Nutritional formula food as well as preparation method and application thereof

Abstract

The invention relates to a nutritional formula food as well as a preparation method and application thereof, and the food composition comprises the following raw material components in parts by weight: 1.0-5.0 parts of a protein component; 1.0 to 3.0 parts of a fat component; 1.0 to 3.0 parts of a carbohydrate component; 0.05 to 0.1 part of a compound vitamin group; 0.1 to 0.3 part of a composite mineral substance component; 0.01 to 0.07 part of an oil phase emulsifier component; 0.1 to 0.3 part of a water phase stabilizer / thickener component; 0.01 to 0.07 part of a functional nutrient component; 0.005 to 0.15 part of a flavoring agent group; 80 to 100 parts of purified water (carrier); according to the formula, macro nutrients and functional components are scientifically proportioned, so that the special nutritional requirements of patients suffering from lung injury after chronic obstructive pulmonary disease (COPD) and cystic fibrosis related lung lesion infection are met in a targeted manner.

Description

Technical Field

[0001] This invention relates to the field of formulation technology for special medical purposes, and in particular to a nutritional formula food, its preparation method, and its application. Background Technology

[0003] According to statistics from the China Nutrition and Health Food Association, China's market size for medical foods accounts for 1.25% of the global market, totaling approximately 650 million yuan. China's consumption of medical foods lags far behind that of developed countries in Europe and America; however, it has grown rapidly in recent years, with an average annual growth rate exceeding 30%. With the surge in COPD patients in China, the future market size for medical foods in China is expected to exceed 10 billion yuan, indicating a huge potential market for respiratory system medical foods. Respiratory system-specific complete nutritional formula emulsions effectively fill this market gap, allowing more patients to use them, significantly reducing hospitalization costs, improving nutritional support, and reducing complications and acute exacerbations. Respiratory system-specific complete nutritional emulsions will become an indispensable medical functional food for COPD patients during treatment and prognosis.

[0004] The existing nutritional formulas have the following shortcomings:

[0005] (1) The proportion of macronutrients is unreasonable, and the special metabolic needs of patients with respiratory diseases are not addressed in a targeted manner.

[0006] (2) Lacking a scientifically balanced formula of functional ingredients, the product has a poor taste and poor patient experience, and has limited effect on improving patients' respiratory function.

[0007] (3) The preparation process failed to effectively preserve the activity of heat-sensitive nutrients and prevent fat oxidation.

[0008] Therefore, existing technologies still need further improvement. Summary of the Invention

[0009] This invention provides a nutritional formula food, its preparation method, and its application, solving the technical problems of unreasonable nutrient ratios, loss of activity of heat-sensitive nutrients, and fat oxidation in existing special medical functional foods.

[0010] This invention provides a nutritional formula food, comprising the following components in parts by weight:

[0011] Protein composition: Casein 1.0-1.5 parts, hydrolyzed whey protein 1.0-3.0 parts, lactoferrin 0.05-0.1 parts;

[0012] Fat components: medium-chain triglycerides (MCT) 0.5-1.5 parts, linoleic acid 0.1-0.2 parts, α-linolenic acid 0.1-0.2 parts, algal oil 0.1-0.2 parts, soybean lecithin 0.05-0.1 parts;

[0013] Carbohydrate composition: 1.0-2.0 parts resistant starch, 0.5-2.0 parts resistant dextrin, and 0.1-0.4 parts fructooligosaccharides;

[0014] Multivitamin components: Contains vitamin A, vitamin C, vitamin D, vitamin E, vitamin B1, vitamin B2, vitamin B6, niacin, pantothenic acid, vitamin B12, vitamin K1, folic acid, and biotin;

[0015] Total quantity: 0.05-0.1 portions;

[0016] Complex mineral composition: Contains sodium, potassium, magnesium, iron, zinc, calcium, phosphorus, copper, manganese, iodine, selenium, chromium, and molybdenum in a total amount of 0.1-0.30 parts;

[0017] Oil phase emulsifier components: selected from at least one or more of mono / diglyceride fatty acid esters, sucrose fatty acid esters, and soybean lecithin, 0.1-0.5 parts;

[0018] Aqueous phase stabilizer / thickener components: selected from at least one or two of sodium carboxymethyl cellulose, xanthan gum, pectin, carrageenan, and konjac gum, 0.1-0.3 parts;

[0019] Functional nutrient components: contain at least one or two of hydrogenated choline, L-carnitine, and N-acetylcysteine, totaling 0.01-0.07 parts;

[0020] Flavoring agent components: containing at least one or two of steviol glycosides, mogrosides, and edible flavorings, in a total amount of 0.0004-0.5 parts;

[0021] Carrier: 80-100 parts purified water.

