Intestinal tract preparation composition and preparation method thereof

Abstract

The invention discloses an intestinal preparation composition and a preparation method thereof, and belongs to the technical field of biological medicines. The intestinal tract preparation composition provided by the invention comprises the following components in parts by mass: 5-6 parts of cooked carbon water powder; 5.1 parts of powdered vegetable oil; 6-8 parts of protein; 0.5 to 1.5 parts of fructo-oligosaccharide; 0.9 to 1.1 parts of electrolyte salt; 0.08 to 0.15 part of compound yeast powder; the compound yeast powder comprises yeast powder containing B vitamins, yeast powder containing zinc and yeast powder containing vitamin D. The intestinal tract preparation composition provided by the invention is a semi-fluid, low-residue and comprehensive-nutrition product, can effectively improve the cleanliness of the intestinal tract, has definite nutritional ingredients, can enhance satiety, meets body requirements, and improves the compliance of patients. The device is suitable for people before enteroscopy, before and after gastrointestinal surgery, before and after perianal disease surgery, after polyp resection and the like. The invention also provides a preparation method of the intestinal preparation composition.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, and in particular to an intestinal preparation composition and its preparation method. Background Technology

[0002] Colorectal cancer is a common malignant tumor of the digestive tract. Its mortality rate ranks second among malignant tumors worldwide. Colonoscopy is the most direct and accurate method for diagnosing and treating colonic diseases, but successful examination depends on proper bowel preparation. Inadequate bowel preparation often leads to missed colonic lesions, increased operational difficulty, prolonged operation time, and shortened examination intervals. Studies have shown that the main reason for diagnosing colon cancer shortly after polypectomy is missed lesions. The main reason for missed lesions is inadequate bowel preparation. It has been reported that the rate of inadequate bowel preparation is as high as 20-30%.

[0003] Therefore, it is important to provide a bowel preparation composition to achieve good bowel preparation. Summary of the Invention

[0004] The present invention aims to at least solve one of the technical problems existing in the prior art. To this end, the present invention proposes an intestinal preparation composition that can effectively improve the pass rate of colonoscopy preparation.

[0005] The present invention also provides a method for preparing the above-mentioned intestinal preparation composition.

[0006] According to an embodiment of a first aspect of the present invention, a bowel preparation composition is provided, comprising, by weight, the following components:

[0007]

[0008] The compound yeast powder includes yeast powder containing B vitamins, yeast powder containing zinc, and yeast powder containing vitamin D.

[0009] The intestinal preparation composition according to embodiments of the present invention has at least the following beneficial effects:

[0010] The intestinal preparation composition provided by this invention uses cooked carbohydrate powder and powdered vegetable oil to provide energy, supplemented by protein and electrolytes, thus providing the necessary nutrients for the body as a whole. Combined with dosage, it can significantly increase satiety and reduce food residue. Compared to conventional low-residue diets (porridge, noodles, eggs, etc., avoiding vegetables, fruits, and meats) and commercially available residue-free liquid diets, the intestinal preparation composition provided by this invention offers better compliance and more comprehensive nutrition.

[0011] In the intestinal preparation composition provided by this invention, fructooligosaccharides act as prebiotics, promoting the growth of beneficial bacteria such as Bifidobacteria and Lactobacillus in the intestine, maintaining the balance of the intestinal microecology, improving intestinal health, and enhancing intestinal function. Compound yeast powder can enhance the absorption and digestion functions of the gastrointestinal tract, promote gastrointestinal mucosal peristalsis, regulate endocrine function, and maintain the homeostasis of the internal environment. The two work synergistically to significantly improve intestinal peristalsis, further reduce food residue, and expel intestinal gas, thus significantly enhancing the intestinal preparation effect.

[0012] The compound yeast powder selected in this invention, in addition to proteins, carbohydrates, and lipids, is also rich in various vitamins, minerals, and enzymes. For example, by immobilizing zinc in the yeast, the toxic side effects and gastrointestinal irritation of chemically derived inorganic and organic zinc are eliminated, allowing zinc to be absorbed and utilized by the body more efficiently and safely. Therefore, the compound yeast powder provided by this invention, besides regulating the intestinal environment, also has significant nutritional supplementation and flavor-modifying effects, and is safe and healthy; it has a significant effect on the balanced nutritional intake of special groups such as post-operative patients and the elderly.

