Fecal fungi capsule for reducing uric acid as well as preparation method and application of fecal fungi capsule

Abstract

The invention relates to the technical field of coprophilous fungus transplantation, in particular to a coprophilous fungus capsule for reducing uric acid and a preparation method and application thereof. The coprophilous fungi capsule comprises a wall material and a core material, the wall material is an enteric capsule shell, and the core material comprises whole coprophilous fungi and poria cocos enzymatic hydrolysate; the concentration of effective viable bacteria in the whole coprophilous fungus composite capsule is at least 2.5 * 10 < 12 > CFU / g. According to the preparation method, coprophilous fungus transplantation and microbial fermentation are combined, whole coprophilous fungi are added into poria cocos enzymatic hydrolysate to prepare the coprophilous fungus capsules, the poria cocos enzymatic hydrolysate provides carbohydrate prebiotics, meanwhile, the content of poria cocos triterpenes in the poria cocos enzymatic hydrolysate is increased through coprophilous fungus fermentation, the diuretic effect of the coprophilous fungus capsules is enhanced, and the uric acid reducing effect of the coprophilous fungus capsules is assisted. The coprophilous fungus capsule reduces uric acid from multiple aspects of direct uric acid reduction, harmful bacterium growth inhibition, diuresis and inflammation resistance, and provides a new thought for uric acid reduction.

Description

Technical Field

[0001] This invention relates to the field of fecal microbiota transplantation technology, specifically to a fecal microbiota capsule for lowering uric acid, its preparation method, and its application. Background Technology

[0002] Hyperuricemia, a common metabolic disease, has seen a significant increase in incidence worldwide in recent years. It is not only the pathological basis for gout attacks but also closely related to various serious complications such as kidney disease and cardiovascular disease, posing a significant threat to patients' health and quality of life. Traditional treatments for hyperuricemia mainly focus on lowering uric acid levels with medication and lifestyle interventions; however, these methods are not effective in some patients and may have certain side effects. Against this backdrop, fecal microbiota transplantation (FMT), as an emerging treatment method, provides new ideas and directions for the treatment of hyperuricemia. Summary of the Invention

[0003] Addressing a technological gap in existing technologies, this invention is the first to combine fecal microbiota transplantation and microbial fermentation. Whole fecal microbiota are added to a Poria cocos enzymatic hydrolysate to prepare fecal microbiota capsules. While providing prebiotic carbohydrates, the fermentation process by the fecal microbiota increases the content of Poria cocos triterpenes in the hydrolysate, enhancing the diuretic effect of the fecal microbiota capsules and assisting their uric acid-lowering effect. The fecal microbiota capsules of this invention achieve uric acid-lowering effects through multiple mechanisms, including direct uric acid reduction, inhibition of harmful bacteria growth, diuresis, and anti-inflammation. The specific details of this invention are as follows: In a first aspect, the present invention provides a fecal microbiota capsule, the fecal microbiota capsule comprising a wall material and a core material, the wall material being an enteric-coated capsule shell, and the core material comprising whole fecal microbiota and Poria cocos enzymatic hydrolysate; the effective viable bacteria concentration in the whole fecal microbiota composite capsule is at least 2.5*10⁻⁶. 12 CFU / g. The whole fecal microbial sludge includes at least *Lactobacillus fermentatus*, *Lactobacillus johnsonii*, *Lactobacillus paracasei*, *Lactobacillus plantarum*, and *Pseudomonas diffusa*. Preferably, the whole fecal microbial sludge also includes *Bifidobacterium*, *Clostridium truncatum*, and *Faecalibacterium prausnitzii*.

[0004] Furthermore, the concentration of Poria cocos hydrolysate in the fecal microbiota capsule is 5%~20%.

[0005] Further, the Poria cocos enzymatic hydrolysate is obtained by enzymatic hydrolysis of Poria cocos using a polysaccharide hydrolase. Optionally, the polysaccharide hydrolase includes at least one of β-glucanase, cellulase, pectinase, and amylase. Optionally, the polysaccharide hydrolase is β-glucanase.

[0006] Furthermore, the fecal microbiota capsule also includes a lyophilization protectant. Optionally, the lyophilization protectant includes at least one of dimethyl sulfoxide (DMSO), glycerol, proline, trehalose, sucrose, lactose, mannitol, polyvinylpyrrolidone (PVP), polyethylene glycol (PEG), dextran, serum albumin, glycine, and monosodium glutamate.

