Research On The Medicinal Value And Utilization Of Tea Polyphenol

Tea is dry product of the tender leaf or the shoot of Camellia sinensis after the processing.Tea is one of the most popular drinks in the world. Researches prove that the tea can exhibit a series of pharmacology function, including anti-cancer, anti-senility, anti-radiation, anti-oxidized, eliminating free radical, anti-hyperglycemia and anti-hyperlipidemia and so on. Tea is one of the mainstays of civilization in many countries, particularly in Japan. Over 300 kinds of chemical composition, such as flavones, flavone's glycosides, polyphenol, minerals, amino acids and polysaccharide were discovered in the tea, but tea polyphenol (TP) is main ingredient.Coronary heart disease, angina pectoris, hyperlipidemia, and cerebral arteriosclerosis have been always main disease, and affected our health and life expectancy and quality seriously. To prevent and to therapy these diseases have been always one of the important aims for medical and health workers, and to research and develop this kind of drug becomes new research hot spots.According to the excellent function of tea polyphenol in medical and health, Xinnaojian granule was extracted and was composed on a basis of traditional Chinese medicines theory.The prescription originated from with standard number WS3-B-3151-98. The basic pharmaceutical research of the preparation technology and the quality standard of Xinnaojian granule have been carried out according to the eighth new Chinese drug development from < the Registration Provisions in China >.In this thesis, our research mainly included extraction & process optimization and quality standard of the tea polyphenol, processing technology of Xinnaojian granule, the quality standard of granule and stability in experimental processing.1. Study on the extraction of the tea polyphenol Extraction of the tea polyphenol is mainly following "the Xinnaojian tablets" in this research. After mixing green tea 1 and water 8～10, heated for 50 minutes and filtered(pH value: 9) regulated by saturated limewater. After filtrate cooling, stilled forl0 minutes, filtered, deposit dissolved in the diluted hydrochloric acid and the pH value to 4, filtered, extracting filtrates with the ethyl acetate, then impregnate was reclaimed under decompression and low-temperature drying. On this basis, the extraction technology was optimizedWe examined the degrees of extraction and the amount of solvent using the single factor experiment. Because there were not in the old standard, the best amount and the degrees of extraction were determined. Extraction was divided in two degrees using the same volume ethyl acetate after dissolving. Through tested and verified timely, obtained several batches tea polyphenol. Their identification and each examination were accord with the regulation (acidity, water, residue on ignition, heavy metal, arsenic salt and caffeine). So we deemed the content of tea polyphenol was stable. Extraction was reasonable, practicable.2. Study on the forming process of Chinese medicine granuleThis research initially was determined the forming process of Xinnaojian granule according to the original tablet. It was composed of tea polyphenol. Firstly, we inspected a serious of factors which affected the quality of Xinnaojian granule through the single factor experiment. The major effect factor was the proportion and the amount used of the powdered sugar and the dextrin, as well as auxiliary shape medicinal and tea polyphenol proportion. We added the Aspartame and Citrate in order to improve palatability, and determined the best amount. After the inspection, it was the most ideal that wetting agent was 70% ethyl alcohol. It had fine reproducibility. We determined to use aluminum foil compound bag packing through determination granule critical relative humidity.3. The quality standard of granule and stability in experimental processing.The quality standards, including coloration distinction method, were carded out by means of differential using iron trichloride (FeCl₃) and vanillin as standard. Results showed that all test results were accorded with the regulation of correlative criterion, negative non interference. Each inspection item (heavy metal, arsenic salt, preparation general rule inspection, water, dissolution, the gross deviation) conformed to the requirement. The content determination of TP was assayed by the UV. The standard was that: Colorimetric method. The testing solution was made according to method of the content determination item; the pure water was the blank comparison, and then was detected in 540nm wavelength. Results: This method had a good linear relationship in 20.48～81.92ug/ml. The average recovery rate was 99.96%, RSD=1.93%. Our studies indicated that these methods were simple, speedy, accurate, sensitive, reproducible and specific.We provided the scientific basis for the drugs production, the packing, storing, and the transportation and so on, and established the validity through stability inspection and the rule of quality changed of this medicine in temperature, humidity, packing and so on. Stability three batches samples were tested according to (Volâ…¡, 2005) appendicesâ…©â…¨C the "Guiding Principles of Drug Stability Experiments".Stability was inspected under each condition through accelerated and long-term test of Xinnaojian granule. Results showed that the high temperature and the glare were not obvious effect to Xinnaojian granule. But the humidity environment was on the contrary. So we determined to use aluminum foil compound bag packing. The accelerated test indicated that the granule character and the tea polyphenol content conformed to the stipulation under the temperature 40℃and the relative humidity 75%. The long-term test indicated that it was accord with the regulation, too, under the temperature 25℃and the relative humidity 60% after 6 months.