CN111406935A - Carbohydrate component formula food suitable for preoperative taking and having special medical application and application thereof - Google Patents

Carbohydrate component formula food suitable for preoperative taking and having special medical application and application thereof Download PDF

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Publication number
CN111406935A
CN111406935A CN202010461635.7A CN202010461635A CN111406935A CN 111406935 A CN111406935 A CN 111406935A CN 202010461635 A CN202010461635 A CN 202010461635A CN 111406935 A CN111406935 A CN 111406935A
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preoperative
food
special medical
formula food
carbohydrate component
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张磊
朱成龙
高丽鹤
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Shandong Tanke Biotechnology Co ltd
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Shandong Tanke Biotechnology Co ltd
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    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/30Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
    • A23L29/35Degradation products of starch, e.g. hydrolysates, dextrins; Enzymatically modified starches
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/125Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23VINDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00Food compositions, function of food ingredients or processes for food or foodstuffs

Abstract

The invention relates to a carbohydrate component formula food with special medical application suitable for preoperative taking and application thereof, wherein the carbohydrate component formula food with special medical application suitable for preoperative taking comprises the following components in parts by weight: 90-99 parts of modified maltodextrin, 0.5-6.0 parts of oligosaccharide, 0.05-0.5 part of acidity regulator and 0.001-0.050 part of essence for food. The invention is developed by scientifically proportioning improved slowly digestible maltodextrin, oligosaccharide, acidity regulator, food essence and the like, and is a carbohydrate component formula food with special medical application, which can meet the requirements of hunger and thirst feeling of patients before operation, promote intestinal microecological recovery and improve insulin resistance of patients after operation and is suitable for preoperative taking.

Description

Carbohydrate component formula food suitable for preoperative taking and having special medical application and application thereof
Technical Field
The invention relates to a carbohydrate component formula food suitable for preoperative taking and having special medical application and application thereof, belonging to the technical field of special foods.
Background
The formula food for special medical application is specially processed and prepared for meeting the special requirements of people with limited food intake, digestive absorption disorder, metabolic disorder or specific disease states on nutrients or diet. The product must be eaten alone or in combination with other foods under the guidance of doctors or clinical dieticians, and mainly comprises three types: a total nutrient formula food, a specific total nutrient formula food, a non-total nutrient formula food.
Currently, pre-operative fasting is a conventional method for reducing the capacity and acidity of gastric contents to reduce the risk of pulmonary aspiration, however, some studies report that too long fasting and drinking forbiddance do not reduce the content of gastric contents, but rather cause the patient to be thirsty, hungry, or even hypoglycemia or dehydration. To promote rapid postoperative recovery in patients, many international guidelines recommend shortening the fasting time for elective surgery. These guidelines recommend fasting solid food for 6h prior to surgery and liquid deprivation for 2h, especially the european accelerated rehabilitation society recommends ingestion of carbohydrate solution for 2h prior to surgery.
Traditional preoperative fasting causes the liver glycogen storage of the body to be completely consumed, so that energy substances capable of being directly utilized are exhausted, and the body is in a catabolic state. The increased blood glucose level in the diet can cause many metabolic changes, such as the cessation of gluconeogenesis, the decrease and increase of hepatic glycogen release, the activation of glucose transporters in muscle tissue (e.g., glucose transporter 4), the conversion of glucose uptake into myoglycogen by skeletal muscle cells, and the breakdown of fat and protein. This anabolic change persists for about 4 hours after feeding with insulin release and glycogen storage, and anabolism is ideal when a patient is subjected to surgery.
Studies have shown that preoperative intake of carbohydrate fluids increases glycogen storage in the body, reduces glycogen catabolism, decreases insulin resistance, and has a positive impact on post-operative glycemic control and muscle protection in patients. The european society of anesthesiology's new guidelines also indicate that the preoperative oral carbohydrate is safe for obese, gastroesophageal reflux disease, diabetes, and pregnant patients.
In developed countries such as the United states and European Union, special medical food has corresponding regulations, development and application; national GB29922-2013 general rules of formula food for special medical applications clearly stipulated in national food safety standards, and 2.1.3 non-total nutrient formula food: can meet the partial nutritional requirements of target people.
Chinese patent document CN111011863A discloses a medical electrolyte composition and a preparation method thereof, wherein the composition comprises the following components by mass percent: 8 to 22 percent of maltodextrin, 2 to 6 percent of crystalline fructose, 0.3 to 3 percent of oligosaccharide, 0.1 to 0.7 percent of compound mineral, 0.2 to 1 percent of citric acid, 0 to 0.05 percent of food essence and the balance of water. However, the monosaccharide crystalline fructose contained in the invention enables the composition to have high osmotic pressure and low gastric emptying speed, and increases the risks of food aspiration and reflux in the operation.
