CN114343171A - Full-nutrition formula special medical food for diabetes - Google Patents

Abstract

The invention discloses a full-nutrition formula special medical food for diabetes, which comprises ginkgo powder, auxiliary material powder, dietary fiber, mineral substances, vitamins and functional factors, wherein the ginkgo powder, the auxiliary material powder, the dietary fiber, the mineral substances, the vitamins and the functional factors are quantitatively mixed and processed by adopting an integrated multidimensional technology, and are granulated and molded by a multiple embedding technology, and finally are subpackaged to prepare a finished product. The complete nutrition formula special medical food for the diabetes mellitus, which is disclosed by the invention, is prepared from gingko serving as a raw material, is used for researching and developing a complete nutrition formula special medical gingko meal replacement powder for the diabetes mellitus patients over 10 years old by utilizing the blood sugar and blood fat reducing functions of the gingko, solves the key technical bottleneck in the research and development of gingko products by utilizing the modern food processing technology, develops diversified special medical gingko food with high added value, improves the technological content and the added value of the gingko products, and has important significance for controlling the development of the diabetes mellitus and improving the life quality of the diabetes mellitus patients.

Description

Full-nutrition formula special medical food for diabetes

Technical Field

The invention relates to the field of health foods, in particular to a full-nutrition formula special medical food for diabetes.

Background

The diabetes total nutrient formula special medical food is specially processed and prepared for meeting special needs of people with limited food intake, digestive absorption disorder, metabolic disorder or specific disease states on nutrients or diet, wherein the specific total nutrient formula food refers to the special medical food which can be used as a single nutrient source and meets the nutritional needs of target people under specific diseases or medical conditions, such as the diabetes total nutrient formula food, and the diabetes total nutrient formula food in foreign countries has earlier research and systematic research, such as Cavazz research finds that the gamma-linolenic acid and at least one alkanoyl-L-carnitine (such as acetyl L-carnitine) can be applied to the diabetes patients. The researches of Yimam and the like find that the special medical food containing aloesin has obvious effect on reducing fasting blood sugar, human plasma insulin and fructosamine levels of diabetics, and along with the continuous development of science and technology, the requirements of people on the preparation process of the special medical food of the full-nutrition formula for the diabetics are higher and higher.

The existing special medical food for the diabetes total nutrient formula has certain disadvantages when in use, the domestic market is mainly the special medical food for the diabetes population under 10 years old, the product mainly comprises carbohydrate slow release type with the raw sugar index GI <55, polyunsaturated fatty acid which replaces the carbohydrate level type with proper reduction, water-soluble dietary fiber type with proper addition and the like, but the product has single form and unobvious functionality, and the special medical food for the diabetes population over 10 years old is lacked, so certain adverse effects are brought to the use process of people, and therefore, the special medical food for the diabetes total nutrient formula is provided.

Disclosure of Invention

Technical problem to be solved

Aiming at the defects of the prior art, the invention provides a special food with a full-nutrition formula for diabetes, which takes ginkgo as a raw material, researches and develops a special meal powder with a full-nutrition formula for diabetes patients over 10 years old by utilizing the blood sugar and blood fat reducing functions of the ginkgo, meets the requirements of diabetes patients in China on the special meal powder with full nutrition, solves the key technical bottleneck in the research and development of ginkgo products by utilizing the modern food processing technology, develops diversified special ginkgo foods with high added values, improves the technological content and the added value of the ginkgo products, has important significance for controlling the development of diabetes and improving the life quality of the diabetes patients, and can effectively solve the problems in the background technology.

(II) technical scheme

In order to achieve the purpose, the invention adopts the technical scheme that: the special medical food with the total nutrient formula for the diabetes comprises ginkgo powder, auxiliary material powder, dietary fibers, mineral substances, vitamins and functional factors, wherein the ginkgo powder and the auxiliary material powder are independently processed, the ginkgo powder, the auxiliary material powder, the dietary fibers, the mineral substances, the vitamins and the functional factors are quantitatively mixed and processed by adopting an integrated multidimensional technology, and are granulated and molded by a multiple embedding technology, and finally subpackaged to obtain a finished product.

As a preferred technical scheme, the ginkgo powder is prepared by adopting gingko kernels, the gingko kernels are ground into ginkgo pulp, the ginkgo powder is prepared by a detoxification and debitterizing and spray drying mode, cellulase, alpha-amylase, neutral protease, alcohol dehydrogenase and the like are utilized to carry out multi-enzyme combined enzymolysis, bitter substances and toxic substances in the ginkgo are removed, protein macromolecules are degraded into polypeptide, and the polypeptide is spray dried to prepare the ginkgo powder.

