A nutritional composition that helps to lubricate the intestines and promote bowel movement

Abstract

The present application provides a kind of nutrition composition which is helpful to lubricate intestine and defecate, which is composed of natto, red rice, taurine, vitamin B1, vitamin B2 and acceptable adjuvant in specific content ratio.The present application has the advantages that: the composition has synergistic effect, can lubricate intestine and defecate, is used for preventing or assisting treatment of functional constipation, and has small side effect and does not produce dependency.In addition, the compound form of the product can significantly improve the compliance of the user population and save the overall use cost.

Description

Technical Field

[0001] This invention relates to a nutritional composition containing natto, red yeast rice, taurine, vitamin B1, and vitamin B2, used to lubricate the intestines, promote bowel movements, and improve constipation symptoms. This invention belongs to the field of health food technology. Background Technology

[0002] Constipation is a common digestive symptom characterized by hard, dry stools, difficulty in defecation, or fewer than three bowel movements per week. From an etiological perspective, constipation can be divided into organic and functional types. The former often requires treatment targeting the underlying cause, including surgical intervention, while the latter has no obvious organic lesions and is mainly caused by intestinal dysfunction. It is also related to factors such as insufficient dietary fiber and fluid intake, poor eating habits, lack of exercise, and even genetic predisposition.

[0003] Most medications for constipation are laxatives. They increase intestinal water content, promote peristalsis, soften stool, or lubricate the intestines to facilitate defecation. Primarily used for functional constipation, they are categorized into bulk-forming, stimulant, lubricating, osmotic, and swelling laxatives, such as senna leaves and rhubarb. While these laxatives can relieve constipation in the short term, long-term use can lead to drug dependence and adverse reactions such as inert colon and melanosis coli. Currently, both the food and pharmaceutical industries are interested in bioactive substances with laxative effects. Compared to pharmaceuticals, natural active substances generally have better efficacy in disease prevention and are less toxic and have fewer side effects, thus gaining popularity among users.

[0004] Natto is made from soybeans or other legumes through a special process. It is rich in protein, unsaturated fatty acids, soy isoflavones, lecithin, and vitamins, and has benefits such as helping to regulate blood lipids and supplement nutrition. Red yeast rice is a traditional Chinese medicine and food with a history of over a thousand years. It is made from various types of rice, including indica, japonica, and glutinous rice, fermented with Monascus purpureus. Taurine is an amino acid derived from sulfur-containing amino acids. It is widely distributed in various tissues and organs of the body, mainly existing in a free state in interstitial fluid and intracellular fluid. It not only participates in regulating cell volume but also provides a basis for bile salt formation and plays an important role in regulating intracellular free calcium concentration. Vitamin B1 is a water-soluble vitamin, part of the vitamin B complex, and is crucial for energy metabolism and maintaining nervous system function. Vitamin B2 is a coenzyme component of flavin enzymes and plays a role in transferring hydrogen ions in the biological oxidative respiratory chain. Clinically, it is mainly used to prevent and treat angular cheilitis, glossitis, scrotal dermatitis, and seborrheic dermatitis caused by vitamin B2 deficiency.

[0005] In our exploratory experiments, we combined the above-mentioned substances in various forms and proportions. The results showed that a certain ratio of natto, red yeast rice, vitamin B1, and vitamin B2 used together effectively increased the propulsion rate of charcoal powder in the small intestine of rats, i.e., promoted small intestinal peristalsis. Based on this, the present invention, through optimization, provides a multi-component composition with synergistic effects that can improve intestinal propulsion function, shorten defecation time, increase stool volume, and thus improve constipation symptoms. Summary of the Invention

[0006] In view of the shortcomings of current products for the prevention or treatment of constipation, the present invention provides a safe and effective composition.

[0007] To achieve the above objectives, the present invention adopts the following technical solution:

[0008] A composition comprising:

[0009] a) Natto; b) Red yeast rice; c) Vitamin B1; d) Vitamin B2; e) Acceptable excipients or carriers or mixtures thereof.