[0013] The intestinal preparation composition provided by this invention is ready to consume after preparation. It is a semi-liquid, low-residue, nutritionally complete product that effectively improves intestinal cleansing, provides clearly defined nutrients, enhances satiety, meets the body's needs, and improves patient compliance. It is suitable for individuals before and after colonoscopy, gastrointestinal surgery, perianal disease surgery, and polyp removal.

[0014] This invention provides a standard pre-operative or pre-colonoscopy bowel preparation meal, a semi-liquid, low-residue, nutritionally complete product that effectively improves bowel cleanliness, provides clearly defined nutritional components, enhances satiety, meets the body's needs, and improves patient compliance and safety. This invention significantly improves bowel preparation outcomes, reduces cecal intubation time, reduces oral PEG dosage, increases the detection rate of colonic polyps and the rate of defoaming of the intestines, and does not increase the occurrence of adverse reactions.

[0015] According to some embodiments of the present invention, the intestinal preparation composition further includes at least one of a carbohydrate supplement, a sweetener, a thickener, and a nutritional fortifier.

[0016] According to some embodiments of the present invention, when the intestinal preparation composition includes the carbohydrate supplement, the carbohydrate supplement is maltodextrin.

[0017] Preferably, the mass ratio between the powdered vegetable oil and the carbohydrate supplement is 5.1:4.5 to 5.5; for example, it can be about 5.1:5.

[0018] According to some embodiments of the present invention, when the intestinal preparation composition includes the sweetener, the sweetener is selected from crystalline fructose.

[0019] Preferably, the mass ratio between the powdered vegetable oil and the sweetener is 5.1:3.5 to 4.5; for example, it can be about 5.1:4.

[0020] According to some embodiments of the present invention, when the intestinal preparation composition includes the thickener, the thickener includes sodium carboxymethyl cellulose. Thus, the thickener, in addition to its thickening effect, also provides sodium ions (electrolytes).

[0021] Preferably, the mass ratio of the powdered vegetable oil to the thickener is 5.1:0.4 to 0.5. For example, it can be approximately 5.1:0.44.

[0022] According to some embodiments of the present invention, when the intestinal preparation composition includes the nutritional fortifier, the nutritional fortifier includes at least one of vitamin A, vitamin C, iron, and calcium.

[0023] Preferably, the mass ratio between the powdered vegetable oil and the nutrient fortifier is 5.1:0.3 to 0.4. For example, it can be about 5.1:0.33 or about 5.1:0.35.

[0024] According to some embodiments of the present invention, the cooked carbohydrate powder includes at least one of rice flour and wheat flour. Rice flour is preferred. Rice is sweet and neutral in nature, and has the effects of replenishing qi, strengthening the spleen and stomach, nourishing essence and strengthening will, harmonizing the five internal organs, clearing blood vessels, improving hearing and vision, relieving irritability, quenching thirst, and stopping diarrhea. It is known as the "king of grains".

[0025] Preferably, the rice flour undergoes an extrusion process to expand the starch granules, thereby improving digestibility and reducing the burden on the gastrointestinal tract. This makes it suitable for individuals with weak digestive function (such as postoperative patients). Furthermore, after reconstitution, the rice flour has a delicate, semi-liquid texture without clumping and possesses a natural rice aroma that enhances palatability.

[0026] According to some embodiments of the present invention, the powdered vegetable oil includes at least one of powdered sunflower seed oil and powdered flaxseed oil.

[0027] Preferably, the powdered vegetable oil is a mixture of powdered sunflower seed oil and powdered flaxseed oil. The mass ratio of the powdered sunflower seed oil to the powdered flaxseed oil is 3.5–4:1. Using this combination of two powdered vegetable oils in a suitable mass ratio results in a higher content of linoleic acid and linolenic acid in the resulting intestinal preparation composition. In addition to providing energy to the body, it also helps maintain vascular and metabolic health.

[0028] According to some embodiments of the present invention, the protein includes at least one of soy protein isolate and whey protein concentrate.

