| BackgroundObesity has become an important factor threatening health.The Report on the Status of Nutrition and Chronic Diseases of the Chinese Population(2020)released data that the overweight and obesity of adult residents in China exceeds 50%,children and adolescents aged 6～17 years old are close to 20%,and children under 6 years old reach 10%,and the current situation of overweight and obesity of the population can be described by a faster rise in overweight and obesity,a higher level of prevalence,and the whole population is affected,while the complications caused by obesity Hypertension,dyslipidemia,diabetes,gout,etc.cause greater harm to the human body.There is a lack of effective evaluation methods for herbal health products.Chinese medicine compound health products refer to a class of products composed of Chinese medicine raw materials,including drugs,health food,functional products,etc.,which are suitable for subhealth without any harm.Since the declaration regulations of traditional Chinese medicine health food are clear and play the role of health care function mainly,therefore,this topic of traditional Chinese medicine compound health care products selects health food for demonstration research.China’s health food has been developed for more than 30 years,and the problems in the process of R&D and evaluation of herbal health food have been gradually exposed,which seriously restrict the development of the industry.In the current market of herbal health food,most of the product promotion and formula analysis of herbal health food lack specific TCM typology and evidence expression,and the effect of some products is only a simple superposition of raw material functions,which often leads to the use of the wrong population,the efficacy is not significant or even play the opposite role.At the same time,Chinese medicine compound health food products lack the support of Chinese medicine theory in terms of formulation theory,health care function claim,suitable scope of population,function and safety evaluation technology,consumption precautions,etc.,and the modern scientific connotation of products is not clear,product development and evaluation system is not standardized,etc.,which also cannot highlight the preventive health advantages of Chinese medicine health food products.This topic is problem-oriented to carry out research on the specific problems existing in the industry.According to the serious situation of high incidence and danger of obesity in China and the unique advantages of Chinese medicine in obesity diagnosis and typing,prevention and health care,we choose Chinese medicine compound health food with weight loss function as the carrier and carry out theoretical research and demonstration of Chinese medicine compound health food based on the theory of diagnosis and health care.The research and demonstration of research and development of herbal compound health food based on the theory of evidence-based health care.The corresponding types of symptoms of the target population are used to guide the design of Chinese health food products in the R&D stage,and the user conditions and product characteristics are combined to make Chinese health products work better,so as to achieve evidence-based health care and precise health care.Purpose(1)Demonstrate the research and development of a traditional Chinese medicine compound weight-loss health food with reasonable Chinese medicine formula,quality control system and standard,mature production technology,and good effectiveness and safety.(2)Provide a basis for establishing the evaluation method and evaluation system of Chinese medicine compound health food.Content(1)Formulation screening.According to the TCM classification of obese people,the most common clinical evidence of spleen deficiency and dampness obstruction was selected as the research evidence type,according to the corresponding principle of formula evidence,further combined with TCM clinical weight loss and spleen and dampness medicine experience and modern pharmacological research,to establish the formulation of Poria lotus leaf tablets,and to analyze and evaluate its effectiveness and rationality.(2)Process research.Research to determine the product dosage form specifications of Poria lotus leaf formula,the extraction process of Poria lotus leaf tablets,the key parameters of the preparation process to determine.(3)Quality control.The establishment of Poria lotus leaf tablets including lotus alkaloids,geranin,crude polysaccharides,total flavonoids and total anthraquinones,including the content determination method of the index components.(4)Weight loss function evaluation.To determine the weight loss function of Poria lotus leaf tablets by animal evaluation study.