KR20220033790A - Bowel Cleansing Composition - Google Patents

Abstract

The present invention relates to a bowel-cleansing composition comprising: as a first bowel-cleansing ingredient, one or more selected from fructooligosaccharide, inulin, allulose, tagatose, β-4-galactosyl-lactose and a monk fruit extract; and, as a second bowel-cleansing ingredient, ascorbic acid or a mixture of ascorbic acid and ascorbate, wherein the total dose comprises 5 g to 300 g of the first bowel-cleansing ingredient and 0.5 g to 40 g of the second bowel-cleansing ingredient. The bowel-cleansing composition does not induce an elevation in blood pressure after ingestion, has excellent bowel-cleansing ability and improved convenience of administration and safety, and thus can be effectively used for bowel-cleansing for colonoscopy, endoscopic surgeries and the like, bowel-cleansing prior to abdominal surgeries, and bowel treatment prior to anal surgeries, such as for hemorrhoids, and can be used for treating diseases such as chronic and acute constipation and alleviating the symptoms thereof.

Description

Bowel Cleansing Composition

The present invention relates to a composition for cleansing the intestines, and more specifically, by containing specific prebiotics or monk fruit and ascorbic acid to solve the problem of increasing blood sugar in some existing intestinal cleansers, It relates to a novel composition for cleansing the intestines, which improves ease of administration by reducing the overall dosage, and at the same time further improves intestinal cleansing, and secures safety.

Colorectal cancer is one of the most common cancers worldwide and is the second most common cancer in Korea after gastric cancer. Colonoscopy is essential for diagnosing colon cancer. Colonoscopy is very important because it can fundamentally block colorectal cancer by detecting and removing colon polyps that occur in 40-50% of adults in advance.

In order to perform an accurate colonoscopy, it is essential to clean the intestines thoroughly in advance. Even if you fast for several days, feces will always remain in the large intestine. Intestinal cleansers are essential medicines that enable accurate colonoscopy by rinsing out intestinal remnants such as feces before colonoscopy.

However, most of the existing intestinal cleansers had a lot of difficulty in taking them because the dosage was too large and the taste was not good. Many people avoid colonoscopy due to the difficulty of taking it, as well as stop taking the intestinal precipitant in a state where the bowel cleansing is not sufficient, or the ingested bowel cleansing agent is discharged again due to vomiting. It can be said that this problem is fundamentally caused by the bad taste of the intestinal cleansing agent. In the case of the recently developed pill-type intestinal cleanser, the amount of water or beverages to be taken is still 3 liters, so there is no difference in the total dosage compared to other bowel cleansing agents, but the unpleasant taste of the intestinal cleanser The importance of the taste of the intestinal purifier can be seen from the fact that many people prefer it because of the advantage of being able to take it without directly feeling it. Therefore, it seems that the difficulty of taking the intestinal precipitant is more affected by the peculiar unpleasant taste of the intestinal precipitant than by a large dose.

The unpleasant taste of most intestinal cleansers originates from the unique taste of polyethylene glycol (PEG) or sodium sulfate, which is used as the main ingredient in intestinal cleansers. In addition, since the existing bowel preparations are not at a satisfactory level not only in terms of ease of use but also in cleansing power, 25 to 30% of those undergoing colonoscopy will undergo colonoscopy in a state where bowel cleansing is not sufficient. . There is a report that insufficient intestinal cleanliness reduces the detection rate of colon polyps by 47% despite colonoscopy. In addition, almost all intestinal cleansers tend to generate air bubbles in the large intestine after bowel cleansing, and many bubbles (bubbles) remaining in the large intestine after taking the intestinal cleansers interfere with accurate examination by interfering with the endoscopic view.

Therefore, avoiding colonoscopy due to the difficulty of taking a bowel preparation, or failing to accurately detect polyps due to insufficient bowel preparation may harm public health by missing an opportunity to prevent colorectal cancer. Therefore, there is a need to develop an intestinal cleansing agent having a strong cleansing power while improving taste by excluding PEG and sodium sulfate.

Accordingly, the ideal main ingredient of a new intestinal cleansing agent should be a substance that tastes good and has a laxative function. As such a new bowel cleansing agent, a sweet sugar alcohol with laxative effect and ascorbic acid, which has a laxative effect while giving a refreshing feeling, as the main ingredients, have been recently developed. However, most sugar alcohols have a problem in that they increase blood sugar levels after taking them.

Glycemic Index (GI) is used as an index to measure the degree of raising blood sugar after taking. The glycemic index is evaluated on a scale of 0 to 100 by measuring the level of blood sugar rise of each substance after setting the blood sugar level to rise 2 hours after taking the glucose as 100. That is, a substance with a glycemic index of 0 is a substance that does not raise blood sugar at all, and a substance with a glycemic index of 100 is a substance that raises blood sugar in the same way as glucose.