[0010] In this invention, natto is a product made by fermenting at least one of soybeans, black beans, chickpeas, kidney beans, red beans, mung beans, and lentils with Bacillus natto; red yeast rice is a product made by fermenting at least one of indica rice, japonica rice, and glutinous rice with Monascus purpureus; vitamin B1 is selected from one or more of thiamine hydrochloride and thiamine nitrate; and vitamin B2 is selected from one or more of riboflavin and riboflavin 5'-phosphate sodium.

[0011] In this invention, the ratio of natto: red yeast rice: vitamin B1: vitamin B2 in the composition, based on content, ranges from 2 to 100: 50 to 1500: 0.05 to 4: 0.05 to 2.

[0012] In this invention, the ratio of natto: red yeast rice: vitamin B1: vitamin B2 in the composition, based on content, ranges from 10 to 40: 200 to 1000: 0.25 to 1.5: 0.25 to 1.

[0013] In this invention, as a preferred embodiment, the amount of natto is 2 to 100 parts, the amount of red yeast rice is 50 to 1500 parts, the amount of vitamin B1 is 0.05 to 4 parts, and the amount of vitamin B2 is 0.05 to 2 parts.

[0014] In this invention, as a preferred embodiment, the amount of natto is 10-40 parts, the amount of red yeast rice is 200-1000 parts, the amount of vitamin B1 is 0.25-1.5 parts, and the amount of vitamin B2 is 0.25-1 part.

[0015] In this invention, a portion can be a microgram, a milligram, a gram, a microliter, a milliliter, a deciliter, etc.

[0016] In this invention, the active ingredients of natto include nattokinase, natto isoflavones, and vitamin K2.

[0017] In this invention, the active ingredients of red yeast rice include lovastatin and monacolin K.

[0018] In this invention, the composition also includes taurine.

[0019] In this invention, taurine is selected from one or more of taurine precursors, taurine metabolites, and their acceptable salts or esters.

[0020] In this invention, the ratio of natto: red yeast rice: taurine: vitamin B1: vitamin B2 in the composition, based on content, ranges from 2 to 100: 50 to 1500: 1 to 30: 0.05 to 4: 0.05 to 2.

[0021] In this invention, the ratio of natto: red yeast rice: taurine: vitamin B1: vitamin B2 in the composition, based on content, ranges from 10 to 40: 200 to 1000: 5 to 20: 0.25 to 1.5: 0.25 to 1.

[0022] In this invention, as a preferred embodiment, the amount of natto is 2 to 100 parts, the amount of red yeast rice is 50 to 1500 parts, the amount of taurine is 1 to 30 parts, the amount of vitamin B1 is 0.05 to 4 parts, and the amount of vitamin B2 is 0.05 to 2 parts.

[0023] In this invention, as a preferred embodiment, the amount of natto is 10-40 parts, the amount of red yeast rice is 200-1000 parts, the amount of taurine is 5-20 parts, the amount of vitamin B1 is 0.25-1.5 parts, and the amount of vitamin B2 is 0.25-1 part.

[0024] In this invention, the ratio of natto: red yeast rice: vitamin B1: vitamin B2, based on content, is 10:200:0.25:0.25;

[0025] Alternatively, the ratio of natto: red yeast rice: taurine: vitamin B1: vitamin B2 could be 10:200:5:0.25:0.25.

[0026] Alternatively, the ratio of natto: red yeast rice: taurine: vitamin B1: vitamin B2 could be 2:50:1:0.05:0.05.

[0027] Alternatively, the ratio of natto: red yeast rice: taurine: vitamin B1: vitamin B2 could be 40:1000:20:1.5:1.

[0028] In this invention, natto is 10 parts, red yeast rice is 200 parts, vitamin B1 is 0.25 parts, and vitamin B2 is 0.25 parts;

[0029] Alternatively, the ingredients could be 10 parts natto, 200 parts red yeast rice, 5 parts taurine, 0.25 parts vitamin B1, and 0.25 parts vitamin B2.

[0030] Alternatively, the ingredients are 2 parts natto, 50 parts red yeast rice, 1 part taurine, 0.05 parts vitamin B1, and 0.05 parts vitamin B2.

[0031] Alternatively, the ingredients could be 40 parts natto, 1000 parts red yeast rice, 20 parts taurine, 1.5 parts vitamin B1, and 1 part vitamin B2.

