A probiotic and traditional chinese medicine extract composition for promoting intestinal lubrication and defecation

Abstract

The present application provides a kind of composition, by specific content proportion of probiotics, traditional Chinese medicine extract and acceptable adjuvant composition is formed.Therein, probiotics includes lactobacillus, lactobacterium, bifidobacterium;Traditional Chinese medicine extract includes astragalus extract, radix codonopsis extract.The advantages of the present application are: the composition has synergistic effect, can moisten intestines, defecate, for preventing or auxiliary treatment functional constipation, especially suitable for senile qi deficiency type constipation, and side effect is small, does not produce dependence.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 probiotics and traditional Chinese medicine extracts, which helps to lubricate the intestines and promote bowel movements, and is used to prevent or assist in the treatment of functional constipation, especially suitable for functional constipation in the elderly caused by qi deficiency. This invention belongs to the technical field of microorganisms and traditional Chinese medicine extracts. Background Technology

[0002] Functional constipation is a common gastrointestinal disorder, mainly characterized by difficulty in defecation, reduced frequency of bowel movements, or a feeling of incomplete evacuation. Changes in diet, increased stress, and old age with reduced physical activity can all contribute to constipation. Constipation has become a health problem plaguing modern people and affects their quality of life. In cases of long-term constipation, the prolonged retention of feces in the intestines leads to increased production and absorption of harmful substances, damaging the intestinal mucosa and increasing the metabolic burden on the liver, thus harming overall health.

[0003] The human gut is home to approximately 1014 species of microorganisms, collectively known as the gut microbiota. These microorganisms are interdependent and mutually restrictive, and this balance plays a crucial role in maintaining host physiological functions and resisting infection and the risk of autoimmune diseases. Functional constipation is often closely related to gut microbiota imbalance (alterations in composition), abnormal intestinal motility, and abnormal secretion of enteric neurotransmitters.

[0004] Currently, common interventions for functional constipation include lifestyle modifications, pelvic floor interventions, and the use of fiber supplements and mild laxatives. If these are ineffective, it is considered refractory constipation and requires more aggressive drug treatment, including the use of osmotic laxatives, stimulant laxatives, intestinal secretagogues, 5-HT4 receptor agonists, and bile acid transport inhibitors. However, these medications also have adverse reactions such as diarrhea and abdominal pain, as well as side effects such as easy recurrence and drug dependence.

[0005] Probiotics are beneficial microorganisms that can directly alter the structure of the gut microbiota when ingested in appropriate amounts. Probiotics produce short-chain fatty acids through metabolism, which alters intestinal pH, enhances colonic peristalsis, and improves the intestinal mucosal barrier function, thereby protecting the gut. Clinical practice has confirmed that probiotics are effective in treating constipation and are safe with no side effects. The constipation-relieving effects of probiotics are strain-specific. Lactobacillus is a Gram-positive, non-spore-forming bacillus widely distributed in fermented animal and plant products. Lactobacillus casei is a Gram-positive bacterium that can utilize fermentable carbohydrates to produce lactic acid and is widely found in nature, especially in dairy products and fermented foods. Bifidobacterium is a Gram-positive, strictly anaerobic bacterium widely present in the digestive tracts of humans and animals.

[0006] Traditional Chinese medicine is also a common method for treating constipation. Herbs that lubricate the intestines and promote bowel movements include senna leaves, cassia seeds, hemp seeds, rhubarb, and aloe vera. However, research on using qi-tonifying herbs alone to treat constipation is very limited. Astragalus extract, an extract from the root of the legume Astragalus membranaceus, has the effects of enhancing immunity, anti-fatigue, liver protection, and inhibiting osteoclasts. Codonopsis extract, extracted from the dried root of Codonopsis pilosula, mainly consists of crude Codonopsis polysaccharides, and has the effects of tonifying qi and blood, benefiting the lungs and relieving cough, and enhancing immunity.

[0007] In our exploratory experiments, we found that the effect of using probiotics or traditional Chinese medicine extracts alone on relieving constipation was limited. However, by combining these two types of substances in different proportions, we found that the composition could effectively increase the propulsion rate of charcoal powder in the small intestine of rats, that is, promote small intestinal peristalsis. Based on this, the present invention provides a multi-component composition with synergistic effects, which is more effective than using any one component alone, for the prevention or treatment of constipation. Summary of the Invention

[0008] In view of the shortcomings of current health products for preventing and treating constipation, the present invention provides a safe and effective composition.