The glycemic index of sorbitol, which is used as a bowel cleansing agent in some of the sugar alcohols, is relatively low at 4 and 14 for xylitol. Even low sugar alcohol can affect blood sugar rise after taking it. In particular, since colonoscopy is often performed concurrently with other health examinations, including blood sugar tests, an increase in blood sugar due to bowel cleansing may lead to a misdiagnosis for diabetes, etc., and may cause unnecessary additional detailed examinations. It can also pose a risk of spikes in blood sugar for people with diabetes.

As such, the taste and dosage of the newly developed intestinal cleanser containing sugar alcohol and ascorbic acid to solve the difficulties in taking the existing bowel prep. The situation has problems such as influence.

Efforts to overcome the limitations of the existing intestinal cleansing agents remain unresolved, and as a result, it has a reliable intestinal cleansing power while suppressing blood sugar rise, and is easy to take and minimizes side effects such as suppressing blood sugar rise. There is an urgent need for the development of a new safer composition for intestinal cleansing.

The present invention is to solve the problems of the prior art as described above, and an object of the present invention is to have excellent intestinal cleansing power and ease of administration through improved taste, while not causing a rise in blood sugar. It is to provide a novel composition for cleansing the intestines having all of the safety.

Another object of the present invention is to provide a novel composition for intestinal cleansing that can be economically mass-produced and commercialized.

The composition for cleansing the intestines according to the present invention is, as the first intestinal cleansing component, fructooligosaccharide, inulin, allulose, tagatose, β-4-galactosyl-lactose ( β-4-Galactosyl-lactose) and at least one selected from extracts of Monk Fruit; and ascorbic acid or a mixture of ascorbic acid and a salt of ascorbic acid as a second bowel preparation ingredient, the composition comprising 5 to 300 g of the first bowel preparation ingredient and 2 to 40 g of the second intestinal preparation ingredient in a total dose.

The composition for cleansing the intestine according to the present invention contains a first chapter cleansing component such as a specific prebiotic or monkfruit extract having a glycemic index of 0 or a nearly negligible level, and a second chapter cleansing component such as ascorbic acid. By using the combination, it was possible to maintain blood sugar while improving the taste, and at the same time exhibited superior intestinal cleansing power compared to the existing intestinal cleansing agent. In addition, the composition for bowel cleansing according to the present invention greatly improved the ease of administration and compliance by significantly reducing the dosage. The composition for cleansing the intestines according to the present invention has a sweet taste and has improved discomfort symptoms by minimizing discomfort such as nausea, abdominal pain, and vomiting in the process of taking, and by including bicarbonate such as sodium bicarbonate and potassium bicarbonate, It can prevent electrolyte abnormalities such as hyponatremia and hypokalemia that may have occurred in intestinal cleansing, and because it does not contain magnesium, it can be safely used in patients with renal impairment without serious side effects due to hypermagnesemia.

In addition, in the present invention, by using together the first intestinal cleansing ingredients such as specific prebiotics or extracts of monk fruit and the second intestinal cleansing ingredients such as ascorbic acid, it has excellent intestinal cleansing and antibacterial power compared to the dosage, and enters the intestine after cleansing. The safety of the human body was secured by reducing the risk of occurrence of combustible gas.

In particular, the existing intestinal cleansing agent containing sugar alcohol improved the total dosage and taste, but there was a problem in that it raises blood sugar in some patients, resulting in misdiagnosis of health checkups and a sharp rise in blood sugar in diabetic patients. The present invention eliminates the risk of a rise in blood sugar due to ingestion of a bowel preservative by using prebiotics or extracts of monkfruit having a glycemic index of 0 or a nearly negligible level instead of the existing sugar alcohol, and further improves intestinal cleansing. could be improved

In addition, in the process of taking a bowel preparation, nausea and vomiting may occur usually around 30%, which is not only due to the unpleasant taste of the intestinal preparation, but also because the stomach expands by ingesting a large amount of water within a short time. The present invention promotes gastric motility by additionally containing a first intestinal cleansing component such as a specific prebiotic or extract of monk fruit, a second intestinal cleansing component such as ascorbic acid, and, if necessary, a gastrointestinal motility promoter such as ginger powder This can reduce the frequency of nausea and vomiting by allowing the contents to be expelled quickly into the duodenum. This not only enhances the convenience of bowel cleansing, but also prevents the loss of the amount of intestinal cleansing agent due to vomiting, leading to insufficient bowel cleansing, thereby enhancing intestinal cleansing power.

As described above, the composition for bowel cleansing according to the present invention can greatly contribute to the activation of colonoscopy and the like by making the bowel cleansing process much easier and safer, and as a result, not only the early detection of colorectal cancer but also the resection of colon polyps. It can maximize the effect of preventing colon cancer. In addition, the bowel cleansing composition according to the present invention can be used for treatment of constipation, etc. and symptom relief.

