Compositions for gut cleansing for examining for reduction in dose on day

Abstract

The present invention relates to a composition for gut cleansing, and more particularly, to a composition for gut cleansing, which improves safety by reducing the dosage of a test requiring gut cleansing on the day.

Description

Technical Field

[0001] The present invention relates to a composition for intestinal cleansing, in particular to a composition for intestinal cleansing which greatly improves safety and convenience of taking by reducing the dosage on the day of examination requiring intestinal cleansing. Background Art

[0002] Colonoscopy is a very effective means to completely prevent colon cancer. However, the screening rate of colonoscopy is low worldwide, and one of the biggest reasons for the low screening rate is the difficulty of taking bowel cleansers. Unfortunately, most bowel cleansers are considered difficult to take by many people because the dosage is too large (2 to 4L) and the taste is mostly disgusting. In particular, all existing bowel cleansers are inconvenient to take, and a relatively large amount of 1 to 2L of bowel cleansers or water must be taken in a short period of time in the early morning on the day of the colonoscopy.

[0003] In addition, this existing method of taking intestinal cleansers may cause safety issues for the subjects. First, two-thirds of colonoscopy patients also undergo gastroscopy, and it is recommended to fast for at least 8 hours during gastroscopy, including water, which will be a direct contradiction to the method of taking intestinal cleansers during colonoscopy. In addition, most endoscopic examinations are performed under sleep anesthesia, and mixed solutions such as intestinal cleansers are prohibited from being administered within 3 hours before sleep anesthesia ("Simplified Sedation Therapy for Non-anesthetized Pain Medicine Medical Staff", Doo-jae Min, Department of Anesthesiology and Pain Medicine, Korea University Ansan Hospital, 2020).

[0004] In order to further promote colonoscopy and prevent the occurrence of colon cancer as much as possible through more accurate examinations, a new composition of intestinal cleansers is required, which reduces the total dose, improves the taste to increase the convenience of taking, and especially greatly reduces the dose taken in the early morning of the examination day to improve safety. Summary of the invention

[0005] The object of the present invention is to provide a composition for intestinal cleansing, which greatly reduces the dosage taken on the day of examination to improve safety while showing excellent intestinal cleansing effect.

[0006] The present invention provides a composition for intestinal cleaning, which is a composition for intestinal cleaning taken before an examination requiring intestinal cleaning.

[0007] The composition is taken in divided doses one day before and on the day of the examination.

[0008] The total dose taken on the day of the examination was less than 700 mL.

[0009] The present invention also provides an intestinal cleaning method, comprising administering a composition for intestinal cleaning to a human before an examination requiring intestinal cleaning, wherein the intestinal cleaning method comprises:

[0010] The composition is applied in divided doses on the day before and on the day of the examination.

[0011] The total dose (or doses) administered on the day of the examination was less than 700 mL.

[0012] The present invention also provides a composition for intestinal cleaning, which is a composition for intestinal cleaning used before an examination requiring intestinal cleaning.

[0013] The composition is taken in divided doses one day before and on the day of the examination.

[0014] The total dose taken on the day of the examination was less than 700 mL.

[0015] In one embodiment, the total dose or dosage taken or administered on the day of the examination may be 600 mL or less.

[0016] In one embodiment, the total dose or dosage taken or administered on the day of the examination may be 500 mL or less.

[0017] In one embodiment, the total dose or administration volume taken or applied on the day of the examination may be 360, 400, 450, 480, 500, 568 or 600 mL.

[0018] In one embodiment, the total dose or administration amount of the composition for intestinal cleansing taken or applied one day before and on the day of the examination may be 1.0 L to 4.0 L.

[0019] In one embodiment, the composition for intestinal cleansing comprises: a prepared solution prepared by dissolving a composition in the form of powder, granules, liquid preparation, tablet or capsule containing an active ingredient in a water-soluble solvent; and other water-soluble solvents,

[0020] The composition for intestinal cleansing is administered in a manner of taking or applying other water-soluble solvents after taking or applying the prepared solution, and the manner may be repeated a total of 2 to 4 times on the day before and on the day of the examination.

[0021] In one embodiment, the composition for intestinal cleansing can be in any form of a solution, a suspension, or an emulsion.

[0022] In one embodiment, the composition for intestinal cleansing comprises:

[0023] At least one sugar alcohol selected from the following ingredients as a first effective ingredient, the ingredients comprising xylitol, sorbitol, glycerol, erythritol, threitol, arabitol, ribitol, mannitol, galactitol, fucitol, iditol, inositol, heptyl alcohol, isomalt, maltitol, lactitol, maltotriitol, maltotetraitol and hydrogenated glucose;

[0024] Ascorbic acid or a mixture of ascorbic acid and a salt of ascorbic acid as a second active ingredient; and

[0025] Water-soluble solvents,

[0026] The first active ingredient may be contained in an amount of 10 g / L to 500 g / L based on the total composition, the second active ingredient may be contained in an amount of 1 g / L to 300 g / L based on the total composition, and the water-soluble solvent may be contained in an amount of 1.0 L to 3.0 L.

[0027] In one specific embodiment, the composition for intestinal cleansing comprises:

[0028] 110 g of D-sorbitol;

[0029] 15g of ascorbic acid;

[0030] 2.1 g of sodium bicarbonate;

[0031] 0.9 g of potassium bicarbonate; and

[0032] 1.0L to 3.0L of water,

[0033] Here, the water may be applied in the form of a solution in which the components are dissolved, or may be applied alone.

[0034] In a more specific embodiment, the composition for intestinal cleansing,

[0035] Contains 1.0L to 1.5L of water, or a total dose of 1.0L to 1.5L taken the day before and on the day of the test,

[0036] The total dose taken on the day of the examination may be less than 500 mL.

[0037] In a more specific embodiment, the composition for intestinal cleansing,

[0038] Contains 1.28L, 1.35L or 1.44L of water, or a total of 1.28L, 1.35L or 1.44L taken the day before and the day of the test,

[0039] The total dose taken on the day of the examination may be 360 ​​mL, 460 mL or 480 mL.

[0040] In one embodiment, the composition for intestinal cleansing comprises:

[0041] Polyethylene glycol as the first active ingredient;

[0042] Ascorbic acid or a mixture of ascorbic acid and an ascorbate as a second active ingredient; and

[0043] Water-soluble solvents,

[0044] The first active ingredient may be contained in an amount of 10 g / L to 500 g / L based on the total composition, the second active ingredient may be contained in an amount of 1 g / L to 300 g / L based on the total composition, and the water-soluble solvent may be contained in an amount of 1.0 L to 3.0 L.

[0045] In one embodiment, the composition for intestinal cleansing is

[0046] further comprising at least one selected from the group consisting of sodium chloride, potassium chloride and sodium sulfate as a third active ingredient,

[0047] The third active ingredient may be included in an amount of 0.5 g / L to 50 g / L based on the total composition.

[0048] In a more specific embodiment, in the composition for intestinal cleansing,

[0049] The polyethylene glycol may have an average molecular weight of 3000 to 4000 Da.

[0050] In a more specific embodiment, the composition for intestinal cleansing comprises:

[0051] 200 g of polyethylene glycol 3350;

[0052] 9.4 g of ascorbic acid;

[0053] 11.8 g of sodium ascorbate;

[0054] 15 g of anhydrous sodium sulfate;

[0055] 5.382 g of sodium chloride;

[0056] 2.030 g of potassium chloride; and

[0057] 1.0 to 3.0L of water,

[0058] The water may be applied in the form of a solution in which the ingredients are dissolved, or may be applied alone. In a more specific embodiment, the composition for intestinal cleansing is

[0059] Contains 3.0 L of water, or the total dose taken on the day before and on the day of the examination is 3.0 L, and the total dose taken on the day of the examination can be 600 mL.

[0060] In a more specific embodiment, the composition for intestinal cleansing comprises:

[0061] 140 g of polyethylene glycol 3350;

[0062] 7.54 g of ascorbic acid;

[0063] 48.11 g of sodium ascorbate;

[0064] 9 g of anhydrous sodium sulfate;

[0065] 5.2 g of sodium chloride;

[0066] 2.2 g of potassium chloride; and

[0067] 1.0 to 3.0 L of water, wherein the water can be applied in the form of a solution in which the ingredients are dissolved, or can be applied alone. In a more specific embodiment, the composition for intestinal cleansing,

[0068] Contains 2.0L of water, or the total dose taken on the day before and on the day of the examination is 2.0L, and the total dose taken on the day of the examination can be 400mL or 500mL.

[0069] In a more specific embodiment, the composition for intestinal cleansing comprises:

[0070] 160 g of polyethylene glycol 3350;

[0071] 40.6 g of ascorbic acid;

[0072] 9.4 g of sodium ascorbate;

[0073] 18 g of anhydrous sodium sulfate;

[0074] 2.7 g of sodium chloride;

[0075] 1g of potassium chloride; and

[0076] 1.0 to 3.0 L of water, wherein the water can be applied in the form of a solution in which the ingredients are dissolved, or can be applied alone. In a more specific embodiment, the composition for intestinal cleansing,

[0077] Contains 2.0 L of water, or the total dose taken on the day before and on the day of the examination is 2.0 L, and the total dose taken on the day of the examination can be 400 mL.

[0078] In one embodiment, the composition for intestinal cleansing,

[0079] Based on the total composition, it may contain:

[0080] 0.001 g / L to 0.1 g / L of sodium picosulfate or its hydrate;

[0081] 0.5 g / L to 50 g / L magnesium oxide;

[0082] 1 g / L to 50 g / L citric acid; and

[0083] 1.0 to 3.0 L of aqueous solvent.

[0084] In one specific embodiment, the composition for intestinal cleansing comprises:

[0085] 0.03 g of sodium picosulfate hydrate;

[0086] 10.5 g of magnesium oxide;

[0087] 36.0 g of citric acid; and

[0088] 1.0 to 3.0 L of water, wherein the water can be applied in the form of a solution in which the ingredients are dissolved, or can be applied alone. In a more specific embodiment, the composition for intestinal cleansing,

[0089] Contains 3.0 L of water, or the total dose taken on the day before and on the day of the examination is 3.0 L, and the total dose taken on the day of the examination can be 600 mL.

