A composition for modulating gut flora, and a method of preparing and using the same

Abstract

The present application relates to a kind of composition for regulating intestinal flora and its preparation method and application, belong to health care product technical field.The present application provides a kind of composition for regulating intestinal flora, including traditional Chinese medicine extract, prebiotic and microbial viable powder, the traditional Chinese medicine extract includes spilanthes acmella willd extract, liquorice extract and pericarpium citri reticulatae extract.The component of the present application is novel, compatibility is unique, wherein traditional Chinese medicine extract realizes anti-inflammatory repair film, optimizes intestinal microenvironment, solves the problem of poor environment for probiotic colonization;Prebiotic realizes long-acting bacteria, stable bacteria;Microbial viable powder quickly restructures flora structure, three form organic closed loop, improve flora imbalance from root, solve the defects of existing product rebound, shallow conditioning, at the same time, all components of the present application are food-grade drug-food homologous raw materials, mild non-stimulating, no dependence, no side effect, can be adapted to adult, working people, sub-health intestinal disorder and other types of population, more wide adaptation scene.

Description

Technical Field

[0001] This invention relates to the field of health care product technology, and in particular to a composition for regulating intestinal flora, its preparation method and application. Background Technology

[0002] The gut microbiota is the most complex micro-ecosystem in the human body, participating in key physiological processes such as nutrient absorption, energy metabolism, intestinal barrier construction, and immune regulation. In a healthy body, the gut microbiota maintains a dynamic balance of beneficial, neutral, and harmful bacteria. When the body is subjected to prolonged external stimuli such as irregular eating habits, excessive sleep deprivation, high stress, antibiotic intervention, and environmental pollution, gut microbiota imbalance is highly likely to occur. This manifests as a decrease in the abundance of beneficial bacteria and an abnormal proliferation of opportunistic pathogens, leading to symptoms such as constipation, diarrhea, bloating, intestinal sensitivity, and indigestion. Long-term gut microbiota dysbiosis can also induce low-grade intestinal inflammation, impaired intestinal barrier function, immune dysfunction, and metabolic abnormalities, seriously affecting physical and mental health.

[0003] Existing intestinal conditioning products are mainly divided into probiotic preparations, prebiotic products, and a small number of traditional Chinese medicine compound products. They generally suffer from technical defects and compatibility shortcomings: single probiotics have weak resistance to gastric acid and bile, short in vivo colonization cycles, and are prone to loss and rebound, only able to temporarily replenish live bacteria and unable to improve the intestinal endogenous environment; single prebiotics can only provide carbon sources for the intestinal flora, without anti-inflammatory, protective, or strengthening effects, and have limited improvement effects for people with severe intestinal damage and severe flora imbalance; conventional traditional Chinese medicine and probiotic compound products are arbitrarily combined, without fully considering the compatibility between the medicinal properties of traditional Chinese medicine and the activity of strains, which easily leads to problems such as antibacterial, activity attenuation, and poor synergy, making it difficult to achieve the integrated conditioning effect of "nourishing bacteria, protecting the membrane, anti-inflammation, and strengthening the body".

[0004] Based on this, the present invention is proposed. Summary of the Invention

[0005] The purpose of this invention is to provide a composition for regulating intestinal flora, its preparation method and application, so as to solve the problem that the intestinal conditioning products in the prior art have single ingredients and poor effects.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a composition for regulating intestinal flora, comprising the following components in parts by weight: 10-25 parts of Chinese herbal extract, 40-65 parts of prebiotics, and 8-20 parts of live microbial powder; The herbal extracts include purslane extract, licorice extract, and tangerine peel extract; The mass ratio of the purslane extract, licorice extract, and tangerine peel extract is 3~5:2~4:1~3.

[0007] Preferably, the prebiotics include xylooligosaccharides, isomaltooligosaccharides, and stachyose; The mass ratio of xylooligosaccharide, isomaltooligosaccharide and stachyose is 1:1~3:2~4.

[0008] Preferably, the viable count of the microbial live bacteria powder is 1~3×10⁻⁶. 9 CFU / g.

[0009] Preferably, the live microbial powder includes Bifidobacterium longum and Lactobacillus fermentum; The ratio of viable counts of Bifidobacterium longum and Lactobacillus fermentum is 1~2:1~2.