According to the manufacturing method according to the present invention, it is possible to economically mass-produce and commercialize the composition for intestinal cleansing.

1 is a graph showing the evaluation results of excellent bowel cleansing power, nausea rate, and bubble generation rate of a composition for cleansing the intestine according to an embodiment and a control example of the present invention.
2 is a graph showing the blood glucose measurement results according to the administration of the composition for cleansing the bowel according to an embodiment and a control example of the present invention.

Hereinafter, the present invention will be described in detail with reference to the accompanying drawings.

The composition for cleansing the intestines according to the present invention is, as the first intestinal cleansing component, fructooligosaccharide, inulin, allulose, tagatose, β-4-galactosyl-lactose ( β-4-Galactosyl-lactose) and at least one selected from extracts of Monk Fruit; and ascorbic acid or a mixture of ascorbic acid and a salt of ascorbic acid as a second bowel preparation component, wherein the composition comprises 5 g to 300 g of the first bowel preparation component and 0.5 g to 40 g of the second enteric preparation component in a total dose.

The first intestinal cleansing component used in the present invention has a glycemic index of zero or is almost negligible and functions as a laxative. In the present invention, "a level of almost negligible glycemic index" refers to a level of about 0 to about 2, preferably about 0 to about 1, more preferably about 0 to about 0.5. The first cleaning component used in the present invention is, for example, at least one selected from fructooligosaccharide, inulin, allulose, tagatose, β-4-galactosyl-lactose and monkfruit extract. In the present invention, specific prebiotics such as fructooligosaccharide, inulin, allulose, tagatose, β-4-galactosyl-lactose, etc. or extracts of monkfruit are used in high concentrations as the first intestinal cleansing ingredients to suppress the rise in blood sugar. You can effectively cleanse the intestines while doing this.

Among the first intestinal cleansing ingredients used in the present invention, fructooligosaccharide, inulin, allulose, tagatose, β-4-galactosyl-lactose, etc. are prebiotics and have a glycemic index of 0 or almost negligible. . Prebiotics are substances that are used as food for probiotics, which are beneficial lactic acid bacteria for the human body. It is a monosaccharide that can be absorbed in the small intestine and goes down to the large intestine without being decomposed.

Among the Chapter 1 purifying ingredients used in the present invention, monkfruit is also called Siraitia grosvenoril , and is a perennial plant of the Cucurbitaceae family grown in the highlands of Guangdong, Guangxi, China. The main active ingredients of monkfruit are triterpenoid saponins and flavonoid glycosides, and the main sweetening ingredient is mogroside V. Monkfruit has a sweet taste due to the mogroside V component, so it is in the spotlight as a natural sweetener as an alternative to sugar. It has no calories and does not contain carbohydrates and sugars, so it does not affect blood sugar levels, and effects such as antioxidant effect, hyperlipidemia improvement, and blood sugar lowering effect are known, but there is no mention of intestinal cleansing effect.

In the bowel cleansing composition of the present invention, the extract of monkfruit as the first intestinal cleansing component contains, for example, 1 to 10 times, preferably 3 to 5 times the weight of dried monkfruit, carbon number such as water, ethanol, butanol, etc. A lower alcohol of 1 to 4 or a mixed solvent thereof is used as the extraction solvent, and the extraction temperature is 5 to 100° C., preferably 20 to 90° C., more preferably 10 to 30 hours at room temperature to 80° C., preferably is obtained by extraction for 18 to 25 hours. As the extraction method, cold extraction method, hot water extraction method, ultrasonic extraction method, reflux cooling extraction method or heating extraction method may be used, but is not limited thereto. After extraction, it is filtered and concentrated under reduced pressure to obtain a monkfruit extract. The monkfruit extract can be extracted from roots, stems, leaves, fruits, and the like, and in particular, it can be extracted from monkfruit fruits.

The glycemic index of the extract of prebiotics or monk fruit used in the bowel cleansing composition of the present invention is mostly 0, or about 0 to about 2, which corresponds to a level where the blood glucose level increased after taking it is almost negligible. In one aspect of the present invention, the glycemic index of the probiotics or monkfruit extract may be substantially zero.

Since the glycemic index is substantially 0, prebiotics or extracts of monk fruit may cause diarrhea and abdominal pain as side effects when consumed in excess, so there was caution about consuming too much. When mannitol and sorbitol, which are sugar alcohols, are used as intestinal cleansers, they are fermented by intestinal bacteria and combustible gases such as hydrogen gas and methane gas are produced in the intestine, thereby performing polypectomy electrocautery or surgery during colonoscopy. Research reports have been published that a gas explosion occurred when an electric cauterizer was used during surgery.