[0029] Preferably, the protein is a mixture of soy protein and whey protein concentrate. The mass ratio of soy protein to whey protein concentrate is 2.5–3:1. The whey protein concentrate contains a high proportion of essential amino acids, at 40.8% and 38.5% of the total amino acids, respectively. Whey protein concentrate is a high-quality animal protein, retaining active ingredients such as lactoferrin and immunoglobulins, containing all nine essential amino acids, with high bioavailability and absorption within 30 minutes; its first limiting amino acids are phenylalanine and tyrosine. Soy protein isolate is a high-quality plant protein, with a texture like soy flour and a refreshing soy aroma. It has high protein nutritional value, is cholesterol-free, and contains a special substance—isoflavones; it is easily absorbed by the body; and it contains a large amount of the first limiting amino acids found in whey protein concentrate. Therefore, the nutritional components of soy protein isolate and whey protein concentrate are complementary; the amino acid ratio after mixing them better meets human needs, significantly improving protein bioavailability and enhancing immune function. Combining the above ratios yields a more comprehensive protein combination that is suitable for the human body and easily absorbed.

[0030] According to some embodiments of the present invention, the electrolyte salt includes sodium salt, potassium salt and phosphate salt.

[0031] According to some embodiments of the present invention, the electrolyte salt includes at least one selected from sodium citrate, potassium citrate, potassium dihydrogen phosphate, sodium dihydrogen phosphate, dipotassium hydrogen phosphate, sodium chloride, and potassium chloride.

[0032] According to some embodiments of the present invention, the electrolyte salt includes sodium citrate, potassium citrate, and potassium dihydrogen phosphate.

[0033] Preferably, the mass ratio of sodium citrate, potassium citrate and dipotassium hydrogen phosphate is 1.2-1.6:1:0.8-1.

[0034] According to some embodiments of the present invention, the mass ratio of the yeast powder containing B vitamins, the yeast powder containing zinc, and the yeast powder containing vitamin D is 4-6:4-6:1.

[0035] According to some embodiments of the present invention, the intestinal preparation composition comprises, by weight, the following components:

[0036] 5-6 parts of cooked carbohydrate powder; the cooked carbohydrate powder includes rice flour.

[0037] 5.1 parts of powdered vegetable oil; the powdered vegetable oil is a mixture of powdered sunflower seed oil and powdered flaxseed oil in a mass ratio of 3.5 to 4:1;

[0038] The protein content is 6-8 parts; the protein is a mixture of soy protein isolate and whey protein concentrate in a mass ratio of 2.5-3:1.

[0039] 0.5–1.5 parts of fructooligosaccharides;

[0040] 0.9 to 1.1 parts of electrolyte salt; the electrolyte salt is a mixture of sodium citrate, potassium citrate and dipotassium hydrogen phosphate in a mass ratio of 1.2 to 1.6:1:0.8 to 1;

[0041] Compound yeast powder 0.08–0.15 parts;

[0042] The compound yeast powder is a mixture of yeast powder containing B vitamins, yeast powder containing zinc, and yeast powder containing vitamin D in a mass ratio of 4-6:4-6:1.

[0043] In summary, the intestinal preparation composition provided by this invention, in addition to its own function, also has other additional functions; the combination of all components and dosages, on the basis of significantly improving the intestinal preparation effect, can also improve palatability, nutritional comprehensiveness, and potential nutritional value.

[0044] According to an embodiment of a second aspect of the present invention, a method for preparing the intestinal preparation composition described in the first aspect of the present invention is provided, the method comprising mixing the components of the intestinal preparation composition.

[0045] Since the preparation method adopts all the technical solutions of the intestinal preparation composition of the above embodiments, it has at least all the beneficial effects brought about by the technical solutions of the above embodiments.

[0046] According to some embodiments of the present invention, the preparation method includes the following steps:

[0047] D1. Mix the compound yeast powder and the electrolyte salt;

[0048] D2. Mix the mixture obtained in step D1 with other components.

[0049] According to some embodiments of the present invention, step D1 further includes mixing and breaking down the electrolyte salt before mixing.

[0050] Preferably, the method of mixing and crushing includes at least one of grinding and pulverizing.

[0051] Preferably, the mixture, after crushing, can pass through a 40-mesh sieve.