[0090] In one embodiment, the composition for intestinal cleansing may include, based on the total composition: 10 g / L to 500 g / L of polyethylene glycol;

[0091] 1 g / L to 300 g / L of sorbitol;

[0092] 0.001 g / L to 1 g / L of sodium picosulfate or its hydrate; and

[0093] 1.0 to 3.0 L of aqueous solvent.

[0094] In one specific embodiment, the composition for intestinal cleansing comprises:

[0095] 75 g / L polyethylene glycol;

[0096] 27.3 g / L of sorbitol;

[0097] 0.005 g / L of sodium picosulfate or its hydrate; and

[0098] 1.0 to 3.0 L of water, wherein the water can be applied in the form of a solution in which the ingredients are dissolved, or can be applied alone. In a more specific embodiment, the composition for intestinal cleansing,

[0099] Contains 2.0 L of water, or the total dose taken on the day before and on the day of the examination is 2.0 L, and the total dose taken on the day of the examination can be 400 mL.

[0100] In one embodiment, the composition for intestinal cleansing may include, based on the total composition: 5 g / L to 300 g / L of sodium sulfate;

[0101] 0.1 g / L to 50 g / L potassium sulfate;

[0102] 0.1 g / L to 50 g / L magnesium sulfate; and

[0103] 1.0 to 3.0 L of aqueous solvent.

[0104] In one specific embodiment, the composition for intestinal cleansing comprises:

[0105] 12.333 g / L of anhydrous sodium sulfate;

[0106] 2.206 g / L potassium sulfate;

[0107] 1.128 g / L magnesium sulfate; and

[0108] 1.0 to 3.0L of water,

[0109] Here, the water may be applied in the form of a solution in which the components are dissolved, or may be applied alone.

[0110] In a more specific embodiment, the composition for intestinal cleansing,

[0111] Contains 2.838 L of water, or a total of 2.838 L taken the day before and on the day of the test,

[0112] The total dose taken on the day of the examination can be 568 mL.

[0113] Throughout the specification, when a part “comprises” a certain constituent element, unless otherwise specified, it means that other constituent elements may also be included rather than excluding other constituent elements.

[0114] As used herein, the term "about" means within 10%, preferably within 5%, and more preferably within 1% of a given value or range.

[0115] The present invention relates to a composition for intestinal cleansing, which improves safety by greatly reducing the dosage taken on the day of examination requiring intestinal cleansing, such as in the early morning. Specifically, it relates to a composition for intestinal cleansing, wherein the total dosage of the composition for intestinal cleansing (including all auxiliary solvents such as water) taken on the day of examination is about 700 mL or less, such as about 200 to about 700 mL, preferably about 600 mL or less, and more preferably about 500 mL.

[0116] In one embodiment, the present invention provides a composition for intestinal cleansing, which is a composition for intestinal cleansing taken before an examination requiring intestinal cleansing.

[0117] The composition is taken in divided doses one day before and on the day of the examination,

[0118] The total dose taken on the day of the examination was less than 700 mL.

[0119] In another embodiment, the present invention provides a method for intestinal cleaning, comprising administering a composition for intestinal cleaning to a human being before an examination requiring intestinal cleaning,

[0120] The composition is taken / administered in divided doses on the day before and on the day of the examination,

[0121] The total dose / administered volume taken / administered on the day of the examination was less than 700 mL.

[0122] The total dose or dosage taken on the day of the examination is preferably 600 mL, more preferably 500 mL. For example, the dose can be about 300, about 310, about 320, about 330, about 340, about 350, about 360, about 370, about 380, about 390, about 400, about 410, about 420, about 430, about 440, about 450, about 460, about 470, about 480, about 490, about 500, about 510, about 520, about 530, about 540, about 550, about 560, about 570, about 580, about 590, about 600, about 610, about 620, about 630, about 640, about 650, about 660, about 670, about 680, about 690, or about 700 mL. In a specific example, the total dose taken on the day of the examination can be about 360, about 400, about 450, about 480, about 500, about 568 or about 600 mL. At this time, considering the numerical range of the term "about" defined herein, the value includes all doses within 10%, preferably within 5%, and more preferably within 1% of the above specific value.

[0123] In the present invention, the terms "dose (amount)" or "administration (amount)" can be used interchangeably unless their meanings are particularly changed in interpretation.

[0124] In the present invention, "examinations requiring / necessary intestinal cleansing" refer to examinations that try to completely empty the intestines during colonoscopy, X-ray examinations such as enterography, radiography, or preoperative intestinal cleansing (e.g., preoperative treatment of colon surgery, preoperative treatment of anus surgery, such as hemorrhoids), etc. In addition to the above examinations, any examinations or surgeries that require intestinal cleansing are not particularly limited. In addition, depending on the situation, it may also include treatments for diseases such as chronic constipation or acute constipation. In particular, the above examinations also include situations where gastroscopy and colonoscopy are performed at the same time.

[0125] In the present invention, "composition for intestinal cleansing" refers to a "purgative" or a substance that promotes defecation, and includes the category of laxative effect. As an example, "intestinal cleansing" refers to a defecation that completely empties the large intestine ("complete purgation") or a stronger defecation that almost completely empties the colon ("stronger catharsis"), as well as a milder catharsis, resulting in diarrhea ("partial purgation"). In the present invention, "composition for cleansing the intestine" broadly includes a composition for cleansing the intestine or a composition for manufacturing an intestinal cleanser drug. Similarly, in the present invention, "method for intestinal cleansing" refers to a method for cleansing the intestine using a "composition for intestinal cleansing".

[0126] In one embodiment, the composition of the present invention may be applied in the form of a formulated solution together with an auxiliary solvent such as water, or may be applied as it is.

[0127] In another embodiment, the composition for intestinal cleaning of the present invention can be understood as comprising a first part containing an effective ingredient; and a second part containing a water-soluble solvent, such as an auxiliary solvent of water, etc. Wherein, the first part can be understood as comprising a component showing an intestinal cleaning effect, in addition to the effective ingredient directly showing the intestinal cleaning effect, it also comprises any pharmaceutically acceptable excipient, etc. The first part can be selected from any pharmaceutically acceptable dosage form, such as powder (powder), granules, liquid preparations, tablets, capsules, etc., preferably a dosage form soluble in the second part, such as powder, granules or liquid preparations. When the first part is a tablet or capsule, etc., it can be taken in the form of a prepared solution soluble in water or an auxiliary solution, or it can be taken in the form of a tablet or capsule with water or an auxiliary solution. In this case, the dosage of the solution of 700mL or less according to the present invention will be determined by the amount of water or auxiliary solution taken with the tablet or capsule.

[0128] The second part can be used without restriction as long as it is an auxiliary solvent that can dissolve the first part. Preferably, it can be a water-soluble solvent, such as water, carbonated water, alkaline ion water or beverage, and water can be used in particular. In addition, the beverage can be used without particular restriction as long as it can achieve the effect of the present invention, for example, drip coffee, various fruit juices, cola, soda, gin, etc. can be used as needed.

[0129] The second part can be dissolved in the first part and administered as a liquid preparation, or the second part can be administered alone. In the present invention, the liquid preparation in which the first part is dissolved in the second part according to the uniform mixing of the content, that is, the solution in which an auxiliary solvent such as water is added after the active ingredient and / or other excipients are mixed is called a "prepared solution".

[0130] In one specific example, the composition for intestinal cleansing of the present invention may include: a liquid preparation (prepared solution), prepared by dissolving a composition (first part) in the form of a powder, granule or liquid preparation containing an active ingredient and a pharmaceutically acceptable excipient in an auxiliary solvent, such as a water-soluble solvent; and other auxiliary solutions, such as a water-soluble solvent. In this case, the composition for intestinal cleansing can be administered by taking the prepared solution in the form of a liquid preparation and then taking a water-soluble solvent.

[0131] Therefore, the composition for intestinal cleansing of the present invention, especially the "prepared solution" or the liquid preparation can be in the form of a solution, suspension or emulsion. However, the composition for intestinal cleansing of the present invention and the prepared solution are administered in divided doses of a water-soluble solvent. Depending on the circumstances, the prepared solution and the water-soluble solvent taken in divided doses can also be collectively referred to as a solution, suspension or emulsion.

[0132] The composition for intestinal cleansing of the present invention can be taken all at once (undivided dosing) or taken multiple times (divided dosing). Specifically, undivided dosing refers to divided dosing on the same day (i.e., divided dosing), for example, it can be taken in several hours the night before the examination or in the early morning of the examination day. Specifically, a portion of the total dose can be taken, and the remaining dose can be taken after a period of time, for example, 0.5 to 3 hours later. Divided dosing means taking it in 2 days, one day before the examination and on the day of the examination, for example, taking a portion of the dose the night before the examination and taking the remaining dose in the morning of the examination day.

[0133] In one embodiment, the composition of the present invention can be applied at least twice on the day before the examination and / or on the day of the examination, preferably in two doses on the night before the examination and in the early morning of the day of the examination. The number of doses of "more than 2 times" in the present invention is determined according to the dosage of the prepared solution. For example, if a certain amount of prepared solution is taken the night before the examination and water is drunk separately, it is considered to be taken once. For example, after taking a certain amount of prepared solution the night before the examination, water is drunk separately (the first dose), and then the above process is repeated after a certain period of time (for example, 30 minutes, 1 hour or 1.5 hours). If water is drunk separately after taking a certain amount of prepared solution (the second dose), it is counted as the number of doses, and it is considered to be taken twice in total. However, when a certain amount of prepared solution that should have been taken once is taken multiple times (for example, because it is difficult for the user to take it once, it is taken every 5 to 10 minutes while resting), it is considered to be taken once.

[0134] In one specific example, the composition of the present invention can be administered by taking a water-soluble solvent separately after taking the prepared solution (liquid preparation), and the method is repeated 2 to 4 times in total on the day before and on the day of the examination. However, the above-mentioned "single water-soluble solvent" includes not only taking a water-soluble solvent after taking the liquid preparation completely, but also taking a water-soluble solvent during taking the liquid preparation.