[0032] In this invention, acceptable excipients or carriers or mixtures thereof include one or more of sugars or functional sweeteners, fillers, wetting agents, binders and lubricants.

[0033] In this invention, acceptable excipients or carriers or mixtures thereof include one or more of isomaltitol and magnesium stearate.

[0034] In this invention, the dosage forms of the composition include, but are not limited to, lyophilized powder, oral liquid, injection, ordinary tablet, bilayer tablet, multilayer tablet, granules, capsules, pills, compressed candy, solid beverage, syrup, liquid preparation, powder, etc.

[0035] In this invention, the composition is used in the preparation of a product for preventing constipation.

[0036] In this invention, the composition is used in the preparation of a product for the adjunctive treatment of constipation.

[0037] The beneficial effects of the present invention are: the present invention provides a composition for preventing and treating constipation. The combination of the components produces an unexpected synergistic effect, which can lubricate the intestines and promote bowel movements, improve small intestinal peristalsis, shorten defecation time, increase defecation volume, significantly improve constipation symptoms, and avoid the tolerance caused by long-term consumption of a single component. Detailed Implementation

[0038] The present invention will be further described below with reference to specific embodiments, but this is not intended to limit the present invention. Any equivalent substitutions made in the art in accordance with the content of the present invention shall fall within the protection scope of the present invention.

[0039] To verify the scientific validity of the pharmaceutical composition provided by this invention, and to demonstrate that the combination of multiple components in the pharmaceutical composition is reasonable and that their synergistic effect is not simply the sum of pharmacological effects, the Jin Zhengjun Q-value method is introduced for analysis. The Jin Zhengjun Q-value method, also known as the probability addition method, calculates the pharmacological effects of two drugs used in combination and two drugs used alone within the dose-response curve region using the following formula: Q = E A+B / (E A +EB -E A *E B In the formula, the numerator represents the "measured combined effect," and the denominator represents the "expected combined effect." (To satisfy the analysis of the pharmacological relationship between components and compositions, their pharmacological effects are transformed into effects that can intuitively reflect the strength of pharmacological effects. The calculation formula is: E...) i =1-P i / P 模型组 P i For the pharmacological indicators of each component, P 模型组 (For the pharmacological indicators of the model group), Q is the ratio of the two: when Q is less than 0.85, the combined use of the two drugs is considered antagonistic; when Q is less than 1.15 but greater than 0.85, it is considered additive; and when Q is greater than or equal to 1.15, it is considered synergistic. Based on the calculation formula for the combined use of two drugs, the pharmacological effects of the combined use of three drugs and the pharmacological effects of the three drugs used alone are calculated using the following formula: Q = E A+B+C / (E A +E B +E C -E A *E B -E A *E C -E B *E C -E A *E B *E C ).

[0040] Example 1: Effects of the composition of the present invention on diphenoxylate-induced constipation in rats

[0041] I. Methods

[0042] Experimental animals and grouping: SD rats, half male and half female, weighing 200±20g, were purchased from Guangdong Provincial Medical Laboratory Animal Center. They were housed in an environment with room temperature of 18–28℃ and relative humidity of 40%–70%, with free access to food and water. After one week of acclimatization feeding with standard diet, they were randomly divided into groups as shown in Table 1 below, with 10 rats in each group.

[0043] Model establishment and drug administration: Except for the blank control group, rats in each group were administered compound diphenoxylate suspension by gavage at a dose of 10 mg / kg body weight for 7 consecutive days to replicate the constipation model. After successful model establishment, except for the blank control group and the model control group, rats in the other groups were administered the corresponding test samples by gavage at the doses specified in Table 1. The blank control group and the model control group were administered the same amount of physiological saline by gavage for 10 consecutive days.

[0044] Indicator Testing:

[0045] (1) Number of fecal particles in 24 hours: After the last gavage, all rats were fasted for 24 hours but allowed to drink water. The number of fecal particles in the last 24 hours was recorded.

[0046] (2) Ink propulsion rate (%): Each rat was given 1.0 mL of charcoal solution by gavage. After 30 min, the rat was sacrificed and its abdomen was dissected. The pyloric segment to the ileocecal valve segment of the digestive tract was completely removed. The total length of the small intestine and the length of charcoal propulsion were measured. The charcoal propulsion rate of the small intestine was calculated according to the following formula.