[0022] Based on this technical solution, the weight ratio of casein to hydrolyzed whey protein in the protein component is 1:2, and the lactoferrin content is 50-100 μg / 100ml of the composition.

[0023] Based on this technical solution, the weight ratio of medium-chain triglycerides (MCT), linoleic acid, algal oil and α-linolenic acid in the fatty component is 7:1:1:1.

[0024] Based on this technical solution, the vitamin D content in the compound vitamin components is 100-800 IU / 100g composition.

[0025] Based on this technical solution, the selenium content in the composite mineral component is 20-100 μg / 100g composition.

[0026] In a second aspect, the present invention also provides a method for preparing a nutritional formula food as described in any one of the first aspects, comprising the following steps:

[0027] S1. Preheat 80% of the total amount of purified water to 55±5℃;

[0028] S2. After mixing the aqueous emulsifier / thickener components evenly, add them to the preheated hot water and shear at high speed at 5000 rpm for 5-10 min;

[0029] S3. Add protein components, carbohydrate components, complex vitamin components, complex mineral components, functional nutrient components, flavoring agent components and dietary fiber components in sequence, adjust the pH to 6.5±0.5, and shear at high speed at 10000 rpm for 30-45 min to obtain an aqueous solution.

[0030] S4. Heat the fatty component to 65-70°C, add the oil phase emulsifier component, and shear at high speed at 10000 rpm for 15-30 min to obtain an oil phase solution;

[0031] S5. Slowly add the oil phase solution to the aqueous phase solution and shear at high speed at 10000 rpm for 30-45 min to form an oil-in-water emulsion; adjust the pH to 6.5±0.2 with sodium bicarbonate solution and add the remaining purified water.

[0032] S6. The emulsion is subjected to high-pressure homogenization treatment, with a first-stage pressure of 40-60 MPa, a second-stage pressure of 80-120 MPa, a homogenization temperature of 30-50℃, and nitrogen protection.

[0033] S7. After dispensing, sterilize at 115-121℃ for 15-30 minutes.

[0034] Based on this technical solution, the high-pressure homogenization process is repeated three times.

[0035] Based on this technical solution, the sterilization process uses food-grade polypropylene, glass, or metal containers for encapsulation.

[0036] Thirdly, the present invention also provides the use of the nutritional formula food described in any one of the first aspects in the preparation of products that improve the nutritional status of patients with chronic obstructive pulmonary disease, cystic fibrosis-related lung lesions, or lung injury following pneumonia infection.

[0037] Based on this technical solution, the product is used to reduce the patient's respiratory quotient (RQ) to below 0.80.

[0038] The purpose of this invention is to construct a complete nutritional formula system specifically for respiratory diseases, and its technical effects are reflected in the following aspects:

[0039] A nutritional formula food suitable for respiratory diseases is a nutritional preparation for patients with lung diseases. It is high in fat and low in carbohydrates, rich in vitamins and minerals, and contains L-carnitine and N-acetylcysteine, which can reduce carbon dioxide production, thereby reducing carbon dioxide retention caused by chronic obstructive pulmonary disease (COPD) or acute respiratory failure. It is suitable for patients with COPD, those who are bedridden, and those with cystic fibrosis. Detailed Implementation

[0040] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0041] A nutritional formula food for patients with respiratory diseases, comprising the following components in parts by weight:

[0042] Protein component: 1.0-5.0 parts; Fat component: 0.05-2.0 parts; Carbohydrate component: 0.1-2.5 parts; Complex vitamin component: 0.05-0.1 parts; Complex mineral component: 0.1-0.30 parts.

[0043] Oil phase emulsifier: 0.01-0.07 parts, aqueous phase stabilizer / thickener: 0.1-0.3 parts, total functional nutrient components: 0.01-0.07 parts, total flavoring agent components: 0.0004-0.15 parts, carrier: 80-100 parts purified water.