Chinese patent document CN108841896A discloses a method for producing high-quality maltodextrin, belonging to the technical field of maltodextrin, on the basis of the traditional maltodextrin production process by using an enzyme method, the invention introduces starch branching enzyme from Rhodothermus muscobamensis, cuts off α -1,4 glycosidic bonds, connects the cut short chains to an acceptor chain to form α -1,6 branching points, increases the branching degree of the branching enzyme, has more cluster structures, thereby achieving the purpose of enhancing the stability of maltodextrin and making the maltodextrin not easy to regenerate.
To date, the food with special medical application in domestic market is in the initial stage of research and development, and the raw materials and the proportion are not clear.
Disclosure of Invention
Aiming at the defects of the prior art, the invention provides a carbohydrate component formula food suitable for preoperative taking and having special medical application and application thereof.
The technical scheme of the invention is as follows:
a carbohydrate component formula food suitable for preoperative use and having special medical purposes comprises the following components in parts by weight: 90-99 parts of modified maltodextrin, 0.5-6.0 parts of oligosaccharide, 0.05-0.5 part of acidity regulator and 0.001-0.050 part of essence for food.
Preferably, the carbohydrate component formula food suitable for the special medical application taken before the operation comprises the following components in parts by weight: 94-98 parts of modified maltodextrin, 1.0-4.0 parts of oligosaccharide, 0.1-0.4 part of acidity regulator and 0.005-0.030 part of essence for food.
According to the present invention, the oligosaccharide is preferably one or more of fructo-oligosaccharide, isomaltooligosaccharide, galacto-oligosaccharide, lactulose oligosaccharide, primary arabinofuranose, glucosylsucrose, maltooligosaccharide, cyclodextrin, gentiooligosaccharide, soybean oligosaccharide and xylooligosaccharide.
Preferably according to the invention, the acidity regulator is one or more of citric acid, citrate or malic acid.
According to the invention, the modified maltodextrin is preferably maltodextrin modified by a biological enzyme method, and the specific modification method comprises the following steps:
the preparation method comprises the steps of taking sodium acetate (pH 6.5, 25% w/v) as a buffer solution, boiling Waxy Corn Starch (WCS) into paste, adding Branching Enzyme (BE) at 65 ℃, stirring for 24 hours to obtain a suspension of the branching enzyme treated waxy corn starch, carrying out boiling water bath for 10 minutes after stirring is finished, then mixing and stirring for 10 minutes with 1M sodium acetate buffer solution, incubating the mixture with β -amylase (BA) for 24 hours at 55 ℃ after stirring is finished, boiling the water bath for 10 minutes after incubation is finished, then dialyzing in deionized water, and finally freeze-drying, grinding and sieving with a 120-mesh sieve to obtain the biological enzyme method modified maltodextrin.
According to the invention, the mass-to-volume ratio of the waxy corn starch to the sodium acetate buffer is 300:1, unit g/L, based on the dry weight of the waxy corn starch.
According to the invention, the addition amount of the branching enzyme is preferably 300-500U/g based on the dry weight of the waxy corn starch.
Preferably, according to the invention, the weight ratio of the suspension of the branching enzyme-treated waxy maize starch to 1M sodium acetate buffer is 19: 1.
According to the invention, the β -amylase is preferably added in an amount of 0.6-0.7% of the dry weight of the waxy corn starch.
According to the invention, the molecular weight cut-off of the dialysis bag used for dialysis is 3000-4000.
The preparation method of the carbohydrate component formula food suitable for preoperative taking and special medical application comprises the following steps:
weighing → mixing → homogenizing → pasteurising → spray drying → cooling → mixing → packaging.
According to the invention, the homogenizing pressure is 25-50 MPa, the homogenizing time is 15-25 min, and the temperature is 50-60 ℃; further preferably, the pressure is 35-40 MPa, the time is 18-21 min, and the temperature is 54-58 ℃.
Preferably, the pasteurization time is 15-20 min, and the temperature is 70-77 ℃; further preferably, the time is 16-18 min, and the temperature is 72-75 ℃.
According to the invention, the feeding temperature of spray drying is preferably 40-50 ℃, the feeding concentration is 35-50%, the sample injection speed is 3-10 m L/min, the air inlet temperature is 140-180 ℃, the spray flow is 4-10 m L/min, the pressure of a spray head is 15-20 MPa, the temperature of a drying chamber is 85-95 ℃, the feeding temperature is further preferably 43-47 ℃, the feeding concentration is 42-47%, the sample injection speed is 5-8 m L/min, the air inlet temperature is 160-175 ℃, the spray flow is 6-8 m L/min, the pressure of the spray head is 16-18 MPa, and the temperature of the drying chamber is 89-93 ℃.
An oral solution of carbohydrate component formula food suitable for preoperative use and special medical application is prepared by adding 100m L water into 12.5g formula food, wherein the osmotic pressure is controlled to be below 245 mmol/L, and the pH value is controlled to be 5-6.5.
