Composition for bowel cleansing

Abstract

The present invention relates to a composition for bowel cleansing, comprising polyethylene glycol, sulfate and ascorbate ingredients.

Description

Composition for colon cleansing

[0001] [Cross-reference with related applications]

[0002] This application claims the benefit of priority to Korean Patent Application No. 10-2024-0120333, filed September 4, 2024, and Korean Patent Application No. 10-2025-0085191, filed June 26, 2025, the entire contents of which are incorporated herein by reference.

[0003] The present invention relates to a composition for colon cleansing comprising polyethylene glycol, sulfate and ascorbate components.

[0004]

[0005] Colon cancer is one of the most common cancers worldwide, and its incidence is steadily increasing. Because it often lacks specific symptoms, early detection is difficult. Colonoscopy is essential for early detection.

[0006] To enhance the accuracy of colonoscopy, a colon cleansing process is necessary before the examination. However, since most colon cleansing procedures are accomplished by patients self-administering a colon cleansing agent, it's crucial that patients are comfortable with the full dosage and avoid serious side effects.

[0007] A 4-liter product containing polyethylene glycol was developed, but the large volume resulted in frequent failures. A 2-liter product was also developed, but demand for a reduced dosage remains. A 1-liter product was later developed, but concerns about the potential side effects of the hyperosmotic agent, such as dehydration and electrolyte imbalance, were reported.

[0008] In addition, gastric residual fluid is a risk factor for aspiration. As gastric residual fluid increases, the risk of aspiration increases. If gastric residual fluid is aspirated into the lungs, it can cause serious side effects such as pneumonia and pulmonary edema, and can cause irreversible damage to the lungs. Considering that colonoscopies are mostly performed under general anesthesia, anesthesia can suppress the protective airway reflex, which increases the risk or possibility of aspiration, in which gastric residual fluid flows back into the airway and enters the lungs. Therefore, it is important to reduce the amount of gastric residual fluid taken during colonoscopy. The problem of large amounts of gastric residual fluid remaining in patients taking existing hyperosmotic bowel preparations is emerging.

[0009] Under this technical background, the present invention aims to provide a safe bowel cleansing agent with high patient compliance and low risk of side effects such as dehydration, electrolyte imbalance, and gastric retention.

[0010]

[0011] The purpose of the present invention is to provide a composition for colon cleansing that has a low dosage and significantly lower risk of side effects.

[0012] In order to achieve the above purpose, one aspect of the present invention provides a composition for colon cleansing comprising polyethylene glycol, sulfate, and ascorbate components.

[0013] In addition, another aspect of the present invention provides a method for administering the composition for colon cleansing.

[0014] The composition for colon cleansing of the present invention has excellent convenience of administration and compliance due to a small dosage, and not only has excellent bowel cleansing ability, but also has excellent safety due to low concerns about side effects such as dehydration, electrolyte imbalance, and gastric retention, so it can be used as an effective colon cleansing agent.

[0015] However, the effects of the present invention are not limited to the effects mentioned above, and other effects not mentioned will be clearly understood by those skilled in the art from the description below.

[0016]

[0017] Hereinafter, the present invention will be described in detail.

[0018]

[0019] One aspect of the present invention provides a composition for colon cleansing comprising polyethylene glycol, sulfate, and ascorbate components.

[0020] The above colon cleansing composition is a composition for the purpose of cleansing the colon before colonoscopy, and can be used in the same sense as a colon cleansing agent, a bowel cleansing agent, etc.

[0021] In the present invention, the polyethylene glycol (PEG) may be a typical polyethylene glycol used in a composition for colon cleansing. The average molecular weight of the polyethylene glycol may be an average molecular weight of a typical polyethylene glycol used in a composition for colon cleansing, and may be, for example, 100 to 10,000, but is not limited thereto. For example, the average molecular weight of the polyethylene glycol may be 2,000 to 8,000, specifically 2,000 to 5,000, and more specifically 3,000 to 4,000. The polyethylene glycol of the present invention may be polyethylene glycol 3350 (PEG3350) or polyethylene glycol 4000 (PEG4000).

[0022] In the composition for colon cleansing of the present invention, the content of polyethylene glycol may be 20 g or more, 25 g or more, 30 g or more, or 35 g or more, and may be 60 g or less, 55 g or less, 50 g or less, 45 g or less, or 40 g or less. For example, the content of polyethylene glycol may be 20 g to 60 g, 20 g to 50 g, 30 g to 50 g, or 30 g to 40 g. The content of polyethylene glycol may be 36 g.