As a preferred technical scheme, the auxiliary material powder is prepared from multiple auxiliary materials, wherein the auxiliary materials are one or more of tartary buckwheat, oat, buckwheat, soybean protein isolate, whey protein powder, corn peptide, beef dry powder, sesame powder, peanut, rice, corn, pumpkin, dehydrated Chinese cabbage, dehydrated green root vegetable, dehydrated carrot, dehydrated red sweet pepper, dehydrated broccoli, dehydrated mushroom, yellow finemeal, burdock powder, bamboo powder, medlar powder, yam powder, mulberry powder, lily powder, hawthorn powder, maltodextrin, sodium caseinate, maltitol and xylitol, and the auxiliary material powder is prepared by the auxiliary materials in a pretreatment, purification treatment and superfine grinding mode.

As a preferable technical scheme, the dietary fiber is one or more of dietary fibers such as resistant dextrin, inulin, soybean oligosaccharide, inulin, polydextrose, fructo-oligosaccharide and physically modified starch, lecithin, olive oil and sunflower seed oil, and comprises water-soluble dietary fiber and insoluble dietary fiber.

As a preferable technical scheme, the mineral substance is one or more of calcium bicarbonate, magnesium carbonate, sodium iron ethylene diamine tetraacetate, zinc gluconate, sodium phosphate, potassium chloride, ferrous sulfate, manganese sulfate, copper sulfate, chromium trichloride and sodium selenate.

As a preferable technical scheme, the vitamins are selected from one or more of VA, VD3, VE, VB1, VB2, VB6, VB12, nicotinamide, D-calcium pantothenate, VC, folic acid, choline, biotin, VK1 and inositol.

As a preferable technical scheme, the functional factors are one or two of taurine and L-carnitine.

As a preferred technical scheme, the method for preparing the diabetes total nutrient formula special medical food by using the ginkgo powder, the auxiliary material powder, the dietary fiber, the mineral substance, the vitamin and the functional factor comprises the following operation steps:

s1: selecting semen Ginkgo, performing multi-enzyme combined enzymolysis with cellulase, alpha-amylase, neutral protease, alcohol dehydrogenase, etc., removing bitter substances and toxic substances from semen Ginkgo, degrading protein macromolecules into polypeptide, and spray drying to obtain semen Ginkgo powder;

s2: selecting auxiliary materials, pretreating the auxiliary materials, further purifying, and finally carrying out superfine grinding to obtain auxiliary material powder;

s3: performing physical property evaluation and content detection on the raw materials such as the ginkgo powder, the auxiliary material powder, the dietary fiber, the mineral substance, the vitamin, the functional factor and the like, and quantitatively mixing the ginkgo powder, the auxiliary material powder, the dietary fiber, the mineral substance, the vitamin, the functional factor and the like by adopting an integrated multi-position technology after the detection is finished;

s4: and (3) granulating after the raw materials are mixed, wherein the granulating operation adopts various embedding technologies, subpackaging is carried out after the granulating is finished, the finished product is finished, the safety of the finished product is detected and evaluated, a result is obtained, the result is analyzed, and the preparation of the diabetes total nutrient formula special medical food is finished after the clinical success.

(III) advantageous effects

Compared with the prior art, the invention provides a full-nutrition formula special medical food for diabetes, which has the following beneficial effects: the special food with the total nutrient formula for the diabetes mellitus is prepared from ginkgo serving as a raw material, and is used for researching and developing special meal powder with the total nutrient formula for the diabetes mellitus patients over 10 years old by utilizing the blood sugar and blood fat reducing functions of the ginkgo, so that the requirement of the diabetes mellitus patient group in China on the special meal powder with the total nutrient formula is met, the key technical bottleneck in the development of ginkgo products is solved by utilizing the modern food processing technology, diversified special ginkgo foods with high added values are developed, the scientific and technological content and the added value of the ginkgo products are improved, the special meal powder with the total nutrient formula for the diabetes mellitus is developed, the risk of acute and chronic complications is prevented or reduced by the blood sugar and blood fat reducing effects of the ginkgo, the food intake of the diabetes mellitus patients is controlled, the important significance is realized for controlling the development of the diabetes mellitus and improving the life quality of the diabetes mellitus patients, the utilization value of the ginkgo is fully improved, and the development of the ginkgo food industry chain is moved to play a positive role, the gingko meal replacement powder serving as the diabetes total nutrient formula food is developed by serving local economic development and creating more social benefits, the special medical food for gingko is designed to meet the special requirements of people with high blood sugar, various types of diabetics, stress hyperglycemia patients and people with high blood sugar caused by other reasons, weak and sickly people who need nutrition supplement, people who need tube feeding for consciousness disorder or coma people, people who need preoperative preparation and postoperative nutrition supplement, people who have difficulty in swallowing and lose chewing ability and need oral fluid and the like on food, the key technical bottleneck in gingko industry development and gingko product research and development is solved by utilizing modern food processing high and new technology, diversified gingko special medical purpose food is developed, the technological content and the added value of gingko series products are improved, the whole special medical food for the diabetes total nutrient formula is simple in structure and convenient to operate, and the using effect is better than that of the traditional mode.