[0010] The present invention provides a method for preparing the composition, comprising the following steps: (1) A traditional Chinese medicine extract was obtained by mixing purslane extract, licorice extract and tangerine peel extract in a certain proportion; (2) Mix xylooligosaccharide, isomaltooligosaccharide and stachyose in proportion and stir for 8-12 minutes to obtain prebiotics; (3) Mix the Chinese herbal extract with prebiotics, stir for 8-12 minutes, add live microbial powder, and homogenize for 4-8 minutes to obtain the composition.

[0011] Preferably, the stirring speed in step (2) is 60~100 rpm.

[0012] Preferably, the stirring temperature in step (3) is 20~24℃.

[0013] Preferably, the rotational speed for homogenization in step (3) is 180~220 rpm.

[0014] This invention provides the application of the composition or the composition prepared by the method described above in the preparation of health products that regulate the balance of intestinal flora and repair the intestinal mucosa.

[0015] This invention provides the application of the composition or the composition prepared by the method described above in the preparation of health products that improve intestinal function and relieve intestinal inflammation.

[0016] The present invention has the following technical effects and advantages: This invention employs a novel combination of purslane, licorice, and dried tangerine peel, all derived from medicinal and edible sources, along with prebiotics such as xylooligosaccharides, isomaltooligosaccharides, and stachyose, and a live microbial powder composed of Bifidobacterium longum and Lactobacillus fermentum. The novel composition and unique formulation address the issue of poor colonization environment for probiotics by utilizing the herbal extracts for anti-inflammatory and membrane repair. The prebiotics provide long-lasting bacterial nourishment and stabilization, while the live microbial powder rapidly reconstructs the gut microbiota structure. These three components form an organic closed loop, fundamentally improving gut microbiota imbalance and overcoming the shortcomings of existing products that are prone to rebound and only provide superficial treatment. Furthermore, all components of this invention are food-grade medicinal and edible raw materials, gentle, non-irritating, non-addictive, and without side effects, making it suitable for a wider range of people, including adults, office workers, and those with sub-healthy gut disorders. Detailed Implementation

[0017] This invention provides a composition for regulating intestinal flora, comprising the following components in parts by weight: 10-25 parts of Chinese herbal extract, 40-65 parts of prebiotics, and 8-20 parts of live microbial powder; The preferred mass fraction of the herbal extract is 15-20 parts, more preferably 17 parts; The prebiotic is preferably 50 to 55 parts by weight, and more preferably 53 parts by weight. The preferred mass fraction of the live microbial powder is 12 to 16 parts, more preferably 14 parts; The herbal extracts include purslane extract, licorice extract, and tangerine peel extract; The mass ratio of the purslane extract, licorice extract, and tangerine peel extract is 3~5:2~4:1~3, preferably 4:3:2.

[0018] In this invention, the prebiotics include xylooligosaccharides, isomaltooligosaccharides, and stachyose; The mass ratio of xylooligosaccharide, isomaltooligosaccharide and stachyose is 1:1~3:2~4, preferably 1:2:3.

[0019] In this invention, the viable count of the microbial live bacteria powder is 1~3×10⁻⁶. 9 CFU / g, preferably 2×10 9 CFU / g.

[0020] In this invention, the live microbial powder includes Bifidobacterium longum and Lactobacillus fermentum; The ratio of viable counts of Bifidobacterium longum and Lactobacillus fermentum is 1~2:1~2, preferably 1:1.

[0021] The present invention provides a method for preparing the composition, comprising the following steps: (1) A traditional Chinese medicine extract was obtained by mixing purslane extract, licorice extract and tangerine peel extract in a certain proportion; (2) Mix xylooligosaccharide, isomaltooligosaccharide and stachyose in proportion and stir for 8-12 minutes to obtain prebiotics; The stirring time is preferably 10 minutes; (3) Mix the Chinese herbal extract with prebiotics, stir for 8-12 minutes, add live microbial powder, and homogenize for 4-8 minutes to obtain the composition; The stirring time is preferably 10 minutes; the homogenization time is preferably 6 minutes.

[0022] In this invention, the stirring speed in step (2) is 60~100 rpm, preferably 80 rpm.

[0023] In this invention, the stirring temperature in step (3) is 20~24℃, preferably 22℃.

[0024] In this invention, the rotational speed for homogenization in step (3) is 180~220 rpm, preferably 200 rpm.

[0025] This invention provides the application of the composition or the composition prepared by the method described above in the preparation of health products that regulate the balance of intestinal flora and repair the intestinal mucosa.

[0026] This invention provides the application of the composition or the composition prepared by the method described above in the preparation of health products that improve intestinal function and relieve intestinal inflammation.