The raw materials involved in the invention are food-grade raw materials, and can be purchased in the market or prepared according to the existing food-grade technology.
The invention comprises the following effective components and the functions:
maltodextrin, 2: the traditional food can cause rapid rise of blood sugar while supplementing energy for preoperative patients, is not beneficial to maintaining steady state of blood sugar and achieving the effect of continuous function, and adopts a biological enzyme method to carry out branching modification on maltodextrin, so that the transparency and the stability of the food are improved, aggregation, coagulation and precipitation are not easy to happen, and the digestion performance of the food is also improved; in terms of safety of preoperative oral carbohydrates, the amount of liquid is the most important factor affecting gastric emptying, followed by the composition of the liquid, the speed of emptying of the gastric liquid decreases with increasing osmotic pressure, while maltodextrin gives little osmotic pressure in the mix.
The oligosaccharide is functional oligosaccharide, such as fructo-oligosaccharide, isomaltooligosaccharide, galacto-oligosaccharide and the like, and research shows that the oligosaccharide also has the important physiological functions of ① regulating intestinal flora and improving the intestinal environment, ② generating nutrient substances and promoting nutrient absorption, ③ removing harmful substances and playing an antioxidation role, ④ reducing blood sugar and cholesterol, ⑤ protecting a mucous membrane system and regulating organism immunity, in addition, the oligosaccharide has certain sweetness, can improve the taste of a carbohydrate component, and is beneficial to storage of the carbohydrate due to the characteristics of antioxidation activity, antifungal activity, inhibition of bacterial proliferation and the like.
Acidity regulator: the acidity regulator selected in the invention is citric acid, citrate, malic acid and the like, can be prepared into a buffer system, and has the characteristic of stabilizing the pH value of food; such acidity regulators also have a pleasant, refreshing sour taste with a rapid loss of taste sensation, which modifies the sweet taste in carbohydrates.
Essence for food: the food essence selected in the invention is natural food essence, has relatively high safety, can increase appetite and is beneficial to digestion and absorption.
The invention has the beneficial effects that:
1. the modified maltodextrin is modified by a biological enzyme method, has increased transparency and stability, is not easy to agglomerate and precipitate, and improves the overall quality of the carbohydrate component formula food suitable for the special medical application taken before an operation, and finally forms β -limit dextrin with large molecular weight, and the proportion of α -1 and 6 branch points is more, the hydrolysis rate of a-1 and 6 bonds in a human body is lower than that of a-1 and 4 bonds, so the digestion and absorption speed is slower, the digestion performance is improved, the blood sugar of a patient before the operation cannot be increased rapidly, and the energy supply is more durable.
2. The food formula of the invention adopts functional oligosaccharide, avoids the use of monosaccharide, can reduce the osmotic pressure of the oral solution prepared from the carbohydrate component formula food with special medical application suitable for preoperative taking, and the osmotic pressure of the prepared oral solution belongs to the hypotonic category; as the preoperative patients generally carry out preventive injection of antibiotics to cause unbalance of intestinal flora and increase of pathogenic bacteria, the regulation function of the functional oligosaccharide on the intestinal flora can be realized through direct and indirect effects. The functional oligosaccharide can be directly combined with phytohemagglutinin on the surface of pathogenic bacteria to adsorb pathogenic bacteria. After binding with functional oligosaccharides, the pathogenic bacteria lose their ability to recognize and bind to the intestinal lining, and can no longer utilize functional oligosaccharides to obtain nutrients, which eventually leads to death and excretion from the body. The functional oligosaccharide can also indirectly regulate the intestinal flora by promoting the proliferation of beneficial bacteria such as bifidobacterium and the like and inhibiting harmful bacteria.
3. The carbohydrate component formula food suitable for preoperative taking and special medical application is solid powder, the osmotic pressure of the prepared oral solution belongs to the hypotonic range, the quantity of liquid is the most important factor in the aspect of safety of preoperative oral carbohydrate and influence on gastric emptying, and the liquid is composed secondly, the emptying speed of intragastric liquid is reduced along with the increase of the osmotic pressure, so that the hunger and thirst feeling of a patient before a preoperative can be relieved, the intestinal microecology recovery is promoted, and the insulin resistance of the patient after the operation is improved.
4. In the production process, the spray drying technology is adopted, so that the mixing property of the product can be effectively improved, and the mixing uniformity of the product is better.
Detailed Description
The invention will be further described with reference to specific examples to better understand the invention, without limiting the scope of the invention thereto.
Methods not described in detail in the present invention are well known to those skilled in the art. The raw materials involved in the invention are food-grade raw materials, and can be purchased in the market or prepared according to the existing food-grade technology.
Example 1
A carbohydrate component formula food suitable for preoperative use and having special medical purposes comprises the following components in parts by weight: 97 parts of modified maltodextrin, 2.79 parts of oligosaccharide, 0.2 part of acidity regulator and 0.01 part of essence for food.
