Bowel cleansing composition

Abstract

The present invention relates to a bowel cleansing composition comprising polyethylene glycol and ascorbate ingredients, the bowel cleansing composition of the present invention being easier to take, while having an excellent bowel cleansing effect, thereby being usable as an effective bowel cleansing agent.

Claims

1. A bowel cleansing composition comprising polyethylene glycol (PEG) and ascorbate ingredients, wherein a weight ratio between polyethylene glycol and ascorbate ingredients is 2.5:1 to 4:1, a content of polyethylene glycol ingredients is 140 g to 180 g, a content of ascorbate ingredients is 45 g or more and less than 55 g, and the ascorbate ingredients comprise ascorbic acid and sodium ascorbate at a weight ratio of 3.5:1 to 5:1, wherein the composition is in the form of tablet, granule, powder, capsule or liquid.

2. The bowel cleansing composition according to claim 1, wherein the content of ascorbic acid is 35 to 45 g and the content of sodium ascorbate is 8 to 11 g.

3. The bowel cleansing composition according to claim 1, comprising sodium sulfate, wherein a weight ratio between polyethylene glycol and sodium sulfate is 7:1 to 12:1.

4. The bowel cleansing composition according to claim 3, wherein a content of sodium sulfate is 16 to 20 g as an anhydride.

5. The bowel cleansing composition according to claim 1, comprising 2 to 3.5 g of sodium chloride.

6. The bowel cleansing composition according to claim 1, comprising 0.5 to 2 g of potassium chloride.

7. A bowel cleansing solution, comprising polyethylene glycol (PEG) and ascorbate ingredients, wherein a content ratio between polyethylene glycol and ascorbate ingredients is 2.5:1 to 4:1, a content of polyethylene glycol is 140 g/L to 180 g/L, a content of ascorbate ingredients is 45 g/L or more and less than 55 g/L, and ascorbate ingredients comprise ascorbic acid and sodium ascorbate at a molar ratio of 4:1 to 6:1.

8. The bowel cleansing solution according to claim 7, wherein a content of ascorbic acid is 200 to 255 mM and a content of sodium ascorbate is 40 to 55 mM.

9. The bowel cleansing solution according to claim 7, comprising sulfate, wherein a molar ratio between polyethylene glycol and sulfate is 1:2 to 1:3.5.

10. The bowel cleansing solution according to claim 9, comprising 110 to 140 mM of sulfate.

11. The bowel cleansing solution according to claim 9, comprising 35 to 60 mM of sodium chloride.

12. The bowel cleansing solution according to claim 9, comprising 7 to 27 mM of potassium chloride.

13. The bowel cleansing solution according to claim 7, wherein a concentration of sodium ions is 200 to 500 mEq/L.

14. The bowel cleansing solution according to claim 12, wherein a concentration of potassium ions is 5 to 30 mEq/L.

15. The bowel cleansing solution according to claim 11, wherein a concentration of chloride ions is 30 to 90 mEq/L.

16. The bowel cleansing solution according to claim 7, wherein the bowel cleansing solution is hypertonic.

17. The bowel cleansing solution according to claim 7, wherein the bowel cleansing solution is taken at a dose of 1200 mL or less.

18. The bowel cleansing composition according to claim 1, wherein the average molecular weight of polyethylene glycol is 2,000 to 8,000.

19. The bowel cleansing composition according to claim 1, wherein the average molecular weight of polyethylene glycol is 3,000 to 4,000.

20. The bowel cleansing solution according to claim 7, wherein the average molecular weight of polyethylene glycol is 2,000 to 8,000.

21. The bowel cleansing solution according to claim 7, wherein the average molecular weight of polyethylene glycol is 3,000 to 4,000.

22. The bowel cleansing composition according to claim 1, wherein the bowel cleansing composition comprises: (i) 160 g of polyethylene glycol with the average molecular weight of 3,000 to 4,000, (ii) 40.6 g of ascorbic acid, (iii) 9.4 g of sodium ascorbate, (iv) 16 to 20 g of sodium sulfate, (v) 2 to 3.5 g of sodium chloride, and (vi) 0.5 to 2 g of potassium chloride.