Drawings

FIG. 1 is a schematic view of the whole structure of a diabetes total nutrient formula specialized medical food of the invention.

FIG. 2 is a schematic structural diagram of a process flow in a diabetes total nutrient formula special medical food of the invention.

Detailed Description

The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings and the detailed description, but those skilled in the art will understand that the following described embodiments are some, not all, of the embodiments of the present invention, and are only used for illustrating the present invention, and should not be construed as limiting the scope of the present invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

As shown in fig. 1 and 2, a diabetes total nutrient formula special medical food comprises ginkgo powder, auxiliary material powder, dietary fiber, mineral substances, vitamins and functional factors, and is characterized in that: the ginkgo powder and the auxiliary material powder are separately processed, the ginkgo powder, the auxiliary material powder, the dietary fiber, the mineral substance, the vitamin and the functional factor are quantitatively mixed and processed by adopting an integrated multidimensional technology, and are granulated and formed by a multiple embedding technology, and finally are subpackaged to prepare a finished product.

Furthermore, the ginkgo powder is prepared from gingko seeds, the gingko seeds are ground into ginkgo pulp, the ginkgo powder is prepared in a detoxification and debitterizing and spray drying mode, cellulase, alpha-amylase, neutral protease, alcohol dehydrogenase and the like are utilized for multi-enzyme combined enzymolysis, bitter substances and toxic substances in the ginkgo are removed, protein macromolecules are degraded into polypeptide, and the ginkgo powder is prepared by spray drying.

Furthermore, the auxiliary material powder is prepared from a plurality of auxiliary materials, wherein the auxiliary materials comprise one or more of tartary buckwheat, oat, buckwheat, soybean protein isolate, whey protein powder, corn peptide, beef dry powder, sesame powder, peanut, rice, corn, pumpkin, dehydrated Chinese cabbage, dehydrated green root vegetable, dehydrated carrot, dehydrated red sweet pepper, dehydrated broccoli, dehydrated mushroom, yellow fine powder, burdock powder, bamboo powder, medlar powder, yam powder, mulberry powder, lily powder, hawthorn powder, maltodextrin, sodium caseinate, maltitol and xylitol, and the auxiliary material powder is prepared by carrying out pretreatment, purification treatment and superfine grinding on the auxiliary materials.

Furthermore, the dietary fiber is one or more of dietary fiber such as resistant dextrin, inulin, soybean oligosaccharide, inulin, polydextrose, fructo-oligosaccharide and physically modified starch, lecithin, olive oil and sunflower seed oil, and comprises water-soluble dietary fiber and insoluble dietary fiber.

Further, the mineral is selected from one or more of calcium bicarbonate, magnesium carbonate, sodium ferric ethylenediamine tetraacetate, zinc gluconate, sodium phosphate, potassium chloride, ferrous sulfate, manganese sulfate, copper sulfate, chromium trichloride, and sodium selenate.

Further, the vitamins are selected from one or more of VA, VD3, VE, VB1, VB2, VB6, VB12, nicotinamide, D-calcium pantothenate, VC, folic acid, choline, biotin, VK1 and inositol.

Furthermore, the functional factor is one or two of taurine and L-carnitine.