Wherein the oligosaccharide is a mixture of fructo-oligosaccharide, isomaltooligosaccharide, galacto-oligosaccharide and the like in weight ratio;
the acidity regulator is citric acid and malic acid, and the weight ratio is 4: 1;
the essence for food is strawberry essence;
the modified maltodextrin is modified by a biological enzyme method, and comprises the following specific modification steps:
boiling Waxy Corn Starch (WCS) into paste by using sodium acetate (pH 6.5, 25% w/v) as a buffer solution, adding branching enzyme (BE, 300U/g, based on the dry weight of the waxy corn starch) at 65 ℃, stirring for 24 hours to obtain a suspension of the branching enzyme treated waxy corn starch, (BE-WCS), boiling in a water bath for 10 minutes after stirring is finished, mixing the suspension of the branching enzyme treated waxy corn starch with 1M sodium acetate buffer solution, stirring for 10 minutes, incubating the mixture with β -amylase (BA) for 24 hours at 55 ℃, boiling in the water bath for 10 minutes after incubation is finished, dialyzing in deionized water (the cut-off molecular weight of a dialysis bag is 3000), removing oligosaccharide released by β -amylase reaction and salt ions in the buffer solution, freeze-drying, grinding, and sieving by a 120-mesh sieve to obtain the maltodextrin modified by the biological enzyme method.
The mass-volume ratio of the waxy corn starch to the sodium acetate buffer solution is 300:1, the unit g/L, and the weight ratio of the branching enzyme treatment waxy corn starch suspension to the 1M sodium acetate buffer solution is 19: 1.
The preparation method of the carbohydrate component formula food suitable for preoperative taking and special medical application comprises the following steps:
weighing → mixing → homogenizing → pasteurising → spray drying → cooling → mixing → packaging.
Wherein, the main process parameters are as follows:
homogenizing: pressure 36Mpa, time 20min, temperature 56 deg.C;
pasteurization: the time is 17min, and the temperature is 73 ℃;
spray drying, wherein the feeding temperature is 45 ℃, the feeding concentration is 44%, the sample injection speed is 7m L/min, the air inlet temperature is 168 ℃, the spray flow is 7m L/min, the pressure of a spray head is 17MPa, and the temperature of a drying chamber is 91 ℃.
An oral liquid suitable for preoperative administration and containing carbohydrate component formula food for special medical application is prepared by adding water of 100m L into 12.5g formula food, and has osmotic pressure controlled below 120 mmol/L and pH controlled at 5.5.
Example 2
A carbohydrate component formula food suitable for preoperative use and having special medical purposes comprises the following components in parts by weight: 96 parts of modified maltodextrin, 3.685 parts of oligosaccharide, 0.3 part of acidity regulator and 0.015 part of essence for food.
Wherein the oligosaccharide is a mixture of fructo-oligosaccharide, lactosucrose, galacto-oligosaccharide and the like in weight proportion;
the acidity regulator is citric acid and malic acid, and the weight ratio is 4: 1;
the essence for food is strawberry essence;
the modified maltodextrin is modified by a biological enzyme method, and comprises the following specific modification steps:
boiling Waxy Corn Starch (WCS) into paste by using sodium acetate (pH 6.5, 25% w/v) as a buffer solution, adding branching enzyme (BE, 400U/g, calculated by the dry weight of the waxy corn starch) at 65 ℃, stirring for 24 hours to obtain a suspension of the branching enzyme treated waxy corn starch, (BE-WCS), boiling water bath for 10 minutes after stirring is finished, then mixing the suspension of the branching enzyme treated waxy corn starch with 1M sodium acetate buffer solution, stirring for 10 minutes, incubating the mixture with β -amylase (BA) for 24 hours at 55 ℃, boiling water bath for 10 minutes after incubation is finished, then dialyzing in deionized water (the molecular weight cut-off of a dialysis bag is 3500), removing oligosaccharide released by β -amylase reaction and salt ions in the buffer solution, freeze-drying, grinding, and sieving by a 120-mesh sieve to obtain the maltodextrin modified by the biological enzyme method.
The mass-volume ratio of the waxy corn starch to the sodium acetate buffer solution is 300:1, the unit g/L, and the weight ratio of the branching enzyme treatment waxy corn starch suspension to the 1M sodium acetate buffer solution is 19: 1.
The preparation method of the carbohydrate component formula food suitable for preoperative taking and special medical application comprises the following steps:
weighing → mixing → homogenizing → pasteurising → spray drying → cooling → mixing → packaging.
Wherein, the main process parameters are as follows:
homogenizing: pressure 36Mpa, time 20min, temperature 56 deg.C;
pasteurization: the time is 17min, and the temperature is 73 ℃;
spray drying, wherein the feeding temperature is 45 ℃, the feeding concentration is 44%, the sample injection speed is 7m L/min, the air inlet temperature is 168 ℃, the spray flow is 7m L/min, the pressure of a spray head is 17MPa, and the temperature of a drying chamber is 91 ℃.