[0009] To achieve the above objectives, the present invention adopts the following technical solution:

[0010] A composition comprising:

[0011] a) probiotics, b) traditional Chinese medicine extracts, c) acceptable excipients or carriers or mixtures thereof; wherein the probiotics are selected from one or more of Lactobacillus, Lactobacillus, and Bifidobacterium, and the traditional Chinese medicine extracts are selected from one or two of Astragalus membranaceus extract and Codonopsis pilosula extract.

[0012] In this invention, the lactobacillus is selected from one or more of Lactobacillus delbrueckii bulgaricus, Lactobacillus acidophilus, Lactobacillus curvatureii, Lactobacillus delbrueckii subsp. lactis, Lactobacillus gasseri, Lactobacillus helveticus, Lactobacillus johnsonii, and Lactobacillus maltii subsp. maltii; the casei is selected from one or more of Lactobacillus paracasei, Lactobacillus rhamnosus, and Lactobacillus casei; and the bifidobacteria are selected from one or more of Bifidobacterium animalis subsp. animalis, Bifidobacterium animalis subsp. lactis, Bifidobacterium adolescentis, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium longum subsp. longum, and Bifidobacterium longum subsp. infantis.

[0013] In this invention, the Chinese herbal extract is obtained by solvent extraction, filtration, purification, concentration and drying of the effective parts of the plant.

[0014] In this invention, the main components of Astragalus extract include Astragalus polysaccharides, Astragalus saponins, Astragalus isoflavones, etc.

[0015] In this invention, the main components of Codonopsis pilosula extract include Codonopsis pilosula saponins, Codonopsis pilosula polysaccharides, Codonopsis pilosula alkaloids, etc.

[0016] In this invention, the mass ratio of probiotics to traditional Chinese medicine extract is 1-8:1-8, preferably 1-3:1-3, and more preferably 1:1.

[0017] In this invention, the probiotic is Lactobacillus delbrueckii bulgaricus, and the traditional Chinese medicine extract is Codonopsis pilosula extract. The ratio of Lactobacillus delbrueckii bulgaricus to Codonopsis pilosula extract by mass is 1:1.

[0018] Alternatively, the probiotic is Bifidobacterium animalis subsp. animalis, and the Chinese medicine extract is Astragalus membranaceus extract. By mass ratio, the ratio of Bifidobacterium animalis subsp. animalis to Astragalus membranaceus extract is 1:1.

[0019] Alternatively, the probiotic is Lactobacillus acidophilus, and the Chinese medicine extract is Astragalus extract, with the mass ratio of Lactobacillus acidophilus to Astragalus extract being 1:1.

[0020] Alternatively, the probiotics may be Lactobacillus acidophilus and Lactobacillus paracasei, and the traditional Chinese medicine extract may be Codonopsis pilosula extract, with the mass ratio of probiotics to traditional Chinese medicine extract being 2:1; preferably, the mass ratio of Lactobacillus acidophilus, Lactobacillus paracasei, and Codonopsis pilosula extract is 1:1:1.

[0021] Alternatively, the probiotics may be Lactobacillus acidophilus, Lactobacillus paracasei, or Bifidobacterium animalis subsp. lactis, and the herbal extracts may be Astragalus membranaceus extract or Codonopsis pilosula extract, with the mass ratio of probiotics to herbal extracts being 3:2; preferably, the mass ratio of Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium animalis subsp. lactis, Astragalus membranaceus extract, and Codonopsis pilosula extract is 1:1:1:1:1.

[0022] In this invention, the composition contains 50-400 parts of probiotics and 50-400 parts of traditional Chinese medicine extract; preferably, the composition contains 100-300 parts of probiotics and 100-300 parts of traditional Chinese medicine extract.

[0023] In this invention, the probiotic is Lactobacillus delbrueckii bulgaricus, and the traditional Chinese medicine extract is Codonopsis pilosula extract, wherein the probiotic is 50 parts and the traditional Chinese medicine extract is 50 parts.