[0135] The amount of auxiliary solvents such as the prepared solution or water can be selected by a person of ordinary skill in the art, as long as the total solution dose of the prepared solution and auxiliary solutions such as water taken on the day of the examination (for example, a few hours before the examination, such as 3 hours before, 2 hours before or 1 hour before) is less than about 700 mL, for example, about 200 to about 700 mL, preferably less than about 600 mL, and more preferably less than about 500 mL.

[0136] In addition, the total dose of the composition for intestinal cleaning of the present invention can be about 1.0 to about 5.0L, for example, about 1.0 to about 4.0L, specifically, any value between about 1.0 to about 3.0L. In a specific example, the total dose can be about 1.0L, about 1.28L, about 1.35L, about 1.44L, about 2.0L, about 2.838L, about 3.0L, etc. In this case, the total dose can refer to the dose taken one day before the examination and on the day of the examination. Therefore, the total dose of the composition for intestinal cleaning of the present invention, taken one day before the examination and on the day of the examination can be the above-mentioned value, for example, about 1.0L to about 4.0L.

[0137] In one embodiment, the composition for intestinal cleansing of the present invention may contain one or more of the following ingredients as active ingredients.

[0138] ● Polyethylene glycol (PEG), for example, PEG having a number average molecular weight of 1,000 to 10,000, preferably, PEG having a number average molecular weight of 2,000 to 6,000, more preferably, PEG having a number average molecular weight of 3,000 to 5,000, specifically, polyethylene glycol 3350;

[0139] ● Ascorbic acid or a salt thereof, for example an alkali metal (e.g. sodium or potassium) or alkaline earth metal (e.g. calcium) salt of ascorbic acid, a specific example being sodium ascorbate;

[0140] ● at least one sugar alcohol selected from the group consisting of xylitol, sorbitol, glycerol, erythritol, threitol, arabitol, ribitol, mannitol, dulcitol, fucitol, iditol, inositol, heptanoic acid, isomalt, maltitol, lactitol, maltotriitol, maltotetraitol and hydrogenated glucose;

[0141] Picosulfates, such as sodium picosulfate or a hydrate thereof;

[0142] Citric acid;

[0143] Magnesium oxide;

[0144] ● (anhydrous) sodium sulfate;

[0145] Potassium sulfate;

[0146] ●(Anhydrous) magnesium sulfate;

[0147] Sodium chloride;

[0148] ●Anhydrous sodium hydrogen phosphate;

[0149] Sodium dihydrogen phosphate monohydrate; and

[0150] ●Potassium chloride.

[0151] The composition for intestinal cleansing of the present invention may further comprise a pharmaceutically acceptable excipient or additive suitable for intestinal cleansing. The excipient or additive is not particularly limited as long as it is commonly used in intestinal cleansing compositions.

[0152] For example, when a composition for intestinal cleansing contains ascorbic acid as an active ingredient, it may be difficult to take due to its high acidity, which may make it too sour. Therefore, as a component for neutralizing the sour taste, a bicarbonate such as sodium bicarbonate or potassium bicarbonate may be further included.

[0153] In addition, the composition for intestinal cleansing of the present invention may be added with an appropriate amount of antioxidant to prevent oxidation of ascorbic acid. Such antioxidants include, but are not limited to, ferulic acid, amino acids such as glycine and histidine, hyaluronic acid, tocopherol, and the like.

[0154] In addition, the composition for intestinal cleansing of the present invention may contain a sweetener to improve the taste. The sweeteners that can be used include, for example, sucralose, maltodextrin, glucose, sucrose, dextrose, saccharin, aspartame and stevia, but are not limited thereto.

[0155] In addition, an appropriate amount of edible fruit flavoring can be added to the composition for intestinal cleansing of the present invention to increase dosage compliance. Such fruit flavoring can use strawberry flavor, orange flavor, apple flavor, grape flavor, lemon flavor, banana flavor, cherry flavor, etc.

[0156] In addition, the composition for intestinal cleansing of the present invention may further comprise a chelating agent to chelate trace amounts of iron ions and copper ions potentially contained in the aqueous solvent. Such chelating agents include, for example, Versene TM CA Chelating Agent (The Dow Chemical Company), but not limited thereto.

[0157] In addition, the composition for intestinal cleaning of the present invention may further include a defoaming agent to remove intestinal gas or intestinal bubbles that often appear after intestinal cleaning. In one aspect of the present invention, for example, simethicone can be used as a defoaming agent, but is not limited thereto. Simethicone used as a defoaming agent in the present invention can be mixed into the composition for intestinal cleaning in the form of a suspension. Its use method can be carried out according to the conventionally known method.

[0158] The composition for intestinal cleaning of the present invention may further contain known cleaning ingredients or auxiliary ingredients to enhance the cleaning effect. Additional cleaning ingredients and cleaning enhancing aids include, for example, citric acid, magnesium such as magnesium oxide, sodium docusate, senna extract (sennoside, etc.), aloe extract (aloe vera, etc.), pectin, zinc such as zinc oxide, caffeine, etc., but are not limited thereto.

[0159] The composition for intestinal cleaning of the present invention can be a PEG series, a PSMC series, an oral sulfate series or a sorbitol series.

[0160] [Table 1]

[0161]

[0162]

[0163] Specifically, the composition for intestinal cleaning of the present invention may include the following effective ingredients. At this time, the following composition may also be taken in two or more times on the day before the examination or on the day of the examination, and the amount of auxiliary solvents such as the preparation solution or water may be appropriately selected by a person of ordinary skill in the art. However, the total solution dosage of the day when the preparation solution and auxiliary solvents such as water taken on the day of the examination (e.g., a few hours before the examination) are all added together is about 700 mL or less, for example, about 200 mL to about 700 mL, preferably about 600 mL or less, and more preferably about 500 mL or less.

[0164] [Composition Example I]

[0165] 1) A composition comprising polyethylene glycol 3350; ascorbic acid or sodium ascorbate; and anhydrous sodium sulfate (which may also contain potassium chloride, sodium chloride, or other additives) as active ingredients.

[0166] 2) A composition comprising polyethylene glycol 3350 and sodium chloride as active ingredients.

[0167] 3) A composition comprising D-sorbitol / mannitol; and ascorbic acid or sodium ascorbate as active ingredients.

[0168] 4) A composition comprising anhydrous sodium hydrogen phosphate; and sodium dihydrogen phosphate monohydrate as active ingredients.

[0169] 5) A composition comprising sodium picosulfate hydrate; magnesium oxide; and citric acid as active ingredients.

[0170] 6) A composition comprising anhydrous sodium sulfate and anhydrous magnesium sulfate (which may further comprise potassium sulfate) as active ingredients.

[0171] 7) A composition comprising D-sorbitol; polyethylene glycol 3350; and sodium picosulfate hydrate as active ingredients.

[0172] 8) A composition comprising D-sorbitol / mannitol; ascorbic acid or sodium ascorbate; sodium bicarbonate; and potassium bicarbonate as active ingredients.

[0173] In a specific embodiment, the composition for intestinal cleansing of the present invention may comprise the following effective ingredients.

[0174] [Composition Example II]

[0175] 1) A composition comprising 100 to 400 g of polyethylene glycol 3350, 10 to 80 g of ascorbic acid or sodium ascorbate, and 5 to 40 g of anhydrous sodium sulfate (and may further comprise 1 to 5 g of potassium chloride, 1 to 10 g of sodium chloride and other additives). The composition is taken in two doses of about 1 L to 2 L of a prepared solution and about 1 L of water in total, but the total solution dose of the prepared solution and water taken on the day is about 700 mL or less, preferably about 600 mL or less, and more preferably about 500 mL or less.

[0176] 2) A composition comprising 350 to 450 g of polyethylene glycol 3350 and 10 to 15 g of sodium chloride as active ingredients. The composition is taken in divided doses of a total of about 4 L of the prepared solution, but the total solution dose for the day, which is the total of the prepared solution and water taken on the day, is about 700 mL or less, preferably about 600 mL or less, and more preferably about 500 mL or less.

[0177] 3) A composition comprising 50 to 150 g of D-sorbitol and 5 to 30 g of ascorbic acid or sodium ascorbate as active ingredients. The composition is taken in two doses of about 0.5 L of a prepared solution and 1.0 L of water, but the total solution dose of the prepared solution and water taken on the same day is checked to be less than about 700 mL, preferably less than about 600 mL, and more preferably less than about 500 mL.

[0178] 4) A composition comprising 10 to 20 g of anhydrous sodium hydrogen phosphate and 30 to 50 g of sodium dihydrogen phosphate monohydrate as active ingredients. When the composition is a tablet, it is taken in divided doses with about 2 L of water, but the total amount of water taken on the day is checked to be about 700 mL or less, preferably about 600 mL or less, and more preferably about 500 mL or less.

[0179] 5) A composition comprising 20 to 50 g of sodium picosulfate hydrate, 5 to 15 g of magnesium oxide, and 30 to 50 g of citric acid as active ingredients. The composition is taken in two doses of about 0.3 L to 0.4 L of a prepared solution and about 2 L of water, but the total solution dose of the prepared solution and water taken on the same day is about 700 mL or less, preferably about 600 mL or less, and more preferably about 500 mL or less.

[0180] 6) A composition comprising 25 to 45 g of anhydrous sodium sulfate and 2 to 5 g of anhydrous magnesium sulfate (and 1 to 10 g of potassium sulfate) as active ingredients. When the composition is a tablet, it is taken in divided doses with about 2.5 to 3.0 L of water. When the composition is a powder, it is taken in divided doses with about 0.9 to 1.0 L of a preparation solution and about 1.8 to 2.0 L of water, but the total solution dose of the preparation solution and water taken on the day is checked to be less than about 700 mL, preferably less than about 600 mL, and more preferably less than about 500 mL.