An oral liquid suitable for preoperative administration and containing carbohydrate component formula food for special medical application is prepared by adding water of 100m L into 12.5g formula food, and has osmotic pressure of 150 mmol/L and pH value of 5.5.
Example 3
A carbohydrate component formula food suitable for preoperative use and having special medical purposes comprises the following components in parts by weight: 97 parts of modified maltodextrin, 2.79 parts of oligosaccharide, 0.2 part of acidity regulator and 0.01 part of essence for food.
Wherein the oligosaccharide is a mixture of fructo-oligosaccharide, isomaltooligosaccharide, galacto-oligosaccharide and the like in weight ratio;
the acidity regulator is citric acid and malic acid, and the weight ratio is 4: 1;
the essence for food is strawberry essence;
boiling Waxy Corn Starch (WCS) into paste by using sodium acetate (pH 6.5, 25% w/v) as a buffer solution, adding branching enzyme (BE, 500U/g, calculated by the dry weight of the waxy corn starch) at 65 ℃, stirring for 24 hours to obtain a suspension of the branching enzyme treated waxy corn starch, (BE-WCS), boiling water bath for 10 minutes after stirring is finished, then mixing the suspension of the branching enzyme treated waxy corn starch with 1M sodium acetate buffer solution, stirring for 10 minutes, incubating the mixture with β -amylase (BA) for 24 hours at 55 ℃, boiling water bath for 10 minutes after incubation is finished, then dialyzing in deionized water (the cut-off molecular weight of a dialysis bag is 4000), removing oligosaccharide released by β -amylase reaction and salt ions in the buffer solution, freeze-drying, grinding, and sieving by a 120-mesh sieve to obtain the maltodextrin modified by the biological enzyme method.
The mass-volume ratio of the waxy corn starch to the sodium acetate buffer solution is 300:1, the unit g/L, and the weight ratio of the branching enzyme treatment waxy corn starch suspension to the 1M sodium acetate buffer solution is 19: 1.
The preparation method of the carbohydrate component formula food suitable for preoperative taking and special medical application comprises the following steps:
weighing → mixing → homogenizing → pasteurising → spray drying → cooling → mixing → packaging.
Wherein, the main process parameters are as follows:
homogenizing: the pressure is 38Mpa, the time is 19min, and the temperature is 55 ℃;
pasteurization: the time is 18min, and the temperature is 75 ℃;
spray drying, wherein the feeding temperature is 46 ℃, the feeding concentration is 46%, the sample feeding speed is 8m L/min, the air inlet temperature is 170 ℃, the spray flow is 8m L/min, the pressure of a spray head is 18MPa, and the temperature of a drying chamber is 90 ℃.
An oral liquid suitable for preoperative administration and containing carbohydrate component formula food for special medical application is prepared by adding water of 100m L into 12.5g formula food, and has osmotic pressure of 140 mmol/L and pH value of 5.5.
Comparative example 1
A carbohydrate module formula for a specific medical use suitable for pre-operative administration as described in example 1, except that: the maltodextrin was not modified by the biological enzyme method.
Comparative example 2
A carbohydrate module formula for a specific medical use suitable for pre-operative administration as described in example 1, except that: no oligosaccharide is added.
Comparative example 3
A carbohydrate module formula for a specific medical use suitable for pre-operative administration as described in example 1, except that: 1/3 for the modified maltodextrin quality was replaced by crystalline fructose of equivalent quality.
Experimental example 1
Through comparative analysis and evaluation, the carbohydrate component formula food with special medical application, which is suitable for preoperative taking, prepared in the embodiments 1 to 3 and the comparative examples 1 to 2 improves subjective comfort, blood glucose concentration, blood insulin concentration, insulin resistance index and intestinal flora of the surgical patients.
Grouping experiments: selected surgery patients without gastroparesis and special aspiration risk, aged 18-75 years, were randomly divided into a drinking prohibited group (30 cases), a comparative example 1 group (30 cases), a comparative example 2 group (30 cases), an example 1 group (30 cases), an example 2 group (30 cases) and an example 3 group (30 cases);
the intervention method comprises the steps of soaking the carbohydrate component formula food which is prepared in the examples 1-3 and the comparative examples 1-2 and is suitable for preoperative use and is used for special medical purposes, stirring uniformly, preparing an oral solution of 400m L, and taking the subjects of the comparative examples 1, 2 and 1 for 2-3 hours before surgery.
Anesthesia and intraoperative observation: neither of examples 1 to 3 nor comparative examples 1 and 2 showed the phenomenon of aspiration and reflux.