(5)Evaluation of the Chinese medicine efficacy of strengthening the spleen and promoting dampness.The 2012 version of the animal evaluation of the weight loss function of health food in the obese rat model for the evaluation of Chinese medicine evidence,to determine the effectiveness of Poria lotus leaf tablets to strengthen the spleen and dampness,to establish the basis for the weight loss function and the combination of the effectiveness of Chinese medicine to strengthen the spleen and dampness evaluation method.Methods(1)Analysis of common TCM symptoms of obesity and the corresponding TCM etiology and pathogenesis,through the determination of the research evidence type,according to the corresponding principles of formula and evidence,combined with clinical use and TCM theory,the formulation of Poria lotus leaf tablets,and the weight loss function of each drug in the formula,the clinical combination of literature analysis,to illustrate the effectiveness and rationality of Poria lotus leaf formula.(2)determine the product formulations,specifications and processes,through the selection of extraction solvent,the implementation of orthogonal tests,the extraction process parameters to determine the extraction rate and the amount of extracted index components as the index;through the excipient screening confirmation,granulation solvent type dosage selection,hardness,fragility,disintegration time frame as the index for the determination of the preparation process.(3)To establish a quality control method for Poria lotus leaf tablets,and to establish a method for the determination of the content of five index components through specificity,repeatability,stability and accuracy methodologies.(4)to 2012 version of the weight loss function as the experimental basis,body weight,weight gain,body fat(peri-epididymal fat,perirenal fat)content or fat/body ratio as the detection index,the Poria lotus leaf tablets weight loss function animal evaluation.(5)The animal models in the 2012 version of the weight loss function evaluation method were evaluated for TCM evidence and the efficacy of Poria lotus leaf tablets in strengthening the spleen and relieving dampness;the fat droplets inside and outside the liver cells were observed by oil red O staining of the liver tissues of rats in each group;the serum alanine transaminase(ALT)and winter aminase(AST)of rats were measured by IFCC rate method,and creatinine(CREA)was measured by immunoturbidimetric method.Serum gastrin(GAS),plasma gastrin(MTL)and gastric growth hormone(Ghrelin)were measured by enzyme-linked immunoassay,and the levels of cholecystokinin(CCK-8),amylase(AMY)and lipase(LPS)were used to compare the gastrointestinal function and pancreatic exocrine function of rats in each group.The levels of serum aldosterone(ALD)and plasma albumin(ALB)were measured by radioimmunoassay to evaluate the aqueous metabolism of rats in each group;the levels of total cholesterol(TC),triglyceride(TG),high-density lipoprotein(HDL-C)and low-density lipoprotein(LDL-C)were measured to observe the lipid metabolism of rats,and the gastrointestinal motility and aqueous metabolism were investigated.Finally,the levels of serum leptin(Lep),plasma neuropeptide Y(NPY),interleukin IL-6,interleukin IL-10 and tumor necrosis factor TNF-α were measured by enzyme-linked immunoassay in rats,and the mechanism of weight loss by Poria lotus leaf tablets was initially investigated.ConclusionThis research project concluded that the established weight loss as well as weight loss compound spleen deficiency and dampness obstruction TCM evidence model evaluation method is basically feasible,and the developed Poria lotus leaf tablets have reasonable formulation,feasible process and controllable quality,showing good weight loss function and TCM efficacy in strengthening the spleen and promoting dampness,specifically in the following aspects.(1)based on Chinese medicine theory and modern literature research,combined with clinical experience in the treatment of obesity,the composition of Poria lotus leaf formula,the formula for Poria,lotus leaf,hawthorn,kudzu,zedoary,cassia,Poria lotus leaf formula in line with the Chinese medicine on the treatment of spleen deficiency dampness evidence of the principle of strengthening the spleen and dampness,each drug in the formula in line with the health food raw material application requirements,through literature analysis,the combination of drugs in the formula has a weight loss function,and has the effect of strengthening the spleen and stomach,and(2)Poria lotus leaf tablets(2)Poria lotus leaf tablets in tablet form,determine the extraction of water as the extraction medium,soak 0.5 h,extraction twice,each time 1.5 h,respectively,12 times the amount of water and 10 times the amount of herbs extraction process;laboratory trial process to microcrystalline cellulose as the main filler,after wet granulation,to obtain the hardness,disintegration and fragility of Poria lotus leaf tablets;at the same time the quality control of key aspects of the index The content determination method of the key components of quality control was confirmed,and the quality control of Poria lotus leaf tablets was established to determine the content of lotus alkaloids,geranin,crude polysaccharides,total flavonoids and total anthraquinones,which laid the foundation for the later establishment of the overall quality standards.