| This thesis takes the folk prescription composed of Rhodiola crenulate radix et rhizome,Astragali radix,Polygonate rhizome and Lycii fructus as the research object,and the Compound Honghuang buccal tablets is made after the study of extraction technology and preparation technology,and then research on its quality standards and preliminary stability was carried out in order to develop an anti-stress,anti-fatigue,and immunity-enhanced health food with improved hypoxia tolerance.The main contents are as follows:1.Study on extraction technology of Compound Honghuang buccal tablets:considering that Rhodiola crenulate raix et rhizome and Astragali radix in the prescription contain both alcohol-soluble and water-soluble components,alcohol extraction was designed first,and the drug residue after alcohol extraction was combined with Polygonate rhizome and Lycii fructus extracted by water then.Taking the contents of salidroside and p-tyrosol in Rhodiola crenulate raix et rhizome,the content of calycosin and formononetin in Astragali radix and the extract yields as the evaluation indicators,the ethanol concentration,the ratio of material to liquid,the extraction time and the number of extraction as the investigation factors,the main influencing factors of alcohol extraction process were analyzed by response surface analysis on the basis of the single factor experiment.The optimal alcohol extraction process optimized by comprehensive evaluation was: reflux extracting twice and138 min per time with ethanol concentration of 70% and material-liquid ratio of 1:14(g/m L).A verification test was conducted under this condition: the theoretical value is close to the predicted value,and the relative error is 0.90%.Then the orthogonal experiment was carried out with the multiple of water addition,extraction time and extraction times as the investigation factors,and the total polysaccharide content and extract yield as the investigation indicators.Establish a quadratic regression model of total polysaccharide and extract yield by Minitab 18.0 software,and further employ multi-objective genetic algorithm to optimize the orthogonal test results.The optimal water extraction process is to add 10 times the amount of water,cook 3 times,and2.94 h per time.A verification test was carried out under this condition.Its obtained process is stable and feasible,effective ingredient yield is high,and it can be used for the extraction of Compound Honghuang buccal tablets.2.Study on the preparation process of Compound Honghuang buccal tablets:taking the appearance,taste,hardness and disintegration time of buccal tablets as indexes,wet granulation and tabletting method has been adopted on the basis of single factor experiment.Optimized by the orthogonal experiment,the best prescription and the Compound Honghuang buccal tablets are 40% of extract powder,60% of lactose-microcrystalline cellulose(3:1),1.0% of aspartame.Its best preparation process is wetly granulating with 75% ethanol,drying,granulating,adding 0.5%magnesium stearate,and tabletting.The buccal tablets prepared under this process have complete and smooth appearance,uniform color,sweet taste,hardness between60-65 N,and its disintegration time limit meets the requirements of the Phaemacopoeia.3.Study on the quality standard of Compound Honghuang buccal tablets: in accordance with the relevant provisions under the 2015 edition of the Chinese Phaemacopoeia General Rules for Preparation of 0101 Tablets,three batches of Compound Honghuang buccal tablets were randomly selected for sensory evaluation of their traits,and the results of weight difference,friability and disintegration time were checked and determined;qualitative identification of Rhodiola crenulate raix et rhizome,Astragali radix,Polygonate rhizome and Lycii fructus and their ingredients in Compound Honghuang buccal tablets has been carried out by TLC;quantitative determination of salidroside,p-tyrosol,calycosins and formononetin in Compound Honghuang buccal tablets has been carried out by HPLC.The results shows that Compound Honghuang buccal tablets was round tablets,which is light brown in appearance,sweet in smell,slightly bitter and sweet fragrance of medicinal herbs in taste;The difference of tablet weight,fragility and disintegration time of three batches of buccal tablets all meet the requirements of Phaemacopoeia;TLC characteristics of Rhodiola crenulate raix et rhizome,Astragali radix,Polygonate rhizome and Lycii fructus have clear spots and strong specificity,and the negative control has no interference;the range of mass concentration of salidroside,p-tyrosol,calycosin,and formononetin are 0.06～0.6 mg/m L,0.015～0.15 mg/m L,1.3～13 μg/m L and 1.4～14μg/m L respectively,which has a good linear relationship with the the integral of the peak area(r>0.9992),and their average sample recovery rates are 101.46%,101.57%,98.53%,100.30%,RSD are 0.94%,1.29%,1.41%,2.07%(n=9);RSD of precision,stability,repeatability experiments are less than 3.0%,and it can be used for the quality control of Compound Honghuang buccal tablets.4.Preliminary stability study of Compound Honghuang buccal tablets: The accelerated test observation has been carried out by adopting aluminum-plastic packaging bags as simulated market packaging for 3 months.The result shows that the indexse of the Compound Honghuang buccal tablets have no significant changes in 3 months compared with 0 mouth,which suggests that the Compound Honghuang buccal tablets should be packaged with low moisture permeability and good sealing,and could be stored under suitable conditions. |
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