Subjective comfort related indexes (thirst and hunger) of the patients are measured by a Visual Analogue Scale (VAS) at 2h after the day and the night before the operation and at 1h after the operation respectively, and test results are shown in Table 1.
TABLE 1 subjective comfort before Subjects VAS score results (units: points)
Figure BDA0002511199610000071
Note: a: the P is less than 0.05 vs.
As can be seen from Table 1, comparison among groups shows that the thirst and hunger VAS scores of 2h after noon and afternoon before operation of each group have no statistical significance (P is more than 0.05), and in 1h before operation, compared with a drinking prohibited group, the thirst and hunger VAS scores of the groups of examples 1-3 are remarkably reduced (P is less than 0.05); the comparison in the group shows that compared with the 2h before the day, the afternoon and the meal before the operation, the VAS scores of thirst and hunger sensation are not statistically significant (P is more than 0.05), and compared with the 2h after the afternoon and the meal before the operation, the VAS scores of thirst and hunger sensation are significantly reduced (P is less than 0.05) in the 1h before the operation of the group 1-3; the above shows that the preoperative oral administration of the carbohydrate component formula food with special medical application can effectively relieve the thirst and hunger of preoperative patients.
Determination of blood glucose and serum insulin concentrations: peripheral venous blood of the testee is extracted with fasting before and after operation, and the blood sugar concentration and the serum insulin concentration of the patient are respectively measured. The IR index was calculated using a steady state mode evaluation method (HOMA). The IR index (fasting blood glucose concentration x fasting insulin concentration)/22.5, and the test results are shown in tables 2 and 3.
TABLE 2 comparison of blood glucose levels of subjects (unit: mmol/L)
Drinking forbidding group Comparative example 1 group EXAMPLE 1 group EXAMPLE 2 group EXAMPLE 3 group
Before operation 4.77±0.09 4.79±0.04 4.73±0.12 4.74±0.09 4.76±0.08
After operation 10.53±0.28a 8.46±0.59a,b 6.95±0.61a,b,c 6.98±0.60a,b,c 6.93±0.53a,b,c
Note: a: before each group of the operation, P is less than 0.05 vs; b: p is less than 0.05vs postoperative drinking prohibition group; c: p < 0.05 vs. comparative example 1 after surgery.
As can be seen from Table 2, the comparison among groups shows that the blood glucose concentration of the preoperative subjects of each group is not statistically different (P is greater than 0.05), and the blood glucose concentration of the subjects of the postoperative examples 1-3 and the comparative example 1 is lower than that of the drinking prohibited group (P is less than 0.05), which indicates that the carbohydrate component formula food for special medical application suitable for preoperative taking can effectively avoid the body stress blood glucose rise caused by preoperative fasting; and the blood sugar concentration of the subjects in the group of comparative example 1 is higher than that in the groups of examples 1-3 (P is less than 0.05), which shows that the maltodextrin modified by the biological enzyme method plays a role in stabilizing the blood sugar concentration of postoperative patients.
TABLE 3 comparison of blood insulin values of subjects (unit: μ IU/m L)
Drinking forbidding group Comparative example 1 group EXAMPLE 1 group EXAMPLE 2 group EXAMPLE 3 group
Before operation 8.52±0.28 8.45±0.33 8.42±0.23 8.30±0.39 8.44±0.44
After operation 41.15±0.40a 16.96±1.09a,b 10.45±0.29a,b,c 10.42±0.27a,b,c 10.47±0.29a,b,c
Note: a: before each group of the operation, P is less than 0.05 vs; b: p is less than 0.05vs postoperative drinking prohibition group; c: p < 0.05 vs. comparative example 1 after surgery.
As can be seen from Table 3, the comparison among groups shows that the blood insulin concentrations of the subjects before operation in each group are not statistically different (P > 0.05), and the blood insulin concentrations of the subjects in the groups of the postoperative examples 1-3 and the comparative example 1 are lower than that of the drinking prohibited group (P < 0.05), which indicates that the carbohydrate component formula food for special medical use suitable for preoperative taking can effectively avoid the blood insulin concentration increase caused by preoperative fasting; and the blood insulin concentration of the subjects in the comparative example 1 group is higher than that in the examples 1-3 groups (P is less than 0.05), which shows that the maltodextrin modified by the biological enzyme method plays a role in stabilizing the blood insulin concentration of postoperative patients.
Table 4 subject insulin resistance index results
Drinking forbidding group Comparative example 1 group EXAMPLE 1 group EXAMPLE 2 group EXAMPLE 3 group
Before operation 1.80±0.07 1.80±0.08 1.77±0.06 1.80±0.05 1.78±0.08
After operation 19.27±0.56a 6.38±0.28a,b 3.22±0.29a,b,c 3.23±0.30a,b,c 3.22±0.24a,b,c
Note: a: before each group of the operation, P is less than 0.05 vs; b: p is less than 0.05vs postoperative drinking prohibition group; c: p < 0.05 vs. comparative example 1 after surgery.