[0024] Alternatively, the probiotics are Lactobacillus delbrueckii bulgaricus strain, and the Chinese herbal extract is Codonopsis pilosula extract, with 300 parts of probiotics and 300 parts of Chinese herbal extract.

[0025] Alternatively, the probiotics are Bifidobacterium animalis subspecies, and the Chinese medicine extract is Astragalus membranaceus extract, with 50 parts of probiotics and 50 parts of Chinese medicine extract.

[0026] Alternatively, the probiotics are Bifidobacterium animalis subspecies, and the Chinese medicine extract is Astragalus membranaceus extract, with 300 parts of probiotics and 300 parts of Chinese medicine extract.

[0027] Alternatively, the probiotics may be Lactobacillus acidophilus, and the herbal extract may be Astragalus membranaceus extract, with 100 parts probiotics and 100 parts herbal extract.

[0028] Alternatively, the probiotics may be Lactobacillus acidophilus or Lactobacillus paracasei, and the herbal extract may be Codonopsis pilosula extract, wherein the probiotics comprise 200 parts and the herbal extract comprises 100 parts; preferably, the probiotics comprise 100 parts, the Lactobacillus paracasei comprises 100 parts, and the Codonopsis pilosula extract comprises 100 parts.

[0029] Alternatively, the probiotics may be Lactobacillus acidophilus, Lactobacillus paracasei, or Bifidobacterium animalis subsp. lactis, and the herbal extracts may be Astragalus membranaceus extract or Codonopsis pilosula extract, wherein the probiotics comprise 300 parts and the herbal extracts comprise 200 parts; preferably, the probiotics comprise 100 parts, Lactobacillus paracasei comprises 100 parts, Bifidobacterium animalis subsp. lactis comprises 100 parts, Astragalus membranaceus extract comprises 100 parts, and Codonopsis pilosula extract comprises 100 parts.

[0030] In this invention, a portion can be a microgram, a milligram, a gram, a microliter, a milliliter, a deciliter, etc.

[0031] In this invention, the total number of live probiotics is 1×10⁻⁶. 7 CFU / g ~ 1×10 12 CFU / g; the total live bacteria count of probiotics is preferably 1×10⁻⁶. 8 CFU / g ~ 1×10 11 CFU / g; specifically, the total viable count of Lactobacillus is 1×10⁻⁶. 8 CFU / g ~ 1×10 11 CFU / g, preferably 1×10 9 ~1×10 10 CFU / g; Total viable count of Lactobacillus was 1×10⁻⁶. 8 CFU / g ~ 1×10 11 CFU / g, preferably 1×10 9 ~1×10 10 CFU / g; the total viable count of Bifidobacteria was 1×10⁻⁶. 8 CFU / g ~ 1×10 11 CFU / g, preferably 1×10 9 ~1×10 10 CFU / g.

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

[0033] In this invention, the cryoprotectant for the bacterial powder includes one or more of inulin, maltodextrin, and fructooligosaccharides.

[0034] In this invention, the dosage forms of the composition include, but are not limited to, solid beverages (powders, granules, microcapsules), tablets (ordinary tablets, bilayer tablets, multilayer tablets, chewable tablets, lozenges, compressed candies), lyophilized powders, oral liquids, injections, pills, syrups, semi-solid preparations (gels, gel candies, soft candies), capsules (hard capsules, soft capsules, crystals), candies, liquid preparations, and other dosage forms.

[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] In this invention, the composition is used in the preparation of products for the prevention and treatment of functional constipation.

[0038] In this invention, the composition is used in the preparation of a product for preventing and treating constipation caused by qi deficiency in the elderly.

[0039] The beneficial effects of this invention are as follows: This invention mixes the selected probiotics and traditional Chinese medicine extracts in a certain form and proportion, and according to a certain processing technology, formulates a composition product with the function of moisturizing and relieving constipation. The combined supplementation of each component produces an unexpected synergistic effect, which can promote the intestinal peristalsis of constipated rats, shorten defecation time, increase defecation volume, significantly improve constipation symptoms, help moisturize the intestines and relieve constipation, and achieve the purpose of preventing and assisting in the treatment of constipation, especially suitable for constipation of elderly people with qi deficiency. Detailed Implementation

[0040] 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.