[0023] In the present invention, the sulfate may be included in the form of an alkali metal salt and / or an alkaline earth metal salt thereof. For example, the sulfate may be at least one selected from the group consisting of sodium sulfate, potassium sulfate, and magnesium sulfate, but is not limited thereto. The sulfate may be sodium sulfate, and the sulfate may be an anhydrous or hydrated. Specifically, the sulfate of the present invention may be anhydrous sodium sulfate.

[0024] In the composition for colon cleansing of the present invention, the content of the sulfate may be 30 g or more, 31 g or more, 32 g or more, 33 g or more, 34 g or more, or 35 g or more, and may be 40 g or less, 39 g or less, 38 g or less, 37 g or less, or 36 g or less. For example, the content of the sulfate may be 30 g to 40 g, 31 g to 39 g, 32 g to 38 g, 33 g to 37 g, or 34 g to 36 g. For example, the content of the sulfate may be 35 g.

[0025] In the present invention, the ascorbate component may be ascorbic acid, a salt of ascorbic acid, or a mixture thereof, and may particularly be ascorbic acid. The ascorbate may be at least one selected from the group consisting of sodium salt, potassium salt, magnesium salt, and calcium salt, and may particularly be sodium ascorbate, but is not limited thereto.

[0026] In the composition for colon cleansing of the present invention, the content of the ascorbate component may be 10 g or more, 12 g or more, 14 g or more, 15 g or more, or 16 g or more, and may be 30 g or less, 25 g or less, or 20 g or less. For example, the content of the ascorbate component may be 10 g to 30 g, 10 g to 25 g, 15 g to 25 g, or 15 g to 20 g.

[0027] In the bowel cleansing composition of the present invention, the ascorbate component may be ascorbic acid. The bowel cleansing composition of the present invention may contain ascorbic acid as the ascorbate component and may not contain ascorbate salt. In the bowel cleansing composition of the present invention, the content of the ascorbic acid may be 10 g or more, 12 g or more, 14 g or more, 15 g or more, or 16 g or more, and may be 30 g or less, 25 g or less, or 20 g or less. For example, the content of the ascorbic acid may be 10 g to 30 g, 10 g to 25 g, 15 g to 25 g, or 15 g to 20 g. For example, the content of the ascorbic acid may be 18 g.

[0028] The composition for colon cleansing of the present invention has a reduced content of polyethylene glycol and an increased content of sulfate compared to conventional compositions for colon cleansing, and by including polyethylene glycol, sulfate, and ascorbate components in the above content ranges, it has an excellent colon cleansing effect and is also safe due to its low dosage and thus can be usefully used as a composition for colon cleansing.

[0029] The composition for colon cleansing of the present invention may have a reduced content of polyethylene glycol, an increased content of sulfate, and may contain only ascorbic acid without containing ascorbate, compared to a conventional composition for colon cleansing. By containing polyethylene glycol, sulfate, and ascorbic acid in the above-mentioned content range, the dosage is low, so that the convenience of taking the composition is high, while the colon cleansing effect is excellent and the safety is also excellent, so that the composition can be usefully used as a composition for colon cleansing.

[0030] In the present invention, the composition for colon cleansing may further comprise an electrolyte component. The electrolyte may include an alkali metal salt, an alkaline earth metal salt, etc., and may be at least one selected from the group consisting of sodium salt, potassium salt, calcium salt, magnesium salt, chloride salt, iodide salt, bicarbonate, and carbonate, but is not limited thereto. In particular, the electrolyte in the present invention may be sodium chloride or potassium chloride, and more specifically, sodium chloride and potassium chloride.

[0031] The electrolyte may be included in the bowel cleansing composition in an appropriate content range to ensure safety by reducing the patient's electrolyte absorption or loss and minimizing problems such as dehydration due to ingestion of the bowel cleansing agent. In the bowel cleansing composition of the present invention, the content of the electrolyte may be 0.1 g or more, 0.5 g or more, 1 g or more, or 2 g or more, and may be 10 g or less, 8 g or less, 5 g or less, 4 g or less, or 3 g or less. For example, the content of the electrolyte may be 0.1 g to 10 g, 0.1 g to 5 g, 1 g to 5 g, or 2 g to 4 g. For example, when the bowel cleansing composition of the present invention includes sodium chloride and potassium chloride as electrolytes, the content of the sodium chloride may be 1 g to 3 g, and the content of the potassium chloride may be 0.1 g to 2 g. Additionally, the composition for colon cleansing of the present invention may include 2 g of sodium chloride and 1 g of potassium chloride.