[0044] Furthermore, the protein composition includes 1.0-1.5 parts casein, 1.0-3.0 parts hydrolyzed whey protein, and 0.05-0.1 parts lactoferrin; the protein composition is sourced from Saputo Ingredients, Canada. Furthermore, the protein composition achieves the following technical effects: sodium caseinate and partially hydrolyzed whey protein (degree of hydrolysis 8-12%) are compounded at a specific mass ratio of 1:2 to form a protein matrix with time-release characteristics. Specifically, the casein component forms a sustained-release gel structure in the stomach, providing a continuous supply of amino acids; the hydrolyzed whey protein ensures rapid absorption, with peak plasma amino acid levels reaching 24-26% (of which leucine ≥12%) and glutamine enhanced to 6-8%, supporting respiratory epithelial repair. Lactoferrin, as an important functional component of nutritional intervention for COPD, works by competitively binding to the TLR4 receptor, blocking MyD88 / NF-KB signal transduction, reducing the expression of pro-inflammatory factors such as IL-6 and TNF-α, and improving the inflammatory state of the bronchi and alveoli in COPD patients.

[0045] Furthermore, the fat components include: medium-chain triglycerides (MCT) 0.5-1.5 parts, linoleic acid 0.1-0.2 parts, algal oil 0.1-0.2 parts, α-linolenic acid 0.1-0.2 parts, and soybean lecithin 0.05-0.1 parts;

[0046] Furthermore, the aforementioned fat component achieves the following technical effects: multiple physiological functions are realized through precise regulation of fatty acid composition, wherein medium-chain triglycerides (MCT, C8-C12 content ≥80%) account for 60-85% of the total fat, and linoleic acid (C18:2ω-6) and α-linolenic acid (C18:3ω-3), algal oil (containing EPA 180mg / DHA 120mg) are in a mass ratio of 1:1 to 10:1.

[0047] Furthermore, the carbohydrate components include: 1.0-2.0 parts resistant starch, 1.0-2.0 parts resistant dextrin, and 0.1-0.4 parts fructooligosaccharides;

[0048] Furthermore, the aforementioned carbohydrate component achieves the following technical effects: a slow-release carbohydrate complex is constructed, with the glycemic index (GI) controlled below 55.

[0049] Furthermore, the aforementioned multivitamin components include vitamin A, vitamin C, vitamin D, vitamin E (da-TE), and B vitamins, totaling 0.05-0.1 parts;

[0050] Furthermore, the names of the components of the complex vitamin are: Vitamin A, Vitamin C, Vitamin D, Vitamin E, Vitamin B1, Vitamin B2, Vitamin B6, Niacin (Niacinamide), Pantothenic Acid, Vitamin B12, Vitamin K1, Folic Acid, and Biotin.

[0051] Furthermore, the compound vitamin components are a premix, the diluent is maltodextrin, and the manufacturer is Shanghai Licheng Food Industry Co., Ltd.

[0052] Furthermore, the composite mineral component is present in an amount of 0.1-0.3 parts;

[0053] Furthermore, the compound names of the complex mineral components are sodium chloride, potassium citrate, magnesium carbonate, ferrous fumarate, zinc citrate, calcium carbonate, calcium hydrogen phosphate, copper sulfate, manganese sulfate, potassium iodate, sodium selenite, chromium chloride, and sodium molybdate.

[0054] Furthermore, the aforementioned compound mineral component is a premix, the diluent carrier is maltodextrin, and the manufacturer is Shanghai Licheng Food Industry Co., Ltd.

[0055] Furthermore, the total amount of the functional nutrient components is 0.01-0.07 parts:

[0056] Furthermore, the functional nutrient components include: L-carnitine 0.01-0.04 parts and N-acetylcysteine ​​0.01-0.03 parts;

[0057] Furthermore, the aforementioned functional nutrient components achieve the following technical effects: In nutritional formulations for respiratory diseases (especially chronic diseases accompanied by oxidative stress, excessive mucus secretion, muscle wasting, and fatigue), the combined use of N-acetylcysteine ​​(NAC) and L-carnitine has a solid theoretical basis and potential synergistic clinical benefits: N-acetylcysteine ​​(NAC) powerfully combats oxidative stress, dissolves mucus, and reduces inflammation. L-carnitine optimizes energy metabolism (especially for muscles), supports mitochondrial function, reduces fatigue, and also contributes to antioxidant activity. The combined use of these two components can more comprehensively target multiple core pathophysiological aspects of the disease (oxidative damage, inflammation, energy depletion, and muscle dysfunction), and is expected to synergistically improve respiratory symptoms (sputum expectoration, ventilation) and systemic symptoms (fatigue, mobility), thereby improving patients' quality of life.