[0047] Small intestine charcoal propulsion rate (%) = Charcoal propulsion length (cm) / Total small intestine length (cm) × 100%

[0048] II. Results

[0049] Table 1. Effects of the composition of the present invention on the number of fecal particles and the propulsion rate of charcoal in the small intestine of rats at 24 h. n = 9 to 10)

[0050]

[0051] Note: Compared with the blank control group, aa P<0.01; compared with the model control group, b P<0.05, bb P<0.01.

[0052] As shown in Table 1, compared with the blank control group, the number of fecal particles and the small intestinal charcoal propulsion rate of rats in the model control group were significantly reduced at 24 h (P < 0.01), indicating that the constipation model was successfully established. Compared with the model control group, there were no significant changes in the natto group, red yeast rice group, VB1+VB2 group, and taurine group; the number of fecal particles and the small intestinal charcoal propulsion rate of rats in the natto + red yeast rice + VB1 + VB2 group and the natto + red yeast rice + taurine + VB1 + VB2 group were significantly increased at 24 h, and the natto + red yeast rice + taurine + VB1 + VB2 group was more effective than the natto + red yeast rice + VB1 + VB2 group. This indicates that the combination of natto, red yeast rice, vitamin B1, and vitamin B2, or the combination of natto, red yeast rice, taurine, vitamin B1, and vitamin B2, has a significant effect on improving small intestinal peristalsis in rats.

[0053] Meanwhile, the Q-value for the 24-hour stool particle count in the natto + red yeast rice + VB1 + VB2 group compared to the corresponding natto alone group, red yeast rice group, and VB1 + VB2 group was 1.45, and the Q-value for the 24-hour stool particle count in the natto + red yeast rice + taurine + VB1 + VB2 group compared to the corresponding natto + red yeast rice + VB1 + VB2 group and taurine group was 1.33. Both are greater than 1.15, indicating that the quadruple or pentad combination group has a surprisingly synergistic effect in promoting small intestinal peristalsis and improving constipation symptoms compared to the single or two-drug groups, and therefore can be used for bowel lubrication and defecation.

[0054] Example 2: Effects of the composition of the present invention on loperamide-induced constipation in rats

[0055] I. Methods

[0056] Experimental animals and grouping: SD rats, half male and half female, weighing 200±20g, were purchased from Guangdong Provincial Medical Laboratory Animal Center. They were housed in an environment with room temperature of 18–28℃ and relative humidity of 40%–70%, with free access to food and water. After one week of acclimatization feeding with standard diet, they were randomly divided into groups as shown in Table 2 below, with 10 rats in each group.

[0057] Model establishment and drug administration: Except for the blank control group, rats in each group were administered loperamide by gavage at a dose of 5 mg / kg body weight for 8 consecutive days to replicate the constipation model. After successful model establishment, except for the blank control group and the model control group, rats in the other groups were administered the corresponding test samples by gavage at the doses specified in Table 2. The blank control group and the model control group were administered the same amount of physiological saline by gavage for 1 consecutive month.

[0058] Indicator detection: (1) Time of first black stool: After the last administration, the rats were gavaged with ink and the time of first black stool was observed in each group. (2) Number of fecal particles in 24 hours: The number of fecal particles in the last 24 hours was recorded. (3) Vasoactive intestinal peptide (VIP): Blood was collected from the abdominal aorta after anesthesia with 10% chloral hydrate intraperitoneal injection, allowed to stand at room temperature for 30 minutes, and centrifuged at 4℃ and 3000r / min for 10 minutes to separate the serum. Serum VIP was measured according to the ELISA kit method. VIP can inhibit intestinal relaxation and inhibit the tension of the colon and rectum, directly affecting the occurrence of constipation.