[0032] In the present invention, the composition for colon cleansing may further include simethicone.

[0033] In the composition for colon cleansing of the present invention, the content of simethicone may be 0.01 g or more, 0.1 g or more, 0.2 g or more, or 0.3 g or more, and may be 2 g or less, 1.5 g or less, 1.2 g or less, 1 g or less, 0.8 g or less, or 0.5 g or less. For example, the content of simethicone may be 0.01 g to 2 g, 0.1 g to 1 g, 0.3 g to 1 g, or 0.3 g to 0.6 g. For example, the content of simethicone may be 0.32 g.

[0034] The present invention may provide a composition for colon cleansing comprising polyethylene glycol, sulfate, ascorbate, and electrolyte components. The present invention may provide a composition for colon cleansing comprising polyethylene glycol, sulfate, ascorbate, and simethicone. The present invention may provide a composition for colon cleansing comprising polyethylene glycol, sulfate, ascorbate, electrolyte, and simethicone. The present invention may provide a composition for colon cleansing comprising polyethylene glycol, sodium sulfate, ascorbic acid, sodium chloride, potassium chloride, and simethicone. The description of each component and composition is as described above.

[0035] The present invention provides a composition for colon cleansing that can achieve sufficient colon cleansing for examination even when administered in a small dose.

[0036] The composition for colon cleansing of the present invention may be administered in a volume of 1 L or less. For example, the composition may be administered in a volume of 0.9 L or less, or 0.8 L or less, or may be administered in a volume of 0.7 L or less. For example, the composition for colon cleansing of the present invention may be administered in a volume of 0.7 L to 1 L or 0.7 L to 0.9 L. For example, the composition for colon cleansing of the present invention may be administered in a volume of 0.8 L.

[0037] The composition for colon cleansing of the present invention may be provided by packaging the total dosage at once, or may be provided by dividing the total dosage into two or more portions.

[0038] In addition, the bowel cleansing composition of the present invention may be administered in its entirety at one time (non-divided administration or same-day divided administration) or divided into several times (divided administration or two-day divided administration). As an example of non-divided administration (same-day divided administration), the bowel cleansing composition of the present invention may be administered over several hours on the evening before the examination or on the morning of the examination. Specifically, a portion of the total dosage may be administered, and the remainder may be administered after a certain period of time, for example, 0.5 to 3 hours. As an example of divided administration (or two-day divided administration), the bowel cleansing composition of the present invention may be administered in its entirety on the evening before the examination and the remainder on the morning of the examination.

[0039] After taking the colon cleansing composition of the present invention, additional water may be taken. Specifically, after taking the colon cleansing composition, a certain amount of water, for example, 0.5 to 2 L, 1 to 2 L, or 1.5 to 2 L, may be additionally taken. The additional water may be taken after taking the entire colon cleansing composition, or may be taken between taking the colon cleansing composition. Water may also be taken before taking the colon cleansing composition of the present invention.

[0040] The composition for colon cleansing of the present invention may be provided in the form of powder, granules, liquid, tablet, capsule, etc., but is not limited thereto.

[0041] The bowel cleansing composition of the present invention may be provided in the form of a powder and taken in the form of a solution by dissolving it in water. For example, the bowel cleansing composition of the present invention may be prepared and taken in the form of a solution of 1 L or less. The bowel cleansing composition of the present invention may be prepared and taken in the form of a solution of 0.9 L or less, 0.8 L or less, or 0.7 L or less. The bowel cleansing composition of the present invention may be prepared and taken in the form of a solution of 0.7 L to 1 L or 0.7 L to 0.9 L. The bowel cleansing composition of the present invention may be prepared and taken in the form of a solution of 0.8 L.

[0042] The composition for colon cleansing of the present invention may further comprise pharmaceutically acceptable additives. The additives may be any pharmaceutically acceptable additives commonly used in each formulation, such as sweeteners, flavoring agents, disintegrants, binders, plasticizers, lubricants, coating agents, pH regulators, diluents, excipients, and coating agents.

[0043] The ascorbate component of the present invention may be replaced with citric acid or a salt thereof.

[0044] The present invention provides a composition for colon cleansing comprising 20 g to 60 g of polyethylene glycol, 30 g to 40 g of sulfate, and 10 g to 30 g of ascorbate.

[0045] The present invention provides a composition for colon cleansing comprising 30 g to 40 g of polyethylene glycol, 30 g to 40 g of sulfate, and 10 g to 30 g of ascorbate.

