The Technology And Quality Research Of Gardenia Total Iridoid Glycoside Extract

The gardenia extraction was extracted from the dry powder extracts of traditional Chinese medicine Gardenia by modern technology,the total iridoid glycosides were the mainly effective substance. The extraction was the preparation study for the nasal administration used for the treatment of brain diseases, convalescence and sequelae of brain protection. In this thesis, modern technology was used for the study on the effective extraction refining,, quality standards and initial stability of the extraction from the nasal spray formulation of Gardenia, and the herbs, extracts and preparations of the spectrum of activity relationships were explored.In technology research, combined with the need for industrialized production, respectively, the effective parts of the extraction process and purification of macroporous resin purification were investigated. Throughout the study Gardenia total iridoid,glycoside content,geniposide content was used as the estimate index,adopt integrated score, weighting coefficients were the total glycosides 40%, Geniposide 40%, the extract rate 20%.Orthogonal test was used for comparing water extraction, alcohol extraction and percolation, determined by a single factor and macroporous resin and alcohol precipitation of refined and effective parts of the various parameters to determine the best conditions were:herbs 8 times the amount of water, extracted 3 times,0.5h/times, extract concentrated to 0.5g crude drug/ml, plus the amount of ethanol to more than 50% Alcohol, alcohol recovery and liquid concentrate to (1:1) to 2BV/h adsorption rate of the sample (2.5g crude drug/g resin) D101 macroporous resin column (diameter to height ratio of 1:3) to 2BV/h elution elution rate of water to colorless, then more than 50% concentration of ethanol to 2BV/h speed of elution, eluate collected 3BV, recycling ethanol, vacuum or spray drying to obtain dried extract paste. And conducted three validation batches amplification, the results showed that the technology was feasible.In terms of quality standard, using modern analytical methods,3 batches of extract shape, TLC, water, heavy metals arsenic salts, organic residues, microorganisms, content determination had been systematically studied, compared with the extract developed improve quality standards. Extract preparation in accordance with quality standards, on the semi-finished products were left at room temperature for 6 months accelerated testing of stability samples and study, indicators include character, identification, moisture, microorganisms, content determination, etc., the initial stability of three batches of samples showed that the extract was stable.For a single or a few indicators of the quality control of components, often not fully reflect the quality of traditional Chinese medicine.The preparation of this thesis in the index components based on the determination, the establishment of a fully reflect the fingerprints of the ingredients to better control and evaluation its quality. Activity relationship study using spectral methods, the gardenia of raw materials, extracts and preparations in the HPLC fingerprint of the change in composition is associated with the efficacy results, the use of the method of mathematical statistics fingerprinting and pharmacodynamic study of gardenia spectrum of sub-nasal spray of a preliminary exploration activity relationship study.