The Development And Research Of A Kind Of Ultrafine Chinese Medical FSMP Based On The Tumor Full Nutrition

ObjectiveTumor full nutritional formula is a special food designed for the tumor who are malnourished that belongs to specific nutrients in Food for special medical purpose(hereinafter referred to as "FSMP").In our country,the incidence of tumor malnutrition is extremely high,but the types of FSMP on tumor are rare and most of the products rely on imports.Domestic enterprises are less committed to the research and production,so it can not meet the clinical needs.On nutritional effects,FSMP is similar to Medicated food in our country:Rich resources of Medicine food homology such as poria cocos?ginseng and Chinese yam.In terms of nutrition,Poria cocos?Ginseng and Chinese yam are rich in protein?a variety of essential amino acids that human body needs?polysaccharide?trace elements etc.In terms of pharmacological effects,their main ingredients can anti-tumorn improve the body' s immune ability and antioxidation,these effects are closely related with the occurrence and development of tumor.Based on the above background,the purpose of this subject is designed to put poria cocos?ginseng and Chinese yam into FSMP and complete the development of a new type of FSMP on tumor according to the current related guidelines.And preliminary investigate the stability?safety and nutrition function so as to its further development and form listed products provide prophase research foundation.Methods1.The formula design and technical process research of Tumor full nutritional formula.1.1 Formula design mainly refer to?National Food Safety Standards-General Principles for FSMP)?(hereinafter referred to as the?General Principles?).According to the tumor patient nutritional requirements,combining with the relevant laws and regulations about foods,adding other nutrients?poria cocos?ginseng?Chinese yam ultrafine powder and food additives.1.2 Put the formula dosage scaling up for production.According to the technological process well designed beforehand to produce three batches of end products and analyze the quality.Combined with other relevant products' national standards and industry standards,preliminary make the product Quality standards.2.The preliminary research on the stability of the tumor full nutritional formula.2.1 The test of influencing factors.Under the condition of strong light?high temperature?high humidity,To examine the product's color?organization?solubility?moisture?protein and fat content?vitamin C and the change of the total number of colonies at 0?5 and 10 days.2.2 Accelerated testing.Under three kinds of packaging specification in plastic bags,metal tins and aluminum foil bags,The three production batches of tumor full nutritional formula are in accordance with?The requirements for stability study of FSMP?(hereinafter referred to as "the stability study")to carry out the acceleration.Examine the product's color?organization?solubility?moisture?protein and fat content?vitamin C and the change of the total number of colonies at 0?1?2?3 and 6 months in the temperature of 37?±2? and humidity under the condition of 75%±5%·3.To explore the tumor full nutritional formula's acute toxicity on mice.With reference to the requirements of((Technical Standards for Testing&Assessment of Health Food?of the ministry of health.According to the maximum dose lavage in mice,given tumor full riutritional formula suspension liquid once a day.Regular diet and drinking water after lavage,Observe the changes of appearance?behavior and secretion in mice every day for 14 consecutive days.Weighing animals body weight regularly.Gross anatomy inspections in a timely manner for poisoning death or dying animals during lavage.Live animals in lavage cycle will take off the cervical vertebra to death for a gross anatomy examination,inspection organs including heart?liver?spleen?lung?kidney?stomach?small intestine and other organs.4.The research of the tumor full nutritional formula improve nutritional status in mice.80 tumor-bearing mice are randomLy divided into 4 groups.In addition to the model group were injected cisplatin injection,model group and treatment group lavage distilled water at the same time.The other two groups lavage Oral Impact and homemade tumor full nutritional formula.To observe changes in general of the mice and to record the changes of the weight,regularly measuring size of the tumors.Dissected the mice and weighing the tumors,calculated the inhibitory rate after the experiment.To detect the total protein(TP)?albumin(Alb)and prealbumin(PA)of serum.Results1.The formula design and technical process research of Tumor full nutritional formula.1.1 Three batches of finished products' protein?fat and carbohydrate,their.average energy ratio are 19%?39%and 42%respectively.Other nutrients' content are reasonable and stable.Pollutants?mycotoxin and microbial test results are within the scope of?General Principles?.1.2 Formed a preliminary draft product quality standards including raw material demands?sensory?solubility?physical and chemical indicators?the main nutrients?other nutrients?pollutants?mycotoxins?microorganism and other related projects.2.The preliminary research on the stability of the tumor full nutritional formula.2.1 The test of influencing factors.Under the condition of strong light?high temperature and high humidity,Formula are unstable.Agglomeration situation?Solubility?the moisture content and protein content are severity affected by humidity.Under the action of three kinds of factors,the content of vitamin C is gradually reduced,and sensitive to temperature and humidity.The total number of colonies are within the limits during the test.2.2 Accelerated testing.The acceleration of three kinds of packing material test results show that the color of the formula gradually deepens,plastic bags agglomerate the worst and its solubility volatility is the biggest.Three kinds of packaging specifications,water gradually rise,protein content show a trend of gradual decline.In plastic bag packing condition,products present the most unstable.During the period of accelerated experiment,the total number of colonies are within limits.3.To explore the tumor full nutritional formula's acute toxicity on mice.After lavage a daily maximum dose lavage(11.18 g/kg.BW),the body weight in mice showed in normal growth and the heart?liver?spleen?lung?kidney?stomach?small intestine and other organs hadn' t found anything abnormal.4.The research of the tumor full nutritional formula improve nutritional status in mice.Tumor full nutritional formula can improve the mental status of tumor mice caused by cisplatin.Compared with simple treatment group,in Tumor full nutritional formula+treatment group,the weight of mice significantly increased(P<0.01).Tumor weight showed no significant difference(P>0.05).The total protein(PT)and albumin(Alb)of mice significantly increased(P<0.01?P<0.05),and prealbumin(PA)of mice significantly lower(P<0.05).Conclusion1.This topic finished Tumor full nutritional formula's formula design and technical process research.Determined the composition of product formula and process route.2.Tumor full nutritional formula in the condition of influencing factors(high temperature?high humidity and strong light)?accelerated experimental conditions,its stability are poor.It should be stored in a cool,dry place away from sunlight.The best packaging material is aluminum foil bag.3.Tumor full nutritional formula showed no obvious acute toxic side effects to experimental animals.4.Tumor full nutritional formula can effectively improve the nutritional status of animals and assist the chemotherapy drugs inhibit the growth of tumor.