However, the inventors of the present invention have focused on using this as a major component of a bowel cleansing agent by reversely exploiting the diarrhea-inducing potential, which is a side effect of prebiotics or monkfruit having a glycemic index of substantially 0, and as the first intestinal cleansing component, By using specific prebiotics or extracts of monkfruit in a specific amount together with the second intestinal cleansing ingredient such as ascorbic acid and ginger powder as a gastrointestinal motility promoter if necessary, it maintains blood sugar while maintaining excellent intestinal cleansing power compared to the dosage. and minimized the risk of explosion due to intestinal gas generation and suppressed bubble formation.

The content of the first intestinal cleansing component used in the present invention is in the range of 5 g to 300 g, 10 g to 250 g, 25 g to 200 g, 50 g to 150 g, 60 g to 120 g in total dose, but is not limited thereto. If the content of the Chapter 1 purifying component is out of the above range, severe dehydration may occur if the content is excessively large. In addition, when the content of the first intestinal cleansing component is out of the above range and the concentration is low, intestinal cleansing may be incomplete.

Ascorbic acid used as the second intestinal cleansing ingredient in the present invention is a water-soluble vitamin known as vitamin C, and is an essential vitamin that plays various roles in maintaining human health. In the present invention, ascorbic acid is a bowel cleansing component that functions as a laxative, and also serves to minimize the generation of intestinal gas by inhibiting intestinal bacteria activity by exhibiting an antibacterial action. For this purpose, the second intestinal cleansing ingredient is formulated in a total dosage of 0.5 g to 40 g, 1 g to 40 g, 2 g to 30 g, 3 g to 15 g. Chapter 2 If the content of the purifying ingredient is excessively high outside the range of the above concentration, the acidity of the solution may be excessively increased and the acidity may be excessively made to make it difficult to take. can cause etc. On the other hand, when the content of the second intestinal cleansing component is low out of the above concentration range, the antibacterial effect is lowered, and there is a risk of excessively generating combustible gas in the intestine.

The salt of ascorbic acid used as the second intestinal purifying component in the present invention is an alkali metal or alkaline earth metal salt of ascorbic acid. The alkali metal may be, for example, sodium or potassium, and the alkaline earth metal may be, for example, calcium, but is not limited thereto. The salt of ascorbate used in the present invention is sodium ascorbate or calcium ascorbate.

Ascorbic acid salt lowers the acidity of the solution compared to the case of using ascorbic acid alone, thereby inhibiting the absorption of ascorbic acid, which is known to increase absorption as the acidity increases, thereby further enhancing the bowel cleansing effect.

When the Chapter 2 purifying component is a mixture of ascorbic acid and ascorbic acid salt, the mass ratio of ascorbic acid to ascorbic acid salt may be 99:1 to 60:40. If the mass ratio of ascorbic acid to ascorbic acid salt is out of the above range, excess sodium, calcium, potassium or magnesium may be absorbed into the human body, causing electrolyte abnormalities or hypercalcemia or hypermagnesemia.

For the purpose of reducing the frequency of occurrence of nausea and vomiting, the composition for cleansing the intestine of the present invention promotes gastric motility so that the composition for cleansing the intestine is rapidly discharged into the duodenum, ginger, plum, jujube, cinnamon, malt (malt) ) may further contain extracts or powders or concentrates, such as. These components function as gastrointestinal motility promoters, and may be mixed in an amount of 0.2 g to 10 g, 0.5 g to 8 g, 1 g to 6 g, 1.5 g to 4 g as a total dose. If the content of these gastrointestinal motility promoters is excessively high outside the above range, bowel cleansing ability may be reduced by inhibiting bowel movement, and if the concentration is low outside the above range, nausea and vomiting may not be sufficiently suppressed. In one aspect of the present invention, as a gastrointestinal motility promoter, it may include an extract of ginger or plum, a powder or concentrate thereof, preferably ginger powder. Plums are rich in organic acids such as citric acid and malic acid, which stimulate the body's endocrine glands to actively secrete digestive juices and enzymes, thereby promoting gastrointestinal movement. Gingerol, which is contained in ginger, is a component that gives ginger's unique fragrance and pungent taste. Ginger not only prevents nausea and vomiting, but also has a bowel cleansing effect and intestinal gas removal effect, so it can suppress the formation of bubbles due to taking a bowel cleansing agent. In particular, when ginger extract is taken with a bowel cleansing agent, the gas-removing effect of ginger can suppress the formation of air bubbles throughout the colon. it is possible to do

In the present invention, "extract" refers to a water-soluble or fat-soluble extract, and an extract obtained by a conventional method in the art may be used.

In general, many bubbles remain in the large intestine after taking the intestinal cleansers to remove the bubbles. When taking the intestinal cleansers, the foaming inhibitor simethicone is taken together or the diluted simethicone solution is inserted into the endoscope during colonoscopy. It is a common method to remove the foam by injecting it into the intestine through a small tube in the stomach. However, when the simethicone dilution solution is injected through the tube of the endoscope insertion unit during the examination, the range that the simethicone dilution solution can be applied at once is very limited. Therefore, when bubbles are formed over a wide range, it is inconvenient to inject the diluent at most a dozen times or more. In addition, even when taking a simethicone preparation when taking a bowel cleansing agent, the dosage is usually only about 10 ml, so there is a limit in suppressing the occurrence of air bubbles throughout the large intestine.

