KR20200072750A - Oral balanced fluid composition and method of preparing the same - Google Patents

Abstract

The present invention relates to an oral medical fluid composition capable of preventing and alleviating dehydration symptoms and alleviating electrolyte imbalance, and a method for manufacturing the same. The oral medical fluid composition containing glucose, sodium, chloride, citrate, potassium, malic acid, vitamin C, sucralose, and zinc of the present invention exhibits an osmotic pressure similar to an osmotic pressure of body fluids, so that it is possible to induce rapid moisture absorption in individuals in need of replenishment of body fluids, and also improve the sensory performance compared to conventional oral medical fluids, thereby being able to be usefully used as a body fluid supplement which replaces sports drinks as well as intravenous fluids.

Description

Oral balanced fluid composition and method of preparing the same}

The present invention relates to an oral sap composition and a method for manufacturing the same, which can prevent and improve the symptoms of dehydration and improve electrolyte imbalance.

Maintaining the amount of fluid in the human body is very important, but when excessive physical activity, the human body falls into a state of insufficient body fluid. If such a fluid deficiency condition persists, it may show symptoms of sagging, thirst, fatigue, dizziness, and mild muscle spasm. In severe cases, it may result in decreased urine volume, electrolyte imbalance, shock, kidney failure, loss of consciousness, and brain damage. You can do this.

Hypothyroidism may occur due to blood dilution when ingesting plain water in order to improve such a lack of fluid, and when ingesting a drink having a higher osmotic pressure than body fluid, blood may be concentrated and hypernatremia may occur. .

An oral rehydration solution (ORS) has been developed to solve this problem of fluid shortage, and a therapy using it as a solution for replenishing water and electrolytes to patients with diarrhea and dehydration is called oral fluid therapy. Since the route of sodium and glucose movement in the small intestine in the small intestine was discovered in 1960, oral fluids developed based on this are regarded as the most important medical advances of the 20th century, and due to the supply of oral fluids from the World Health Organization, diarrhea in underdeveloped countries Mortality was significantly reduced.

The basis of oral fluids is a glucose-electrolyte solution, and its usefulness has already been verified, but the most suitable composition has not been confirmed yet, and it replaces glucose with rice or grains to reduce osmotic pressure and increase caloric value, or Various attempts have been made in the form of adding or modifying amino acids. However, there has been concern that the World Health Organization's standard oral fluids cause hypernatremia in infants and toddlers who have diarrhea caused by non-choleragenic causative agents.

Therefore, there is a need to develop a new oral liquid solution that can solve this problem and rapidly promote water absorption in the development of an oral liquid solution.

The present inventors have been carrying out research for the development of a new oral solution, while quickly promoting the absorption of moisture through adjusting the ratio of glucose and sodium, confirming that it is possible to prepare an oral solution with improved sensory properties and completing the present invention Did.

Accordingly, an object of the present invention is to provide an oral fluid composition having an osmotic pressure similar to that of a body fluid and a method for manufacturing the same.

To achieve the above object, the present invention provides an oral sap composition comprising glucose, sodium, chloride, citrate, potassium, malic acid, vitamin C, sucralose and zinc.

In addition, the present invention comprises the steps of mixing glucose, sodium, chloride, citrate, potassium, malic acid, vitamin C, sucralose and zinc; It provides a method for preparing an oral sap powder comprising a.

In addition, the present invention comprises the steps of mixing the oral sap powder prepared by the above method in water; It provides a method for preparing an oral infusion formulation comprising a.

The oral fluid composition comprising glucose, sodium, chloride, citrate, potassium, malic acid, vitamin C, sucralose, and zinc of the present invention exhibits an osmotic pressure similar to that of body fluids, resulting in rapid hydration in individuals in need of replenishment of body fluids Not only can it induce absorption, but the sensory performance is improved compared to the existing oral fluid, it can be useful as a body fluid supplement to replace sports drinks as well as intravenous fluids.

1 is a view showing the results of comparing the urine discharge for 4 hours after drinking water, commercial sports drinks, oral fluid composition (ringer water), 1L of coffee.

The present invention provides an oral fluid composition comprising glucose, sodium, chloride, citric acid salt, potassium, malic acid, vitamin C, sucralose and zinc.

Oral fluid composition for oral administration according to the present invention is formulated into a powder formulation and can be easily ingested, and the osmotic pressure and osmotic pressure of the body fluid are similar, thereby preventing unnecessary loss of body fluid and helping to quickly absorb moisture. In addition, the oral infusion composition of the present invention may be characterized by improved functionality compared to the conventional oral infusion composition and sports drinks exhibiting low preference with salty and unnecessary sweetness.