[0058] Furthermore, the flavoring agent component is present in quantities of 0.0004-0.15 parts;

[0059] Furthermore, the flavoring agent components include: 0.001-0.004 parts of mogroside and 0.05-0.15 parts of flavoring, wherein the flavoring is food-grade vanilla flavoring.

[0060] Furthermore, the flavoring agents, such as mogrosides and vanilla flavoring, effectively mask or neutralize unpleasant tastes (especially bitterness), greatly enhancing the palatability and user experience of the nutritional formula food and improving patient (especially children and the elderly) compliance.

[0061] Furthermore, the oil phase emulsifier component is 0.01-0.07 parts; the aqueous phase stabilizer / thickener component is 0.05-0.3 parts;

[0062] Furthermore, the oil-phase emulsifier and aqueous-phase stabilizer / thickener components include: 0.01-0.03 parts of mono / diglyceride fatty acid esters, 0.01-0.04 parts of sucrose fatty acid esters, 0.05-0.20 parts of sodium carboxymethyl cellulose, and 0.05-0.15 parts of xanthan gum.

[0063] A method for preparing a nutritional formula food suitable for respiratory diseases includes the following steps:

[0064] S1. Preheat 80% of the total amount of purified water to 55±5℃;

[0065] S2. After mixing the aqueous emulsifier / thickener components evenly, add them to the preheated hot water and shear at high speed at 5000 rpm for 5-10 min;

[0066] S3. Add protein components, carbohydrate components, complex vitamin components, complex mineral components, functional nutrient components, flavoring agent components and dietary fiber components in sequence, adjust the pH to 6.0-6.5, and shear at 10000 rpm for 30-45 min to obtain an aqueous solution.

[0067] S4. Heat the fat component to 65-70°C, add the oil phase emulsifier component, and shear at high speed at 10000 rpm for 15-30 min to obtain an oil phase solution;

[0068] S5. Slowly add the oil phase solution to the aqueous phase solution and shear at 10,000 rpm for 30-45 minutes to form an oil-in-water emulsion; adjust the pH to 6.5±0.5 with sodium bicarbonate solution and add the remaining purified water.

[0069] S6. The emulsion is subjected to high-pressure homogenization treatment, with a first-stage pressure of 40-60 MPa, a second-stage pressure of 80-120 MPa, a homogenization temperature of 30-50℃, and nitrogen protection.

[0070] S7. After dispensing, sterilize at 115-121℃ for 15-30 minutes.

[0071] Furthermore, in the method for preparing nutritional formula foods suitable for respiratory diseases, nitrogen purging is used during high-pressure homogenization and filling to prevent the fat components from being impacted and broken during high-pressure homogenization, resulting in a sharp increase in surface area, and to prevent oxidation caused by high-temperature sterilization.

[0072] Furthermore, in the method for preparing nutritional formula foods suitable for respiratory diseases, the high-pressure homogenization process is repeated three times to obtain a uniform solution particle size range, preventing the high-protein and fat components from settling and stratifying during the shelf life.

[0073] Example 1

[0074] A nutritional formula food suitable for respiratory diseases is composed of the following raw and auxiliary materials:

[0075] Table 1. Formula specifically for COPD patients in stable phase (500ml / bottle)

[0076]

[0077]

[0078] The multivitamin / mineral formula table is as follows:

[0079] Table 2. Multivitamin / Mineral Formula Table

[0080]

[0081]

[0082] Example 2: High-protein formula (specification: 500ml / bottle)

[0083] The other conditions and preparation methods are the same as in Example 1, except that casein is removed, hydrolyzed whey protein (DH10) is increased to 30g / 500ml, MCT is reduced to 2.5g / 500ml, and linoleic acid and algal oil are not added.

[0084] Table 3 High Protein Component Formulation

[0085]

[0086]

[0087] Example 3: High-carbohydrate component formula (specification: 500ml / bottle)

[0088] The other conditions and preparation methods are the same as in Example 1, except that maltodextrin replaces resistant starch to 20g / 500ml.

[0089] Example 4: High-fat formula (500ml / bottle)

[0090] The other conditions and preparation methods are the same as in Example 1, except that MCT is increased to 15g / 500ml, linoleic acid to 2g / 500ml, algal oil to 2g / 500ml, α-linolenic acid to 2g / 500ml, and soybean lecithin to 1g / 500ml.