[0027] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0028] The method for preparing purslane extract in this embodiment is as follows: The purslane was washed, dried, and pulverized through a 60-mesh sieve to obtain purslane powder. The purslane powder was mixed with water at a mass-to-volume ratio of 1g:20mL and extracted at 60℃ for 60min (shaking once every 15min) to obtain an extract. The extract was centrifuged at 5000rpm for 15min, and the supernatant was collected and dried to obtain the purslane extract.

[0029] The preparation method of licorice extract is as follows: Licorice was washed, dried, and pulverized through a 60-mesh sieve to obtain licorice powder. The licorice powder was mixed with 70% methanol at a mass-to-volume ratio of 1g:10mL, and extracted three times by ultrasound (300W power, 50℃ temperature) for 1.5h each time. The extracts were combined, filtered, concentrated under reduced pressure, and dried to obtain licorice extract.

[0030] The preparation method of tangerine peel extract is as follows: Select dried, mold-free tangerine peel, pulverize it and pass it through a 30-mesh sieve to obtain tangerine peel powder. Mix the tangerine peel powder with 60% ethanol at a mass-to-volume ratio of 1g:12mL, and extract twice by ultrasound (power 200W, temperature 55℃), 40min each time. Combine the extracts, filter, centrifuge at 4000rpm for 15min, collect the supernatant, concentrate under reduced pressure, and dry to obtain tangerine peel extract.

[0031] Bifidobacterium longum was Bifidobacterium longum BB536 (purchased from Wuhan Gray Algae Biotechnology Co., Ltd., shelf number: HZB360327), and Lactobacillus fermentum was Lactobacillus fermentum (purchased from Wuhan Gray Algae Biotechnology Co., Ltd., shelf number: HZB225108).

[0032] The preparation method of the live microbial powder is as follows: *Bifidobacterium longum* BB536 and *Lactobacillus fermentum* are inoculated into their respective culture media for activation and culture, followed by scale-up culture to obtain bacterial solutions. These solutions are then freeze-dried to obtain live bacterial counts of 2 × 10⁻⁶. 9 The bacterial powder, at a CFU / g ratio, was prepared by mixing Bifidobacterium longum BB536 bacterial powder and Lactobacillus fermentum bacterial powder at a live count ratio of 1:1, resulting in a total live count of 2 × 10⁻⁶. 9 CFU / g of live microbial powder.

[0033] Example 1

[0034] A composition for regulating gut microbiota includes 17g of traditional Chinese medicine extract, 53g of prebiotics and 14g of live microbial powder; The preparation method is as follows: (1) A traditional Chinese medicine extract was obtained by mixing purslane extract, licorice extract and tangerine peel extract in a mass ratio of 4:3:2; (2) Mix xylooligosaccharide, isomaltooligosaccharide and stachyose in a mass ratio of 1:2:3 and stir at 80 rpm for 10 min to obtain prebiotics; (3) Mix 17g of Chinese herbal extract with 53g of prebiotics, stir at 22°C for 10min, add 14g of live microbial powder, and homogenize at 200rpm for 6min to obtain the composition.

[0035] Example 2

[0036] A composition for regulating gut microbiota includes 12g of traditional Chinese medicine extract, 63g of prebiotics and 9g of live microbial powder; The preparation method is as follows: (1) A traditional Chinese medicine extract was obtained by mixing purslane extract, licorice extract and tangerine peel extract in a mass ratio of 5:2:1; (2) Mix xylooligosaccharide, isomaltooligosaccharide and stachyose in a mass ratio of 1:3:2 and stir at 100 rpm for 8 min to obtain prebiotics; (3) Mix 12g of Chinese herbal extract with 63g of prebiotics, stir at 20°C for 10min, add 9g of live microbial powder, and homogenize at 180rpm for 8min to obtain the composition.

[0037] Example 3

[0038] A composition for regulating gut microbiota includes 22g of traditional Chinese medicine extract, 43g of prebiotics and 19g of live microbial powder; The preparation method is as follows: (1) A traditional Chinese medicine extract was obtained by mixing purslane extract, licorice extract and tangerine peel extract in a mass ratio of 3:4:3; (2) Mix xylooligosaccharide, isomaltooligosaccharide and stachyose in a mass ratio of 1:1:4 and stir at 60 rpm for 12 min to obtain prebiotics; (3) Mix 22g of Chinese herbal extract with 43g of prebiotics, stir at 22°C for 10min, add 19g of live microbial powder, and homogenize at 220rpm for 5min to obtain the composition.