Hereinafter, the present invention will be described in detail.

Oral rehydration solution of the present invention (Oral rehydration solution) refers to a fluid that can be taken orally to correct the electrolyte imbalance that may occur due to loss of body fluids, oral balance solution composition, oral solution preparation, oral It can be used interchangeably with fluids, oral fluids, oral Ringer's fluids, and Ringer's water.

The oral fluid composition of the present invention includes glucose, sodium, chloride, citrate, potassium, malic acid, vitamin C, sucralose and zinc.

That is, the oral sap composition of the present invention includes glucose, and glucose is 50 to 60% (w/w), preferably 55 to 60% (w/w), more preferably, compared to the total components of the oral sap. 55 to 57% (w/w). In addition, in the oral fluid composition of the present invention, glucose may be included in 70 to 80 mmol/L, preferably 75 to 80 mmol/L, and more preferably 75 to 78 mmol/L.

In addition, the oral fluid composition of the present invention contains sodium. The sodium may be included in an amount of 50 to 60% (w/w), preferably 55 to 60% (w/w), and more preferably 55 to 57% (w/w) compared to the total components of the total oral fluid. . Sodium may be supplied from a variety of sodium sources, preferably sodium chloride, sodium phosphate, sodium citrate, trisodium citrate, sodium hydroxide, sodium pyrophosphate, sodium salt of sodium hydrogen carbonate, more preferably sodium chloride and citrate It may be a sodium salt of trisodium acid. When the sodium of the oral solution composition of the present invention is sodium chloride and sodium salt of trisodium citrate, it may be included as 40 to 43 mmol/L as sodium chloride and 30 to 35 mmol/L as trisodium citrate, but is not limited thereto.

The oral fluid composition of the present invention may be characterized in that glucose and sodium are included in a 1.5:1 to 1:1 molar ratio, more preferably in a 1:1 molar ratio. When glucose and sodium are included in the molar ratio as described above, the osmotic pressure can be maintained at a level similar to that of the body fluid. In addition, in the case of a commercial sports drink, glucose and sodium are included in a molar ratio of about 15:1 to 25:1, so that unnecessary sweetness is too strong and osmotic pressure is significantly higher than that of body fluids. By maintaining the osmotic pressure similar to the body fluid, there is an advantage that can quickly restore the required electrolyte balance in the body.

In addition, glucose and sodium may be included in the oral fluid composition at 60 to 80 mmol/L, respectively, more preferably 70 to 80 mmol/L, and even more preferably 75 to 78 mmol/L.

In the present invention, the chloride may be provided from various sources of chloride, preferably sodium chloride, potassium chloride, magnesium chloride, ammonium chloride and combinations thereof, more preferably sodium chloride, chloride provided from potassium chloride.

The oral fluid composition of the present invention preferably has an osmotic pressure similar to that of body fluids, preferably a slightly lower osmotic pressure than that of body fluids, such as 265 to 280 mOsm/L, preferably 265 to 275 mOsm/L. have. When the osmotic pressure of the oral fluid composition is higher than the osmotic pressure of body fluids of 285 mOsm/L, moisture in the body fluid may move and dehydration may occur. Dilution of body fluids may occur. The oral sap composition of the present invention exhibits an osmotic pressure of 265 to 280 mOsm/L, which is slightly lower than the osmotic pressure of body fluids, and through this, it is possible to induce rapid water absorption.

The oral infusion composition of the present invention may include additional components according to needs and preferences, and preferably may further include calcium, magnesium, and a sweetener. For example, the oral infusion composition of the present invention is preferably aldothrose such as erythrose and throse, ribose, lyxose, xylose, aldopentose such as arabinose, allose, thalose, and gulose. Ketopentose such as glucose, altose, mannose, galactose, aldohetose such as idorose, erythrulose, ketopentose such as xylulose, and ribulose, phycose, fructose Α-diglucoside, isotrehalose, sophorose, laminari, such as ketohexose, trehalose, kojibiose, nigeroose, maltose, and isomaltose, such as sorbose and tagatose In addition to α-, β-diglucosides such as β-diglucoside, such as bios, cellobiose, and genthiobiose, and neotrehalose, lactose, sucrose, isomaltulose (palatinose), and the like may be further included. .

In addition, the present invention comprises the steps of mixing glucose, sodium, chloride, citrate, potassium, malic acid, vitamin C, sucralose and zinc; It provides a method for preparing an oral sap powder comprising a.