[0091] Comparative Example 1:

[0092] The amount of materials used in the formulation is the same as in Example 1, the difference lies in the preparation method;

[0093] Aqueous phase preparation method:

[0094] Heat 350ml of purified water to 50±2℃, add stabilizer (CMC-Na, xanthan gum) in sequence, shear at 5000rpm for 5min, add protein components, carbohydrate components, functional components, vitamins and mineral components, stir to dissolve, and then turn on high shear at 10000rpm for 15min.

[0095] Oil phase preparation method:

[0096] Heat the fat component to 65±2℃, add the emulsifier stabilizing components (mono / diglyceride fatty acid esters, sucrose fatty acid esters), shear at 10000 rpm for 10 min, slowly add the oil phase to the aqueous phase, turn on high shear, shear at 10000 rpm for 30 min, adjust the pH to 6.5±0.5 with sodium bicarbonate solution, and add the remaining purified water.

[0097] Homogenization process: First stage pressure 50MPa, second stage pressure 100MPa, high-pressure homogenization once.

[0098] Post-processing:

[0099] Filling and sterilization: Treat at 118℃ for 15 min (F0 value ≥ 8.0)

[0100] Comparative Example 2:

[0101] The other conditions and preparation methods are the same as in Example 1, except that lactoferrin, N-acetylcysteine, and L-carnitine are not added.

[0102] Experimental Example 1

[0103] Key indicators such as physicochemical properties, microbiological properties, functional properties, sensory properties, and stability of each embodiment and comparative example.

[0104] Table 4 Key Indicator Testing Methods and Requirements

[0105]

[0106] Table 5. Measured data for each embodiment and comparative example.

[0107]

[0108] The results showed that in Examples 1 and 4, the fat energy ratio was approximately 55% (meeting the 50-60% requirement for COPD patients); in Example 3 (high carbohydrate), the increased osmotic pressure and decreased viscosity may lead to rapid gastric emptying, which in turn increases glucose metabolism and increases the risk of elevated RQ; in terms of synergistic effects of functional components: NAC + L-carnitine improved mitochondrial β-oxidation efficiency, and the RQ of patients in Example 1 group decreased to 0.78±0.03 (comparative Example 2 group: 0.85±0.05).

[0109] Meanwhile, three homogenizations plus nitrogen purging (Examples 1 and 4) resulted in increased emulsion stability (centrifugal precipitation rate <2%) due to D90 particle size ≤8μm, and nitrogen purging reduced peroxide value by more than 40%, demonstrating the good process stability of this method.

[0110] Protection of heat-sensitive components: Vitamin C retention rate >88%, compared to only 75% in Comparative Example 1 due to prolonged shearing and oxidation.

[0111] The ORAC values ​​of Examples 1 and 4 exceeded 7000 μmol TE / 100g, indicating that oxidative stress in COPD patients was relieved; and the retention rate of lactoferrin activity >94% confirmed that its anti-inflammatory pathway (TLR4 / NF-κB) regulation ability was not destroyed by the process, which also confirmed its functional effectiveness.

[0112] In summary, the optimal formulation is Example 1. Its physical stability (particle size / stratification control), chemical stability (low oxidation, high nutrient retention), and functional effectiveness (antioxidant, RQ reduction) are achieved through precise macro-ratio (high fat, low carbohydrate) + functional components (NAC + L-carnitine + lactoferrin) + three homogenization nitrogen filling processes, which simultaneously achieve nutritional support and respiratory metabolism improvement, providing evidence-based medical solutions for COPD patients.

[0113] Application and Implementation Methods

[0114] Example 1: Clinical Trial

[0115] Study subjects: One hundred patients with chronic obstructive pulmonary disease (COPD) who received treatment in our hospital between June 2022 and June 2024 were selected as the study subjects. Patients were randomly divided into a control group and an observation group using a random number table, with 50 patients in each group.

[0116] The control group received comprehensive treatment, including:

[0117] (1) Oxygen therapy management: Use nasal cannula to administer oxygen at low flow rates (1-2.5 L / min) to maintain fingertip oxygen saturation (SpO) ≥ 85%; (2) Airway management: Combine nebulized inhalation of β-receptor agonists (salbutamol) and anticholinergic drugs (ipratropium bromide) to relieve bronchospasm; (3) Sputum expectoration therapy: Use expectorants (ambroxol) in conjunction with physical expectoration techniques to promote the clearance of airway secretions; (4) Anti-infection therapy: Select sensitive antibiotics based on sputum culture and drug sensitivity results; (5) Respiratory support: For patients with severe dyspnea or persistent hypercapnia (elevated PaCO2), provide timely non-invasive positive pressure ventilation (NPPV); (6) Nutritional support: Provide routine dietary guidance.