[0039] Comparative Example 1

[0040] Compared with Example 1, this method excludes the traditional Chinese medicine extract and retains only 53g of prebiotics and 14g of live microbial powder. The preparation method is as follows: (1) Mix xylooligosaccharide, isomaltooligosaccharide and stachyose in a mass ratio of 1:2:3 and stir at 80 rpm for 10 min to obtain prebiotics; (2) 53g of prebiotics and 14g of live microbial powder were homogenized at 200rpm for 6min to obtain a composition.

[0041] Comparative Example 2

[0042] Compared with Example 1, this method excludes live microbial powder and retains only 17g of traditional Chinese medicine extract and 53g of prebiotics. The preparation method is as follows: (1) A traditional Chinese medicine extract was obtained by mixing purslane extract, licorice extract and tangerine peel extract in a mass ratio of 4:3:2; (2) Mix xylooligosaccharide, isomaltooligosaccharide and stachyose in a mass ratio of 1:2:3 and stir at 80 rpm for 10 min to obtain prebiotics; (3) Mix 17g of Chinese herbal extract with 53g of prebiotics and stir at 22°C for 10 minutes to obtain the composition.

[0043] Comparative Example 3

[0044] Compared with Example 1, the composition of the Chinese herbal extract and prebiotics is different. The Chinese herbal extract is a mixture of Astragalus membranaceus extract and Dioscorea opposita extract in a mass ratio of 1:1, and the prebiotics are a mixture of inulin and fructooligosaccharides in a mass ratio of 1:1. The preparation method is the same as that in Example 1.

[0045] Experimental Example

[0046] 1. Laboratory animals and grouping treatment

[0047] SPF-grade male C57BL / 6 mice, aged 6-8 weeks and weighing 20±2g, were purchased from Spiford (Beijing) Biotechnology Co., Ltd. The mice were placed in an animal room with an ambient temperature of 23℃, relative humidity of 55%, and a 12-hour light / dark cycle, with free access to food and water.

[0048] Methods for establishing a mouse model of gut microbiota imbalance: Mice were administered an antibiotic solution (a mixture of lincomycin hydrochloride, cefazolin sodium, and ampicillin sodium prepared with physiological saline at pH 7.4, with the concentration of all three antibiotics being 100 mg / mL) twice daily, 0.2 mL each time, for 3 consecutive days to establish a mouse model of gut microbiota imbalance.

[0049] The experiment was divided into a blank control group, a model group, and treatment groups 1-4. The blank control group consisted of 10 healthy mice, while each of the model and treatment groups 1-4 consisted of 10 mice with gut microbiota imbalance. Mice in the blank control and model groups were administered physiological saline by gavage twice daily, 0.2 mL each time. Mice in treatment groups 1-4 were administered the combined solution by gavage twice daily, 0.2 mL each time. The combined solution in treatment group 1 was a mixture of physiological saline at pH 7.4 and the composition of Example 1, with a concentration of 100 mg / mL; the combined solution in treatment group 2 was a mixture of physiological saline at pH 7.4 and the composition of Comparative Example 1, with a concentration of 100 mg / mL; the combined solution in treatment group 3 was a mixture of physiological saline at pH 7.4 and the composition of Comparative Example 2, with a concentration of 100 mg / mL; and the combined solution in treatment group 4 was a mixture of physiological saline at pH 7.4 and the composition of Comparative Example 3, with a concentration of 100 mg / mL. Mice were fed normally and administered the sample via gavage for 5 consecutive days. After 5 days, 1g of feces from each group was collected and 9mL of sterile physiological saline was added under aseptic conditions. The mixture was vortexed until homogenized and filtered through four layers of sterile gauze to obtain an intestinal bacterial solution with a concentration of 0.1g / mL. 1mL of the 0.1g / mL intestinal bacterial solution was diluted with 9mL of sterile physiological saline to obtain an intestinal bacterial solution with a concentration of 0.01g / mL, which was then set aside. 1mL of the 0.01g / mL intestinal bacterial solution was inoculated onto the culture media of Lactobacillus, Bifidobacterium, Escherichia coli, and Enterococcus, with three replicates. Lactobacillus was cultured on LBS agar, and Bifidobacterium on BS agar in an anaerobic incubator for 24h; Escherichia coli was cultured on EMB agar, and Enterococcus faecalis agar in a light incubator for 48h. After the culture was completed, the colony count was calculated, and the results were expressed in logarithmic form, with the unit being Log(CFU / mL). The mean (x) was calculated, and the final colony count was expressed as x±s, where s is the standard deviation. The colony count results of each bacteria in different treatment groups are shown in Table 1.