The composition for bowel cleansing according to the present invention may further include a bubble formation inhibitor in order to effectively suppress bubble formation over all areas in the large intestine to which the intestinal cleansing solution comes into contact even with a small dose. In one aspect of the present invention, for example, simethicone may be used as a foaming inhibitor, but is not limited thereto. As one aspect, the content of the foaming inhibitor used in the present invention may be 100mg to 2g, 150mg to 1.5g, 200mg to 1g in the case of simethicone, and in the case of a foaming inhibitor other than simethicone, it is limited thereto. it is not going to be When the bubble formation inhibitor exceeds the upper limit of the above criteria, side effects such as abdominal pain, rash, swelling of the face or tongue, or difficulty breathing may appear.

The bowel cleansing composition of the present invention may further include a component for improving compliance with the dosage and alleviating upper gastrointestinal symptoms such as nausea, nausea, and vomiting, which are common while taking the bowel cleansing agent.

The bowel cleansing composition of the present invention may further contain an extract or powder or concentrate of mint, chamomile, lemon balm, quince, etc. for the purpose of alleviating symptoms such as nausea and vomiting. These ingredients function as gastrointestinal stabilizers and can be mixed in a total dosage of 5 g to 50 g. In one aspect of the present invention, the gastrointestinal stabilizer may be mint or chamomile. The menthol component of peppermint relaxes the muscles of the digestive system, and the pectin component of chamomile stabilizes the movement of the intestines to relieve symptoms such as nausea and vomiting.

Since the bowel cleansing composition of the present invention containing ascorbic acid has high acidity and may be difficult to take due to excessive sour taste, it may contain bicarbonate such as sodium bicarbonate and potassium bicarbonate as a component for neutralizing it. there is.

The content of sodium bicarbonate may be used in the range of 0.1 g to 10 g as a total dose. Exceeding this range may lead to poor adherence to dosage due to excessive salty taste and may cause hypernatremia. The content of potassium hydrogen carbonate may be 10 mg to 2 g in total dose. Exceeding this range may lead to hyperkalemia by ingesting more potassium than the recommended daily intake. When hyperkalemia develops, it can pose risks, including heart failure.

To the composition for cleansing the intestines of the present invention, an appropriate amount of edible fruit flavor may be added to increase dosage compliance. Strawberry flavor, orange flavor, apple flavor, grape flavor, lemon flavor, banana flavor, cherry flavor, etc. may be used as these fruit flavors.

An appropriate amount of antioxidant may be added to the composition for bowel cleansing of the present invention to prevent oxidation of ascorbic acid. Examples of such antioxidants include, but are not limited to, amino acids such as ferulic acid, glycine, and histidine, hyaluronic acid, and tocopherol.

In addition, the bowel cleansing composition of the present invention may further include an adsorbent for adsorbing trace amounts of iron ions and copper ions that may be contained in an aqueous solvent. Such adsorbents include, but are not limited to, for example, Versene(TM) CA chelating agent (Dow).

The bowel cleansing composition according to the present invention may contain a water-soluble solvent and/or may contain a water-soluble solvent when taken. The water-soluble solvent used in the present invention may be, for example, water, alkaline ionized water, beverage, or the like. In addition, there is no particular limitation on the type as long as the effect of the present invention can be achieved as a beverage. For example, a beverage that does not raise blood sugar levels such as drip coffee, tea, various juices, etc. is preferable. In one aspect of the present invention, water or alkaline ionized water may be used as the water-soluble solvent. Alkaline ionized water can increase the cleansing effect by partially neutralizing the acidity of the intestinal cleansing composition according to the present invention to reduce the absorption of ascorbic acid.

The total capacity of the water-soluble solvent included in and/or taken together in the composition for cleansing the bowel according to the present invention may be 0.1L to 3L, 0.2L to 2L, 0.3L to 1.5L, 0.4L to 1L, limited thereto it is not going to be If the volume of the solvent is less than 0.1L, the ingredients may not be completely dissolved in the solvent. The composition for bowel cleansing according to the present invention can reduce the total dose to 1.5L or less, thereby improving the ease of administration, and having excellent cleansing power compared to the dose. However, depending on the individual, in case of thirst or dehydration, the total dose may be increased to 3L.

The bowel cleansing composition according to the present invention may be in a solid dosage form such as powder, granule, tablet, capsule, or the like.

In one aspect of the present invention, the composition for bowel cleansing includes the first intestinal cleansing component and the second intestinal cleansing component, and, if necessary, a gastrointestinal motility promoter, a bubble formation inhibitor, a gastrointestinal tract stabilizer, and other additives are mixed as a powder and packaged in one pouch Or, it may be divided into two or more pouches and packaged, but is not limited thereto.