Further, the preparation of the diabetes total nutrient formula special medical food by using the ginkgo powder, the auxiliary material powder, the dietary fiber, the mineral substances, the vitamins and the functional factors comprises the following operation steps:

s1: selecting semen Ginkgo, performing multi-enzyme combined enzymolysis with cellulase, alpha-amylase, neutral protease, alcohol dehydrogenase, etc., removing bitter substances and toxic substances from semen Ginkgo, degrading protein macromolecules into polypeptide, and spray drying to obtain semen Ginkgo powder;

s2: selecting auxiliary materials, pretreating the auxiliary materials, further purifying, and finally carrying out superfine grinding to obtain auxiliary material powder;

s3: performing physical property evaluation and content detection on the raw materials such as the ginkgo powder, the auxiliary material powder, the dietary fiber, the mineral substance, the vitamin, the functional factor and the like, and quantitatively mixing the ginkgo powder, the auxiliary material powder, the dietary fiber, the mineral substance, the vitamin, the functional factor and the like by adopting an integrated multi-position technology after the detection is finished;

s4: and (3) granulating after the raw materials are mixed, wherein the granulating operation adopts various embedding technologies, subpackaging is carried out after the granulating is finished, the finished product is finished, the safety of the finished product is detected and evaluated, a result is obtained, the result is analyzed, and the preparation of the diabetes total nutrient formula special medical food is finished after the clinical success.

Example (b):

a core technology for removing toxic substances and bitter substances in ginkgo by an enzyme method is utilized to prepare non-toxic and bitter-free ginkgo powder as a basic raw material, and the full-nutritional formula special medical ginkgo meal replacement powder is developed for people with diabetes over 10 years old.

Research on key technology for preparing ginkgo powder and auxiliary material materials thereof

Adopts the key technology of spray drying of nontoxic bitter-free ginkgo powder

Performing multi-enzyme combined enzymolysis with cellulase, alpha-amylase, neutral protease, alcohol dehydrogenase, etc. to remove bitter and toxic substances from semen Ginkgo, degrading protein macromolecules into polypeptide, and spray drying to obtain semen Ginkgo powder.

Superfine grinding technology for auxiliary materials

The auxiliary materials are pretreated, further purified and finally superfine crushed.

Raw material physical property evaluation and content detection technology system construction

Adopts the technologies of electronic bionics, high performance liquid chromatography analysis and the like to establish a technical system for evaluating the physical properties of the special medical food raw materials and detecting the content.

Research on formula of diabetes total-nutrient formula special-medical ginkgo meal replacement powder

Prescription design basis of special medical ginkgo meal replacement powder for total nutrient prescription for diabetes

A nutritional model of protein (amino acid), fatty acid, carbohydrate, vitamin and mineral substances for the diabetes patients over 10 years old is constructed by adopting a nutriomics method.

High-quality proteins such as whey protein, beef protein powder, soybean protein isolate and the like and other vegetable proteins such as ginkgo protein and the like are added to fully play the complementary role of the proteins and improve the biological value of the proteins.

Transporters play an important role in a wide range of cellular activities, such as nutrient uptake, metabolite release and signal transduction, and a large number of diseases are associated with malfunction of membrane transporters. Thus, by adding specific glycocarrier proteins such as uracil transporters, strong sugars are taken up and utilized in the cell. Ensuring that the energy supply ratio of protein is 19.3% -20.1% and the nitrogen content is 3.3g/100 g-3.5 g/100 g.

Controlling the fat energy supply ratio to be 28-34% so as to provide essential fatty acids for human body as basic requirement, saturated fatty acids: monounsaturated fatty acids: polyunsaturated fatty acid =1:1:1, and the ratio of omega-3 to omega-6 polyunsaturated fatty acid is controlled between 1: 4-1: 10.

Controlling the carbohydrate energy supply ratio to 45.9% -50.2%, the specific carbohydrate combination design is effective in controlling Glycemic Index (GI) which is a low Glycemic Index (GI) formula, GI < 55%.

According to the general rule of formula food for special medical use GB29922-2013, the content of certain nutrients is properly adjusted according to the range requirements of vitamins and mineral elements. Ensure the requirement of normal adult nutrients on vitamins and strengthen the vitamins such as nicotinic acid and the like related to the glucose tolerance factor. Aiming at the characteristics of sugar metabolism, protein metabolism, fat metabolism disturbance and electrolyte metabolism disturbance of a diabetic patient, the vitamin associated with the diabetes is strengthened. The mineral substance requirement of normal adult nutrients is ensured, and the element which can enhance the sensitivity of the insulin by strengthening the trivalent chromium.