In the present invention, the step of preparing a mixture by mixing glucose, sodium, chloride, citrate, potassium, malic acid, vitamin C, sucralose, and zinc is mixed such that the molar ratio of glucose and sodium is 1.5:1 to 1:1. It can be characterized by, glucose, sodium, chloride, citrate, potassium, malic acid, vitamin C, sucralose and zinc, etc. can be carried out by mixing evenly in an anhydrous state.

In addition, the oral sap composition of the present invention may be prepared in a powder formulation, and when prepared in a powder formulation, may be commercialized by being subdivided into an amount suitable for mixing in 500 ml of drinking water. The powdering step in the present invention can be performed without limitation through conventional methods well known in the art.

In addition, the present invention comprises the steps of mixing the oral sap powder prepared by the above manufacturing method in water; It provides a method for preparing an oral fluid formulation comprising a.

The oral fluid preparation of the present invention can be prepared by, for example, a method of mixing powdered oral fluid powder into 500 ml of drinking water.

In addition, the present invention comprises the steps of administering an oral fluid composition or oral fluid preparation to an individual comprising glucose, sodium, chloride, citrate, potassium, malic acid, vitamin C, sucralose and zinc; It provides a method for preventing or treating dehydration, including.

The individual is preferably a mammal, including a human, and may include, without limitation, an individual in need of prevention or treatment of dehydration due to excessive loss or risk of loss of body fluids.

Hereinafter, the present invention will be described in detail by examples and experimental examples. However, the following examples and experimental examples are merely illustrative of the present invention, and the contents of the present invention are not limited by the following examples and experimental examples.

Example 1. Preparation of oral fluid powder

An oral fluid (hereinafter referred to as'Linger Water') was prepared based on the following ingredient list in order to prepare an oral fluid powder that can be taken orally and has a body fluid replenishment effect equivalent to intravenous fluid.

Ringer Water Ingredient List (based on 500ml) edifice Weight (g) content (%) Glucose 7.00 56.61 Trisodium citrate 1.45 11.73 Sodium chloride 1.25 10.11 Malsan 1.00 8.08 Potassium chloride 0.75 6.06 Vitamin C 0.50 4.04 Spices 0.35 2.83 Sucralose 0.035 0.28 zinc 0.03 0.24 Sum 12.365 99.98

The components were uniformly mixed in an anhydrous state, and powdered to prepare them. Ringer Water was prepared to be consumed by mixing 1 packet per 500 ml of drinking water, and 1 packet was prepared in small portions at about 11 g.

Table 2 shows the osmotic pressure of the manufactured Ringer Water.

edifice Concentration (mmol/L) Glucose 77.71 Sodium as sodium chloride 42.77 Sodium as trisodium citrate 33.69 Chloride with sodium chloride
(Chloride as sodium chloride) 42.77 Chloride with potassium chloride
(Chloride as potassium chloride) 20.12 Citrate with trisodium citrate
(Citrate as trisodium citrate) 11.23 Citrate with zinc citrate
(Citrate as Zinc citrate) 0.01 potassium 20.12 Malsan 14.91 Ascorbic acid (Vit.C) 5.68 Sucralose 0.02 zinc 0.01 Sum 269.04

To prevent loss of body fluids due to excessive physical activity and to enhance functionality, Ringer Water was prepared by additionally supplying zinc, calcium, magnesium, and vitamin C. Adding zinc can increase the resistance to infection, help heal trauma, and improve diarrhea. In addition, the addition of calcium and magnesium can prevent muscle cramps that may occur during excessive physical activity, and vitamin C can promote fatigue recovery and strengthen immunity.

Example 2. Ringer Water Dehydration Prevention Protocol

The protocol of using Ringer Water for prevention of dehydration is shown in Table 3 below. Low-intensity activities mean activities that consume 200 kcal per hour, such as walking, biking, badminton, and gymnastics. Medium-intensity activities mean activities that consume 350 kcal per hour, such as hiking, tennis, and horseback riding, and high-intensity activities per hour. Activities that consume more than 500kcal, such as jogging, aerobics, jump rope, etc.