23. The bowel cleansing solution according to claim 7, wherein the bowel cleansing solution comprises: (i) 160 g/L of polyethylene glycol with the average molecular weight of 3,000 to 4,000, (ii) 40.6 g/L of ascorbic acid, (iii) 9.4 g/L of sodium ascorbate, (iv) 16 to 20 g/L of sodium sulfate, (v) 2 to 3.5 g/L of sodium chloride, and (vi) 0.5 to 2 g/L of potassium chloride.

24. The bowel cleansing solution according to claim 11, wherein a concentration of sodium ions is 200 to 500 mEq/L.

25. The bowel cleansing solution according to claim 12, wherein a concentration of chloride ions is 30 to 90 mEq/L.

Description

DESCRIPTION OF DRAWINGS

(1) FIG. 1 is a view confirming that there is no stool present in a large intestine as a result of visually identifying a degree of bowel cleansing in the group administered with a bowel cleansing composition.

(2) FIG. 2 is a view confirming that there is still stool present in a large intestine as a result of visually identifying a degree of bowel cleansing in the group not administered with a bowel cleansing composition.

MODE FOR INVENTION

(3) Hereinafter, the present invention will be described in more detail through examples. However, these examples are for illustrative purpose only and the scope of the present invention is not limited thereto.

Preparation Example 1: Preparation of Bowel Cleansing Composition and Solution

(4) The bowel cleansing composition of the present invention was prepared in Examples 1 to 4 in accordance with the ingredients and content as shown in the Table 3 below.

(5) TABLE-US-00003 TABLE 3 Ingredients Example Example Example Example (g) 1 2 3 4 PEG3350 160 140 150 170 Na.sub.2SO.sub.4 18 16 17.5 18.5 NaCl 2.7 2.0 2.5 3.0 KCl 1.0 0.5 0.8 1.2 Ascorbic acid 40.6 36 39 43 Sodium ascorbate 9.4 8 9 10

(6) The bowel cleansing compositions of the above table 3 were prepared in Examples 1 to 4 solutions by dissolving in water so that the volume of liquid medicine to be 1 L. The molar concentration (mM) of ingredients contained in the solutions of Examples 1 to 4 and the molar ratio of main ingredients therein are shown in Table 4 below.

(7) TABLE-US-00004 TABLE 4 Ingredients Example Example Example Example (mM) 1 2 3 4 PEG3350 47.76 41.79 44.78 50.75 Na.sub.2SO.sub.4 126.76  112.68  123.24  130.28  NaCl 46.15 34.19 42.74 51.28 KCl 13.41  6.71 10.73 16.10 Ascorbate ingredients 278.16  244.95  267.05  294.82  Molar ratio of 1:5.82 1:5.86 1:5.96 1:5.81 PEG:ascorbate ingredient Molar ratio of ascorbic 4.86:1     5.06:1     4.88:1     4.84:1     acid:sodium ascorbate Molar ratio of 1:2.65 1:2.70 1:2.75 1:2.57 PEG:Na.sub.2SO.sub.4

(8) The bowel cleansing compositions of Examples 1 to 4 may be provided in the form of including two pouches (pouch A not containing ascorbate ingredients and pouch B containing ascorbate ingredients), wherein the pouches A and B can be taken by dissolving in water to be 1 L together. For example, the bowel cleansing composition of Example 1 may be provided in the form of including the pouches A and B, as shown in the Table 5 below, and may be provided in the same manner in the case of the bowel cleansing compositions of Examples 2 to 4.

(9) TABLE-US-00005 TABLE 5 Pouch A Pouch B PEG3350 Na.sub.2SO.sub.4 NaCl KCl Ascorbate ingredients 160 18 2.7 1.0 50

(10) In addition, the bowel cleansing compositions of Examples 1 to 4 may be provided in the form of including four pouches (pouches A(1) and A(2) not containing ascorbate ingredients and pouches B(1) and B(2) containing ascorbate ingredients), wherein the pouches A(1) and B(1) can be taken by dissolving in water to be 500 mL together, and the pouches A(2) and B(2) can be taken by dissolving in water to be 500 mL together. For example, the bowel cleansing composition of Example 1 may be provided in the form of including the pouches A(1), A(2), B(1) and B(2), as shown in Tables 6 and 7 below, and the bowel cleansing compositions of Examples 2 to 4 may also be provided in the same manner.