The dietary fiber is added to control the absorption and utilization of sugar by the body, and ensure the stable level of blood sugar, and the content of the dietary fiber is not less than 0.2g/100kJ (1.0g/100 kcal).

Selected raw materials

1. Main material ginkgo powder

2. The auxiliary materials are dietary fibers such as tartary buckwheat, oat, buckwheat, soybean protein isolate, whey protein powder, corn peptide, beef dry powder, sesame powder, peanut, rice, corn, pumpkin, dehydrated Chinese cabbage, dehydrated green root vegetable, dehydrated carrot, dehydrated red sweet pepper, dehydrated broccoli, dehydrated mushroom, yellow meal, burdock powder, bamboo powder, medlar powder, yam powder, mulberry powder, lily powder, hawthorn powder, maltodextrin, sodium caseinate, maltitol, xylitol, dietary fibers (resistant dextrin, inulin and soybean oligosaccharide), inulin, polydextrose, fructo-oligosaccharide, physically modified starch and the like, and the auxiliary materials comprise water-soluble dietary fibers and insoluble dietary fibers. Lecithin, olive oil and sunflower seed oil.

3. Functional factors such as taurine and L-carnitine.

4. The vitamins are selected from VA, VD3, VE, VB1, VB2, VB6, VB12, nicotinamide, D-calcium pantothenate, VC, folic acid, choline, biotin, VK1, inositol, etc.

5. The minerals are selected from calcium bicarbonate, magnesium carbonate, sodium ferric ethylene diamine tetraacetate, zinc gluconate, sodium phosphate, potassium chloride, ferrous sulfate, manganese sulfate, copper sulfate, chromium trichloride, sodium selenate, etc.

Research on processing technology of special medical gingko meal replacement powder with total nutrient formula for diabetes

The processing process is strictly carried out according to the standard requirements of GB29923-2013 standard of 'standard operation on good production of foods with special medical application formulas'. The technology of integrating multi-dimensional mixing and multiple embedding granulation is adopted, the problems of solubility, dispersibility and uniformity of the product and sinking of mineral substances during the storage of the product are solved, and the activity of nutrients is effectively protected.

Firstly, the problems of mixing uniformity and mineral substance sedimentation of powder products are improved through multi-dimensional mixing, so that the mixing uniformity of the powder products is more than 97%; secondly, the stability and the mixing dispersibility of the powder are improved by granulation, so that the granulation loss rate of the powder product is less than 2%, the particle size is maintained at about 60 meshes, and the product solubility is more than 99%; finally, the protein powder is selected to endow a layer of protein coating on the surface of the product particles, so that the nutritional activity of the product can be effectively protected, directional release can be realized, and the effect of nutrients is improved.

Safety research of special medical gingko meal replacement powder with full-nutrition formula for diabetes

Evaluation of product quality safety

Since the national standard of the formula food for special medical use, which is not issued in the state at present, is not published, the standard execution of the national standard milk powder GB19644-2010 for food safety is referred. The product is finally based on the qualified inspection report of the product for the test provided by the food inspection organization with legal qualification.

The use of the food additive should meet the regulations of the GB2760-2014 food additive use standard, and the use of the food nutrition enhancer should meet the regulations of the GB14880-2011 food nutrition enhancer use standard.

The GI condition of the special medical gingko meal replacement powder in the diabetes total nutrient formula is judged by measuring the GI of the special medical gingko meal replacement powder, and the GI of the product is required to be less than 55 percent.

GI = (area under postprandial blood glucose curve for ingestion of 50g carbohydrate-containing food)/(area under postprandial blood glucose curve for ingestion of 50g glucose (or white bread) × 100

Area under the postprandial glucose curve =1/2 (fasting glucose + 3h glucose after meal) + 1h glucose + 2h after meal.

The specific measurement method comprises the steps of finding 10-15 healthy volunteers (or diabetics), eating the diabetic total nutrient formula special medical ginkgo meal replacement powder containing 50g of carbohydrate in the fasting state in the morning, and measuring the blood sugar of 1 hour, 2 hours and 3 hours after fasting and meal. The same group of people were fed 50g of glucose and fasting and 1 hour, 2 hour, 3 hour post-prandial blood glucose were measured. Calculating the GI value of the special medical gingko meal replacement powder in the diabetes total nutrient formula. GI values were measured in at least 10 subjects to obtain sufficient test efficacy. Both male and female subjects may be included in the study.

