Study On The Preparation Technology And Quality Control Of Hawthorn Fruit And Leaf Compound Granules

Hyperlipidemia is an important risk factor for cardiovascular and cerebrovascular diseases,such as atherosclerosis and stroke.Chemical drugs with single target design have long cycle and many adverse reactions in treating chronic diseases such as diabetes.It is of long-term significance to improve the quality of life of residents and reduce the medical burden by using traditional Chinese medicine with small side effects.Hawthorn fruit and leaf have the functions of regulating the disorder of glucose and lipid metabolism,resisting atherosclerosis,etc.Hawthorn fruit is a kind of traditional Chinese medicine with homology of medicine and food,and it is also a traditional health food.The previous research of our research group showed that the regulating effect of hawthorn fruit and leaf on glucose and lipid metabolism disorder was obviously better than that of single use,and it could be synergistic.Based on the research results of pharmacodynamics and pharmacology,the effective parts of hawthorn fruit and leaf were combined to study its preparation technology and quality control method,and developed it into a functional products with the functions of lowering blood sugar and blood lipid and reducing weight.The research contents are as follows:1.Study on Extraction and purification technology of hawthorn fruit and leaf Based on the quality study of different varieties of hawthorn fruit and leaf,the contents of total flavonoids,organic acids,total polysaccharides and five kinds of flavone monomers(vitexin-4’’-O-glucoside,vitex-2-O-rhamnoside,vitexin,hyperin and rutin)were used as evaluation indexes,the organic acids of hawthorn fruit were measured separately,the extraction solvent and extraction method were investigated respectively,and the purification effects of ethanol sedimentation and chitosan flocculation sedimentation were compared.The extraction process of hawthorn fruit was determined as follows: taking hawthorn fruit,using 50 % ethanol as the extraction solvent,adding 8 times of solvent,soaking at room temperature for 2 hours,extracting under reflux for 3 times,each time for1 hour,concentrating the extractive solution under reduced pressure to 0.6 g(crude drug)/m L,ethanol sedimentation,standing for 4 hours,filtering,concentrating filtrate under reduced pressure at 60 ℃,and dried to obtain the hawthorn fruit extract.The extraction process of hawthorn leaf was as follows: Hawthorn leaf crushed through 60 mesh sieve,soaked overnight at room temperature with water as extraction solvent,adding10 times of solvent,ultrasonic extraction is performed once,the extraction time is 2 h,filtering,2 % of chitosan solution is added to remove impurities,standing for 4 h,filtering,the filtrate is concentrated under reduced pressure at 60 ℃ and dried to obtain hawthorn leaf extract.2.Study on preparation technology and properties of hawthorn fruit and leaf compound granulesThe auxiliary materials used in spray drying of hawthorn concentrated solution were investigated,and it was determined that hawthorn concentrated solution was added with15 % resistant dextrin and then spray dried to obtain hawthorn fruit extract.Study the composition of the prescription,taking the difficulty of granulation,molding rate,angle of repose,etc.as evaluation indexes,the ratio of mannitol was investigated,the ratio of stevioside and lemon essence was selected to improve the taste,and the effects of different concentrations of wetting agent and drying temperature on granulation were investigated.The final formula of hawthorn fruit and leaf compound granules was determined as follows:hawthorn fruit extract powder 35 %,hawthorn leaf extract powder 25.4 %,mannitol 36 %,stevioside 2.4 % and lemon essence 1.2 %.The wetting agent was 95 % ethanol,and the drying temperature was 40 ℃,the obtained particles had good fluidity and uniform color;through the investigation of critical relative humidity,the environmental humidity should be strictly controlled below 57 % during the preparation and packaging of granules.3.Study on quality control method of of hawthorn fruit and leaf compound granules The TLC identification method of granules was established.Total flavonoids,total polysaccharides,organic acids and four kinds of flavonoid monomer compounds(GLV,RHV,VIT,HP)were used as the quality control components of the granules,and the contents of total flavonoids and total polysaccharides were determined by sodium nitrite colorimetry and phenol sulfuric acid colorimetry respectively;the content of organic acid was determined by acid-base titration;an HPLC method for the determination of flavonoids was established,which met the requirements after the investigation of methodology.Through various content determinations,it is determined that the content limit of this product is that the content of organic acid shall not be lower than 19 mg/g,polysaccharides shall not be higher than 343 mg/g,flavonoids shall not be lower than 26mg/g,and the content of GLV,RHV,VIT and HP shall not be less than 1.74 mg/g and 0.18mg/g、2.42 mg/g、3.52 μg/g.4.Preliminary pharmacodynamic study on hawthorn fruit and leaf compound granules C57BL/6 mice were induced by 60 % high-sugar and high-fat feed combined with 2 %glucose water to establish obesity and glucose and lipid metabolism disorder model,at the same time,the mice were given different doses of hawthorn fruit and leaf compound granules.After 14 weeks of continuous administration,behavioral evaluation was made on mice in each group.Body fat rate,Lee’s index,blood sugar and blood lipid levels of mice were measured,and morphological changes of liver tissue were observed.The results showed that,compared with Mod group,hawthorn fruit and leaf compound granules could effectively control the weight gain of mice,significantly reduce the body fat rate and Lee’s index,reduce the fasting blood glucose,TC,TG and LDL-C levels of mice,and increase the HDL-C level,reduce liver index,protect liver morphology and structure,effectively prevent fatty degeneration of liver cells,enhance anti-fatigue ability of mice,and have good effects of reducing weight and regulating glucose and lipid metabolism disorder.