(11) TABLE-US-00006 TABLE 6 Pouch A(1) Pouch B(1) PEG3350 Na.sub.2SO.sub.4 NaCl KCl Ascorbate ingredients 80 9 1.35 0.5 25

(12) TABLE-US-00007 TABLE 7 Pouch A(2) Pouch B(2) PEG3350 Na.sub.2SO.sub.4 NaCl KCl Ascorbate ingredients 80 9 1.35 0.5 25

(13) Further, the bowel cleansing compositions of Examples 1 to 4 may be provided in the form of including the following eight pouches (pouches A(1), A(2), A(3) and A(4) not containing ascorbate ingredients and pouches B(1), B(2), B(3) and B(4) containing ascorbate ingredients), wherein the pouches A(1) and B(1) can be taken by dissolving in water to be 250 mL together, while in the same manner, the pouches A(2) and B(2), the pouches A(3) and B(3), and the pouches A(4) and B(4) can be taken by dissolving in water to be 250 mL together, respectively. Alternatively, the pouches A(1), A(2), B(1) and B(2) can be taken by dissolving in water to be 500 mL together, while the pouches A(3), A(4), B(3) and B(4) can be taken by dissolving in water to be 500 mL together. For example, the bowel cleansing composition of Example 1 may be provided in the form of including the pouches A(1), A(2), A(3), A(4), B(1), B(2), B(3) and B(4), as shown in Tables 8 to 11 below, and the bowel cleansing compositions of Examples 2 to 4 may also be provided in the same manner.

(14) TABLE-US-00008 TABLE 8 Pouch A(1) Pouch B(1) PEG3350 Na.sub.2SO.sub.4 NaCl KCl Ascorbate ingredients 40 4.5 0.675 0.25 12.5

(15) TABLE-US-00009 TABLE 9 Pouch A(2) Pouch B(2) PEG3350 Na.sub.2SO.sub.4 NaCl KCl Ascorbate ingredients 40 4.5 0.675 0.25 12.5

(16) TABLE-US-00010 TABLE 10 Pouch A(3) Pouch B(3) PEG3350 Na.sub.2SO.sub.4 NaCl KCl Ascorbate ingredients 40 4.5 0.675 0.25 12.5

(17) TABLE-US-00011 TABLE 11 Pouch A(4) Pouch B(4) PEG3350 Na.sub.2SO.sub.4 NaCl KCl Ascorbate ingredients 40 4.5 0.675 0.25 12.5

Mode for Invention

Experimental Example 1: Confirmation of Bowel Cleansing Effect in Animal Model

(18) An animal model was used to confirm the bowel cleansing effect of the bowel cleansing solution of the present invention. Specifically, 20 mL of the bowel cleansing solution of Example 1 was administered to Sprague-Dawley rats. The rat was exsanguinated and sacrificed in six hours after starting the administration. Thereafter, the large intestine part was removed to check the degree of bowel cleansing.

(19) As a result of confirming the degree of bowel cleansing in the group administered with the bowel cleansing solution and the group not administered with the same, it was confirmed that stool present in the large intestine was well removed in the group administered with the bowel cleansing solution (FIG. 1). Bowel cleansing was well performed in all of the six rats administered with the bowel cleansing solution, and five of them were very excellent degree of bowel cleansing. On the other hand, it was confirmed that stool is still present in the large intestine of the group not administered with the bowel cleansing solution (FIG. 2).

(20) Through this, it was found that the bowel cleansing solution of the present invention exhibits very excellent bowel cleansing effect.

Experimental Example 2: Comparison of Bowel Cleansing Effect and Safety in Animal Model

(21) In order to confirm the effect depending on the composition of the bowel cleansing solution of the present invention, a comparative bowel cleansing solution was prepared to compare the bowel cleansing effect and safety in an animal model.

(22) The ingredients and content of the compositions of Example 1 and Comparative Examples 1 to 4 are shown in Table 12 below, and were prepared by dissolving in water so that the total volume of the liquid medicine to be 1 L.

(23) TABLE-US-00012 TABLE 12 Ingredients Example Comparative Comparative Comparative Comparative (g) 1 Example 1 Example 2 Example 3 Example 4 PEG3350 160 80 160 160 160 Na.sub.2SO.sub.4 18 18 18 18 18 NaCl 2.7 2.7 2.7 2.7 2.7 KCl 1.0 1.0 1.0 1.0 1.0 Ascorbic acid 40.6 83.32 24.48 19.58 7.34 Sodium ascorbate 9.4 19.29 27.54 33.05 46.82 Total volume of 1 L liquid medicine

(24) The molar concentrations of ingredients of the solution for bowel cleansing according to the above Table 12 are shown in Table 13 below.