[0041] 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 +E B -E A *E BIn 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 (The pharmacological index of the model group), Q is the ratio of the two: when Q is less than 0.85, the two drugs are considered to have an antagonistic effect; when Q is less than 1.15 and greater than 0.85, it is considered to have an additive effect; when Q is greater than or equal to 1.15, it is considered to have a synergistic effect.

[0042] Example 1: Effects of the composition of the present invention on diphenoxylate-induced constipation in rats

[0043] I. Methods

[0044] 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.

[0045] 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 viable bacterial count in the samples was 1 × 10⁻⁶. 10 CFU / g, the blank control group and the model control group were given the same amount of physiological saline by gavage for 15 consecutive days.

[0046] Indicator Testing:

[0047] (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.

[0048] (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.

[0049] Small intestine charcoal propulsion rate (%) = Charcoal propulsion length (cm) / Total small intestine length (cm) × 100%

[0050] II. Results

[0051] 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 in 24 hours (P<0.01), indicating that the constipation model was successfully established. Compared with the model control group, there were no significant changes in the low-dose *Lactobacillus delbrueckii* bulgaricus group, the low-dose *Bifidobacterium animalis* subspecies group, and the single-drug group of traditional Chinese medicine extract. The 24-hour fecal particle count and small intestinal carbon propulsion rate of rats in the high-dose *Lactobacillus delbrueckii* bulgaricus group, the high-dose *Bifidobacterium animalis* subspecies group, the low (high)-dose *Lactobacillus delbrueckii* bulgaricus + *Codonopsis pilosula* extract group, and the low (high)-dose *Bifidobacterium animalis* subspecies + *Astragalus membranaceus* extract group were significantly increased. Furthermore, the effect of the low-dose *Lactobacillus delbrueckii* bulgaricus + *Codonopsis pilosula* extract group was similar to that of the high-dose *Lactobacillus delbrueckii* bulgaricus group, while the effect of the low-dose *Bifidobacterium animalis* subspecies + *Astragalus membranaceus* extract group was better than that of the high-dose *Bifidobacterium animalis* subspecies group. This indicates that the combination of probiotics and traditional Chinese medicine extracts significantly improves small intestinal peristalsis in rats, and the combined effect is better than that of single-drug therapy.

[0052] Meanwhile, the Q values ​​of the low-dose *Lactobacillus delbrueckii* bulgaricus + Codonopsis pilosula extract group and the corresponding low-dose *Lactobacillus delbrueckii* bulgaricus and low-dose Codonopsis pilosula extract groups in increasing 24-hour fecal particle count and small intestinal carbon propulsion rate were 1.56 and 1.57, respectively, both greater than 1.15. Similarly, the Q values ​​of the high-dose *Lactobacillus delbrueckii* bulgaricus + Codonopsis pilosula extract group, the low-dose *Bifidobacterium animalis* subsp. *animal* + Astragalus membranaceus extract group, and the high-dose *Bifidobacterium animalis* subsp. *animal* + Astragalus membranaceus extract group and the corresponding single-drug groups were all greater than 1.15. This indicates that the combined groups have an unexpected synergistic effect compared to the single-drug groups in counteracting diphenoxylate-induced intestinal inhibition, promoting small intestinal peristalsis, increasing fecal particle count, and improving constipation symptoms, and therefore can be used for bowel lubrication and laxative purposes.

[0053] 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)

[0054]

[0055]

[0056] 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.

[0057] Example 2: Effects of the composition of the present invention on loperamide-induced constipation in rats

[0058] I. Methods

[0059] 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.

[0060] 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 viable bacterial count in the samples was 1 × 10⁻⁶. 9 CFU / g, the blank control group and the model control group were given the same amount of physiological saline by gavage for 1 month.

[0061] 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.