[0046] The present invention provides a composition for bowel cleansing comprising 20 g to 60 g of polyethylene glycol, 30 g to 40 g of sulfate, 10 g to 30 g of ascorbate component, and 0.1 g to 10 g of electrolyte.

[0047] The present invention provides a composition for bowel cleansing comprising 30 g to 40 g of polyethylene glycol, 30 g to 40 g of sulfate, 10 g to 30 g of ascorbate component, and 0.1 g to 10 g of electrolyte.

[0048] The present invention provides a composition for colon cleansing comprising 20 g to 60 g of polyethylene glycol, 30 g to 40 g of sulfate, 10 g to 30 g of ascorbate component, and 0.01 g to 2 g of simethicone.

[0049] The present invention provides a composition for colon cleansing comprising 30 g to 40 g of polyethylene glycol, 30 g to 40 g of sulfate, 10 g to 30 g of ascorbate component, and 0.01 g to 2 g of simethicone.

[0050] The present invention provides a composition for bowel cleansing comprising 20 g to 60 g of polyethylene glycol, 30 g to 40 g of sulfate, 10 g to 30 g of ascorbate, 0.1 g to 10 g of electrolyte, and 0.01 g to 2 g of simethicone.

[0051] The present invention provides a composition for bowel cleansing comprising 30 g to 40 g of polyethylene glycol, 30 g to 40 g of sulfate, 10 g to 30 g of ascorbate, 0.1 g to 10 g of electrolyte, and 0.01 g to 2 g of simethicone.

[0052] The present invention provides a composition for bowel cleansing comprising 20 g to 60 g of polyethylene glycol, 30 g to 40 g of sulfate, 10 g to 30 g of ascorbate, 0.1 g to 5 g of sodium chloride, 0.1 g to 5 g of potassium chloride, and 0.01 g to 2 g of simethicone.

[0053] The present invention provides a composition for bowel cleansing comprising 30 g to 40 g of polyethylene glycol, 30 g to 40 g of sodium sulfate, 10 g to 30 g of ascorbic acid, 0.1 g to 5 g of sodium chloride, 0.1 g to 5 g of potassium chloride, and 0.01 g to 2 g of simethicone.

[0054] The present invention provides a composition for bowel cleansing comprising 30 g to 50 g of polyethylene glycol, 30 g to 40 g of sodium sulfate, 15 g to 20 g of ascorbic acid, 0.5 g to 3 g of sodium chloride, 0.1 g to 2 g of potassium chloride, and 0.1 g to 1 g of simethicone.

[0055] The present invention provides a composition for bowel cleansing comprising 30 g to 40 g of polyethylene glycol, 30 g to 40 g of sodium sulfate, 15 g to 20 g of ascorbic acid, 1 g to 2 g of sodium chloride, 0.1 g to 1 g of potassium chloride, and 0.2 g to 0.5 g of simethicone.

[0056] The present invention provides a composition for bowel cleansing comprising 36 g of polyethylene glycol, 35 g of sodium sulfate, 18 g of ascorbic acid, 2 g of sodium chloride, 1 g of potassium chloride, and 0.32 g of simethicone.

[0057] The composition for colon cleansing of the present invention may not contain ascorbate.

[0058] The composition for colon cleansing of the present invention may have a reduced content of polyethylene glycol, an increased content of sulfate, and may contain only ascorbic acid without containing ascorbate, compared to a conventional composition for colon cleansing. By containing polyethylene glycol, sulfate, and ascorbic acid in the above-described content range, the composition for colon cleansing may have an excellent colon cleansing effect and excellent safety even with a small dosage, and thus may be usefully used as a composition for colon cleansing.