(25) TABLE-US-00013 TABLE 13 Ingredients Example Comparative Comparative Comparative Comparative (mM) 1 Example 1 Example 2 Example 3 Example 4 PEG3350 47.76 23.88 47.76 47.76 47.76 Na.sub.2SO.sub.4 126.76  126.76  126.76  126.76  126.76  NaCl 46.15 46.15 46.15 46.15 46.15 KCl 13.41 13.41 13.41 13.41 13.41 Ascorbate ingredients 278.16  570.83  278.18  278.17  278.17  Molar ratio of 1:5.82 1:23.9 1:5.82 1:5.82 1:5.82 PEG:ascorbate ingredient Molar ratio of 4.86:1     4.86:1     1:1   1:1.5  1:5.67 ascorbic acid:sodium ascorbate Molar ratio of 1:2.65 1:5.31 1:2.65 1:2.65 1:2.65 PEG:Na.sub.2SO.sub.4

(26) The bowel cleansing effect of solutions of Example and Comparative Example was measured by using a rat animal model in the same manner as shown in Experimental Example 1. In order to objectively evaluate the bowel cleansing effect, the grade of bowel cleansing effect was measured based on the criteria as shown in Table 14 below. The criteria was based on Harefield Cleansing Scale which is widely used as the criteria for measurement of the degree of bowel preparation in clinical trials. The degree of bowel preparation of rats was evaluated by dividing into 1 to 5 grades.

(27) TABLE-US-00014 TABLE 14 Grade Criteria Grade 1 Only clean or transparent liquid is present Grade 2 Small amount of brown liquid is present, with little semi-solid stool Grade 3 Brown liquid, completely removable semi-solid stool is present Grade 4 Partially removable semi-solid stool is present Grade 5 Irremovable, hard stool is present

(28) Comparison of Bowel Cleansing Effect and Safety According to Content Ratio Between Polyethylene Glycol and Ascorbate Ingredients

(29) The solution of Comparative Example 1 in Tables 12 and 13 had a polyethylene glycol content (80 g) that is half of the solution of Example 1 (160 g), while the concentration of ascorbate ingredients (570.83 mM) is about double of the solution of Example 1 (278.16 mM). After the oral administration of the solution of Example 1 (n=6) and the solution of Comparative Example 1 (n=6) to 12 rats, the degree of bowel preparation was evaluated according to criteria of the Table 14 and the results are shown in Table 15 below.

(30) TABLE-US-00015 TABLE 15 Degree of bowel cleansing (n) Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Example 1 3 2 1 0 0 Comparative 0 3 2 1 0 Example 1

(31) As can be seen from the above table, it can be seen that the bowel cleansing effect according to the content of polyethylene glycol and ascorbate ingredients of the solution of Example 1 is outstandingly excellent. In addition, in order to measure the safety when taking the bowel cleansing solution, a blood test was performed on rats taking the solution of Example 1 and the solution of Comparative Example 1. In the group of animals taking the solution of Comparative Example 1, a dead individual occurred and gastric mucosal injury was observed. In contrast, in the group of animals taking the solution of Example 1, there is no dead individual. As a result of measuring a concentration of asparate aminotransferase (AST), alkaine aminotransferase (ALT), blood urea nitrogen (BUN), creatinine, red blood cell (RBC), hemoglobin (HGB), mean corpuscular hemoglobin concentration (MCHC), hematocrit (HCT), etc. in a blood test, it was confirmed that numerical changes were significantly low in the individuals taking the solution of Example 1 than those of individuals taking the solution of Comparative Example 1, thereby exhibiting more excellent safety.

(32) From the above results, it can be seen that the bowel cleansing solution of the present invention according to the content ratio of polyethylene glycol and ascorbate ingredient is excellent in both bowel cleansing effect and safety, and can be usefully used as a solution for bowel cleansing.

(33) Comparison of Bowel Cleansing Effect and Safety According to Molar Ratio Between Ascorbic Acid and Sodium Ascorbate

(34) The solution of Comparative Example 2 and Example 1 of Tables 12 and 13 have the same content of polyethylene glycol and ascorbate ingredients. However, the solution of Example 1 had a molar ratio between ascorbic acid and sodium ascorbate contained in the ascorbate ingredients of about 4.86:1, while the solution of Comparative Example 2 had a molar ratio of 1:1, and the molar ratio is different from each other.