[0118] In addition to the routine treatment received by the control group, the observation group received nutritional support and rehabilitation training interventions as described in Example 1. The specific plan is as follows:

[0119] (1) Nutritional support plan

[0120] Method: The complete nutritional formula of Example 1 was used, and the oral or nasogastric tube route was selected according to the patient's tolerance.

[0121] Dosage adjustment: The initial dose is 500 mL / day, gradually increasing to 1000 mL / day, administered in divided doses to avoid gastrointestinal discomfort.

[0122] Example 1: The formula contains sufficient protein, fat, carbohydrates, vitamins, and minerals to meet basic metabolic needs.

[0123] Treatment and monitoring: Continuous intervention for 10 weeks, during which nutritional intake is dynamically monitored and dosage is adjusted to ensure that the target calorie intake is achieved.

[0124] (2) Assisted Rehabilitation Training Program

[0125] Respiratory muscle training: Under the guidance of a rehabilitation physician, 1-2 times daily, 10-15 minutes each time. Training methods include pursed-lip breathing, abdominal breathing, etc., to strengthen respiratory muscles.

[0126] Endurance training: For those who can tolerate it, use bedside treadmill exercises or passive limb movements to gradually improve exercise endurance.

[0127] Adjust training intensity individually to avoid over-fatigue.

[0128] Safety monitoring: Observe the patient's reaction throughout the process, adjust the training plan in a timely manner, and prevent the condition from worsening.

[0129] (3) Health Education

[0130] Educate patients and their families about the importance of nutritional management and rehabilitation exercises, guide them on the correct operating methods, and improve treatment adherence.

[0131] Evaluation indicators

[0132] Lung function (FEV1% of predicted value, FEV1 / FVC), medical history, nutritional status (BMI (kg / m²) 2 Evaluation indicators include: serum prealbumin, exercise endurance (6MWD (meters), mMRC dyspnea score), metabolic indicators (respiratory quotient (RQ = VCO production / VO consumption), resting energy expenditure), inflammatory markers (serum IL-6 (pg / mL), high-sensitivity CRP (mg / L)), quality of life (SGRQ total score, CAT score), and safety (gastrointestinal adverse reaction rate, liver function abnormalities (elevated ALT)).

[0133] Table 6 Comparison of nutritional indicators before and after treatment in the two groups of patients.

[0134]

[0135]

[0136]

[0137] Results Analysis

[0138] 1. After consuming the sample from Example 1 for 10 weeks, the predicted FEV1% increased from (48.5±6.2)% to (53.2±5.8)% (t=5.32, P<0.01), and the FEV1 / FVC ratio improved from 0.52±0.05 to 0.56±0.04 (t=3.87, P<0.05). This indicates a significant improvement in lung function in the observation group.

[0139] 2. The number of acute exacerbations per year decreased from (1.8±0.6) times to (1.1±0.4) times (Z=4.15, P<0.001). Kaplan-Meier analysis showed that the median time to first exacerbation increased to 60 days (Log-rank χ²). 2 =8.76, HR=0.62, 95% CI 0.45-0.82), indicating that the acute exacerbation was under control.

[0140] 3. Before and after the intervention, nutritional status, metabolic and inflammation control, and quality of life indicators showed significant improvement, and functional abilities were enhanced; furthermore, the incidence of adverse reactions was low and mild, indicating good safety.

[0141] The above results confirm that nutritional intervention in Example 1 can simultaneously improve lung function, nutritional status and systemic inflammation in COPD patients, and prolongs the time to first exacerbation by 41% (HR=0.62), which has important clinical significance.

[0142] In summary, this invention provides a complete nutritional formula food specifically for patients with respiratory diseases and its preparation method. This formula, through the scientific ratio of macronutrients and functional components, specifically meets the special nutritional needs of patients with chronic obstructive pulmonary disease (COPD), cystic fibrosis-related lung lesions, and post-infectious lung injury.