[0181] 7) A composition comprising 40 to 100 g of D-sorbitol, 100 to 300 g of polyethylene glycol 3350, and 5 to 20 mg of sodium picosulfate hydrate as active ingredients, which is taken in divided doses with about 1 L of a preparation solution and about 1 L of water, but when the total solution dose of the preparation solution and water taken on the day is checked, the total dose is about 700 mL or less, preferably about 600 mL or less, and more preferably about 500 mL or less.

[0182] 8) A composition comprising 50 to 150 g of D-sorbitol, 10 to 20 g of ascorbic acid or sodium ascorbate, 1 to 5 g of sodium bicarbonate, and 0.5 to 1.5 g of potassium bicarbonate as active ingredients, which is taken in divided doses with about 0.8 to 1.1 L of a preparation solution and about 0.3 to 0.5 L of water, but when the total solution dose of the preparation solution and water taken on the day is checked, it is about 700 mL or less, preferably about 600 mL or less, and more preferably about 500 mL or less.

[0183] In a more specific embodiment, the composition for intestinal cleaning of the present invention may include the following effective ingredients. In this case, the following composition may also be taken two or more times on the day before the examination or on the day of the examination, and the amount of auxiliary solvents such as the preparation solution or water may be appropriately selected by a person skilled in the art. However, the total solution dosage on the day of the examination, which is a total of the preparation solution and auxiliary solvents such as water taken on the day of the examination, is about 700 mL or less, for example, 200 to 700 mL, preferably about 600 mL or less, and more preferably about 500 mL or less.

[0184] [Table 2]

[0185] [Composition Example III]

[0186]

[0187] In a more specific embodiment, the composition for intestinal cleansing of the present invention may include the following ingredients. The following composition may be taken in two or more divided doses on the day before or on the day of the examination, and the amount of the preparation solution or auxiliary solvent such as water may be appropriately selected by a person skilled in the art. However, the total solution dose on the day of the examination, which is a total of the preparation solution and auxiliary solvent such as water taken on the day of the examination, is about 700 mL or less, for example, 200 to 700 mL, preferably about 600 mL or less, and more preferably about 500 mL or less.

[0188] [Table 3]

[0189] [Composition Example IV]

[0190]

[0191]

[0192]

[0193] In one embodiment, the composition of the present invention can be packaged in separate packaging units in batches according to the convenience of taking, or can be provided in the form of a kit packaged separately for each component. In particular, ascorbic acid can be packaged separately from other ingredients according to its chemical properties. At this time, the kit may include instructions for use of the method of taking or the method of use mentioned in the entire specification of the present invention. In another embodiment, the composition for intestinal cleansing of the present invention can be provided in the form of a suitably packaged kit in total doses according to the number of times taken. Specifically, the composition for intestinal cleansing of the present invention can be provided by packaging the total dose together, or the total dose can be packaged into 2 or more.

[0194] In one embodiment, in the intestinal cleansing composition of the present invention, the first component, the second component, the third cleansing component as needed, the defoaming agent, the gastrointestinal stabilizer, and other additives can be packaged together with a water-soluble solvent into a whole form (i.e., a liquid).

[0195] In another embodiment, the composition for intestinal cleaning of the present invention can be provided in the form of a kit packaged in multiple packaging units. For example, the first component and the second component can be packaged together, and the water-soluble solvent can be packaged separately, or the second component and the water-soluble solvent can be packaged together, and the first cleaning component can be packaged separately, or the first component and the water-soluble solvent can be packaged together, and the second cleaning component can be packaged separately, or the first cleaning component and a part of the water-soluble solvent can be packaged together, and the second component and a part of the water-soluble solvent can be packaged together, or the first component and the second component can be packaged together with a part of the water-soluble solvent, and the remaining water-soluble solvent can be packaged separately, and the water-soluble solvent agent can use commercially available products (e.g., mineral water, carbonated water, etc.), but is not limited thereto. In addition, the third cleaning component, defoaming agent, gastrointestinal stabilizer, and other additives can be formulated in various two-liquid forms as needed.

[0196] For example, some examples of the compositions of the present invention can be provided in the form of a kit packaged as follows.

[0197] [Table 4]

[0198]

[0199] Of course, the above composition may further comprise the above excipients / additives.

[0200] In one embodiment, the present invention provides a composition for intestinal cleansing, comprising:

[0201] At least one sugar alcohol selected from the following ingredients as a first effective ingredient, the ingredients comprising xylitol, sorbitol, glycerol, erythritol, threitol, arabitol, ribitol, mannitol, galactitol, fucitol, iditol, inositol, heptyl alcohol, isomalt, maltitol, lactitol, maltotriitol, maltotetraitol and hydrogenated glucose;

[0202] Ascorbic acid or a mixture of ascorbic acid and a salt of ascorbic acid as a second active ingredient; and

[0203] Water-soluble solvents,

[0204] Based on the total composition, the content of the first active ingredient may be 10 g / L to 500 g / L, preferably about 30 g / L to about 300 g / L, more preferably about 50 g / L to about 100 g / L, particularly preferably about 70 g / L to about 90 g / L.

[0205] Based on the total composition, the content of the second active ingredient may be 1 g / L to 300 g / L, preferably about 3 g / L to about 100 g / L, more preferably about 5 g / L to about 50 g / L, particularly preferably about 10 g / L to about 15 g / L.

[0206] The content of the water-soluble solvent is about 1.0 to about 3.0L, preferably about 1.0 to about 1.5L.

[0207] At this time, the composition for intestinal cleansing may further comprise sodium bicarbonate and / or potassium bicarbonate as a third active ingredient.

[0208] The third active ingredient is present in an amount of about 0.5 g / L to about 5 g / L, preferably about 1 g / L to about 3 g / L, and more preferably about 1.5 g / L to about 2.5 g / L, based on the total composition.

[0209] The composition for intestinal cleansing may further comprise a suitable amount of fragrance, for example, the fragrance may be in an amount of about 1.5 g / L to about 3.0 g / L based on the total composition.

[0210] In one specific example, the composition for intestinal cleansing may include:

[0211] About 110 g of D-sorbitol;

[0212] About 15g of ascorbic acid;

[0213] About 2.1 g of sodium bicarbonate;

[0214] about 0.9 g of potassium bicarbonate; and

[0215] About 1.0L to about 3.0L of water.

[0216] The content (g) of each component may be the content of the first part, ie, the content of the effective component. At this time, the water may be applied in the form of a solution in which the components are dissolved, or may be applied alone.

[0217] In another specific example, the composition comprises about 1.0 L to about 1.5 L of water, or for examination, the total dose taken on the day of examination and the day before the examination can be about 1.0 L to about 1.5 L, but the total dose taken on the day of examination is about 500 mL or less.

[0218] In another specific example, the composition comprises about 1.28 L, about 1.35 L or about 1.44 L of water, or for the examination, the total dose taken on the day of the examination and the day before the examination is about 1.28 L, about 1.35 L or about 1.44 L, and the total dose taken on the day of the examination is about 360 mL or about 500 mL. In this case, "dose" refers to the dose when the composition is administered in the form of a liquid preparation, for example, when the liquid preparation is a solution, it refers to the total solution dose.

[0219] In a more specific example, in the composition for intestinal cleansing according to the present invention, the composition, packaging method and administration method of the first part may be as follows.

[0220] [Table 5]

[0221] Element Total amount (g) Bag 1 pack weight (g) D-Sorbitol 110 3 36.67 ascorbic acid 15 3 5.00

[0222] The composition may further comprise the following excipients.

[0223] [Table 6]

[0224] Element Total amount (g) Bag 1 pack weight (g) Sodium bicarbonate 2.1 3 0.70 Potassium bicarbonate 0.9 3 0.30

[0225] The composition may further comprise the following excipients.

[0226] [Table 7]

[0227] Element Total amount (g) Bag 1 pack weight (g) Green grape powder 2.4 3 0.80

[0228] The composition can be dissolved in water or the like and taken in the form of a prepared solution having the following contents.

[0229] [Table 8]

[0230] Element Total Bag 1 pack of solution Solution preparation 960mL 3 320mL

[0231] The composition can be taken in divided doses at a ratio of 'the day before the test: the day of the test 2:1' with 960 ml of total prepared solution and 480 ml of additional water. For example, the specific method of taking is as follows. (In the following example, the composition (e.g., the first part) packaged in 1 packet is a powder, and when diluted and dissolved in water to prepare a prepared solution, the content of the prepared solution is substantially the same as the content of the water used for dissolution. Therefore, in the following example, the content of water for dissolving the components of 1 packet is substantially the same as the content of the prepared solution. Below, the same applies when the first part is used as a powder in a specific example of the present invention.

[0232] 1) Take the solution diluted in 320mL of water one day before the test, and then take another sachet diluted in the same way. Then drink another 320mL of water. If your lips are dry or you are very thirsty, you can drink water appropriately. (Total 960mL)

[0233] 2) On the day of the test, dilute 1 sachet in 320 mL of water and drink an additional 160 mL of water. (Total 480 mL)

[0234] Alternatively, the following approach may be adopted.

[0235] 1) The night before colonoscopy, take 720 mL of the prepared solution and drink 360 mL of water (a total of 1080 mL).

[0236] 2) On the morning of the colonoscopy, take 240 mL of the prepared solution and drink 120 mL of water (360 mL total).

[0237] or,

[0238] 1) The night before the colonoscopy, take 320 mL of the prepared solution and drink an additional 130 mL of water. Then take 320 mL of the prepared solution in the same way, and then drink another 130 mL of water. (Total 900 mL)

[0239] 2) On the morning of the colonoscopy, take 320 mL of the prepared solution and drink 130 mL of water (450 mL in total).

[0240] or

[0241] 1) Take 320mL of the prepared solution the night before your colonoscopy, and then take another 320mL of the prepared solution in the same way. Then, drink an additional 160mL of water. (800mL in total)

[0242] 2) On the morning of the colonoscopy, take 320 mL of the prepared solution and drink 160 mL of water. (Total 480 mL)

[0243] In one embodiment, the present invention provides a composition for intestinal cleansing, comprising:

[0244] Polyethylene glycol as the first active ingredient;

[0245] Ascorbic acid or a mixture of ascorbic acid and an ascorbate as a second active ingredient; and

[0246] Water-soluble solvents,

[0247] Based on the total composition, the content of the first active ingredient is about 10 g / L to about 500 g / L, preferably about 30 g / L to about 300 g / L, more preferably about 50 g / L to about 200 g / L.