(35) With regard to a total of 12 rats, the degree of bowel preparation of groups taking Example 1 (n=6) and Comparative Example 2 (n=6) was measured according to the criteria of Table 14, and the results are shown in Table 16 below.

(36) TABLE-US-00016 TABLE 16 Degree of bowel cleansing (n) Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Example 1 3 2 1 0 0 Comparative 0 1 5 0 0 Example 2

(37) The solutions of Comparative Examples 3 and 4 and Example 1 of Tables 12 and 13 have the same content of polyethylene glycol and ascorbate ingredients. However, the solution of Example 1 had a molar ratio between ascorbic acid and sodium ascorbate contained in the ascorbate ingredients of about 4.86:1, while the solutions of Comparative Examples 3 and 4 have a molar ratio of 1:1.5 and 1:5.67, respectively, and the molar ratio are different from each other.

(38) With regard to a total of 18 rats, the degree of bowel preparation of groups taking Example 1 (n=6), Comparative Example 3 (n=6) and Comparative Example 4 (n=6) was measured according to the criteria of Table 14, and the results are shown in Table 17 below.

(39) TABLE-US-00017 TABLE 17 Degree of bowel cleansing (n) Grade 1 Grade 2 Grade 3 Grade 4 Grade 5 Example 1 4 1 1 0 0 Comparative 0 3 3 0 0 Example 3 Comparative 0 3 3 0 0 Example 4

(40) As can be seen from the above table, it can be seen that the solutions of Example 1 and Comparatives Examples 2, 3 and 4 contain the same amount of polyethylene glycol and ascorbate ingredients, but the solution of Example 1 has more excellent bowel cleansing ability compared to the solutions of Comparative Examples 2, 3 and 4, which have different ratio between ascorbic acid and sodium ascorbate. Further, a blood test was performed on rats taking the solution of Example 1 and the solutions of Comparative Examples 2, 3 and 4, in order to measure the safety when taking the bowel cleansing solution. As a result, it was confirmed that the numerical changes of AST and NA+ in the blood of rats taking the solutions of Comparative Examples 2, 3 and 4 were much higher than those of rats taking the solution of Example 1. It was confirmed that the solution of Example 1 is a bowel cleansing solution having higher safety compared to the solutions of Comparative Examples 2, 3 and 4.

(41) From the above results, it can be seen that the bowel cleansing solution of the present invention according to a content ratio between ascorbic acid and sodium ascorbate is excellent in both bowel cleansing effect and safety, and thus it can be usefully used as a solution for bowel cleansing.

Experimental Example 3: Comparison of Bowel Cleansing Effect and Safety in Clinical Trials

(42) After the administration of the bowel cleansing solution of Example 1 and Coolprep Powder, a commercial product, to a patient group which is randomly selected, the bowel cleaning effect was confirmed. The bowel cleansing solution of Example 1 was taken in a volume of 1 L, and Coolprep Powder is a product that is taken in a volume of 2 L as a liquid medicine. The composition of Example 1 and Coolprep Powder is shown in Table 18 below.

(43) TABLE-US-00018 TABLE 18 Example 1 Coolprep Powder Ingredients (g) (g) PEG3350 160 200 Na.sub.2SO.sub.4 18 15 NaCl 2.7 5.38 KCl 1.0 2.03 Ascorbic acid 40.6 9.4 Sodium ascorbate 9.4 11.8 Volume of liquid medicine 1 L 2 L

(44) The patient group was divided into three, and taking the bowel cleansing solution of Example 1 on the day of colonoscopy (split-dose administration on the day, Test Group 1), taking the bowel cleansing solution of Example 1 by dividing into the day before colonoscopy and the day of colonoscopy (two-day split-dose administration, Test Group 2), and taking Coolprep Powder by dividing into the day before colonoscopy and the day of colonoscopy (two-day split-dose administration, Test Group 3), respectively. Specifically, Test Group 1 was taken 500 mL of the bowel cleansing solution of Example 1 for about 30 minutes, then taken 500 mL of the bowel cleansing solution of Example 1 for about 30 minutes in about one to two hours later, and then further taken 1 L of water. After taking the bowel cleansing solution, water was divided into 500 mL and drink.