[0059] Specifically, the present invention may provide a composition for colon cleansing comprising polyethylene glycol, sulfate, and ascorbic acid, but not including ascorbate. The present invention may provide a composition for colon cleansing comprising 30 g to 40 g of polyethylene glycol, 30 g to 40 g of sulfate, and 10 g to 30 g of ascorbic acid, but not including ascorbate. The present invention may provide a composition for colon cleansing comprising 30 g to 40 g of polyethylene glycol, 30 g to 40 g of sulfate, and 15 g to 20 g of ascorbic acid, but not including ascorbate. The present invention may provide a composition for colon cleansing comprising 36 g of polyethylene glycol, 35 g of sodium sulfate, and 18 g of ascorbic acid, but not including ascorbate. The composition for colon cleansing may further comprise an electrolyte. The above composition for colon cleansing may further comprise simethicone. The composition for colon cleansing may further comprise an electrolyte and simethicone. The composition for colon cleansing may further comprise sodium chloride, potassium chloride, simethicone, or a mixture of two or more thereof. The composition for colon cleansing may further comprise sodium chloride, potassium chloride, and simethicone. The electrolyte may be sodium chloride, potassium chloride, or a mixture thereof. The content of the electrolyte may be 0.1 g to 10 g or 0.5 g to 5 g. The content of the simethicone may be 0.01 g to 2 g. The contents of the sodium chloride and the calcium chloride may be 0.1 g to 5 g, 0.1 g to 3 g, or 0.1 g to 2 g, respectively. The above composition for colon cleansing may comprise 2 g of sodium chloride, 1 g of potassium chloride, and 0.32 g of simethicone. The above composition for colon cleansing may comprise 36 g of polyethylene glycol, 35 g of sodium sulfate, 18 g of ascorbic acid, 2 g of sodium chloride, 1 g of potassium chloride, and 0.32 g of simethicone, and may not comprise ascorbate.The above colon cleansing composition may be a composition for preparation as a 0.8 L solution. The above colon cleansing composition may be prepared as a 0.8 L solution and taken orally. The above colon cleansing composition may be prepared as a 0.8 L solution, and after taking 0.4 L of the solution, an additional 0.8 L of water may be taken, and after a certain period of time, the remaining 0.4 L of the solution may be taken and an additional 0.8 L of water may be taken.

[0060] The present invention provides a colon cleansing composition comprising the above-described components and contents, which exhibits excellent bowel cleansing properties even in small doses of 1 L or less and exhibits excellent safety. The colon cleansing composition can maintain stable blood component levels even after administration. The colon cleansing composition can also maintain a low level of gastric retention even after administration.

[0061] Gastrointestinal retention refers to the liquid that remains in the stomach and is not completely discharged from the stomach to the duodenum even after a certain period of time. This gastrointestinal retention is a risk factor for aspiration. As the gastrointestinal retention increases, the risk of aspiration increases. If the gastrointestinal retention is aspirated into the lungs, it can cause serious side effects such as pneumonia and pulmonary edema, and can cause irreversible damage to the lungs. Considering that most colonoscopies are performed under general anesthesia, it is important to reduce gastrointestinal retention during colonoscopy. There was a problem that a lot of gastrointestinal retention remained in patients taking existing hyperosmotic bowel cleansing agents. However, the bowel cleansing composition of the present invention contains the above-mentioned ingredients in the above-mentioned contents, and provides a bowel cleansing composition that exhibits excellent bowel cleansing power even with a small dosage of 1 L or less, can reduce gastrointestinal retention, and enables safe endoscopic examination.

[0062] The present invention provides a 0.7 L to 1 L solution for colon cleansing prepared by mixing the above colon cleansing composition with a solvent such as water. The present invention provides a 0.8 L solution for colon cleansing prepared by mixing the above colon cleansing composition with a solvent such as water.

[0063] The composition for colon cleansing of the present invention is a composition for colon cleansing for preparing a 0.7 L to 1 L solution by mixing with a solvent such as water. The composition for colon cleansing of the present invention is a composition for colon cleansing for preparing a 0.8 L solution by mixing with a solvent such as water.

[0064] The present invention provides a composition for colon cleansing prepared as a 0.7 L to 1 L solution and administered. The present invention provides a composition for colon cleansing prepared as a 0.8 L solution and administered.

[0065]

[0066] Another aspect of the present invention provides a method of administering the composition for colon cleansing.

[0067] Another aspect of the present invention provides a method for preparing a composition for colon cleansing, comprising the step of mixing the polyethylene glycol, sulfate and ascorbate components.

[0068] Another aspect of the present invention provides a use of a composition comprising polyethylene glycol, sulfate and ascorbate components for bowel cleansing.

[0069] The ingredients and their contents mentioned in the above administration method, the above manufacturing method and the above bowel cleansing use are the same as those described in the above composition or the above solution.

[0070]

[0071] Hereinafter, the present invention will be described in detail through examples and experimental examples.

[0072] However, the following examples and experimental examples specifically illustrate the present invention, and the content of the present invention is not limited by the following examples and experimental examples.

[0073]

[0074] [Example]

[0075] The composition for colon cleansing of Example 1 was prepared according to the composition in Table 1 below. Specifically, PEG3350, sodium sulfate, sodium chloride, potassium chloride, and simethicone were mixed and filled into a pouch (Pouch A). At this time, simethicone was granulated and mixed. Thereafter, ascorbic acid was weighed and filled into a pouch (Pouch B).