[0248] Based on the total composition, the content of the second active ingredient is about 1 g / L to about 300 g / L, preferably about 3 g / L to about 100 g / L, more preferably about 5 g / L to about 60 g / L.

[0249] The content of the water-soluble solvent is about 1.0 to about 3.0 L.

[0250] The composition for intestinal cleansing may further comprise one or more selected from the group consisting of sodium chloride, potassium chloride and sodium sulfate as a third active ingredient, for example, all three of the above ingredients may be included. In this case, based on the total composition, the content of the third active ingredient is about 0.5 g / L to about 50 g / L, preferably about 3 g / L to about 30 g / L, and more preferably about 5 g / L to about 25 g / L.

[0251] The polyethylene glycol may have an average molecular weight of 3000 to 4000 Da, preferably polyethylene glycol 3350.

[0252] In one specific example, the composition for intestinal cleansing may include:

[0253] About 200 g of polyethylene glycol 3350;

[0254] About 9.4 g of ascorbic acid;

[0255] About 11.8 g of sodium ascorbate;

[0256] About 15 g of anhydrous sodium sulfate;

[0257] About 5.382 g of sodium chloride;

[0258] About 2.030 g of potassium chloride; and

[0259] About 1.0 to about 3.0 L of water. The content (g) of each component may be the content of the first part, that is, the active ingredient. At this time, the water may be applied in the form of a solution in which the components are dissolved, or may be applied alone.

[0260] In a more specific example, the composition may contain about 3.0 L of water, or for examination, the total dose taken on the examination day and the day before the examination may be about 3.0 L, and the total dose taken on the examination day may be about 600 mL.

[0261] In a more specific example, the composition, packaging method, and administration method of the first part of the composition for intestinal cleansing according to the present invention may be as follows.

[0262] [Table 9]

[0263] Active ingredients Content (g) unit Total units Total content Polyethylene glycol 3350 50 1 pack 4 200.000 Anhydrous sodium sulfate 3.75 1 pack 4 15.000 ascorbic acid 2.35 1 pack 4 9.400 Sodium Ascorbate 2.95 1 pack 4 11.800 Sodium chloride 1.3455 1 pack 4 5.382 Potassium chloride 0.5075 1 pack 4 2.030

[0264] 1) The night before your colonoscopy, take 1.6L of the prepared solution and drink 800mL of water.

[0265] 2) On the morning of the colonoscopy, take 400 mL of the prepared solution and drink 200 mL of water (600 mL total).

[0266] In other specific examples, the composition for intestinal cleansing may include:

[0267] About 140 g of polyethylene glycol 3350;

[0268] About 7.54 g of ascorbic acid;

[0269] About 48.11 g of sodium ascorbate;

[0270] About 9 g of anhydrous sodium sulfate;

[0271] About 5.2 g of sodium chloride;

[0272] About 2.2 g of potassium chloride; and

[0273] About 1.0 to about 3.0 L of water. The content (g) of each component may be the content of the first part, that is, the active ingredient. At this time, the water may be applied in the form of a solution in which the components are dissolved, or may be applied alone.

[0274] In more specific examples, the composition may contain about 2.0 L of water, or for examination, the total dose taken on the day of examination and the day before examination may be about 2.0 L, and the total dose taken on the day of examination may be about 400 mL or about 500 mL.

[0275] In a more specific example, the composition, packaging method, and administration method of the first part of the composition for intestinal cleansing according to the present invention may be as follows.

[0276] [Table 10]

[0277] Active ingredients Content (g) unit Total units Total content Polyethylene glycol 3350 100 Dose1 1 100.000 Polyethylene glycol 3350 40 Dose2 1 40.000 Anhydrous sodium sulfate 9 Dose1 1 9.000 Potassium chloride 1 Dose1 1 1.000 Potassium chloride 1.2 Dose2 1 1.200 Sodium chloride 2 Dose1 1 2.000 Sodium chloride 3.2 Dose2 1 3.200 Sodium Ascorbate 48.11 Dose2 1 48.110 ascorbic acid 7.54 Dose2 1 7.540

[0278] 1) The night before your colonoscopy, take 750 mL of the prepared solution and drink 750 mL of water.

[0279] 2) On the morning of the colonoscopy, take 250 mL of the prepared solution and drink 250 mL of water (500 mL total).

[0280] or;

[0281] 1) The night before your colonoscopy, take 800 mL of the prepared solution and drink 200 mL of water.

[0282] 2) On the morning of the colonoscopy, take 200 mL of the prepared solution and drink 200 mL of water (400 mL total).

[0283] In other specific examples, the composition for intestinal cleansing may include:

[0284] About 160 g of polyethylene glycol 3350;

[0285] About 40.6 g of ascorbic acid;

[0286] About 9.4 g of sodium ascorbate;

[0287] About 18 g of anhydrous sodium sulfate;

[0288] About 2.7 g of sodium chloride;

[0289] About 1g of potassium chloride; and

[0290] About 1.0 to about 3.0 L of water. The content (g) of each component may be the content of the first part, that is, the active ingredient. At this time, the water may be applied in the form of a solution in which the components are dissolved, or may be applied alone.

[0291] In a more specific example, the composition may contain about 2.0 L of water, or for examination, the total dose taken on the examination day and the day before the examination may be about 2.0 L, and the total dose taken on the examination day may be about 400 mL.

[0292] In a more specific example, the composition, packaging method, and administration method of the first part of the composition for intestinal cleansing according to the present invention may be as follows.

[0293] [Table 11]

[0294] Active ingredients Content (g) unit Total units Total content ascorbic acid 20.3 Agent B 2 40.6 Sodium Ascorbate 4.7 Agent B 2 9.4 Polyethylene glycol 3350 80 A dose 2 160 Potassium chloride 0.5 A dose 2 1 Sodium chloride 1.35 A dose 2 2.7 Anhydrous sodium sulfate 9 A dose 2 18

[0295] 1) The night before your colonoscopy, take 800 mL of the prepared solution and drink 200 mL of water.

[0296] 2) On the morning of the colonoscopy, take 200 mL of the prepared solution and drink 200 mL of water (400 mL total).

[0297] In one embodiment, the present invention provides a composition for intestinal cleansing, based on the total composition, comprising:

[0298] About 0.001 g / L to 0.1 g / L of sodium picosulfate or a hydrate thereof; preferably about 0.005 g / L to about 0.05 g / L;

[0299] From about 0.5 g / L to about 50 g / L of magnesium oxide, preferably from about 1 g / L to about 10 g / L;

[0300] From about 1 g / L to about 50 g / L of citric acid, preferably from about 5 g / L to about 30 g / L; and

[0301] About 1.0 to about 3.0 L of an aqueous solvent.

[0302] In one specific example, the composition for intestinal cleansing may include:

[0303] About 0.03 g of sodium picosulfate hydrate;

[0304] About 10.5 g of magnesium oxide;

[0305] about 36.0 g of citric acid; and

[0306] About 1.0 to about 3.0 L of water. The content (g) of each component may be the content of the first part, that is, the active ingredient. At this time, the water may be applied in the form of a solution in which the components are dissolved, or may be applied alone.

[0307] In a more specific example, the composition may contain about 3.0 L of water, or for examination, the total dose taken on the day of examination and the day before examination may be about 3.0 L, and the total dose taken on the day of examination may be about 600 mL.

[0308] In a more specific example, the composition, packaging method, and administration method of the first part of the composition for intestinal cleansing according to the present invention may be as follows.

[0309] [Table 12]

[0310] Active ingredients Content (g) unit Total units Total content Sodium Picosulfate Hydrate 0.01 1 pack 3 0.030 Hard magnesium oxide 3.5 1 pack 3 10.500 Citric acid 12 1 pack 3 36.000

[0311] 1) The night before your colonoscopy, take 240 mL of the prepared solution and drink 2,160 mL of water.

[0312] 2) On the morning of the colonoscopy, take 60 mL of the prepared solution and drink 540 mL of water (600 mL total).

[0313] In one embodiment, the present invention provides a composition for intestinal cleansing, based on the total composition, comprising:

[0314] About 10 g / L to about 500 g / L of polyethylene glycol, preferably about 30 g / L to about 300 g / L, more preferably about 50 g / L to about 100 g / L;

[0315] From about 1 g / L to about 300 g / L of sorbitol, preferably from about 10 g / L to about 100 g / L, more preferably from about 20 g / L to about 50 g / L;

[0316] 0.001 g / L to 1 g / L of sodium picosulfate or its hydrate, preferably about 0.002 g / L to about 0.007 g / L; and about 1.0 to 3.0 L of a water-soluble solvent.

[0317] In one specific example, the composition for intestinal cleansing may include:

[0318] About 75 g / L of polyethylene glycol;

[0319] About 27.3 g / L of sorbitol;

[0320] About 0.005 g / L of sodium picosulfate or its hydrate; and

[0321] About 1.0 to about 3.0 L of water. The content (g) of each component may be the content of the first part, that is, the active ingredient. At this time, the water may be applied in the form of a solution in which the components are dissolved, or may be applied alone.

[0322] In a more specific example, the composition may contain about 2.0 L of water, or for examination, the total dose taken on the examination day and the day before the examination may be about 2.0 L, and the total dose taken on the examination day may be about 400 mL.

[0323] In a more specific example, the composition, packaging method, and administration method of the first part of the composition for intestinal cleansing according to the present invention may be as follows.

[0324] [Table 13]

[0325]

[0326]

[0327] 1) The night before your colonoscopy, take 800 mL of the prepared solution and drink 200 mL of water.

[0328] 2) On the morning of the colonoscopy, take 200 mL of the prepared solution and drink 200 mL of water (400 mL total).