For example, in the composition according to the present invention, the first bowel cleansing component and, if necessary, the gastrointestinal motility promoter, the bubble formation inhibitor, the gastrointestinal tract stabilizer, and other additives are packaged in one pouch, and the second bowel cleansing component is packaged separately, The second cleansing component and, if necessary, the gastrointestinal motility promoter, the bubble formation inhibitor, the gastrointestinal tract stabilizer, and other additives may be packaged in one pouch, and the first bowel cleansing component may be packaged separately.

In one aspect of the present invention, the bowel cleansing composition includes the first intestinal cleansing component and the second intestinal cleansing component, and, if necessary, a gastrointestinal motility promoter, an inhibitor of bubble formation, a gastrointestinal tract stabilizer, and other additives such as tablets and capsules. It may be formulated as an agent. When formulating the components of the composition for intestinal cleansing according to the present invention, it is prepared using a diluent or excipient such as a generally used filler, weight agent, binder, wetting agent, disintegrant, and surfactant.

When the bowel cleansing composition according to the present invention is a solid formulation, it may be formulated in or taken together with a water-soluble solvent when taken, and an additional water-soluble solvent may be taken if necessary.

The bowel cleansing composition according to the present invention may be a one-component or two-component type containing a water-soluble solvent.

In one aspect of the present invention, the bowel cleansing composition includes the first intestinal cleansing component and the second intestinal cleansing component, and, if necessary, all components of the gastrointestinal motility promoter, bubble formation inhibitor, gastrointestinal stabilizer, and other additives together with a water-soluble solvent. It may be packaged in liquid form.

In another aspect of the present invention, the composition for cleansing the intestine may be packaged in a two-part type. For example, the first enteric cleansing component and the second cleansing component are packaged together and the water-soluble solvent is packaged separately, or the second enteric cleansing component and the water-soluble solvent are packaged together and the first enteric cleansing component is packaged separately or the first enteric kosher component and a portion of the water soluble solvent are packaged together and the second enteric kosher component and a portion of the water soluble solvent are packaged together, or the first enteric kosher component, the second enteric kosher component and the water soluble A portion of the solvent may be packaged together and the remainder of the water-soluble solvent may be packaged separately, but is not limited thereto. In addition, if necessary, a gastrointestinal motility promoter, a gastrointestinal tract stabilizer, and other additives may be formulated in various two-component forms.

A method for packaging and using the composition for cleansing the intestine of the present invention in the form of a high concentration solution and a vehicle as a two-component type will be described. For example, the first and second intestinal cleansing ingredients and, if necessary, all ingredients such as gastrointestinal motility promoter, bubble formation inhibitor, gastrointestinal tract stabilizer, and other additives are dissolved in a minimum amount of water-soluble solvent to make a highly concentrated solution, It can be used after dilution in the beverage of the user's choice as a vehicle (the remainder of the volume as an aqueous solvent). If necessary, the solid components of the composition are individually packaged, and the water-soluble solvent is separately packaged, and then the user can mix and use all the components at the time of administration. In addition to this, it may be packaged in various forms, and the form of the two-part composition is not limited to the above packaging method.

When preparing the bowel cleansing composition according to the present invention, the first intestinal cleansing component and the second intestinal cleansing component and, if necessary, all of the components such as a gastrointestinal motility promoter, a bubble formation inhibitor, a gastrointestinal tract stabilizer, and other additives are mixed at the same time, or each The ingredients may be prepared separately and blended in stages.

For example, a method for preparing a composition for cleansing the intestines according to the present invention comprises the steps of: forming a first formulation comprising a specific prebiotic or an extract of monkfruit as a first intestinal cleansing component; forming ascorbic acid or a second combination of ascorbic acid and a salt of ascorbic acid as a second sanitary component; Forming a third formulation comprising a gastrointestinal motility promoter if necessary; forming a fourth formulation comprising an anti-foaming agent and/or a gastrointestinal tract stabilizer as required; and combining the first to fourth combinations to form a composition for cleansing the intestines.

In another aspect of the present invention, in the method for preparing a composition for intestinal cleansing according to the present invention, the first and second formulations and, if necessary, the third and fourth formulations are pre-blended in any combination, and then the water-soluble solvent It may further include the step of blending in.

In another aspect of the present invention, the method for preparing a composition for preparing bowel movements according to the present invention includes, for example, the first formulation and the second formulation, and, if necessary, the third formulation, the fourth formulation, and the water solubility. It is possible to prepare a highly concentrated liquid form containing a part of the solvent in advance, and to dilute it in various beverages as a water-soluble solvent at the time of taking it to adjust the specific concentration and content to drink. The beverage that the user can select is not limited as long as it is a water-soluble solvent, and may be, for example, water, alkaline ionized water, beverage, etc., and may be the same as or different from the water-soluble solvent in the highly concentrated solution.