The relation between the food glycemic index and the intake energy is intuitively understood by calculating the blood glucose load. Blood Glucose Load (GL) = (food Glycemic Index (GI) × available carbohydrates grams)/100. When GL <10 hypoglycemic production load, 10< GL <20 moderate glycemic production load, 20< GL hyperglycemic production load.

According to the principle of toxicological test selection, only the first, second and third stage tests are needed to be carried out on the product. First phase, acute toxicity test. An oral acute toxicity test was performed to determine LD50, combined with acute toxicity, one maximum tolerated dose test. The second stage, genotoxicity test, 30-day feeding test, and traditional teratogenicity test. The genetic toxicity test is carried out on prokaryotic cells and eukaryotic cells, and an in vivo test and an in vitro test are combined with an Ames or gene mutation test; performing micronucleus test or chromosome aberration test; performing a sperm aberration test, etc. The third stage, sub-chronic toxicity test, 90 days feeding test, reproduction test and metabolism test.

Establishment of diabetic rat model

Adopting 100 SD rats of 6-8 weeks old, using Streptozotocin (STZ) to induce type II diabetes mellitus rats as model, and using the prepared special medical ginkgo meal replacement powder for the complete nutrition formula of diabetes mellitus to carry out research for 8 weeks.

The rats are raised in cages and fed with adaptive common feed for 1 week at 20 + -2 deg.C and 60 + -5% humidity. Except for normal control group rats, the rats were fasted for 12 h after being fed with high-fat and high-sugar feed for 8 weeks, and injected into tail vein at the amount of 25mg/kg, STZ (rapid injection strictly according to the body weight of each rat). And (3) measuring the blood sugar value of tail blood of rats fasted for 12 hours after 72 hours by using a portable glucometer, selecting qualified rats for subsequent experiments by taking fasting blood sugar of more than or equal to 11.1 mmol/L as an index of successful model building of the diabetic rats.

Animal grouping and administration

Taking 10 normal control rats and 50 diabetes model rats, dividing into 6 groups, and each group comprises 10 rats. 1 group is normal control group, and is fed with normal maintenance feed; 2 groups are model control groups, and are fed with normal maintenance feed; 3 groups are metformin groups, 50 mg/kg of metformin is respectively taken every day, 6g/kg of diabetes total nutrient formula specialized medical ginkgo meal replacement powder is taken every day, and then normal maintenance feed is matched. 4. The groups 5 and 6 are diabetes total nutrient formula special medical ginkgo meal replacement powder feeding groups, 4g/kg, 6g/kg and 8g/kg of diabetes total nutrient formula special medical ginkgo meal replacement powder are respectively fed every day, and samples are collected after the patients are continuously fed for 8 weeks.

And collecting and processing the specimen.

After the test, the test animals were weighed and the fasted rats were anesthetized by intraperitoneal injection of sodium pentobarbital (120 mg/kg). After the rats are fixed in the supine posture, the chest is opened, blood is taken from the apex of the heart by a 5ml syringe, 4ml of whole blood is taken from each rat, the whole blood is immediately filled into a procoagulant tube, the whole blood is centrifuged after 2h, and the serum of each sample is subpackaged into Eppendorf tubes (EP tubes) and marked for measuring the indexes of blood sugar and serum.

Blood glucose determination

The blood sugar measuring method during molding comprises the following steps: rat tail blood glucose was measured according to the specifications of a portable standard blood glucose meter. Post-mortem blood glucose determination in rats: the determination is carried out on a 7600-20 type full-automatic biochemical analyzer by using a glucose oxidase method.

Serum assay

Serum TG, TC and LDL-C, HDL-C were detected by 7600-20 type full-automatic biochemical analyzer. The glucose tolerance, glycoprotein, specific glycoprotein, total cholesterol, triglyceride, lipoprotein, apolipoprotein and the like are taken as biochemical detection indexes to evaluate the blood sugar and blood fat reducing effects of the special medical ginkgo meal replacement powder in the total nutrient formula of the diabetes.

Clinical effect research of special medical gingko meal replacement powder with full-nutrition formula for diabetes

The appropriate clinical trial group was set up to be selected following the principles of randomization, control and repetition. Before the clinical test is implemented, the formula composition, the production process and the product standard requirements of the product for the test, and relevant data showing the safety, the nutrition sufficiency and the clinical effect of the special medical application of the product are provided for a test unit, and a test report of qualified product for the test issued by a food inspection institution with legal qualification is provided. The applicant is responsible for the quality of the product for clinical trials and the safety of clinical trials.