[0052] According to some embodiments of the present invention, step D1 further includes mixing the compound yeast powder and the thickener before the mixing. The specific steps are as follows:

[0053] First, the compound yeast powder is mixed. Then, the compound yeast powder and the thickener are mixed using an equal-incremental method. The equal-incremental method means that the thickener is added in multiple stages, with each addition equal to the mass of the compound yeast powder (or the sum of the added thickener and the total mass). For example, if there are 3 parts thickener and 1 part compound yeast powder, the equal-incremental method means: first, add 1 part thickener (equal to the mass of the compound yeast powder) to obtain a 2-part mixture; second, add 2 parts thickener (equal to the mass of the mixture); if there is any remaining thickener that does not meet the mass requirements of the equal-incremental method, it can be combined and added together in the final step.

[0054] Preferably, the mixing method of the compound yeast powder includes shaking. Preferably, the mixing time of the compound yeast powder is 2 to 8 minutes; for example, it can be about 5 minutes.

[0055] Preferably, after the thickener is added, the mixing time for each step of the equal-increment method is 2 to 8 minutes; for example, it can be about 5 minutes.

[0056] According to some embodiments of the present invention, in step D1, the mixing with the electrolyte salt is performed by shaking. Preferably, the mixing time with the electrolyte salt is 2 to 8 minutes; specifically, it can be about 5 minutes.

[0057] According to some embodiments of the present invention, in step D2, the mixing time is 25 to 35 minutes. For example, it can be approximately 30 minutes.

[0058] The above mixing methods and mixing times are only limited to ensure uniform mixing under the experimental scale of this invention. In actual production, an appropriate mixing time can be selected according to the mixing equipment, mixing means, production scale, etc. This invention does not impose strict limitations.

[0059] Unless otherwise specified, the term "about" in this invention actually means that the error is allowed to be within ±2%, for example, about 100 is actually 100 ± 2% × 100.

[0060] Other features and advantages of the invention will be set forth in the description which follows, and will be apparent in part from the description, or may be learned by practicing the invention. Detailed Implementation

[0061] The following will describe the concept and technical effects of the present invention clearly and completely with reference to embodiments, so as to fully understand the purpose, features and effects of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are all within the scope of protection of the present invention.

[0062] In the description of this invention, the terms "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0063] In this specific implementation, the compound yeast powder was purchased from Raman Company, Canada; among which, the yeast powder containing B vitamins was of the following type: Complex-B yeast; the type of yeast powder containing vitamin D is... Vita yeast; the model number for zinc-containing yeast powder is... Zn50yeast. Rice flour pretreated using an extrusion process. Fructooligosaccharides were purchased from Shandong Bailong Chuangyuan, grade 95 powder.

[0064] Example 1

[0065] This example provides a gut preparation composition, the specific raw material composition and formulation are shown in Table 1, and the preparation process is as follows:

[0066] S1. Mix yeast powder containing B vitamins, yeast powder containing zinc, and yeast powder containing B vitamins, shake well for 5 minutes to obtain mixture A.

[0067] Mixture A and sodium carboxymethyl cellulose were mixed in equal increments (mixed twice in total), and shaken for 5 minutes each time to obtain mixture B.

[0068] Sodium citrate, potassium citrate, and dipotassium hydrogen phosphate were pulverized in a pulverizer, and the sieve residue was collected through a 40-mesh sieve to obtain mixture C.

[0069] S2. Mix mixture B, compound nutrient fortifier and mixture C, and shake well for 5 minutes.

[0070] S3. Mix the mixture obtained in step S2 with other preparation materials and mix well for 30 minutes.

[0071] For ease of storage, in actual production, the obtained intestinal preparation composition can be dispensed and sealed for preservation; the dispensing dosage can be adjusted according to actual needs. This invention does not impose strict requirements on whether to encapsulate or on the dispensing dosage.

[0072] Example 2

[0073] This example provides an intestinal preparation composition, which differs from Example 1 in that:

[0074] The raw material composition is slightly different, and the specific composition is shown in Table 1.

[0075] Comparative Example 1

[0076] This example provides an intestinal preparation composition, which differs from Example 1 in that:

[0077] The raw material composition is slightly different, and the specific composition is shown in Table 1.

[0078] Comparative Example 2

[0079] This example provides an intestinal preparation composition, which differs from Example 1 in that:

[0080] The raw material composition is slightly different, and the specific composition is shown in Table 1.

[0081] Comparative Example 3

[0082] This example provides an intestinal preparation composition, which differs from Example 1 in that:

[0083] The raw material composition is slightly different, and the specific composition is shown in Table 1.