In the method for preparing the bowel cleansing composition according to the present invention, the mixing method of each component, in the case of a solid, particle shape and size, pH, manufacturing temperature, stirring conditions, packaging container, packaging material, vacuum packaging or gas replacement packaging, etc. The packaging method and the like may be arbitrarily adjusted according to the type, type, transportation, storage method, etc. of the composition for intestinal cleansing to be prepared.

The dosage of the composition for intestinal cleansing according to the present invention starts 3-5 hours before colonoscopy in consideration of the sensitivity of the intestine of the examinee, and can be taken 5-10 times every 5-10 minutes, 50-100cc at a time, However, the present invention is not limited thereto. In addition, the dosage of the composition for bowel cleansing according to the present invention is, for example, 1 hour to 1 hour and 30 minutes, but if you are thirsty, you can additionally take an appropriate amount of mineral water, etc., but is not limited thereto.

An appropriate dose of the composition for bowel cleansing according to the present invention can be variously changed depending on the purpose of the individual for treatment and treatment other than bowel cleansing for colonoscopy and the like. Those skilled in the art can adjust the dosage in order to achieve the desired treatment and treatment in consideration of factors such as the patient's age, weight, medical history, and the like.

The bowel cleansing composition according to the present invention may be administered in one or more application cycles. For example, the total dose of the composition for bowel cleansing may be administered in two or more separate application cycles or in divided doses.

The composition for cleansing the intestines according to the present invention contains a specific concentration of prebiotics or an extract of monk fruit, ascorbic acid, and, if necessary, a gastrointestinal motility stimulant such as ginger powder, so that it can be administered at a significantly reduced dose without raising blood sugar. It not only exhibits improved intestinal cleansing, but also provides convenience in taking it in a very small dose, and as it does not contain disgusting ingredients, it does not cause or minimize discomfort symptoms such as nausea, nausea, vomiting, and gas bloating. It is safe by suppressing the generation of combustible gas.

The manufacturing method according to the present invention can economically mass-produce and commercialize a high-performance composition for bowel cleansing.

Since the composition for bowel cleansing of the present invention does not cause an increase in blood sugar, and has excellent intestinal cleansing power, ease of administration, and safety, not only intestinal cleansing for colonoscopy, etc., but also before colon surgery and anal surgery such as hemorrhoids It can be used for treatment, treatment and prevention of diseases such as chronic or acute constipation.

Hereinafter, the present invention will be described in more detail through examples. However, it should be noted that the following examples are provided for illustrative purposes only to aid understanding of the present invention, and the scope and scope of the present invention are not limited thereto.

<Example 1: Composition for cleansing the intestines using fructooligosaccharide as the main intestinal cleansing component>

Using water as a solvent, a total of 460 ml of a composition for bowel cleansing was prepared including 85 g of fructooligosaccharide, 4 g of ascorbic acid, and 2 g of ginger powder (manufactured by Neo One, “Masgiwon Ginger Powder”). Mixing was carried out by mixing all the powdered ingredients at once and then pouring a solvent to dissolve them.

<Control Example 1: Composition for cleansing the intestines using sugar alcohol as the main intestinal cleansing component>

Using water as a solvent, a total of 460 ml of a bowel cleansing composition containing 75.8 g of sorbitol, 10 g of ascorbic acid, and 20 mg of sodium picosulfate was prepared by mixing in the same manner as in Example 1.

<Test Example 1: Intestinal cleanliness, blood sugar rise, nausea and bubble generation rate experiment (in vivo experiment)>

Intestinal cleansing power, blood sugar rise, nausea rate, and bubble generation rate of the bowel cleansing composition prepared in Example 1 and Control Example 1 were evaluated. Specifically, for colonoscopy subjects, the Example was evaluated through 76 people and the control example was evaluated by 51 people, and the dosage method of Example 1 and Control Example 1 was a total of 460ml for 30 minutes 5 hours before the scheduled test time. Bowel prep solution was taken followed by an additional 920 ml of water to drink over 1 hour.

intestinal cleanliness

Intestinal cleanliness was evaluated by the surgeon dividing the intestinal cleanliness level into three stages: Good, Fair, and Poor, based on the criteria shown in Table 1 below. The bowel cleansing ability was evaluated in a blind test without exposing information about the composition for bowel cleansing that the patient drank to the surgeon performing the colonoscopy for fair evaluation. During colonoscopy, it was evaluated as excellent when the level of bowel cleansing appeared to be clean enough to not miss even a small lesion.