[0143] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A nutritional formula, characterized in that, By weight parts, comprising the following components: Protein component: casein 1.0-1.5 parts, hydrolyzed whey protein 1.0-3.0 parts, lactoferrin 0.05-0.1 parts; Fat component: medium-chain triglyceride (MCT) 0.5-1.5 parts, linoleic acid 0.1-0.2 parts, alpha-linolenic acid 0.1-0.2 parts, algal oil 0.1-0.2 parts, soybean phospholipid 0.05-0.1 parts; Carbohydrate component: resistant starch 1.0-2.0 parts, resistant dextrin 0.5-2.0 parts, fructooligosaccharide 0.1-0.4 parts; Complex vitamin component: containing vitamin A, vitamin C, vitamin D, vitamin E, vitamin B1, vitamin B2, vitamin B6, niacin, pantothenic acid, vitamin B12, vitamin K1, folic acid, biotin; Total amount 0.05-0.1 parts; Complex mineral component: containing sodium, potassium, magnesium, iron, zinc, calcium, phosphorus, copper, manganese, iodine, selenium, chromium, molybdenum, total amount 0.1-0.30 parts; Oil phase emulsifier component: at least one or more of monoglyceride / fatty acid ester, sucrose fatty acid ester, soybean phospholipid, 0.1-0.5 parts; Water phase stabilizer / thickener component: at least one or two of sodium carboxymethyl cellulose, xanthan gum, pectin, carrageenan, konjac gum, 0.1-0.3 parts; Functional nutrient component: containing at least one or two of hydrogenated choline, L-carnitine (L-carnitine), N-acetylcysteine, total amount 0.01-0.07 parts; Flavoring agent component: containing at least one or two of stevioside, mogroside, food flavor, total amount 0.0004-0.5 parts; Carrier: purified water 80-100 parts.

2. The nutritional formula of claim 1, wherein, The weight ratio of casein to hydrolyzed whey protein in the protein component is 1:2, and the lactoferrin content is 50-100 μg / 100 ml of the composition.

3. The nutritional formula of claim 1, wherein, The weight ratio of medium-chain triglyceride (MCT), linoleic acid, algal oil, and alpha-linolenic acid in the fat component is 7:1:1:

1.

4. The nutritional formula of claim 1, wherein, The content of vitamin D in the complex vitamin component is 100-800 IU / 100 g of the composition.

5. The nutritional formula of claim 1, wherein, The content of selenium in the complex mineral component is 20-100 μg / 100 g of the composition.

6. A process for the preparation of a nutritional formula as claimed in any one of claims 1 to 5, characterized in that, The method comprises the following steps: S1. Preheat 80% of the total amount of purified water to 55±5℃; S2. Mix the water phase emulsifier / thickener component uniformly and add it to the preheated water, then high-speed shear at 5000 rpm for 5-10 min; S3. Add the protein component, carbohydrate component, complex vitamin component, complex mineral component, functional nutrient component, flavoring agent component, and dietary fiber component in sequence, adjust the pH to 6.5±0.5, and high-speed shear at 10000 rpm for 30-45 min to obtain a water phase solution; S4. Heat the fat component to 65-70℃, add the oil phase emulsifier component, and high-speed shear at 10000 rpm for 15-30 min to obtain an oil phase solution; S5. The oil phase solution is slowly added into the water phase solution, and high-speed shearing is conducted at 10000 rpm for 30-45 min to form an oil-in-water emulsion; the pH is adjusted to 6.5±0.2 by using a sodium bicarbonate solution, and the rest is made up with purified water; S6. The emulsion is subjected to high-pressure homogenization treatment, with a first-stage pressure of 40-60 MPa, a second-stage pressure of 80-120 MPa, and a homogenization temperature of 30-50°C, under nitrogen protection; S7. After being dispensed, sterilization is conducted at 115-121°C for 15-30 min.

7. The production method according to claim 6, characterized by, The high-pressure homogenization treatment is repeated for 3 times.

8. The preparation method according to claim 6, characterized in that, The sterilization process uses food-grade polypropylene, glass or metal containers for packaging.

9. Use of the nutritional formula food according to any one of claims 1-5 in the preparation of a product for improving the nutritional status of patients with chronic obstructive pulmonary disease, cystic fibrosis-related lung lesions or lung damage after pneumonia infection.

10. Use according to claim 9, characterized in that, The product is used to reduce the respiratory quotient (RQ) of the patient to below 0.80.

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