[0076]

[0077] Pouch AB ingredients PEG3350 anhydrous sodium sulfate sodium chloride potassium chloride simethicone ascorbic acid content (g) 3635210.3218

[0078]

[0079] The composition of Example 1 above is provided in a form including pouches A and B, and can be dissolved in water to prepare a solution of a certain volume and taken. For example, the composition of Example 1 above can be prepared by dissolving pouches A and B together in water to prepare a 700 mL solution and taken.

[0080] In addition, a composition for washing the intestines of Example 2 was prepared according to the composition of Table 2 below in the same manner as Example 1. The composition of Example 2 is provided by being filled into pouches A (1), pouch A (2), pouch B (1), and pouch B (2).

[0081]

[0082] Pouch A(1)B(1)Ingredients PEG3350Anhydrous sodium sulfateSodium chloridePotassium chlorideSimethiconeAscorbic acidContent (g)1817.510.50.169Pouch A(2)B(2)Ingredients PEG3350Anhydrous sodium sulfateSodium chloridePotassium chlorideSimethiconeAscorbic acidContent (g)1817.510.50.169

[0083]

[0084] The composition of the above Example 2 can be taken by dissolving pouches A(1) and B(1) together in water to prepare a 400 mL solution and then dissolving pouches A(2) and B(2) in water to prepare a 400 mL solution and then taking the solution.

[0085]

[0086] [Experimental Example]

[0087] Experimental Example 1. Evaluation of the strength of the composition

[0088] After administering the composition of Example 1 or Comparative Example 1 in Table 3 below to test subjects, bowel cleansing was evaluated. Comparative Example 1 is Coolprepsan, a commercially available product.

[0089]

[0090] Ingredients Example 1 (g) Comparative Example 1 (g) PEG 3350 36200 Anhydrous sodium sulfate 3515 Sodium chloride 25.38 Potassium chloride 12.03 Simethicone 0.32 Ascorbic acid 189.4 Sodium ascorbate -11.8

[0091]

[0092] The test subjects were divided into three groups, and were instructed to take the composition of Example 1 in divided doses on the day before and on the day of colonoscopy (Test Group 1), to take the composition of Example 1 on the day of colonoscopy (Test Group 2), or to take the composition of Comparative Example 1 (Cool Prep San) in divided doses on the day before and on the day of colonoscopy (Test Group 3). The composition of Example 1 was mixed with water to make an 800 mL solution (Solution 1), and the composition of Comparative Example 1 was mixed with water to make a 2 L solution (Solution 2) according to the approved usage of Cool Prep San and taken. Test Group 1 was instructed to take 400 mL of Solution 1 and 800 mL of water on the evening of the day before the test and the morning of the test, respectively. Test group 2 took 400 mL of solution 1 and 800 mL of water on the morning of the test day, and then 400 mL of solution 1 and 800 mL of water 1 to 2 hours later. Test group 3 took 1 L of solution 2 and 500 mL of water on the evening before the test and on the morning of the test day, respectively.

[0093] Bowel cleansing was assessed using the Harefield Cleansing Scale, with grades A and B indicating successful bowel cleansing, and grades C and D indicating unsuccessful bowel cleansing. Grade A indicates excellent cleanliness, with all parts of the colon (rectum, sigmoid colon, descending colon, transverse colon, and ascending colon) being 'empty and clean (4 points)' or 'clear liquid (3 points)'.

[0094] The evaluation results showed that test groups 1 and 2 showed excellent bowel cleansing despite taking 1200 mL less of the drug than test group 3 (Table 4). In addition, test groups 1 and 2 showed a higher proportion of subjects with a cleansing grade of A than test group 3. When comparing test groups 1 and 3, which took the same dosage, the proportion of subjects with a grade of A was approximately 10% higher in test group 1.

[0095]

[0096] Test group 1 Test group 2 Test group 3 Number of subjects 394443 Number of subjects who succeeded in cleansing (proportion %) 39 (100) 44 (100) 43 (100) Number of subjects by purity level (proportion %) A 36 (92.3) 38 (86.4) 36 (83.7) B 3 (7.7) 6 (13.6) 7 (16.3) C or D 0 (0.0) 0 (0.0) 0 (0.0)

[0097]

[0098] In addition, as a result of evaluating the purity score in each part of the large intestine, the purity scores of test groups 1 and 2 were evaluated higher than those of test group 3 in all large intestine parts (Table 5). In particular, the ascending colon is a place with a high risk of developing serrated polyps, and the purity of the ascending colon is very important. The purity score of the subject who took the composition of comparative example 1 (test group 3) was less than 3 points, whereas the purity scores of the subjects who took the composition of example 1 (test groups 1 and 2) were all 3 points or more, and test groups 2 and 3 showed a statistically significant difference (p-value=0.0065).