[0084] Table 1. Raw material composition (parts by weight) of the intestinal preparation compositions in the examples and comparative examples.

[0085]

[0086]

[0087] Test Example 1

[0088] This study tested the performance of the intestinal preparation compositions obtained in the examples and comparative examples. The specific testing method was as follows: 180 patients undergoing colonoscopy were selected as the research subjects and divided into six groups of 30 patients each; these groups were named Example 1, Example 2, Comparative Example 1, Comparative Example 2, Comparative Example 3, and the control group. Except for the control group, the other groups (experimental groups) consumed the intestinal preparation compositions of Examples 1, 2, 3, and Comparative Example 1 two days before the colonoscopy, respectively. They consumed 6 packets (30 grams each) divided into two doses from breakfast to dinner. The mixture was prepared into a paste with warm water, and patients were allowed free access to water but did not eat any other food. The control group consumed a routine low-residue diet (such as porridge, milk, egg custard, noodles, bread, steamed buns, tofu, etc., but no vegetables, fish, meat, or fruit, three meals a day) two days before the colonoscopy, with the same dry weight of food as the experimental groups. Six groups simultaneously followed the same laxative regimen prescribed by the doctors: Patients began fasting at 7:00 PM the day before the examination, and at 8:00 PM, they began taking 1L of polyethylene glycol 4000 electrolyte powder solution (a laxative), 250mL every 10-15 minutes, to be consumed within one hour. On the day of the colonoscopy, 4-6 hours before the procedure, patients began taking 2L of polyethylene glycol 4000 electrolyte powder solution orally. During this time, they were allowed to move around appropriately and gently massage their abdomen to accelerate excretion, and were required to finish the medication within two hours. The colonoscopy was then performed at the scheduled time.

[0089] Observation indicators and efficacy judgment criteria: The bowel cleanliness, time of first defecation and bowel preparation qualification rate, lesion detection rate, blindness rate and time of endoscopic insertion and withdrawal, adverse reactions, willingness to take the medicine again and defoaming effect were compared among the five groups of patients.

[0090] Bowel cleanliness: The Boston Health Preservation System (BBPS) scoring criteria were used, as shown in Table 2. Scores (average values) were assigned to the right colon (cecum and ascending colon), mid-colon (hepatic flexure, transverse colon, splenic flexure), and left colon (descending colon, sigmoid colon, and rectum). The total score was the average of the scores for all three segments (0–9 points). A score ≥2 for each colon segment indicated adequate bowel preparation; a total score <6 points or a score <2 for any colon segment indicated inadequate bowel preparation; a total BBPS score of 6–9 points indicated satisfactory bowel preparation. The pass rate (the percentage of participants who passed all three segments) was calculated. The first bowel movement was calculated from the first administration of polyethylene glycol 4000 electrolyte powder solution. The lesion detection rate indicates the proportion of participants with detected intestinal polyps or inflammatory lesions. The cecum occlusion rate indicates that the colonoscopy returned to the cecum, meaning the entire large intestine had been examined. In terms of defoaming effect, Grade I: a large number of bubbles, affecting observation; Grade II: moderate bubbles, partially limiting the field of view, requiring rinsing; Grade III: no bubbles or very few bubbles. Grades I and II are defined as unsatisfactory, while Grade III is satisfactory.

[0091] The average scores for each group in each item were calculated, and the statistical results are shown in Tables 3 to 7.

[0092] Table 2. BBPS Scale Scoring Criteria

[0093] Fraction Colon to rectum segmental scoring 0 points There is a large amount of solid residue, which is not visible on the mucous membrane. 1 point There is solid or liquid retention, and the mucous membrane is visible. 2 points There is a brown liquid, movable semi-solid residue, and the entire mucous membrane is visible. 3 points Clean, mucous membrane fully visible

[0094] Table 3. Comparison of intestinal cleanliness and pass rate (BBPS score) among the exemplary, comparative, and control groups.

