Finally, the cluster analysis and discriminant analysis were applied for the quality control of tea extracts from different manufacturers. The results showed that the method was reliable and practical, and can be used for the quality standard of tea and other plant extracts.In the sixth chapter, it was mainly about the maca, which was called "Peruvian ginseng". Although it has been widely used all over the world, the main problems about the separation and preparation resulted in the status of the lack of relevant quality standards. This research was about the establishment of the quality standard of maca being as medicinal and edible plant. The process of extraction and separation purification conditions were optimized, the maximum extraction rate was about 5% based on the raw materials. The isocratic and gradient elution HPLC analysis models were established. Combined with the Control extract technology, using three-step chromatographic preparation separation, the eight bioactive components were separated and prepared from the maca extracts. The total content of eight bioactive components accounted about 0.075% based on the raw materials (Dry weight basis, DWB).The research effectively solved many problems about separation and purification. In addition, seven water-soluble active ingredients and eight fat-soluble active ingredients were also charactered and identified. Based on of these, the quality standards of maca were initially established, expecting maca application market to be better regulated and providing a theoretical basis and reference for the related industry.The seventh chapter was mainly about the thermodynamic properties of EGCG, which widely existed in a variety of plant extracts as important bioactive components. EGCG and other drug molecules played a drug effect in the body fluid. In this work, the experimental densities and viscosities were reported for three ternary mixtures (EGCG+LiCl/NaCl/KCl+H2O) at internal temperatures T=(288.15,293.15,298.15, 303.15,308.15) K at atmospheric pressure. From these experimental data, the apparent molar volumes (V?0), limiting partial molar volumes (V?0), experimental slope (Sv), the solvation number (B/V?0), the free energies of activation for solvent ??10? and for solute ??20#, Helper's constant ((?)2V?0/(?)T2)p, the apparent molar isobaric expansions (E?0), and transfer partial molar volumes (?trsV?0) of EGCG from water to LiCl/NaCl/KCl aqueous solutions have been obtained from the experiment. Viscosity B-coefficients of the Jones-Dole equation have been calculated. The free energy of activation per mole of solvent ??10? and the free energy of activation per mole of solute ??20? were obtained and discussed based on transition state theory. These properties could provide valuable information about molecular interactions as well as necessary data for biochemistry and molecular biology applications. These significant parameters could provide necessary data about molecular interactions occurring in simulated body fluids.In the eighth chapter, all the work was summarized, and the future research about the quality evaluation of plant extracts was proposed. |
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