[0099]

[0100] Test group 1 Test group 2 Test group 3 Ascending colon 3.10±0.50 3.27±0.59 2.98±0.41 Transverse colon 3.36±0.54 3.41±0.58 3.16±0.48 Descending colon 3.10±0.45 3.18±0.54 3.07±0.46 Sigmoid colon 3.23±0.48 3.18±0.54 3.09±0.43 Rectum 3.23±0.54 3.11±0.49 3.09±0.43

[0101]

[0102] Experimental Example 2. Safety Evaluation of the Composition

[0103] 2-1. Evaluation of adverse reactions after taking the composition

[0104] The results of evaluating the predicted adverse reactions (8 types, nausea, vomiting, dry mouth, lethargy, abdominal distension, abdominal pain, headache, dizziness) and the proportion (%) of subjects who experienced other adverse reactions in test groups 1 to 3 are as shown in Table 6 below.

[0105]

[0106] Adverse reaction test group 1 Test group 2 Test group 3 Expected adverse reaction (Solicited TEAE) after drug administration 51.115043.48 Expected adverse drug reaction 51.115043.48 Serious and expected adverse reaction 000 Serious and expected adverse drug reaction 000 Adverse reaction (Unsolicited TEAE) after drug administration 24.4441.3028.26 Adverse drug reaction 2.226.522.17 Serious adverse reaction 000 Serious adverse drug reaction 000

[0107]

[0108] No serious adverse reactions were observed in any of the subjects, and there were no statistically significant differences between groups 1 to 3. Mild adverse reactions that may occur when taking the colon cleanser were observed in groups 1 to 3, and no abnormal signs of clinical significance were observed.

[0109] It is known that the incidence of adverse reactions is statistically significantly higher in the case of previously approved 1L bowel preparations compared to 2L bowel preparations (e.g., Coolprep San), but the bowel cleansing composition of the present invention has been confirmed to have excellent safety despite having a small amount of liquid of less than 1L.

[0110]

[0111] 2-2. Evaluation of normal blood parameters after taking the composition

[0112] In the test groups 1 to 3, blood was collected from the subjects before and after taking the bowel cleanser, and the blood concentrations of Hemoglobin, Hematocrit, RBC (red blood cell) Count, WBC (white blood cell) with differentiation, Platelet Count, ALT (alanine transaminase), AST (aspartate transaminase), BUN (blood urea nitrogen), Creatinine, Glucose, LDH (lactate dehydrogenase), TB (total bilirubin), Sodium, Potassium, Total CO2 (HCO3), Chloride, Phosphorus, CPK (creatine phosphokinase), ALP (alkaline phosphatase), Ca, Mg, serum osmolarity, albumin, 25(OH)D, TG (triglyceride), LDL-cholesterol, HDL-cholesterol, and Total cholesterol were measured. Table 7 below shows the percentage of subjects falling within the normal and abnormal ranges for each item, and Table 8 below shows the results of measuring blood levels.

[0113]

[0114] Test group 1 Test group 2 Test group 3 Hemoglobin Before taking NormalAbnormalNormalAbnormalNormalAbnormalAfter taking Normal 1000 1000 1000 Abnormal 000000 Hematocrit Before taking NormalAbnormalNormalAbnormalNormalAbnormalAfter taking Normal 1000 1000 1000 Abnormal 000000 RBC count Before taking NormalAbnormalNormalAbnormalNormalAbnormalAfter taking Normal 1000 1000 1000 Abnormal 000000 ALT Before taking NormalAbnormalNormalAbnormalNormalAbnormalAfter taking Normal 97.732.2795.654.351000 Abnormal 000000 AST Before taking NormalAbnormalNormalAbnormalNormalAbnormalAfter taking AfterNormal97.732.2795.654.351000Abnormal000000LDH taken BeforeNormalAbnormalNormalAbnormalNormalAbnormalTake AfterNormal100010001000Abnormal000000Potassium taken BeforeNormalAbnormalNormalAbnormalNormalAbnormalTake AfterNormal100010001000Abnormal000000Total CO2 taken BeforeNormalAbnormalNormalAbnormalNormalTake AfterNormal100010001000Abnormal000000Chloride taken BeforeNormalAbnormalNormalAbnormalNormalTake AfterNormal100010001000Abnormal000000Phosphorus taken BeforeNormalAbnormalNormalAbnormalNormalAbnormalAfter takingNormal100010001000Abnormal000000