[0095] Group Right colon Mid-colon Mid-colon BBPS Overall Rating Pass rate (e.g., %) Example 1 2.27±0.50 2.36±0.55 2.49±0.56 7.12±0.78 27(90.0％) Example 2 2.37±0.51 2.65±0.40 2.93±0.35 7.95±0.95 28(93.3％) Comparative Example 1 2.13±0.53 2.08±0.50 2.15±0.48 6.36±0.83 24(80.0％) Comparative Example 2 2.15±0.53 1.86±0.48 2.23±0.57 6.24±0.81 23(76.7％) Comparative Example 3 1.92±0.45 2.11±0.53 2.19±0.46 6.22±0.73 23(76.7％) control group 1.78±0.46 2.10±0.43 2.21±0.66 6.17±0.92 22(73.3％)

[0096] As shown in Table 3, the intestinal cleanliness of Examples 1 and 2 was significantly higher than that of the control group, with statistically significant differences (P<0.05). This indicates that adding fructooligosaccharides and compound yeast powder to the intestinal preparation composition significantly helps with intestinal cleanliness. The BBPS scores of Comparative Examples 1-3 were not significantly higher than those of the control group; this suggests that adding compound yeast powder or fructooligosaccharides to the intestinal preparation composition helps improve intestinal cleanliness. Combining all the results, it is clear that there is a significant synergistic effect between fructooligosaccharides and compound yeast powder in improving intestinal cleanliness. Furthermore, comparing the control group with other examples and comparative examples, it is evident that the other components in the intestinal preparation composition provided by this invention, besides compound yeast powder and fructooligosaccharides, also exhibit certain synergistic effects, significantly positively contributing to improved intestinal cleanliness.

[0097] Table 4 compares the time of first defecation and the condition of the last defecation in the examples and comparative examples.

[0098]

[0099] As shown in Table 4, when comparing the time of the first bowel movement and the condition of the last bowel movement after taking the laxative, the results of Examples 1-2 and Comparative Example 1 were significantly better than those of the control group; the results of Comparative Examples 2-3 were not significantly different from those of the control group. This indicates that adding fructooligosaccharides has the effect of promoting defecation and helping to improve intestinal cleanliness, while not adding or adding a small amount of fructooligosaccharides does not have this effect.

[0100] Table 5. Comparison of lesion detection rate and intubation / outtubation time among the examples, comparative examples, and control groups.

[0101] Group (n) Lesion detection rate (%) Blinding rate (%) Scope time (min) Withdrawal time (min) Example 1 22(73.3％) 100 6.9±0.04 9.5±0.08 Example 2 22(73.3％) 100 6.7±0.07 9.6±0.06 Comparative Example 1 19(63.3％) 100 8.2±0.05 12.2±0.09 Comparative Example 2 18(60.0％) 100 8.7±0.08 12.5±0.13 Comparative Example 3 19(63.3％) 100 8.5±0.07 13.3±0.10 control group 18(60.0％) 100 8.3±0.06 13.6±0.11

[0102] As shown in Table 5, all patients were able to reach the ileocecal junction during colonoscopy, indicating that the entire large intestine was examined. Examples 1-2 showed a higher incidence of intestinal polyps or inflammation compared to the control group. Analysis based on insertion and withdrawal times showed that the control group had longer insertion and withdrawal times, and the differences were statistically significant (P < 0.05). Comparisons 1-3 with the control group showed no significant differences (P > 0.05). Furthermore, comparing the examples and the control groups revealed that the effects of the examples were significantly better than those of the control groups; this indicates that the combination of fructooligosaccharides and compound yeast powder has a significant beneficial effect on improving intestinal preparation.

[0103] Table 6 Comparison of adverse reactions and willingness to repeat treatment among patients in the examples, comparison group, and control group.

[0104]

[0105]

[0106] As shown in Table 6, patients in Examples 1-2 and Comparative Examples 1-3 showed a significantly higher willingness to take the medication again than the control group, and their incidence of adverse reactions was also significantly lower than that of the control group, which was statistically significant (P<0.05). This indicates that, compared with a conventional low-residue diet, patients who consume the bowel preparation composition of the present invention before colonoscopy have higher tolerance for bowel preparation and a higher willingness to take it again, and the incidence of adverse bowel reactions is also lower.

[0107] Table 7. Defoaming effects of the examples, comparative examples, and control group.