(45) Test Groups 2 and 3 were taken 500 mL of the bowel cleansing solution of Example 1 (for about 30 minutes) and 1 L of Coolprep Powder (for about 1 hour) in the evening of the day before the test, respectively, and taken 500 mL of water, and then taken 500 mL of the bowel cleansing solution of Example 1 (for about 30 minutes) and 1 L of Coolprep Powder (for about one hour) in the morning of the day of test and taken 500 mL of water.

(46) The Bowel cleansing results were evaluated on Harefield Cleansing Scale, with Grades A and B being successful in the bowel cleansing, and Grades C and D being failure in the bowel cleansing. Grade A is a case where all parts of the large intestine (rectum, S-colon, descending colon, transverse colon, and ascending colon) are in an “empty and clean” or a state of “transparent liquid,” which means the very excellent degree of bowel preparation.

(47) As a result of bowel cleansing, the success rate of the test group taking the bowel cleansing solution of Example 1 was higher than that of the test group taking Coolprep Powder, and the number of patients evaluated as Grade A was greater than Test Group 3 much more in Test Groups 1 and 2. In particular, comparing Test Groups 2 and 3 applying the same method of taking, it can be seen that the evaluation rate of Grade A in Test Group 2 is 80.00%, which is much higher than 55.21% of Test Group 3.

(48) TABLE-US-00019 TABLE 19 Patient Group Test Group 1 Test Group 2 Test Group 3 Number of Patients 94 95 96 Bowel cleansing agent Bowel cleansing Bowel cleansing Coolprep Powder solution of Example solution of Example 1 1 Method of taking Split-dose Split-dose Split-dose administration administration administration on the day Number of A 62 (65.96%) 76 (80.00%) 53 (55.21%) patients for B 29 (30.85%) 18 (18.95%) 38 (39.58%) each grade C 3 (3.19%) 0 (0%) 5 (5.21%) of bowel D 0 (0.00%) 1 (1.05%) 0 (0.00%) preparation Ratio of successful 96.81% 98.95% 94.79% patients

(49) TABLE-US-00020 TABLE 20 Ratio of patients with Grade A Test Group 1 Test Group 2 Test Group 3 Ascending 75.53% (71/94) 83.16% (79/95) 62.50% (60/96) colon Transverse 88.30% (83/94) 94.74% (90/95) 76.04% (73/96) colon Descending 92.55% (87/94) 90.53% (86/95) 82.29% (79/96) colon S-colon 87.23% (82/94) 89.47% (85/95) 81.25% (78/96) Rectum 91.49% (86/94) 92.63% (88/95) 80.21% (77/96)

(50) As a result of comparing the rates at which the degree of bowel preparation was evaluated as Grade A in each part of large intestine (rectum, S-colon, descending colon, transverse colon, and ascending colon), the rate in Test Group 1 or 2 patient group was higher than that of Test Group 3 patient group. In particular, ascending colon has a high risk of serrated polyp, in which Test Groups 1 and 2 showed significantly more excellent degree of bowel preparation in the ascending colon compared to Test Group 3.

(51) In addition, considering that the bowel cleansing composition of Example 1 was taken in a volume of 1 L only as a liquid medicine while Coolprep Powder is a product that is taken in a volume of 2 L as a liquid medicine, it can be seen that the bowel cleansing composition of the present invention showed an excellent bowel cleansing effect than that of the commercial product.

(52) The degree of bowel preparation is very important to determine the accuracy of the colonoscopy, and the bowel cleansing composition of the present invention is a composition having a more excellent bowel cleansing ability compared to Coolprep Powder, the commercial product, and having an excellent effect of increasing accuracy of colonoscopy and disease diagnosis.

(53) Further, it was confirmed that there is no problem in the safety such as imbalance of electrolytes (Na+, etc.), etc., by taking the bowel cleansing solution of Example 1.

(54) From the above results, it can be seen that the bowel cleansing solution of the present invention is clinically excellent in both bowel cleansing effect and safety and thus can be usefully used as a bowel cleansing solution.

Experimental Example 4: Evaluation of the Convenience of Taking in Clinical Trials

(55) In case it is difficult to take a sufficient amount of solution as required to achieve a bowel cleansing effect even if the bowel cleansing effect is excellent, due to the characteristics of taking an excessive amount of solution, there is a problem that it is difficult to achieve the desired effect.