[0059] II. Results

[0060] As shown in Table 2, compared with the blank control group, the time to first black stool and serum VIP were significantly increased in the model control group (P < 0.01), and the number of fecal particles at 24 h was significantly decreased (P < 0.01). Furthermore, the rats in the model control group showed reduced food intake, poorer mental state, decreased activity and frequency of defecation, and harder feces, indicating that the constipation rat model was successfully established. Compared with the model control group, the time to first black stool and serum VIP were significantly decreased in the high-dose natto + red yeast rice group, the low-dose natto + red yeast rice + taurine + VB1 + VB2 group, and the high-dose natto + red yeast rice + taurine + VB1 + VB2 group, and the number of fecal particles at 24 h was significantly increased. Moreover, the differences in various indicators between the low-dose natto + red yeast rice + taurine + VB1 + VB2 group and the high-dose natto + red yeast rice group were small, indicating that different doses of the composition of this invention significantly improve intestinal propulsion, shorten defecation time, and increase fecal volume.

[0061] Meanwhile, the Q values ​​of the low-dose natto + red yeast rice + taurine + VB1 + VB2 group in reducing the time to first black stool, serum VIP, and increasing the number of fecal particles at 24 hours in rats were 1.53, 1.65, and 1.52, respectively, while the Q values ​​of the high-dose natto + red yeast rice + taurine + VB1 + VB2 group were 1.51, 1.50, and 1.51, respectively. All Q values ​​were >1.15, indicating that the components of the composition have a synergistic effect in promoting intestinal peristalsis and improving constipation.

[0062] Table 2. Effects of the composition on the time to first black stool, number of fecal particles at 24 hours, and serum VIP in rats. n = 9 to 10)

[0063]

[0064] Note: Compared with the blank control group, aa P<0.01; compared with the model control group, b P<0.05, bb P<0.01.

Claims

1. A composition comprising: a) Natto, b) Red yeast rice, c) Vitamin B1, d) Vitamin B2, e) An acceptable excipient or carrier or a mixture thereof; wherein the natto is a product fermented from at least one of soybeans, black beans, chickpeas, kidney beans, red beans, mung beans, and lentils by Bacillus natto; wherein the red yeast rice is a product fermented from at least one of indica rice, japonica rice, and glutinous rice by Monascus purpureus; wherein the vitamin B1 is selected from one or more of thiamine hydrochloride and thiamine nitrate; wherein the vitamin B2 is selected from one or more of riboflavin and riboflavin 5'-phosphate sodium.

2. The composition according to claim 1, characterized in that, Based on content, the ratio of natto: red yeast rice: vitamin B1: vitamin B2 in the composition ranges from 2 to 100: 50 to 1500: 0.05 to 4: 0.05 to 2, and preferably from 10 to 40: 200 to 1000: 0.25 to 1.5: 0.25 to 1.

3. The composition according to claim 2, characterized in that, The amount of natto is 2 to 100 parts, preferably 10 to 40 parts; the amount of red yeast rice is 50 to 1500 parts, preferably 200 to 1000 parts; the amount of vitamin B1 is 0.05 to 4 parts, preferably 0.25 to 1.5 parts; and the amount of vitamin B2 is 0.05 to 2 parts, preferably 0.25 to 1 part.

4. The composition according to claim 1, characterized in that, The composition also includes taurine.

5. The composition according to claim 4, characterized in that, The taurine is selected from one or more of taurine precursors, taurine metabolites, and their acceptable salts or esters.

6. The composition according to claim 5, characterized in that, Based on content, the ratio of natto: red yeast rice: taurine: vitamin B1: vitamin B2 in the composition ranges from 2 to 100: 50 to 1500: 1 to 30: 0.05 to 4: 0.05 to 2, and preferably from 10 to 40: 200 to 1000: 5 to 20: 0.25 to 1.5: 0.25 to 1.

7. The composition according to claim 6, characterized in that, The natto is 2-100 parts, preferably 10-40 parts; the red yeast rice is 50-1500 parts, preferably 200-1000 parts; the taurine is 1-30 parts, preferably 5-20 parts; the vitamin B1 is 0.05-4 parts, preferably 0.25-1.5 parts; and the vitamin B2 is 0.05-2 parts, preferably 0.25-1 part.

8. The composition according to claim 1, characterized in that, The acceptable excipients or carriers or mixtures thereof include one or more of isomaltitol and magnesium stearate.

9. Use of the composition according to any one of claims 1 to 8 in the preparation of a product for preventing constipation.

10. Use of the composition according to any one of claims 1 to 8 in the preparation of a product for the adjunctive treatment of constipation.

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