[0329] In one embodiment, the present invention provides a composition for intestinal cleansing, based on the total composition, comprising:

[0330] From about 5 g / L to about 300 g / L of sodium sulfate, preferably from about 7 g / L to about 50 g / L, more preferably from about 10 g / L to about 30 g / L;

[0331] From about 0.1 g / L to about 50 g / L of potassium sulfate, preferably from about 0.5 g / L to about 10 g / L, more preferably from about 0.7 g / L to about 5 g / L;

[0332] From about 0.1 g / L to about 50 g / L of magnesium sulfate, preferably from about 0.5 g / L to about 10 g / L, more preferably from about 0.7 g / L to about 5 g / L; and

[0333] About 1.0 to 3.0 L of aqueous solvent.

[0334] In one specific example, the composition for intestinal cleansing may include:

[0335] About 12.333 g / L of anhydrous sodium sulfate;

[0336] About 2.206 g / L of potassium sulfate;

[0337] About 1.128 g / L of magnesium sulfate; and

[0338] About 1.0 to about 3.0 L of water. The content (g) of each component may be the content of the first part, that is, the active ingredient. At this time, the water may be applied in the form of a solution in which the components are dissolved, or may be applied alone.

[0339] In a more specific example, the composition may contain about 2.838 L of water, or for examination, the total dose taken on the day of examination and the day before examination may be about 2.838 L, and the total dose taken on the day of examination may be about 568 mL.

[0340] In a more specific example, the composition, packaging method, and administration method of the first part of the composition for intestinal cleansing according to the present invention may be as follows.

[0341] [Table 14]

[0342]

[0343] 1) The night before your colonoscopy, take 757 mL of the prepared solution and drink 1,514 mL of water.

[0344] 2) On the morning of the colonoscopy, take 189 mL of the prepared solution and drink 378 mL of water (568 mL total).

[0345] Effects of the Invention

[0346] For most existing intestinal cleansers, the first dose taken the day before and the second dose taken on the day of the examination are the same, and the total dose of the prepared liquid or prepared medicine and water on the day of the examination exceeds at least 1 liter. The end time of taking the intestinal cleanser is also 1-2 hours before the examination, which runs counter to the principle of stopping use 2-3 hours before the examination or at least 3 hours before sleep endoscopy recommended by existing literature. As a result, the existing intestinal cleansers have the problem of inevitably reducing the safety and ease of use for subjects.

[0347] In some intestinal cleansers, the dosage is different between the night before the examination and the day of the examination. On the day of the examination, less prepared solution and water are taken than on the day before the examination. This kind of intestinal cleanser requires taking more than 1L of prepared medicine and water not only on the day before the examination but also on the day of the examination. Therefore, the safety of the above-mentioned colonoscopy and the potential risks that may occur when it is performed simultaneously with gastroscopy cannot be addressed.

[0348] This practice of drinking large amounts of water 1-2 hours before the examination does not completely eliminate the safety issues associated with the risk of aspiration during simultaneous gastroscopy or sleep endoscopy.

[0349] However, the total dose of the composition for intestinal cleaning of the present invention on the day of examination is 700 mL or less, for example, 200 to 700 mL, preferably 600 mL or less, and more preferably 500 mL or less. Although it is very small compared with the existing dose, it shows an intestinal cleaning or cleaning effect that can ensure the effectiveness of colonoscopy, and can more effectively improve the safety of the subject. In addition, due to the small dose, the administration time is correspondingly reduced, which can further ensure the interval with the examination time, minimize the amount of preparation solution and water remaining in the stomach or colon, and improve the safety of the examination. DETAILED DESCRIPTION

[0350] The present invention will be described in more detail below by way of examples. However, the present invention is not limited to the following examples.

[0351] According to the administration method described in each embodiment and comparative example, the compositions of the following compositions were administered to randomly selected patients, and the intestinal cleanliness, endoscopic examination time, intestinal residue, ease of administration, side effects (abnormal conditions - nausea, vomiting, dizziness, etc.), willingness to take the medicine again, etc. were evaluated.

[0352] Example 1

[0353] In this example, a composition having the components and contents shown in the following table was used.

[0354] [Table 15]

[0355] Active ingredients Total content (g) Polyethylene glycol 3350 200.000 Anhydrous sodium sulfate 15.000 ascorbic acid 9.400 Sodium Ascorbate 11.800 Sodium chloride 5.382 Potassium chloride 2.030 Total 243.612

[0356] Directions

[0357] Mix the active ingredients in the above table according to the content, add appropriate amount of water to dissolve, add water to a total of 2L, and then mix evenly to prepare a prepared solution. For a total of 2L of prepared solution, a total of 1L of water must be drunk.

[0358] In each comparative example and embodiment, the total prepared solution is taken with water in divided doses according to the corresponding ratio (%) of the previous day or the current day, or the active ingredients in the above table are divided in divided doses according to the corresponding content of the corresponding ratio (%), and the prepared solution of the previous day or the current day is prepared separately and then taken with water. The taking method (ratio %) of each comparative example and embodiment is as follows.

[0359] [Table 16]

[0360]

[0361] [Table 17]

[0362]

[0363]

[0364] Example 2

[0365] In this example, a composition having the components and contents shown in the following table was used.

[0366] [Table 18]

[0367] Active ingredients Total content (g) Polyethylene glycol 3350 140 Anhydrous sodium sulfate 9 Potassium chloride 2.2 Sodium chloride 5.2 Sodium Ascorbate 48.11 ascorbic acid 7.54 Total 212.05

[0368] Mix the active ingredients in the above table according to the content, add appropriate amount of water to dissolve, add water to make the total amount 1L, and then mix evenly to prepare the prepared solution. For a total of 1L of prepared solution, a total of 1L of water must be drunk.

[0369] In each comparative example and embodiment, the total prepared solution is taken with water in divided doses according to the corresponding ratio (%) of the previous day or the current day, or the active ingredients in the above table are divided in divided doses according to the corresponding content of the corresponding ratio (%), and the prepared solution of the previous day or the current day is prepared separately and then taken with water. The method of taking each embodiment (ratio %) is as follows.

[0370] [Table 19]

[0371]

[0372]

[0373] [Table 20]

[0374]

[0375] Example 3

[0376] In this example, a composition having the components and contents shown in the following table was used. The composition was prepared by mixing each active ingredient.

[0377] [Table 21]

[0378] Active ingredients Total content (g) D-Sorbitol 110 ascorbic acid 15 Sodium bicarbonate 2.1 Potassium bicarbonate 0.9 Ground spices 2.4 Total 130.4

[0379] Directions

[0380] Mix the active ingredients in the above table according to the content, add appropriate amount of water to dissolve, add water to a total of 960mL, and then mix evenly to prepare a prepared solution. For a total of 960mL of prepared solution, a total of 480mL of water must be drunk.

[0381] In each comparative example and embodiment, the total prepared solution is taken with water in divided doses according to the corresponding ratio (%) of the previous day or the current day, or the active ingredients in the above table are divided in divided doses according to the corresponding content of the corresponding ratio (%), and the prepared solution of the previous day or the current day is prepared separately and then taken with water. The method of taking each embodiment (ratio %) is as follows.

[0382] [Table 22]

[0383]

[0384] [Table 23]

[0385]

[0386] Example 4

[0387] In this example, a composition having the components and contents shown in the following table was used.

[0388] [Table 24]

[0389] Active ingredients Total content (g) Sodium Picosulfate Hydrate 0.03 Hard magnesium oxide 10.5 Citric acid 36 Total 46.53

[0390] Directions

[0391] Mix the active ingredients in the above table according to the content, add appropriate amount of water to dissolve, add water to a total of 300mL, and then mix evenly to prepare a prepared solution. For a total of 300mL of prepared solution, a total of 2700mL of water must be drunk.

[0392] In each comparative example and embodiment, the total prepared solution is taken in divided doses according to the corresponding ratio (%) of the previous day or the current day, or the active ingredients in the above table are divided in divided doses according to the corresponding ratio (%) of the content, and the prepared solution of the previous day or the current day is prepared and taken. The method of taking each embodiment (ratio %) is as follows.

[0393] [Table 25]

[0394]

[0395] [Table 26]

[0396]

[0397] Example 5

[0398] In this example, a composition having the components and contents shown in the following table was used.

[0399] [Table 27]

[0400]

[0401]

[0402] Directions

[0403] Mix the active ingredients in the above table according to the content, add appropriate amount of water to dissolve, add water to a total of 946mL, and then mix evenly to prepare a prepared solution. For a total of 946mL of prepared solution, a total of 1892mL of water must be drunk.

[0404] In each comparative example and embodiment, the total prepared solution is taken in divided doses according to the corresponding ratio (%) of the previous day or the current day, or the active ingredients in the above table are divided in divided doses according to the corresponding ratio (%) of the content, and the prepared solution of the previous day or the current day is prepared and taken. The method of taking each embodiment (ratio %) is as follows.

[0405] [Table 28]

[0406]

[0407] [Table 29]

[0408]

[0409] Results of Examples 1 to 5

[0410] According to the administration method described in each embodiment and comparative example, the composition of the following composition was administered to randomly selected patients, and the intestinal cleanliness, time required for examination, gastric / intestinal residue, time required for medication, number of morning bowel movements, medication completion rate, side effects (abnormal conditions - nausea, vomiting, urgent bowel movements, etc.), willingness to take the medication again, etc. were evaluated. The above-mentioned patients were healthy adults who planned to undergo regular outpatient colonoscopy examinations and had no adverse reactions to other commercially available intestinal cleansers before, and patients with serious medical problems, heart disease, diabetes or any other potentially serious symptoms were excluded.

[0411] Among the evaluation items, intestinal cleanliness, residual volume, and time required for examination (minutes) were evaluated by the clinician who performed the endoscopic examination.

[0412] Intestinal cleanliness

[0413] Intestinal cleanliness was confirmed by colonoscopy. In order to objectively evaluate the intestinal cleansing effect, the intestinal cleansing effect was graded according to the Harefield Cleansing Scale, and the intestinal cleanliness of each subject was divided into 5 levels.

[0414] [Table 30]

[0415]

[0416] The above five scores were classified into grades A to D as shown below to evaluate the intestinal cleanliness. Specifically, according to the Harefield cleanliness scale, grades A and B were evaluated as successful intestinal cleansing, and grades C and D were evaluated as failed intestinal cleansing.