As can be seen from Table 4, the comparison between groups shows that there is no statistical difference in the insulin resistance index of the subjects before operation (P > 0.05), and the insulin resistance indexes of the subjects in the groups of the postoperative examples 1-3 and the comparative example 1 are lower than that of the prohibited group (P < 0.05), which indicates that the carbohydrate component formula food for special medical use suitable for preoperative taking of the invention can effectively avoid insulin resistance caused by preoperative fasting; and the insulin resistance of the subjects in the group 1 of the comparative example is higher than that of the subjects in the groups 1 to 3 of the examples (P is less than 0.05), which shows that the maltodextrin modified by the biological enzyme method has the effect of improving the insulin resistance of postoperative patients.
Experimental example 2 detection of Lactobacillus in intestinal tract of subject
The specific detection steps include collecting about 0.5g of aseptically collected feces of subjects of examples 1-3, drink-prohibited and comparative example 2, diluting with sterile diluent (0.5% L-cysteine) for 10 times, diluting for 7 times, shaking and mixing to obtain a uniform suspension, marking the dilution (one plate is divided into 6 grids on average) on a 9cm plate, and pouring L bs agar cultureAnd (3) drying the solidified substrate in a constant temperature box at 50 ℃ for about 30 min. Choose 10-4、10-5、10-6And 3 dilutions, performing surface dot-drop on a flat plate, performing seed drop from high dilution, making two parallel samples for each dilution, wherein the inoculation amount is 20 mu L, putting the flat plate into a 37 ℃ incubator for culturing for 48h after the flat plate is dried, counting, and calculating the number of bacteria in each gram of excrement, wherein the detection method after the test is the same as that before the test, and the results are shown in Table 5.
TABLE 5 results of changes in the fecal flora of subjects (unit: CFU/g)
Drinking forbidding group Comparative example 2 Example 1 Example 2 Example 3
Before operation 5.25±0.08 5.27±0.15 5.24±0.09 5.19±0.12 5.20±0.11
After operation 5.22±0.09 5.25±0.03 7.49±0.31a,b 7.51±0.25a,b 7.55±0.28a,b
Note: a: before each group of the operation, P is less than 0.05 vs; b: p < 0.05 vs. comparative example 2.
As can be seen from Table 5, the comparison among groups shows that the number of lactobacillus in the feces of the subjects among the groups before the operation is not statistically different (P is more than 0.05), the comparison between the comparative example 2 group after the operation and the drinking prohibition group shows that the number of lactobacillus in the feces of the subjects is not statistically different (P is more than 0.05), and the comparison between the operation and the drinking prohibition group and the comparative example 2 group shows that the number of lactobacillus in the feces of the subjects among the groups 1 to 3 can be remarkably increased (P is less than 0.05); the comparison in the group shows that the number of the lactobacillus in the excrement of the test subject before and after the drinking forbidding group and the group of the comparative example 2 has no statistical difference (P is more than 0.05), and the number of the lactobacillus in the excrement of the test subject in the group of the examples 1-3 is higher than that before the operation (P is less than 0.05); the addition of oligosaccharide can effectively improve the number of lactobacillus in intestinal flora.
Experimental example 3 gastric emptying test
The specific test method and the standard are that 40 healthy volunteers without operation are aged 18-75 years and grouped randomly, 10 of each group is A, B, C, D groups, the carbohydrate component formula food with special medical application suitable for preoperative taking and prepared in the examples 1-3 and the comparative example 3 is brewed by warm boiled water and stirred uniformly to prepare the oral solution 400m L, and the healthy volunteers drink the oral solution prepared in the examples 1, 2, 3 and the comparative example 3 respectively in an empty stomach.
A shorter gastric emptying time indicates a lower osmotic pressure of the oral solution at the same dosage of the oral solution.
The anteroposterior diameter (AP) and the cranial-caudal diameter (CC) of the antrum were measured by scanning at the sagittal site of the abdominal aorta level, and at each observation, three measurements were taken using the anteroposterior diameter (AP) and the cranial-caudal diameter (CC) diameters, and the antrum area was calculated as follows.
CSA (antrum area) ═ pi × (AP × CC/4)
The stomach volume (GV) is calculated by using a numerical model formula established by Perlas, wherein the model is suitable for adults with the stomach volume less than 500m L, and the formula is that GV is 27+14.6 × CSA-1.28 × years (y)
Empty stomach means that stomach contents can not be seen in both the supine position and the 45-degree right side lying position, or the stomach contents are liquid, the stomach volume/body weight ratio is less than or equal to 1.5m L/kg, and researches prove that the amount of gastric juice of 1.5m L/kg is a more reliable threshold value, represents the upper limit of normal baseline gastric secretion, and is the recognition standard for clinically evaluating the risk of regurgitation and aspiration at present.