[0062] II. Results

[0063] As shown in Table 2, compared with the blank control group, the time to first black stool and serum VIP in the model control group rats were significantly increased (P<0.01), the number of fecal particles in 24h was significantly decreased (P<0.01), and the rats were observed to have reduced food intake, poor mental state, reduced activity and frequency of defecation, and hard feces, indicating that the constipation rat model was successfully established. Compared with the model control group, there were no significant changes in the Lactobacillus acidophilus group, as well as the single-drug and two-drug groups of the traditional Chinese medicine extract. However, the time to first black stool and serum VIP were significantly reduced in the Lactobacillus acidophilus + Lactobacillus paracasei group, Lactobacillus acidophilus + Lactobacillus paracasei + Bifidobacterium lactis subsp. animalis group, Lactobacillus acidophilus + Astragalus membranaceus extract group, Lactobacillus acidophilus + Lactobacillus paracasei + Codonopsis pilosula extract group, and Lactobacillus acidophilus + Lactobacillus paracasei + Bifidobacterium lactis subsp. animalis + Astragalus membranaceus extract + Codonopsis pilosula extract group. These results indicate that the different ratios and types of the compositions of this invention have the effects of significantly improving intestinal propulsion function, shortening defecation time, and increasing stool volume.

[0064] Meanwhile, the Q values ​​of the effects of the Lactobacillus acidophilus + Lactobacillus paracasei + Bifidobacterium animalis subsp. lactis group on reducing the time to first black stool in rats, increasing the number of fecal particles at 24 hours, and reducing serum VIP were 0.97, 0.86, and 1.11, respectively. Similarly, the Q values ​​of the effects of the Astragalus extract + Codonopsis pilosula extract group were 1.01, 0.92, and 1.04, respectively, all less than 1.15. This indicates that the effects between the components of the probiotic composition or the traditional Chinese medicine extract composition are simply the sum of pharmacological effects. The Q values ​​for the effects of Lactobacillus acidophilus + Astragalus extract group on reducing the time to first black stool in rats, increasing the number of fecal particles at 24 hours, and reducing serum VIP were 1.62, 1.49, and 1.63, respectively. Similarly, the Q values ​​of Lactobacillus acidophilus + Lactobacillus paracasei + Codonopsis pilosula extract group and Lactobacillus acidophilus + Lactobacillus paracasei + Bifidobacterium animalis subsp. lactis + Astragalus extract + Codonopsis pilosula extract group were all >1.15, indicating that the components of the probiotic and traditional Chinese medicine extract combination have a synergistic effect in promoting intestinal peristalsis, increasing the number of fecal particles, and improving constipation.

[0065] 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)

[0066]

[0067]

[0068] 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) probiotics, b) traditional Chinese medicine extracts, c) acceptable excipients or carriers or mixtures thereof; wherein the probiotics are selected from one or more of Lactobacillus, Lactobacillus, and Bifidobacterium, and the traditional Chinese medicine extracts are selected from one or two of Astragalus membranaceus extract and Codonopsis pilosula extract.

2. The composition according to claim 1, characterized in that, The lactobacillus is selected from one or more of Lactobacillus delbrueckii bulgaricus, Lactobacillus acidophilus, Lactobacillus curvatureii, Lactobacillus delbrueckii subsp. lactis, Lactobacillus gasseri, Lactobacillus helveticus, Lactobacillus johnsonii, and Lactobacillus maremi subsp. maremi; the casei is selected from one or more of Lactobacillus paracasei, Lactobacillus rhamnosus, and Lactobacillus casei; and the bifidobacteria is selected from one or more of Bifidobacterium animalis subsp. animalis, Bifidobacterium animalis subsp. lactis, Bifidobacterium adolescentis, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium longum subsp. longum, and Bifidobacterium longum subsp. infantis.

3. The composition according to claim 2, characterized in that, The mass ratio of the probiotics to the traditional Chinese medicine extract is 1-8:1-8, preferably 1-3:1-3, and more preferably 1:

1.

4. The composition according to claim 3, characterized in that, The probiotic is *Lactobacillus delbrueckii* bulgaricus, the herbal extract is *Codonopsis pilosula* extract, and the mass ratio of the probiotic to the herbal extract is 1:1; or the probiotic is *Bifidobacterium animalis* subsp. *animal*, the herbal extract is *Astragalus membranaceus* extract, and the mass ratio of the probiotic to the herbal extract is 1:

1. Alternatively, the probiotic is Lactobacillus acidophilus, the traditional Chinese medicine extract is Astragalus membranaceus extract, and the mass ratio of the probiotic to the traditional Chinese medicine extract is 1:1; Alternatively, the probiotics may be Lactobacillus acidophilus or Lactobacillus paracasei, and the traditional Chinese medicine extract may be Codonopsis pilosula extract, with the mass ratio of the probiotics to the traditional Chinese medicine extract being 2:1; preferably, the mass ratio of Lactobacillus acidophilus, Lactobacillus paracasei, and Codonopsis pilosula extract is 1:1:

1. Alternatively, the probiotics may be Lactobacillus acidophilus, Lactobacillus paracasei, or Bifidobacterium animalis subsp. lactis, and the herbal extracts may be Astragalus membranaceus extract or Codonopsis pilosula extract, with a mass ratio of probiotics to herbal extracts of 3:2; preferably, the mass ratio of Lactobacillus acidophilus, Lactobacillus paracasei, Bifidobacterium animalis subsp. lactis, Astragalus membranaceus extract, and Codonopsis pilosula extract is 1:1:1:1:

1.

5. The composition according to claim 2, characterized in that, The composition contains 50-400 parts of probiotics and 50-400 parts of traditional Chinese medicine extract; preferably, the composition contains 100-300 parts of probiotics and 100-300 parts of traditional Chinese medicine extract.

6. The composition according to claim 5, characterized in that, The probiotic is Lactobacillus delbrueckii bulgaricus, and the traditional Chinese medicine extract is Codonopsis pilosula extract, wherein the probiotic is 50 parts and the traditional Chinese medicine extract is 50 parts. Alternatively, the probiotic is Lactobacillus delbrueckii bulgaricus, and the traditional Chinese medicine extract is Codonopsis pilosula extract, wherein the probiotic is 300 parts and the traditional Chinese medicine extract is 300 parts; Alternatively, the probiotic is Bifidobacterium animalis subsp. animalis, and the traditional Chinese medicine extract is Astragalus membranaceus extract, wherein the probiotic is 50 parts and the traditional Chinese medicine extract is 50 parts. Alternatively, the probiotic is Bifidobacterium animalis subsp. animalis, and the traditional Chinese medicine extract is Astragalus membranaceus extract, wherein the probiotic is 300 parts and the traditional Chinese medicine extract is 300 parts. Alternatively, the probiotic may be Lactobacillus acidophilus, and the herbal extract may be Astragalus membranaceus extract, wherein the probiotic comprises 100 parts and the herbal extract comprises 100 parts; Alternatively, the probiotics may be Lactobacillus acidophilus or Lactobacillus paracasei, and the herbal extract may be Codonopsis pilosula extract, wherein the probiotics are 200 parts and the herbal extract is 100 parts; preferably, the Lactobacillus acidophilus is 100 parts, the Lactobacillus paracasei is 100 parts, and the Codonopsis pilosula extract is 100 parts. Alternatively, the probiotics may be Lactobacillus acidophilus, Lactobacillus paracasei, or Bifidobacterium animalis subsp. lactis, and the herbal extracts may be Astragalus membranaceus extract or Codonopsis pilosula extract, wherein the probiotics comprise 300 parts and the herbal extracts comprise 200 parts; preferably, the Lactobacillus acidophilus comprises 100 parts, the Lactobacillus paracasei comprises 100 parts, the Bifidobacterium animalis subsp. lactis comprises 100 parts, the Astragalus membranaceus extract comprises 100 parts, and the Codonopsis pilosula extract comprises 100 parts.

7. The composition according to claim 3, characterized in that, The total number of live bacteria in the probiotics is 1×10⁻⁶. 7 CFU / g ~ 1×10 12 CFU / g, preferably 1×10 8 CFU / g ~ 1×10 11 CFU / g.

8. The composition according to claim 7, characterized in that, The total number of viable lactobacilli is 1×10⁻⁶. 8 CFU / g ~ 1×10 11 CFU / g, preferably 1×10 9 ~1×10 10 CFU / g; the total viable count of the *Lactobacillus* is 1 × 10⁻⁶. 8 CFU / g ~ 1×10 11 CFU / g, preferably 1×10 9 ~1×10 10 CFU / g; the total viable count of the Bifidobacterium is 1×10⁻⁶. 8 CFU / g ~ 1×10 11 CFU / g, preferably 1×10 9 ~1×10 10 CFU / g.

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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