(56) Accordingly, the bowel cleansing solution of Example 1 was taken on the day of colonoscopy (Test Group 1, N=94) or the bowel cleansing solution of Example 1 was taken by dividing on the day before colonoscopy and the day of colonoscopy (Test Group 2, N=95), after which an evaluation was made on completion rate of taking, medication compliance, ease of completion of taking, intention to reuse and taste.

(57) All patients in Test Groups 1 and 2 took the bowel cleansing solution of Example 1 and the completion rate of taking was 100%. As a result of evaluating medication compliance (=Dose taken/Scheduled dose*100), all the patients of Test Groups 1 and 2 took the bowel cleansing solution at 75% or more, thereby confirming excellent compliance to medication.

(58) The ease of completion of taking to the patients who took the bowel cleansing solution of Example 1 was evaluated by categorizing “Yes” or “No.” As a result, all the patients excluding one in Test Group 1 and all the patients of Test Group 2 answered “Yes.”

(59) The intention to reuse of taking to the patients who took the bowel cleansing solution of Example 1 was evaluated by categorizing “Yes” or “No.” As a result, 70% or more of Test Group 1 and 80% or more of Test Group 2 answered “Yes.”

(60) As a result of the taste of the bowel cleansing solution of Example 1, the patients who answered “Good” or “Fine” were 80% and 87% in Test Groups 1 and 2, respectively, and the patients who answered “Very Bad” were 4% and 1% in Test Groups 1 and 2, respectively.

(61) As a result of evaluation, the bowel cleansing solution of Example 1 was evaluated as being very excellent in both completion rate of taking and medication compliance, being easy to take, and being excellent in both intention to reuse and taste.

Experimental Example 5: Evaluation of Preference

(62) Since the bowel cleansing requires taking a considerable amount of solution required for sufficient bowel preparation, it is important to provide a bowel cleansing solution with higher preference for taking. Preference evaluation was performed for the bowel cleansing solution with different content ratios between ascorbic acid and sodium ascorbate.

(63) The bowel cleansing solution was prepared by dissolving the compositions of Example 1 and Comparative Examples 2 and 5 in water so that a total volume of liquid medicine to be 1 L, and the specific composition is shown in Table 21 below.

(64) TABLE-US-00021 TABLE 21 Ingredients Example Comparative Comparative (g) 1 Example 2 Example 5 PEG3350 160 160 160 Na.sub.2SO.sub.4 18 18 18 NaCl 2.7 2.7 2.7 KCl 1.0 1.0 1.0 Ascorbic acid 40.6 24.48 8.35 Sodium ascorbate 9.4 27.54 45.67 Volume of liquid medicine 1 L

(65) The molar ratio between ascorbic acid and sodium ascorbate contained in the solutions of the Example 1 and Comparative Examples 2 and 5 were 4.86:1, 1:1 and 1:4.86 respectively, and the molar concentration of ascorbate ingredients contained in each solution was about 278 mM. The same amount of additives (flavoring agent and sweetening agent) was contained in the bowel cleansing solutions used for evaluating preference. A total of 96 patients tasted 20 mL of the solutions of Example 1 and Comparative Examples 2 and 5, respectively, and evaluated the preference as 1st (1 point), 2nd (2 points) and 3rd (3 points) (ranking method). And then, preference scores were summed up to perform a t-test verification. As a total preference score becomes lower, preference gets higher.

(66) As a result of the evaluation, the preference scores for the solutions of Example 1 and Comparative Examples 2 and 5 were 174, 204, and 198 points, respectively, in which the preference for the solution of Example 1 was the highest. As a result of t-test verification (reliability of 95%), it was confirmed that the preference for the solution of Example 1 shows a significant difference for the preferences for the solutions of Comparative Examples 2 and 5 (p=0.00554 and p=0.04521). Accordingly, it can be seen that the composition having a high content ratio of ascorbic acid according to the present invention is a composition having a more excellent preference for taking.

(67) The present specification omits the details that those skilled in the art of the present invention can fully recognize and infer, and various modifications can be made more within a range that does not change the technical spirit or essential constitution of the present invention in addition to the specific examples described herein. Thus, the present invention may be implemented in a different manner from those specifically described and exemplified in the present specification, which may be understood by those skilled in the technical field of the present invention.