[0050] Table 1. Colony count results of each bacteria in different treatment groups

[0051] Table 1 shows that the colony counts of Escherichia coli, Enterococcus, Lactobacillus, and Bifidobacterium in the feces of the model group mice were significantly different from those in the blank control group, indicating that the intestinal flora balance of the model group mice was disrupted, and the intestinal flora imbalance model mouse was successfully constructed. By comparing the colony counts of Escherichia coli, Enterococcus, Lactobacillus, and Bifidobacterium in the feces of treatment groups 1-4 with those in the model group and the blank control group, it was found that the colony counts of Escherichia coli, Enterococcus, Lactobacillus, and Bifidobacterium in treatment groups 1-4 were altered to those in the blank control group mice, indicating that the composition solution of treatment groups 1-4 has the effect of regulating the intestinal flora balance. Among them, the regulatory effect of treatment group 1 was significantly higher than that of treatment groups 2-4, further indicating that the components of the composition of treatment group 1 have a synergistic effect and can significantly regulate the intestinal flora balance through mutual cooperation.

[0052] As can be seen from the above embodiments, the present invention provides a composition for regulating intestinal flora, its preparation method, and its application. The present invention uses a novel combination of purslane, licorice, and tangerine peel (medicinal and edible homologous ingredients), combined with prebiotics such as xylooligosaccharides, isomaltooligosaccharides, and stachyose, and a live microbial powder composed of Bifidobacterium longum and Lactobacillus fermentum. The composition is novel and uniquely formulated. The herbal extracts achieve anti-inflammatory and membrane-repairing effects, optimizing the intestinal microenvironment and solving the problem of poor colonization environment for probiotics; the prebiotics provide long-lasting bacterial nourishment and stabilization; and the live microbial powder rapidly reconstructs the flora structure. These three components form an organic closed loop, fundamentally improving flora imbalance and addressing the shortcomings of existing products that are prone to rebound and only provide superficial conditioning. Furthermore, all components of the present invention are food-grade medicinal and edible raw materials, gentle, non-irritating, non-addictive, and without side effects, making it suitable for various populations, including adults, office workers, and those with sub-healthy intestinal disorders, thus broadening its applicability.

[0053] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A composition for regulating intestinal flora, characterized in that, The components include the following parts by mass: 10-25 parts of Chinese herbal extract, 40-65 parts of prebiotics, and 8-20 parts of live microbial powder; The herbal extracts include purslane extract, licorice extract, and tangerine peel extract; The mass ratio of the purslane extract, licorice extract, and tangerine peel extract is 3~5:2~4:1~3.

2. The composition according to claim 1, characterized in that, The prebiotics include xylooligosaccharides, isomaltooligosaccharides, and stachyose; The mass ratio of xylooligosaccharide, isomaltooligosaccharide and stachyose is 1:1~3:2~4.

3. The composition according to claim 1, characterized in that, The viable count of the microbial live bacteria powder is 1~3×10⁻⁶. 9 CFU / g.

4. The composition according to claim 3, characterized in that, The live microbial powder includes Bifidobacterium longum and Lactobacillus fermentum; The ratio of viable counts of Bifidobacterium longum and Lactobacillus fermentum is 1~2:1~2.

5. A method for preparing the composition according to any one of claims 1 to 4, characterized in that, Includes the following steps: (1) A traditional Chinese medicine extract was obtained by mixing purslane extract, licorice extract and tangerine peel extract in a certain proportion; (2) Mix xylooligosaccharide, isomaltooligosaccharide and stachyose in proportion and stir for 8-12 minutes to obtain prebiotics; (3) Mix the Chinese herbal extract with prebiotics, stir for 8-12 minutes, add live microbial powder, and homogenize for 4-8 minutes to obtain the composition.

6. The preparation method according to claim 5, characterized in that, The stirring speed in step (2) is 60~100 rpm.

7. The preparation method according to claim 5, characterized in that, The stirring temperature in step (3) is 20~24℃.

8. The preparation method according to claim 5, characterized in that, The rotational speed for homogenization in step (3) is 180~220 rpm.

9. The use of the composition according to any one of claims 1 to 4 or the composition prepared by the preparation method according to any one of claims 5 to 8 in the preparation of health care products that regulate the balance of intestinal flora and repair intestinal mucosa.

10. The use of the composition according to any one of claims 1 to 4 or the composition prepared by the preparation method according to any one of claims 5 to 8 in the preparation of health care products that improve intestinal function and relieve intestinal inflammation.

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