[0115]

[0116] Test group 1 Test group 2 Test group 3 Hemoglobin (g / dl) Before taking 13.73±1.38 13.43±1.37 13.59±1.17 After taking 14.29±1.42 14.27±1.44 14.08±1.20 Hematocrit (%) Before taking 41.70±3.74 40.65±3.6 141.02±3.34 After taking 43.52±3.79 43.46±4.03 42.48±3.32 RBC count (106 / μL) Before taking 4.53±0.48 4.47±0.39 4.48±0.39 After taking 4.72±0.48 4.75±0.40 4.64±0.36 ALT (U / L) After taking Before 19.53±10.71 20.59±10.38 24.76±12.57 After 23.93±14.10 25.93±12.99 29.09±18.14 AST (IU / L) Before 21.31±6.74 22.17±6.31 24.24±7.84 After 27.39±13.09 29.28±18.24 31.07±17.39 LDH (IU / L) Before 176.07±23.75 182.67±36.00 181.20±38.39 After 183.75±29.19 192.46±37.93 184.89±42.77 Creatinine (mg / dL) Before 0.77±0.160.77±0.160.77±0.16After 0.85±0.210.84±0.150.82±0.17Sodium(mmol / L)Before 139.69±1.93140.04±2.07139.98±1.51After 140.43±2.21140.33±2.37139.76±2.04Potassium(mmol / L)Before 4.34±0.364.31±0.384.31±0.33After 4.35±0.404.36±0.394.46±0.33Total CO2(mmol / L)After Before 27.62±2.44 26.82±2.60 26.85±2.20 After 23.47±2.80 22.93±2.85 24.50±2.79 Chloride (mmol / L) Before 103.58±2.01 104.37±1.73 104.02±1.90 After 106.18±2.43 106.57±2.47 105.16±2.00 Phosphorus (mg / dL) Before 3.51±0.44 3.50±0.46 3.64±0.49 After 3.82±0.58 3.99±0.573.71±0.52.

[0117] As a result of the measurement, blood concentrations were confirmed to be within the normal range after administration in all test groups.

[0118] In the case of a previously approved 1L bowel cleansing agent, it is known that the blood concentrations of several items, such as Hematocrit, Creatinine, LDH, Potassium, and Chloride, are out of the normal range or fluctuate greatly compared to a 2L bowel cleansing agent (e.g., Coolprep San), whereas the bowel cleansing composition of the present invention has been confirmed to have excellent safety despite having a small amount of liquid of less than 1L.

[0119]

[0120] Although representative embodiments of the present invention have been described above as examples, the scope of the present invention is not limited to the specific embodiments described above, and those skilled in the art will be able to make appropriate changes within the scope described in the claims of the present application.

Claims

1. A composition for colon cleansing comprising polyethylene glycol, sulfate, and ascorbate, wherein the content of polyethylene glycol is 20 g to 60 g and the content of sulfate is 30 g to 40 g.

2. A composition for washing the intestines, wherein the sulfate in claim 1 is anhydrous sodium sulfate.

3. A composition for colon cleansing according to claim 1, wherein the ascorbate component is ascorbic acid.

4. A composition for colon cleansing according to claim 1, wherein the ascorbate component contains ascorbic acid and does not contain sodium ascorbate.

5. A composition for washing the intestines, wherein the content of polyethylene glycol in claim 1 is 30 g to 50 g.

6. A composition for colon cleansing according to claim 1, wherein the content of polyethylene glycol is 20 g to 60 g, the content of sulfate is 30 g to 40 g, and the content of ascorbate is 10 g to 30 g.

7. A composition for washing the intestines, further comprising an electrolyte component, according to claim 1.

8. A composition for colon cleansing further comprising simethicone according to claim 1.

9. A composition for colon cleansing according to claim 1, further comprising an electrolyte component and simethicone.

10. A composition for washing the intestines according to claim 7 or claim 9, wherein the electrolyte component is sodium chloride and potassium chloride.

11. A composition for colon cleansing according to claim 9, wherein the content of the electrolyte component is 0.1 g to 10 g, and the content of the simethicone is 0.01 g to 2 g.

12. A composition for bowel cleansing according to claim 1, wherein the composition is administered in a volume of 1 L or less.