[0108] Group (n) Level I (e.g., %) Level II (e.g., %) Level III (e.g., %) Foam removal satisfaction rate Example 1 1(3％) 6(20％) 23(77％) 23(77％) Example 2 2(7％) 4(13％) 24(80％) 24(80％) Comparative Example 1 5(17％) 9(30％) 16(53％) 16(53％) Comparative Example 2 4(13％) 11(37％) 15(50％) 15(50％) Comparative Example 3 4(13％) 9(30％) 17(56％) 17(56％) control group 6(20％) 10(33％) 14(47％) 14(47％)

[0109] The defoaming rate was categorized as follows: Grade I: numerous bubbles affecting observation; Grade II: moderate bubbles partially limiting the field of view, requiring rinsing; Grade III: no bubbles or very few bubbles. Grades I and II were defined as unsatisfactory, while Grade III was satisfactory. The results are shown in Table 7. The intestinal defoaming satisfaction rate in groups 1-2 of Examples was significantly higher than that in comparative examples 1-3 and the control group, with statistically significant differences (P<0.05). However, there was no significant difference in intestinal defoaming satisfaction rate between comparative examples 1-3 and the control group, i.e., P>0.05. This indicates that the combination of fructooligosaccharides and nutrient-rich compound yeast powder promotes gastrointestinal motility and gas expulsion; it has a positive and synergistic effect on improving intestinal preparation.

[0110] Analysis of Test Example 1: Groups 1 and 2 showed significant differences from the control and comparison groups in four aspects: intestinal cleanliness and pass rate, time of first and last defecation, lesion detection rate and time for endoscopic insertion and withdrawal, incidence of adverse reactions and willingness to repeat treatment, and intestinal defoaming effect. This indicates that the intestinal preparation composition provided in Examples 1 and 2 can improve the quality of intestinal preparation, increase the detection rate of colonic polyps, and reduce cecal intubation time. Furthermore, it demonstrates that in improving the intestinal preparation effect, there is a significant synergistic effect among the components of the intestinal preparation composition provided by this invention, particularly the fructooligosaccharides and the compound yeast powder.

[0111] Test Example 2

[0112] In this example, the amount of the laxative polyethylene glycol 4000 electrolyte powder solution was reduced to observe whether the intestinal preparation composition provided by the present invention could still achieve a good intestinal preparation effect.

[0113] The specific testing method was as follows: 100 patients undergoing colonoscopy were selected as the research subjects and divided into two groups of 50 patients each, named Observation Group A and Observation Group B. One day before the colonoscopy, both groups consumed the intestinal preparation composition obtained in Example 1, taking 6 sachets (2 sachets per dose) divided into several doses from breakfast to dinner, with free access to water but no other food. The cathartic regimen for Observation Group A was as follows: patients began fasting at 19:00 the day before the examination, and at 20:00, began taking 1L of polyethylene glycol 4000 electrolyte powder solution, 250mL every 10-15 minutes, to be consumed within 1 hour. On the day of the examination, 4-6 hours before the colonoscopy, patients began taking 2L of polyethylene glycol 4000 electrolyte powder solution orally. During the medication period, they were allowed to move around appropriately and gently massage their abdomen to accelerate excretion, and were required to finish the medication within 2 hours. The laxative regimen implemented in observation group B was that patients would take 2L of polyethylene glycol 4000 electrolyte powder orally 4-6 hours before the colonoscopy on the day of the examination. During the medication period, they could walk around appropriately and gently massage their abdomen to accelerate excretion. The medication was required to be taken within 2 hours. That is, observation group B did not take any laxatives the day before.

[0114] Observational indicators and efficacy judgment criteria: The bowel cleanliness, bowel preparation qualification rate, lesion detection rate, endoscopic insertion and withdrawal time, adverse reaction occurrence, and willingness to repeat treatment were compared between the two groups of patients. Specific indicators and terminology explanations are provided in Test Example 1. Test results are shown in Tables 8-10.

[0115] Table 8. Comparison of intestinal cleanliness and pass rate between observation groups A and B (BBPS score)

[0116] Group Right colon Mid-colon Mid-colon BBPS Overall Rating Pass rate (e.g., %) Observation Group A 2.44±0.56 2.59±0.48 2.71±0.53 7.74±0.82 46(92％) Observation Group B 2.35±0.62 2.51±0.58 2.73±0.48 7.59±0.73 45(90％)

[0117] Table 9. Comparison of lesion detection rate and time of intervention / extraction between observation group A and observation group B.

