The Study On Preparation And Quality Standard Of Grape Polyphenols Effervescent Granules

Objective:(1) Optimizing preparation technology of grape polyphenols effervescent granules.(2) The optimization of grape polyphenols effervescent granule molding process.(3)Establish a grape polyphenols effervescent granules effective composition content determination method and establish its quality control standard.(4) The preliminary research on the stability of grape polyphenols effervescent granules.Methods:(1) With the taste of grape polyphenols effervescent granules quality, effervescent time, particle size and the PH value of indicators, factors affecting the preparation of the preliminary experiments, and then carry out specific analysis on the factors by single factor experiment, find out the factors influencing the scope, determine the best type and composition of materials.(2)The star design- response surface method(X1), with the amount of PEG % % PVP K30- different concentrations of ethanol solution(X2)and the ratio of citric acid and sodium bicarbonate(X3) to examine factors, with the granularity of grape polyphenols effervescent granules(Y1), melting time(Y2) as examining index, using the response surface method(RSM) analysis of the influence of the independent variable on the dependent variable, the better conditions were determined and verified experiment.(3) According to "Chinese pharmacopoeia" 2010 version of the requirements of the granules, grape polyphenol effervescent granules for the particle size,moisture content, the load, melting, microbial limit examination, the quality of the grape seed polyphenols effervescent granules was established effective components of procyanidins UV determination method, and the precision, stability and repeatability was investigated.(4) The reference drug stability test guideline(2010) in the stability requirements of grape polyphenols effervescent granules factors affecting test,accelerated test and long-term test.Results:(1) The grape polyphenols effervescent granules material type and composition: diluent for lactose and dextrin(ratio of 1.5:1);Adhesive is 6% PVP ethanol solution, effervescent agent for citric acid and the closure of sodium bicarbonate(ratio of 1.0:1);For sweet taste masking agent dosage(0.5%).Grape polyphenols effervescent granule preparation: grape polyphenols raw material with thinner, taste masking agent mixed evenly divided into two halves, a join citric acid, another to join the sodium bicarbonate, with just the right amount of spray adhesive made from soft material, 20 mesh granulating, set within 60 ℃oven drying after 24 h, blending, whole grains, 5 g per bag.To quality judgment, the effervescent granules made by various quality indexes accord with regulation, quality is better.(2) The star design- response surface optimization method is adopted for grape polyphenols effervescent granule preparation technology optimization, grape polyphenol effervescent granules best preparation conditions for: the amount of PEG is4.6%, the concentration of PVP K30- ethanol solution was 7%, the ratio of citric acid and sodium bicarbonate of 1.1:1.(3) The grapes effervescent granules quality inspection of the indicators are in line with the "Chinese pharmacopoeia" 2010 version of the particles under request.By UV method to establish the quality standard of this preparation.According to the results of several sample, made the product of procyanidins content, tentative each bag contain procyanidins shall not be less than 30.4 mg.(4) Grape polyphenols effervescent granules through influencing factors test, accelerated test and long-term test, the results of all the indexes meet quality standards.Conclusion:This research adopts the star design-response surface method optimization grape polyphenols effervescent granule preparation technology, the method is scientific, simple, the finished product quality is controllable, the stability is good,and product is suitable for industrial production.