(3)Based on the 2012 version of the weight loss function evaluation method,the results of the weight loss function of Poria lotus leaf tablets were positive in animal experiments.Poria lotus leaf tablets can reduce the body weight of obese rats,control the weight gain,reduce the weight of peri-epidididymal fat and perirenal fat,and reduce the corresponding lipid/body ratio without affecting the food intake of the rats tested.(4)By exploring the modern evaluation indexes of TCM evidence of spleen deficiency and dampness obstruction,we evaluated the high-calorie model feed-induced obese rats in the 2012 version of the weight loss function evaluation method as well as the TCM efficacy of Poria lotus leaf tablets for strengthening the spleen and promoting dampness with weight loss function.The fat percentage of liver tissue in the model control rats was significantly higher than that in the blank control rats,and the levels of GAS,MTL and Ghrelin were significantly lower,while the levels of serum AMY and LPS were significantly higher,suggesting that the gastrointestinal function of the pancreatic exocrine function of the model control rats was impaired;the index of "dampness obstruction" was detected in the model control rats.The plasma ALB level of the control rats was significantly reduced and increased,while the inflammatory factors TNF-α and IL-6 were significantly increased and the anti-inflammatory factor IL-10 was significantly decreased,suggesting that the rats in the model control group showed "damp blockage".The above index changes suggest that the model of "spleen deficiency and dampness" in rats was successfully modeled.Meanwhile,Poria lotus leaf tablets can reduce the degree of liver steatosis in obese rats caused by high-calorie model feed,can promote the secretion of gastrointestinal hormones,increase GAS,MTL and Ghrelin levels and reduce serum AMY and LPS levels to improve the exocrine function of the pancreas to achieve the effect of strengthening the spleen and stomach;can increase plasma ALB levels to regulate water and fluid metabolism and reduce TC,TG levels to regulate blood lipid levels to achieve the effect of resolving turbidity and dampness.At the same time,Poria Lotus Leaf Tablet can up-regulate the level of anti-inflammatory factors and reduce the level of inflammatory factors to regulate the immune status of obesity;reduce serum leptin levels in rats,increase NPY and increase leptin sensitivity.Poria lotus leaf tablets can reduce weight loss in obese rats with spleen deficiency and dampness obstruction by strengthening the spleen and promoting dampness.(5)In comparison with Ginseng and Baijusan,a traditional Chinese medicine for strengthening the spleen and promoting dampness,Poria Lotus Leaf Tablets exerted the effects of strengthening the spleen and stomach,improving gastrointestinal dynamics;resolving dampness and regulating water and fluid metabolism,and the effects were better than those of Ginseng and Baijusan in the regulation of some indexes,and the effects of weight and fat loss were also better than those of Ginseng and Baijusan.In the comparison with orlistat positive control group,although orlistat plays the role of weight reduction and fat reduction,the regulation effect of "spleen deficiency" and "dampness obstruction" and other related indicators is obviously inferior to that of Poria Lotus Leaf Tablets;it indicates that Fu Ling Lotus Leaf Tablets plays the role of strengthening the spleen and stomach,strengthening the spleen and dampness obstruction type of obesity.The effect of Poria lotus leaf tablets on obesity of spleen deficiency and dampness is better than that of orlistat on obese rats;it also proves that under the premise of "identifying the right symptoms",it can achieve better health care function of weight loss.(6)Poria lotus leaf tablet has both weight loss function and spleen-healthy dampness effect in high calorie model feed-induced obese rats,weight loss function evaluation indexes refer to the 2012 version of the weight loss function evaluation method,weight or weight gain,body fat content or fat/body ratio and food intake as the weight loss function evaluation indexes;can be used as the gastrin GAS,gastrin MTL,gastric growth hormone levels.Gastrointestinal hormone levels such as gastrin GAS,gastrin MTL,gastric growth hormone,pancreatic enzymes such as serum amylase AMY and lipase LPS,lipid levels such as total cholesterol TC and triglyceride TG,and metabolic indexes such as albumin ALB,tumor necrosis factor TNF-α,IL-6 level and anti-inflammatory factor IL-10 can be used together as evaluation indexes of the TCM efficacy of strengthening the spleen and promoting dampness. |
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