Selecting the subjects, observing the number of cases, and not less than 100 patients in the test group. The clinical test is carried out for no less than 90 days, the clinical treatment medication is comparable, the nutrition sufficiency and the clinical effect observation index have clinical significance and can meet the statistical requirement.

Before each patient participates in clinical trials, after taking special medical ginkgo meal replacement powder for diabetes, the indexes of 2 hours after one meal are measured every 1 week, the blood sugar level is respectively measured, and the biochemical detection indexes are glucose tolerance, glycoprotein, specific glycoprotein, total cholesterol, triglyceride, lipoprotein, apolipoprotein and the like.

The main observation indexes include safety (tolerance) indexes, nutritional sufficiency and clinical effect observation indexes for special medical application. Gastrointestinal reaction, vital sign, blood, urine, blood biochemical index, etc. The nutritional requirements of basic physiological functions of applicable people are maintained, the nutritional status of the applicable people is maintained or improved, and the indexes of special disease states of the applicable people are controlled or relieved.

The evaluation of clinical nutritional status human body composition has the main indexes of atomic level, molecular level, cell level,

tissue system level, overall level, etc. At the atomic level, reduce a person of matter to several elements including oxygen, hydrogen, carbon, nitrogen, calcium, and the like. Molecular levels, including water, protein, fat, carbohydrate, vitamins and minerals. At the cellular level, including cells, extracellular fluids, and extracellular solids. At the level of the tissue system, subjects to be evaluated included major tissues and organs, body weight ═ adipose tissue + fat-free mass (FFM), fat-free tissue ═ skeletal muscle + bone + internal organs. And the overall level evaluation method comprises anthropometry and human component analysis. Physical measurements of the human body are taken of weight and height, skin fold thickness and circumference, calf circumference, grip strength, pace, etc.

Biochemical testing technique for determining nutrient level (such as determination of vitamins, minerals, proteins, fats, saccharides and their metabolites). Organ function measurement technology, evaluation of intestinal function and microecology, and nutrition conversion. Metabolic analysis technology, measurement of human metabolic rate, nitrogen balance test, etc. Immunoassay technology, stress protein assay, lymphocyte count, etc.

The clinical effect conclusion of the diabetes total nutrient formula special medical ginkgo meal replacement powder is obtained through comprehensive analysis and evaluation of all indexes by comprehensive indexes

The working principle is as follows: the ginkgo biloba extract powder comprises ginkgo biloba powder, auxiliary material powder, dietary fibers, mineral substances, vitamins and functional factors, wherein ginkgo biloba is selected, multi-enzyme combined enzymolysis is carried out by utilizing cellulase, alpha-amylase, neutral protease, alcohol dehydrogenase and the like, bitter substances and toxic substances in ginkgo biloba are removed, protein macromolecules are degraded into polypeptide, and the ginkgo biloba powder is prepared by spray drying; selecting auxiliary materials, pretreating the auxiliary materials, further purifying, and finally carrying out superfine grinding to obtain auxiliary material powder; performing physical property evaluation and content detection on the raw materials such as the ginkgo powder, the auxiliary material powder, the dietary fiber, the mineral substance, the vitamin, the functional factor and the like, and quantitatively mixing the ginkgo powder, the auxiliary material powder, the dietary fiber, the mineral substance, the vitamin, the functional factor and the like by adopting an integrated multi-position technology after the detection is finished; and (3) granulating after the raw materials are mixed, wherein the granulating operation adopts various embedding technologies, subpackaging is carried out after the granulating is finished, the finished product is finished, the safety of the finished product is detected and evaluated, a result is obtained, the result is analyzed, and the preparation of the diabetes total nutrient formula special medical food is finished after the clinical success.

It is noted that, herein, relational terms such as first and second (a, b, etc.) and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. Also, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other identical elements in a process, method, article, or apparatus that comprises the element.

The foregoing shows and describes the general principles and broad features of the present invention and advantages thereof. It will be understood by those skilled in the art that the present invention is not limited to the embodiments described above, which are described in the specification and illustrated only to illustrate the principle of the present invention, but that various changes and modifications may be made therein without departing from the spirit and scope of the present invention, which fall within the scope of the invention as claimed.