[0118] Group Lesion detection rate (cases %) Blinding rate (%) Scope time (min) Withdrawal time (min) Observation Group A 13(26％) 100 7.3±0.05 10.1±0.07 Observation Group B 16(32％) 100 7.0±0.07 9.6±0.09

[0119] Table 10 Comparison of adverse reactions and willingness to repeat treatment between observation group A and observation group B

[0120]

[0121] The results in Tables 8-10 show that there was no significant difference in the results between observation group A and observation group B (P>0.05). This indicates that the present invention, combined with 2L of low-dose polyethylene glycol 4000 electrolyte dispersion solution, demonstrates good patient compliance, high satisfaction, and high safety during bowel preparation, making it worthy of widespread clinical application. Clinically, the dosage of the drug laxative polyethylene glycol 4000 electrolyte dispersion solution is generally around 3L, and it needs to be taken 4 to 6 hours before the examination, with the patient finishing it within 2 hours. The large single dose of the drug makes patients more prone to vomiting, nausea, and other adverse reactions due to poor patient tolerance. The present invention, based on the above-mentioned traditional methods, significantly reduces the dosage of the laxative while still achieving good bowel preparation results.

[0122] In summary, the bowel preparation composition provided by this invention can achieve ideal results in preparing for colonoscopy. It not only achieves high bowel cleanliness but also produces few adverse reactions and is well-tolerated by patients. Furthermore, it significantly reduces the dosage of laxatives, further improving patient tolerance and comfort. It is worthy of widespread clinical application.

[0123] The embodiments of the present invention have been described in detail above. However, the present invention is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of the present invention. Furthermore, the embodiments of the present invention and the features thereof can be combined with each other unless otherwise specified.

Claims

1. A gut preparation composition, characterized in that, The intestinal preparation composition comprises, by weight, the following components: The compound yeast powder includes yeast powder containing B vitamins, yeast powder containing zinc, and yeast powder containing vitamin D.

2. The intestinal preparation composition according to claim 1, characterized in that, The intestinal preparation composition further includes at least one of a carbohydrate supplement, a sweetener, a thickener, and a nutritional fortifier.

3. The intestinal preparation composition according to claim 2, characterized in that, When the intestinal preparation composition includes the carbohydrate supplement, the carbohydrate supplement is maltodextrin; Preferably, when the intestinal preparation composition includes the sweetener, the sweetener is selected from crystalline fructose; Preferably, when the intestinal preparation composition includes the thickener, the thickener includes sodium carboxymethyl cellulose; Preferably, when the intestinal preparation composition includes the nutritional fortifier, the nutritional fortifier includes at least one of vitamin A, vitamin C, iron, and calcium.

4. The intestinal preparation composition according to any one of claims 1 to 3, characterized in that, The carbohydrate powder includes at least one of rice flour and wheat flour; Preferably, the powdered vegetable oil includes at least one of powdered sunflower seed oil and powdered flaxseed oil; Preferably, the protein includes at least one of soy protein isolate and whey protein concentrate.

5. The intestinal preparation composition according to any one of claims 1 to 3, characterized in that, The electrolyte salts include sodium salts, potassium salts, and phosphate salts; Preferably, the electrolyte salt includes at least one of sodium citrate, potassium citrate, potassium dihydrogen phosphate, sodium dihydrogen phosphate, dipotassium hydrogen phosphate, sodium chloride, and potassium chloride.

6. The intestinal preparation composition according to any one of claims 1 to 3, characterized in that, The mass ratio of the yeast powder containing B vitamins, the yeast powder containing zinc, and the yeast powder containing vitamin D is 4-6:4-6:

1.

7. The intestinal preparation composition according to claim 1, characterized in that, The intestinal preparation composition comprises, by weight, the following components: The compound yeast powder is a mixture of yeast powder containing B vitamins, yeast powder containing zinc, and yeast powder containing vitamin D in a mass ratio of 4-6:4-6:

1.

8. A method for preparing the intestinal preparation composition according to any one of claims 1 to 7, characterized in that, The preparation method includes mixing the components of the intestinal preparation composition.

9. The preparation method according to claim 8, characterized in that, The preparation method includes the following steps: D1. Mix the compound yeast powder and the electrolyte salt; D2. Mix the mixture obtained in step D1 with other components.

10. The preparation method according to claim 9, characterized in that, Step D1 also includes mixing and breaking down the electrolyte salts before mixing. Preferably, step D1 further includes mixing the compound yeast powder and the thickener before the mixing.

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