Low intensity activity Medium intensity activities High intensity activity dehydration
Risk Temperature (℃) Sweat discharge
(ml/h) Recommended intake
(artillery) Sweat discharge
(ml/h) Recommended intake
(artillery) Sweat discharge
(ml/h) Recommended intake
(artillery) One 27.5 or less 750 One 1000 One 1250 One 2 27.5 or more 1000 One 1250 One 1500 2 3 29 or more 1250 One 1500 2 1750 2 4 31 or more 1500 2 1750 2 2000 2 5 32 or more 1750 2 2000 2 2250 3

Ringer water 1 bag prepared in Example 1 is preferably mixed with 500ml drinking water to drink, which corresponds to 1.5 times the amount of body fluid loss. When performing medium-intensity or high-intensity activity at 30℃ or higher, drink 2 packets of 1 packet per 500 ml, and drink not to exceed 1 L per hour.

Experimental Example 1. Comparison of osmotic pressure

Osmotic pressure is a very important evaluation factor in oral administration fluids. Since the diffusion of water occurs due to the difference in osmotic pressure, when water is ingested, water moves into body fluids and dilutes the fluid, and when water is consumed, water in the body fluid moves to sea water and dehydration may occur. Therefore, it is very important not to dilute or concentrate the body fluid by maintaining the osmotic pressure that is similar to the body fluid but slightly lower. Accordingly, the ratio of glucose, sodium, and osmotic pressure of Ringerwater prepared in Example 1 was compared with a commercial sports drink, and the results are shown in Table 4.

glucose salt Glucose: sodium Osmotic pressure mmol /L mmol /L mOsm /L Ringer Water 75 75 1: 1 270 Pocari Sweat 275 21 13.1: 1 340 Gatorade 271 20 13.6: 1 330 Power aid 335 18 18.6: 1 391

As can be seen from Table 4, the Ringerwater of the present invention was adjusted to a ratio of glucose and sodium to about a 1:1 molar ratio, showing osmotic pressure of 270 mOsm/L slightly lower than that of body fluids, while a commercial sports drink was sodium It was confirmed that osmotic pressure was higher than body fluid because the content of glucose was high.

In addition, water, intravenous 5% glucose, body fluids, physiological saline for intravenous infusion, commercial sports drinks, osmotic pressure of seawater and Ringer Water were compared, and differences from body fluids were confirmed, and the results are shown in Table 5.

water Ringer Water Intravenous 5% glucose body fluids vein
For injection
Saline sports
beverage sea water Osmotic pressure 0 270 278 285 308 330-391 1000 (mOsm/L) Difference from body fluid -285 -15 -7 0 23 +45~106 715

As can be seen from the above table, Ringerwater showed an osmotic pressure of about 270 mOsm/L slightly lower than that of body fluid, which was confirmed to be an osmotic pressure level similar to that of 5% glucose for intravenous injection. In addition, it was confirmed that the existing sports drink exhibited a slightly lower osmotic pressure than that of the body fluid compared to that exhibiting a much higher osmotic pressure than that of the body fluid, so that absorption into the body fluid was smooth and the superiority of not concentrating the body fluid was confirmed. This difference in osmotic pressure can lead to faster absorption of water compared to water or commercial sports drinks.

Experimental Example 3. Comparison of urine output

In order to evaluate the degree of water supply in the body, the intake of ringer water prepared in Example 1, water, ionic beverage, and coffee, respectively, was compared, and urine discharge was then compared. Eight students from Dongguk University were asked to consume Ringer Water, water, commercial sports drinks (Power Aid), and coffee 1L, and urine every hour to compare the total urine volume for 4 hours and compare the results to FIG. 1. It is shown in.

As shown in FIG. 1, in the group ingesting Ringerwater, urine discharge was 362 ml for 4 hours, which was confirmed to be about 36% less than water and ionic beverage. Through these results, it was confirmed that even if the same amount was supplied, the moisture was absorbed about 1.5 times as much as water or ionic beverage and remained in the body for a long time, so that it was possible to supply the maximum amount of moisture even in a limited amount.

Claims (7)

Oral fluid composition comprising glucose, sodium, chloride, citrate, potassium, malic acid, vitamin C, sucralose and zinc.
According to claim 1, Glucose and sodium, characterized in that contained in a molar ratio of 1.5:1 to 1:1, oral sap composition.
According to claim 1, The glucose and sodium, respectively, characterized in that contained in 60 to 80mmol / L, oral sap composition.
According to claim 1, The oral fluid composition is characterized in that it has an osmotic pressure of 265 to 280mOsm / L, oral fluid composition.
According to claim 1, It characterized in that it further comprises calcium, magnesium, oral fluid composition.
Mixing glucose, sodium, chloride, citrate, potassium, malic acid, vitamin C, sucralose and zinc; Method for preparing an oral sap powder comprising a.
Mixing the oral sap powder prepared by the method of claim 6 with water; Method for preparing an oral infusion formulation comprising a.

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