The Preparation Process Of The Mold Tea Sustained Release Tablets And Quality Standards Of Research

Meicha is made by the tender stems and leaves of A.megalophylla Diels et.Gilg. It is used to treat hypertension in clinic and has a remarkable efficacy. The main effective chemical constituents are flavones, which are proved by pharmacology experiments that can reduce high blood pressure, high blood lipid, glycemia and can protect liver, improve immunity. Furthermore, its adverse effect is low. So it can be produced as a new effective drug of treating cardiovascular diseases.On the chemical constitution study of Meicha, we use some new extraction and refination technologies of modern traditional Chinese medicine, get the effective flavones part from Meicha, and make it into sustained-release tablet, which establish certain experiment base for the new drug study of Meicha sustained-release tablet.First, we collect some correlative data and literature of Meicha to determine Meicha's effective chemical ingredients, pharmacology effect and chemical quality, which point the way of how to design the technology. By orthogonal test and single factor compared, practicable extraction technology, defecation technology and purification technology are selected. The contents of the Total Flavones, Ampelopsi and Myricetin in the rude medicinal materials and Meicha Extraction are measured. By detecting the sustained-release tablet's dissolvability, the tablet's molding technology is selected. For controlling the quality, the tablet is identified by TLC, and the contents of Ampelopsin and Total Flavones are measured by HPLC and UV. By quantitative analysis of the Total Flavones, the tablet's release degree in vitro is tested. The results of the experiments are as follow:The selection of the extraction technology: Compared extraction by water and ethanol, the flavones' transfer rate of extraction by ethanol is higher. Using the orthogonal design, the alcohol degree, alcohol quantity, extraction time and extraction times are considered. The optimization of the extraction technology is: 70% ethanol 9 times capacity of Meicha, extracted 3 times, 60min per time.The selection of the defecation technology: By comparison of the Total Flavones transfer rate and remove impurity rate of concentration deposition and chitosan defecation, concentration deposition can't remove the impurity perfectly. By estimated of chitosan solution concentration, drug solution concentration rate, the added quantity, deposition time, chitosan defecation technology are determined as : concentration rate(l:6), added 0.25% chitosan acetate acid solution to 0.65%(g/100g) at 60 ℃, deposited 12h, filtrated.The selection of the purification technology: By comparison of the Total Flavones transfer rate, the static adsorption quantity, desorption rate and purity of 6 kinds of different macroporous adsorption resin and polyamide are considered. The resin SP850 is selected to purify the Total Flavones and its active adsorption is examined. As a result, 18 times of the Meicha solution(5.0mg/ml) can adsorbed by resin SP850. The purity of the Total Flavones purified by the resin SP850 is 79%. The purification technology are: The resin SP850, 18BV the Meicha solution (5.0mg/ml), flushing with 2BV water, followed by 5BV 70% ethanol, then the flushed solution is treated by decompressed -concentration, desiccated, shattered.The primary study of the Meicha total flavones extraction: The quality of Meicha...