Claims (8)

1. A full-nutrition formula special medical food for diabetes comprises ginkgo powder, auxiliary material powder, dietary fiber, mineral substances, vitamins and functional factors, and is characterized in that: the ginkgo powder and the auxiliary material powder are separately processed, the ginkgo powder, the auxiliary material powder, the dietary fibers, the mineral substances, the vitamins and the functional factors are quantitatively mixed and processed by adopting an integrated multidimensional technology, and are granulated and formed by a multiple embedding technology, and finally subpackaged to prepare a finished product.

2. The diabetes total nutrient formula specialist food as claimed in claim 1, wherein: the ginkgo powder is prepared by adopting gingko kernels, the gingko kernels are ground into ginkgo pulp, the ginkgo powder is prepared by a mode of detoxification, debitterizing and spray drying, cellulase, alpha-amylase, neutral protease, alcohol dehydrogenase and the like are utilized for carrying out multi-enzyme combined enzymolysis, bitter substances and toxic substances in the ginkgo are removed, protein macromolecules are degraded into polypeptide, and the polypeptide is spray dried to prepare the ginkgo powder.

3. The diabetes total nutrient formula specialist food as claimed in claim 1, wherein: the auxiliary material powder is prepared from various auxiliary materials, wherein the auxiliary materials are one or more of tartary buckwheat, oat, buckwheat, soybean protein isolate, whey protein powder, corn peptide, beef dry powder, sesame powder, peanut, rice, corn, pumpkin, dehydrated Chinese cabbage, dehydrated green root vegetable, dehydrated carrot, dehydrated red sweet pepper, dehydrated broccoli, dehydrated mushroom, yellow fine powder, burdock powder, bamboo powder, medlar powder, yam powder, mulberry powder, lily powder, hawthorn powder, maltodextrin, sodium caseinate, maltitol and xylitol, and the auxiliary material powder is prepared by carrying out pretreatment, purification treatment and superfine grinding on the auxiliary materials.

4. The diabetes total nutrient formula specialist food as claimed in claim 1, wherein: the dietary fiber is one or more of dietary fiber such as resistant dextrin, inulin, soybean oligosaccharide, inulin, polydextrose, fructo-oligosaccharide and physically modified starch, lecithin, olive oil and sunflower seed oil, and comprises water-soluble dietary fiber and insoluble dietary fiber.

5. The diabetes total nutrient formula specialist food as claimed in claim 1, wherein: the mineral is selected from one or more of calcium bicarbonate, magnesium carbonate, sodium ferric ethylene diamine tetraacetate, zinc gluconate, sodium phosphate, potassium chloride, ferrous sulfate, manganese sulfate, copper sulfate, chromium trichloride, and sodium selenate.

6. The diabetes total nutrient formula specialist food as claimed in claim 1, wherein: the vitamins are selected from one or more of VA, VD3, VE, VB1, VB2, VB6, VB12, nicotinamide, D-calcium pantothenate, VC, folic acid, choline, biotin, VK1 and inositol.

7. The diabetes total nutrient formula specialist food as claimed in claim 1, wherein: the functional factor is one or two of taurine and L-carnitine.

8. The diabetes total nutrient formula specialist food as claimed in claim 1, wherein: the preparation of the diabetes total nutrient formula special medical food by using the ginkgo powder, the auxiliary material powder, the dietary fiber, the mineral substance, the vitamin and the functional factor comprises the following operation steps:

s1: selecting semen Ginkgo, performing multi-enzyme combined enzymolysis with cellulase, alpha-amylase, neutral protease, alcohol dehydrogenase, etc., removing bitter substances and toxic substances from semen Ginkgo, degrading protein macromolecules into polypeptide, and spray drying to obtain semen Ginkgo powder;

s2: selecting auxiliary materials, pretreating the auxiliary materials, further purifying, and finally carrying out superfine grinding to obtain auxiliary material powder;

s3: performing physical property evaluation and content detection on the raw materials such as the ginkgo powder, the auxiliary material powder, the dietary fiber, the mineral substance, the vitamin, the functional factor and the like, and quantitatively mixing the ginkgo powder, the auxiliary material powder, the dietary fiber, the mineral substance, the vitamin, the functional factor and the like by adopting an integrated multi-position technology after the detection is finished;

s4: and (3) granulating after the raw materials are mixed, wherein the granulating operation adopts various embedding technologies, subpackaging is carried out after the granulating is finished, the finished product is finished, the safety of the finished product is detected and evaluated, a result is obtained, the result is analyzed, and the preparation of the diabetes total nutrient formula special medical food is finished after the clinical success.

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