[0417] <Overall evaluation of colon cleanliness>

[0418] Grade A:All segments scored 1or 2

[0419] Grade B: 1segments scored 3

[0420] Grade C: 1segments scored 4

[0421] Grade D: 1segments scored 5

[0422] Residue

[0423] Gastric residual volume and intestinal residual volume are measured by checking the remaining water in the stomach through the suction channel in the endoscope during endoscopy.

[0424] Time required for the test

[0425] The time from the start to the end of the colonoscopy was recorded.

[0426] Among the evaluation items, the time required for taking medicine (minutes), number of morning bowel movements (times), completion rate of taking medicine (%), abnormal conditions (%), and willingness to take medicine again (%) were evaluated through questionnaires of the subjects (patients). Among them, the completion rate of taking medicine, abnormal conditions, and willingness to take medicine again were calculated by the ratio of the number of subjects corresponding to the relevant items to the total number of subjects.

[0427] The results are shown in Table 31.

[0428] [Table 31]

[0429]

[0430]

[0431] In Examples 1 to 5, the total dose of the solution and water prepared on the same day is less than 700 ml, and, in terms of the success rate of intestinal cleaning, it shows excellent or equivalent effects compared with the comparative examples. As for the gastric residual volume / intestinal residual volume as a safety indicator, the residual volume is significantly reduced compared with each comparative example, and in particular, the gastric residual volume is reduced to less than half compared with the comparative example. Quite a number of colonoscopy patients will undergo gastroscopy at the same time, but it is recommended to fast for at least 8 hours during gastroscopy, including water, which is directly contradictory to the method of taking intestinal cleansers for colonoscopy. From the aspect of improving the safety of the subject, the gastric residual volume is also an important evaluation criterion. When taking the embodiment composition of the present invention, the gastric residual volume is significantly improved, and the safety of the subject is very effectively improved.

[0432] In addition, the time required for endoscopic examination was reduced compared to the comparative example because the intestinal environment was suitable for colonoscopy, so the time to reach the cecum and the recovery time during endoscopic examination were shortened. The simplicity of examination was also improved, and the cleanliness of the intestine and the reduction of residual fluid made it easier to ensure the field of view during endoscopic examination and polyp identification, etc.

[0433] Compared with the comparative example, the time for patients to take medicine was significantly reduced to less than half, and the number of morning bowel movements was also reduced, which increased the convenience of patients taking medicine and improved the completion rate of medicine.

[0434] Compared with the comparative example, abnormal conditions such as nausea, vomiting, and urgency to defecate were significantly reduced.

[0435] The number of patients willing to take the medication again also increased significantly, especially in Example 3, where 100% of the patients were willing to take the medication again.

[0436] Examples 6 to 16

[0437] Similar to Examples 1 to 5, the composition of each active ingredient in the following table is taken in divided doses according to a ratio of 80:20 to 75:25 on the previous day: on the current day (however, the total dose of the prepared solution and water on the current day is 700 mL, 600 mL or less than 500 mL). Examples 6 to 16 are the compositions of products that have been approved as intestinal cleansers by the Korean Ministry of Food and Drug Safety, using the original packaging of these products, and, similar to Examples 1 to 5, the total prepared solution is taken in divided doses according to the corresponding ratio (%) of the previous day or the current day, or each active ingredient is taken in divided doses according to the content corresponding to the corresponding ratio (%), and the prepared solution of the previous day or the current day is prepared separately and then taken. The method of taking each example (ratio %) is as follows.

[0438] [Table 32]

[0439]

[0440]

[0441] Embodiment 17

[0442] Compositions were prepared according to the ingredients and amounts in the following table (see Example 3).

[0443] [Table 33]

[0444]

[0445]

[0446] (1) Example 17-1

[0447] Directions

[0448] Mix the active ingredients in the above table according to the content, add appropriate amount of water to dissolve, add water to a total of 960mL, and then mix evenly to prepare a prepared solution. For a total of 960mL of prepared solution, a total of 390mL of water must be drunk.

[0449] In each comparative example and example, the active ingredients in the above table were divided into two doses according to the corresponding proportions (%), and the solution prepared the day before or the day before was taken together with water.

[0450] In the comparative example, the composition is divided into two packages, and one package is taken on the previous day and the same day. In the embodiment, a total of 3 packaging units are provided, 2 packages on the previous day and 1 package on the morning of the same day. That is, each packaging unit in the embodiment contains 36.67g of D-sorbitol, 5g of ascorbic acid, 0.7g of sodium bicarbonate, 0.3g of potassium bicarbonate, and 0.8g of spice powder. It is recommended that the subject take the medicine as follows: the packaging unit taken the night before is marked as A, and the packaging unit taken on the day of inspection is marked as B.

[0451] (1) At 8:00 pm on the day before the test, take the solution of 1 sachet of Agent A diluted evenly with 320 mL of water within 10 minutes, and drink 130 mL of water. Then, dilute 1 sachet in the same way (320 mL of water) and take it within 10 minutes, and drink 130 mL of water again.

[0452] (2) In the morning or morning of the day of the examination, take the solution of 1 sachet of Agent B diluted with 320 mL of water within 10 minutes, and drink 130 mL of water. For safety during the examination, it is recommended to take it within 2 hours before the examination.

[0453] When taking the comparative example, 4 packages were prepared. That is, each package unit contained 27.5 g of D-sorbitol, 3.75 g of ascorbic acid, 0.525 g of sodium bicarbonate, 0.225 g of potassium bicarbonate, and 0.6 g of spice powder. The subjects were advised to take the medicine as follows: the package unit taken the night before was marked as A, and the package unit taken on the day of the examination was marked as B.

[0454] (1) In the comparative example, at 8:00 pm on the night before the test, the subject took a solution of one packet of Agent A diluted evenly with 240 mL of water within 10 minutes, and drank 97.5 mL of water. Then, another packet was diluted in the same manner (240 mL of water) and taken within 10 minutes, and then drank 97.5 mL of water.

[0455] (2) In the morning or morning of the day of the test, take the solution of 1 sachet of Agent B diluted evenly with 240 mL of water within 10 minutes, and drink 97.5 mL of water. Then, dilute 1 sachet in the same way (240 mL of water) and take it within 10 minutes, and drink 97.5 mL of water again. For safety during the test, it is recommended to take it within 2 hours before the test.

[0456] The administration method of each comparative example and example is as follows.

[0457] [Table 34]

[0458]

[0459] [Table 35]

[0460]

[0461] (2) Example 17-2

[0462] Directions

[0463] Mix the active ingredients in the above table according to the content, add appropriate amount of water to dissolve, add water to a total of 960mL, and then mix evenly to prepare a prepared solution. For a total of 960mL of prepared solution, a total of 320mL of water must be drunk.

[0464] In each comparative example and example, the active ingredients in the above table were divided into two doses according to the corresponding proportions (%), and the solution prepared the day before or the day before was taken together with water.

[0465] The administration method of each comparative example and example is as follows.

[0466] [Table 36]

[0467]

[0468]

[0469] [Table 37]

[0470]

[0471] Embodiment 18

[0472] In this example, a composition having the components and contents shown in the following table was used.

[0473] [Table 38]

[0474] Active ingredients Total content (g) Polyethylene glycol 3350 140 Anhydrous sodium sulfate 9 Potassium chloride 2.2 Sodium chloride 5.2 Sodium Ascorbate 48.11 ascorbic acid 7.54 Total 212.05

[0475] Directions

[0476] The above active ingredients are mixed evenly according to the content, and after adding an appropriate amount of water to dissolve, water is added to make the total amount 1L, and then mixed evenly to prepare a prepared solution. For a total of 1L of prepared solution, a total of 1L of water must be drunk.

[0477] In each comparative example and embodiment, the total prepared solution was taken with water in divided doses according to the corresponding ratio (%) of the previous day or the current day, or the active ingredients in the above table were divided into doses according to the corresponding ratio (%), and the prepared solution of the previous day or the current day was prepared separately and then taken with water.

[0478] The administration method (ratio %) of the prepared solution in each example is as follows.

[0479] [Table 39]

[0480]

[0481] [Table 40]

[0482]

[0483] Embodiment 19

[0484] Compositions were prepared according to the ingredients and amounts in the following table.

[0485] [Table 41]

[0486]

[0487]

[0488] Directions

[0489] The above active ingredients are mixed evenly according to the content, and after adding an appropriate amount of water to dissolve, water is added to make the total amount 1L, and then mixed evenly to prepare a prepared solution. For a total of 1L of prepared solution, a total of 1L of water must be drunk.

[0490] In each comparative example and embodiment, the total prepared solution was taken with water in divided doses according to the corresponding ratio (%) of the previous day or the current day, or the active ingredients in the above table were divided into doses according to the corresponding ratio (%), and the prepared solution of the previous day or the current day was prepared separately and then taken with water.

[0491] The administration method (ratio %) of the prepared solution in each example is as follows.

[0492] [Table 42]

[0493]

[0494] [Table 43]

[0495]

[0496]

[0497] Embodiment 20

[0498] Compositions were prepared according to the ingredients and amounts in the following table.

[0499] [Table 44]

[0500] Active ingredients Total content (g) Polyethylene glycol 3350 150.0 D-Sorbitol 54.6 Sodium Picosulfate Hydrate 0.01 Total 204.61

[0501] Directions

[0502] The above active ingredients are mixed evenly according to the content, and after adding an appropriate amount of water to dissolve, water is added to make the total amount 1L, and then mixed evenly to prepare a prepared solution. For a total of 1L of prepared solution, a total of 1L of water must be drunk.

[0503] In each comparative example and embodiment, the total prepared solution is taken with water in divided doses according to the corresponding ratio (%) of the previous day or the current day, or the active ingredients in the above table are divided in divided doses according to the corresponding content of the corresponding ratio (%), and the prepared solution of the previous day or the current day is prepared separately and then taken with water. The method of taking each embodiment (ratio %) is as follows.