Good A state in which the intestines are cleansed so that even small lesions are not missed Fair A condition in which one or two small lesions less than 5 mm may not be found Poor A condition in which there is a possibility that a lesion larger than 5 mm may have been missed due to insufficient bowel cleansing

The results of the evaluation of intestinal cleanliness according to the criteria of Table 1 are shown in Table 2 below.

sample number intestinal cleanliness (%) Great commonly Inadequate Example 1 85.5 14.5 0 Control Example 1 84.3 13.8 1.9

As can be seen from the above results, the intestinal cleansing power of Example 1 was similar to or slightly superior to that of Control Example 1.

blood sugar measurement

Blood glucose levels were measured by collecting blood before colonoscopy, and the results are shown in Table 3 below.

sample number Blood sugar (mg/dL) Example 1 94.7±8.6 Control Example 1 99.2±9.3

As can be seen from the above results, Example 1 can suppress a rise in blood sugar compared to Control Example 1, so it is less likely to cause a misdiagnosis for diabetes, etc. in a health checkup in parallel with a colonoscopy, and a diabetic patient without the risk of a rise in blood sugar can be taken

Nausea Rate

Among the subjects who took the bowel cleansing composition of Example 1 and Control Example 1, the number of subjects who indicated that they had nausea symptoms was measured, and the ratio is shown in Table 4 below.

sample number Nausea rate (%) Example 1 5.3 Control Example 1 13.7

As can be seen from the above results, Example 1 can lower the rate of nausea compared to Control Example 1, so it can provide convenience when taking a bowel cleansing agent.

Bubbling rate

At the time of colonoscopy after taking the bowel cleansing composition of Example 1 and Control Example 1, the surgeon observed whether bubbles were present in the large intestine of the test subject and measured the rate of bubble generation, and the results are shown in Table 5 below. indicated.

sample number Bubbling rate (%) Example 1 27.7 Control Example 1 64.8

As can be seen from the above results, in the case of Example 1, the bubble generation rate was significantly reduced compared to Control Example 1. Excessive bubble generation not only interferes with a smooth colonoscopy, but also acts as a cause of missing small lesions. If bubbles are generated, they can be washed out using drugs during colonoscopy, but since the range of washing at one time is limited, considerable effort and time are required for this. In the case of the bowel cleansing composition of Example 1, since the rate of bubble generation is low, it is possible to shorten the examination time and devote more time to observation of the lesion, as well as to facilitate the detection of small lesions due to the clear field of view Therefore, it is possible to increase the disease diagnosis rate.

From the above evaluation results, the bowel cleansing composition comprising the first bowel cleansing component having a glycemic index of substantially 0, the second cleansing component such as ascorbic acid, and a gastrointestinal motility promoter such as ginger powder, contains a sugar alcohol such as sorbitol. It can be seen that the intestinal cleansing power is similar to that of the existing composition for cleansing the intestines containing the main component, but the increase in blood sugar is suppressed, and the ratio of nausea and bubble generation is also significantly lower. The effect of the composition for bowel cleansing of the present invention, in particular, suppression of blood sugar rise, is a very important characteristic that should be considered due to the characteristics of colonoscopy, which is often performed as part of a health examination. In addition, the present invention relieves the objection to colonoscopy by increasing the convenience of taking by reducing the side effects of taking a bowel cleansing agent, such as nausea, and by lowering the rate of bubble generation, it is easy to see the inside of the intestine and even small lesions. It has the advantage of being able to find it.

Claims (10)

At least one selected from fructooligosaccharide, inulin, allulose, tagatose, β-4-galactosyl-lactose, and extracts of Monk Fruit as a Chapter 1 purifying ingredient; A composition for cleansing the intestine comprising ascorbic acid or a mixture of ascorbic acid and a salt of ascorbic acid as a second intestinal cleansing ingredient. The method of claim 1,
The composition is an intestinal prep composition comprising 5 g to 300 g of the first intestinal prepative component and 0.5 g to 40 g of the second bowel cleansing component in a total dose. According to claim 1,
The composition further comprises any one powder or extract selected from ginger, plum, jujube, cinnamon and malt as a gastrointestinal motility stimulant, and the gastrointestinal motility stimulator is a composition for bowel cleansing comprising 0.2 g to 10 g in total dose. 4. The method of claim 3,
The gastrointestinal motility promoter is ginger powder, a composition for bowel cleansing. According to claim 1,
The first intestinal cleansing component is fructooligosaccharide, bowel cleansing composition. According to claim 1,
The composition contains a water-soluble solvent, or a composition for intestinal cleansing that contains a water-soluble solvent when taken. 7. The method of claim 6,
The water-soluble solvent is water, alkaline ionized water or beverages, bowel cleansing composition. 7. The method of claim 6,
The total volume of the water-soluble solvent is 0.1L to 3L, bowel cleansing composition. 9. The method according to any one of claims 1 to 8,
The composition is a powder or tablet formulation, bowel cleansing composition. 9. The method according to any one of claims 1 to 8,
The composition is a one-component or two-component type, bowel cleansing composition.

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