We set calculated GV on fasting as baseline, calculated CSA and GV as measured AP and CC values of antrum at experimentally set time points (3, 15, 30, 60, 90, 120min), and at a time point GV returned to baseline on fasting (i.e. no statistical difference compared to GV measured on fasting) and the stomach volume/body weight ratio reached ≦ 1.5m L/kg, i.e. it was considered that the stomach had been emptied of fluid at that time point, this time point was defined as the gastric emptying time (gastropyting time get) for this group of fluids, and the results of gastric emptying time for A, B, C, D of these 4 groups of healthy volunteers are shown in table 6.
TABLE 6 gastric emptying time results (unit: min)
Group A Group B Group C Group D
Time of gastric emptying 74.10±3.25 75.40±3.44 76.00±3.27 139.3±6.22
Note: a: p is less than 0.05 vs.
As can be seen from table 6, after each group of liquids was orally taken, the gastric emptying time of A, B, C volunteers was not significantly different and was below 80min, while the gastric emptying time of group D reached about 140min, which was greatly shortened compared to group A, B, C of group D, indicating that examples 1-3 compared to comparative example 3, the addition of modified maltodextrin could reduce the osmotic pressure of the carbohydrate component formula food with special medical uses suitable for preoperative administration after being formulated into an oral solution, and accelerate the emptying of gastric juice, thereby effectively avoiding the risk of aspiration and reflux of the carbohydrate solution after being taken by preoperative subjects.

Claims (10)

1. A carbohydrate component formula food suitable for preoperative use and having a special medical purpose is characterized by comprising the following components in parts by weight: 90-99 parts of modified maltodextrin, 0.5-6.0 parts of oligosaccharide, 0.05-0.5 part of acidity regulator and 0.001-0.050 part of essence for food.
2. The carbohydrate component formula for special medical use suitable for preoperative use according to claim 1, comprising the following components in parts by weight: 94-98 parts of modified maltodextrin, 1.0-4.0 parts of oligosaccharide, 0.1-0.4 part of acidity regulator and 0.005-0.030 part of essence for food.
3. The carbohydrate module formulation for special medical use suitable for pre-operative use according to claim 1, wherein the oligosaccharides are one or more of fructooligosaccharides, isomaltooligosaccharides, galactooligosaccharides, lactulose oligosaccharides, primary arabino-oligosaccharides, glucose based sucrose, malto-oligosaccharides, cyclodextrins, gentiooligosaccharides, soy oligosaccharides, xylo-oligosaccharides.
4. The carbohydrate module formulation suitable for specific medical uses taken before an operation according to claim 1, wherein said acidity regulator is one or more of citric acid, citrate or malic acid.
5. The carbohydrate component formula food for special medical use suitable for preoperative use according to claim 1, wherein the modified maltodextrin is a maltodextrin modified by a biological enzyme method, and the specific modification method is as follows:
the preparation method comprises the steps of taking sodium acetate (pH 6.5, 25% w/v) as a buffer solution, boiling Waxy Corn Starch (WCS) into paste, adding Branching Enzyme (BE) at 65 ℃, stirring for 24 hours to obtain a suspension of the branching enzyme treated waxy corn starch, carrying out boiling water bath for 10 minutes after stirring is finished, then mixing and stirring for 10 minutes with 1M sodium acetate buffer solution, incubating the mixture with β -amylase (BA) for 24 hours at 55 ℃ after stirring is finished, boiling the water bath for 10 minutes after incubation is finished, then dialyzing in deionized water, and finally freeze-drying, grinding and sieving with a 120-mesh sieve to obtain the biological enzyme method modified maltodextrin.
6. The modification method of claim 5, wherein the mass to volume ratio of the waxy corn starch to the sodium acetate buffer is 300:1 in g/L based on dry weight of waxy corn starch.
7. The modification method according to claim 5, wherein the branching enzyme is added in an amount of 300 to 500U/g based on the dry weight of the waxy corn starch.
8. The modification method of claim 5, wherein the weight ratio of the suspension of branching enzyme treated waxy maize starch to 1M sodium acetate buffer is 19: 1.
9. The modification method of claim 5, wherein the β -amylase is added in an amount of 0.6-0.7% by dry weight of waxy corn starch, and the dialysis bag used for dialysis has a molecular weight cut-off of 3000-4000.
10. An oral solution of carbohydrate component formula food for special medical purposes suitable for preoperative use, which is characterized by being prepared from the carbohydrate component formula food for special medical purposes suitable for preoperative use of claim 1, wherein the formula food is prepared by adding 100m L of water into 12.5g of formula food, the osmotic pressure is controlled to be below 245 mmol/L, and the pH value is controlled to be 5-6.5.
CN202010461635.7A 2020-05-27 2020-05-27 Carbohydrate component formula food suitable for preoperative taking and having special medical application and application thereof Pending CN111406935A (en)

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Application publication date: 20200714