[0504] [Table 45]

[0505]

[0506] [Table 46]

[0507]

[0508]

[0509] Results of Examples 17 to 20

[0510] According to the administration method described in each embodiment and comparative example, the composition of the following composition was administered to randomly selected patients, and the intestinal cleanliness, endoscopy time, intestinal residue, difficulty of taking the medicine, side effects (abnormal conditions - nausea, vomiting, dizziness), willingness to take the medicine again, etc. were evaluated. The above-mentioned patients were healthy adults who planned to undergo regular outpatient colonoscopy examinations and had no adverse reactions to other commercially available intestinal cleansers before, and patients with serious medical problems, heart disease, diabetes or any other potentially serious symptoms were excluded.

[0511] Among the evaluation items, intestinal cleanliness, examination difficulty, residual volume, and time required for examination (minutes) were evaluated by the clinicians who performed the endoscopic examination.

[0512] Intestinal cleanliness

[0513] Intestinal cleanliness was confirmed by colonoscopy. In order to objectively evaluate the intestinal cleansing effect, the intestinal cleansing effect was graded according to the Harefield Cleansing Scale, and the intestinal cleanliness of each subject was divided into 5 levels for evaluation.

[0514] Specifically, according to the Harefield cleanliness scale, 1 to 3 points were evaluated as successful intestinal cleansing, and 4 and 5 points were evaluated as failed intestinal cleansing.

[0515] [Table 47]

[0516]

[0517]

[0518] Endoscopy time

[0519] The time from the start to the end of the colonoscopy was recorded.

[0520] Residue

[0521] The intestinal residual volume is measured by checking the water remaining in the stomach through the suction channel in the endoscope during endoscopy.

[0522] Check Difficulty

[0523] Ease of endoscopy and detection of polyps due to bowel cleanliness and reduction of residual fluid was evaluated.

[0524] Among the evaluation items, difficulty in taking the medicine, abnormal conditions, and willingness to take the medicine again were evaluated through questionnaires of the subjects (patients), and the evaluations were as follows.

[0525] Evaluation criteria for difficulty of taking: not difficult (1 point), slightly difficult (2 points), very difficult (3 points)

[0526] Evaluation criteria for abnormal situations: no occurrence (1 point), few occurrences (2 points), many occurrences (3 points)

[0527] Evaluation criteria for willingness to take medication again: take medication again (1 point), do not take medication (2 points)

[0528] The results are shown in Table 48.

[0529] [Table 48]

[0530]

[0531]

[0532] In Examples 17 to 20, the total dose of the solution and water prepared on the same day was less than 500 ml, and in all items (i.e., cleanliness, difficulty in taking, whether to take the medicine again, time required for colonoscopy, residual amount, etc.), a significantly superior effect was shown compared with the comparative example. In particular, a considerable number of colonoscopy patients will undergo gastroscopy at the same time, but it is recommended to fast for at least 8 hours during gastroscopy, including water, which is directly contradictory to the method of taking intestinal cleansers for colonoscopy. From the perspective of improving the safety of the subject, the residual amount is also an important evaluation criterion. When taking the embodiment composition of the present invention, the residual amount is significantly improved, and the safety of the subject is very effectively improved.

[0533] Through the above examples, the following effects were confirmed.

[0534] In all embodiments, although the dosage on the morning of the examination day was reduced to less than 700 mL, especially less than 600 mL, or even less than 500 mL, it not only showed better intestinal cleanliness and mucosal cleanliness, but also, because the intestinal environment was in a state suitable for colonoscopy, the time to reach the cecum and the recovery time during endoscopic examination were shortened, thereby greatly reducing the time required for examination. In addition, due to the reduction of intestinal cleanliness and residual liquid, it is easier to ensure the field of view for endoscopic examination and polyp identification, and it is also easier for clinicians to perform examinations.

[0535] In addition, the subjects' evaluation of the difficulty of endoscopic examination was very excellent, and the completion rate of medication was improved, the incidence of abnormal conditions was reduced, the difficulty of medication was significantly improved, and it was confirmed that the subjects were willing to take the medication again.

[0536] Considering that most of the compositions used in the embodiments are drugs that have been proven to be effective and safe through existing methods of administration (comparative examples) through clinical trials, etc., and are already licensed and sold in Korea, the new method of administration according to the present invention is more effective and safer than the methods of administration of drugs currently approved on the market.

[0537] This safety can not only reduce the abnormal conditions experienced by patients during medication, but also reduce the amount of water remaining in the intestine during actual colonoscopy, thereby making colonoscopy easier. By shortening the time of colonoscopy, the risks of colonoscopy can be reduced, and a significant improvement in safety has been confirmed. In particular, a considerable number of colonoscopy patients also undergo gastroscopy. It is recommended to fast for at least 8 hours during gastroscopy, including water, which is directly contradictory to the method of taking intestinal cleansers during colonoscopy. From the perspective of improving the safety of the subject, gastric residual volume is also an important evaluation criterion. When taking the composition of the embodiment of the present invention, it is confirmed that the gastric residual volume is significantly improved, and the safety (sagety) of the subject is very effectively improved.

Claims

1. A composition for intestinal cleansing, which is a composition for intestinal cleansing taken before an examination requiring intestinal cleansing, wherein: The composition is taken in divided doses one day before and on the day of the examination. Check that the total dose taken on the day is less than 700 mL.

2. The composition for intestinal cleansing according to claim 1, wherein The total dose taken on the day of the examination was less than 500 mL.

3. The composition for intestinal cleansing according to claim 1, wherein The total dose taken the day before and on the day of the test was 1.0 L to 4.0 L.

4. The composition for intestinal cleansing according to claim 1, wherein The composition for intestinal cleansing comprises: a prepared solution prepared by dissolving a composition in the form of powder, granules, liquid preparation, tablet or capsule containing an active ingredient in a water-soluble solvent; and other water-soluble solvents, The composition for intestinal cleansing is administered in a manner of taking other water-soluble solvents after taking the formulated solution, and the manner is repeated 2 to 4 times in total on the day before and on the day of the examination.

5. The composition for intestinal cleansing according to claim 1, wherein The composition for intestinal cleansing is in any form of solution, suspension and emulsion.

6. The composition for intestinal cleansing according to any one of claims 1 to 5, wherein At least one sugar alcohol selected from the following ingredients as a first effective ingredient, the ingredients comprising xylitol, sorbitol, glycerol, erythritol, threitol, arabitol, ribitol, mannitol, galactitol, fucitol, iditol, inositol, heptyl alcohol, isomalt, maltitol, lactitol, maltotriitol, maltotetraitol and hydrogenated glucose; Ascorbic acid or a mixture of ascorbic acid and a salt of ascorbic acid as a second active ingredient; and Water-soluble solvents, Based on the total composition, the content of the first active ingredient is 10 g / L to 500 g / L, based on the total composition, the content of the second active ingredient is 1 g / L to 300 g / L, and the content of the water-soluble solvent is 1.0 L to 3.0 L.

7. The composition for intestinal cleansing according to claim 6, wherein As a third active ingredient, sodium bicarbonate and / or potassium bicarbonate are also included. The third active ingredient is present in an amount of 0.5 g / L to 5 g / L based on the total composition.

8. The composition for intestinal cleansing according to claim 6, wherein Include: 110 g of D-sorbitol; 15g of ascorbic acid; 2.1 g of sodium bicarbonate; 0.9 g of potassium bicarbonate; and 1.0L to 3.0L of water, The water is applied in the form of a solution in which the components are dissolved, or is applied alone.

9. The composition for intestinal cleansing according to any one of claims 1 to 5, wherein Include: Polyethylene glycol as the first active ingredient; Ascorbic acid or a mixture of ascorbic acid and an ascorbate as a second active ingredient; and Water-soluble solvents, Based on the total composition, the content of the first active ingredient is 10 g / L to 500 g / L, based on the total composition, the content of the second active ingredient is 1 g / L to 300 g / L, and the content of the water-soluble solvent is 1.0 L to 3.0 L.

10. The composition for intestinal cleansing according to claim 9, wherein Include: 200 g of polyethylene glycol 3350; 9.4 g of ascorbic acid; 11.8 g of sodium ascorbate; 15 g of anhydrous sodium sulfate; 5.382 g of sodium chloride; 2.030 g of potassium chloride; and 1.0 to 3.0L of water, The water is applied in the form of a solution in which the components are dissolved, or is applied alone.

11. The composition for intestinal cleansing according to claim 9, wherein Include: 140 g of polyethylene glycol 3350; 7.54 g of ascorbic acid; 48.11 g of sodium ascorbate; 9 g of anhydrous sodium sulfate; 5.2 g of sodium chloride; 2.2 g of potassium chloride; and 1.0 to 3.0L of water, The water is applied in the form of a solution in which the components are dissolved, or is applied alone.

12. The composition for intestinal cleansing according to claim 9, wherein Include: 160 g of polyethylene glycol 3350; 40.6 g of ascorbic acid; 9.4 g of sodium ascorbate; 18 g of anhydrous sodium sulfate; 2.7 g of sodium chloride; 1g of potassium chloride; as well as 1.0 to 3.0L of water, The water is applied in the form of a solution in which the components are dissolved, or is applied alone.

13. The composition for intestinal cleansing according to any one of claims 1 to 5, wherein Based on the total composition, it contains: 0.001 g / L to 0.1 g / L of sodium picosulfate or its hydrate; 0.5 g / L to 50 g / L magnesium oxide; 1 g / L to 50 g / L citric acid; as well as 1.0 to 3.0 L of aqueous solvent.

14. The composition for intestinal cleansing according to any one of claims 1 to 5, wherein Based on the total composition, it contains: 10 g / L to 500 g / L polyethylene glycol; 1 g / L to 300 g / L of sorbitol; 0.001 g / L to 1 g / L of sodium picosulfate or its hydrate; as well as 1.0 to 3.0 L of aqueous solvent.

15. The composition for intestinal cleansing according to any one of claims 1 to 5, wherein Based on the total composition, it contains: 5 g / L to 300 g / L sodium sulfate; 0.1 g / L to 50 g / L potassium sulfate; 0.1 g / L to 50 g / L magnesium sulfate; as well as 1.0 to 3.0 L of aqueous solvent.

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