[0007] Furthermore, the freeze-drying protectant comprises at least 10-15 parts of trehalose, 5-10 parts of skim milk powder, and 2-5 parts of yeast extract.

[0008] Further, the enteric-coated capsule shell is selected from at least one of hydroxypropyl methylcellulose phthalate (HPMCP), hydroxypropyl methylcellulose acetate succinate (HPMCAS), azo polymer, gelatin, hydroxypropyl methylcellulose, and starch. Optionally, the capsule shell material is pharmaceutical grade gelatin (C... 576 H 819 O 142 N 102 S2) n .

[0009] In a second aspect, the present invention provides a method for preparing the aforementioned fecal microbiota capsules, the method comprising at least the following steps: S1. Add polysaccharide hydrolase to the Poria cocos suspension for enzymatic hydrolysis, and obtain Poria cocos hydrolysate after inactivation; S2. Collect feces from healthy individuals, homogenize them under anaerobic conditions, filter them in stages to remove impurities and host cells, centrifuge at 3000-10000g for 10-30 minutes to precipitate microorganisms, discard the supernatant, add a 3.5% trehalose solution, stir evenly, and obtain a high-concentration whole fecal microbial sludge. S3. Take 5%~20% of the Poria cocos enzymatic hydrolysate obtained from S1 and mix it with live bacteria at a concentration of 2.5*10. 12 The steps for preparing core material after mixing whole-culture sludge obtained from S2 with CFU / g; S4. Add the core material obtained in S3 into the enteric capsule shell to obtain fecal microbiota capsules.

[0010] Further, the specific operation of step S1 is as follows: The dried Poria cocos pieces are pulverized using a pulverizer and sieved (80-100 mesh) to obtain uniform Poria cocos powder. The Poria cocos powder is mixed with an acetate-sodium acetate buffer solution with a pH of ~5.0 to prepare a Poria cocos suspension with a concentration of 5%~10%. β-glucanase is added to the Poria cocos suspension and stirred for 2-4 hours at 50-60°C and pH=4.5-5.5. After the reaction is complete, the mixture is boiled at high temperature (above 95°C for 10 minutes) to inactivate the enzyme. After cooling, it is centrifuged at 4°C and 10000g for 20 minutes to remove undissolved residue, obtaining a clear Poria cocos enzymatic hydrolysate. The hydrolysate is filtered through a 0.22μm filter membrane for sterilization to avoid introducing contaminating bacteria. It is stored at 4°C for later use.

[0011] It should be noted that this invention does not specifically limit the preparation of whole fecal microbial sludge. Any steps taken by those skilled in the art to prepare whole fecal microbial sludge using existing technology are protected by this invention. This includes both manual extraction of whole fecal microbial sludge and preparation using fully automated processes.

[0012] Alternatively, the manual extraction of whole-culture fecal microbial sludge can be performed as follows: Homogenization and preliminary separation: In the anaerobic workstation, add 100-200g of fecal sample to 1000-1400mL of physiological saline and mix well. Homogenize under anaerobic conditions using a beater homogenizer for 2-5 minutes to break up fecal particles. Filter through an 80-100 mesh sieve to remove coarse fiber impurities, retaining the homogenate.

[0013] Fine filtration and centrifugal enrichment: A series of filtration stages were performed using stainless steel filters in a nitrogen fume hood. These stages involved passing the sample through 10-mesh, 18-mesh, 35-mesh, and 100-mesh filters sequentially to remove residual impurities and host cells. The sample was then centrifuged at 3000-10000g for 10-30 minutes at 4℃ to precipitate the microorganisms. After discarding the supernatant, a 3.5% (w / w) trehalose solution was added and stirred thoroughly to obtain a high-concentration whole-fecal microbial sludge solution.

[0014] Furthermore, the core material in step S3 also includes 7.5% to 12.5% ​​of a freeze-drying protectant. Preferably, the freeze-drying protectant includes at least 10-15 parts of trehalose, 5-10 parts of skim milk powder, and 2-5 parts of yeast extract.

[0015] In a third aspect, the present invention provides the application of the aforementioned fecal microbiota capsule or the method thereof in any of the following aspects: A1. Applications in the preparation of diuretic products; A2. Applications in the preparation of uric acid-lowering products; A3. Applications in the preparation of anti-inflammatory products; A4. Applications in the preparation of products that regulate gut microbiota.

[0016] Furthermore, the products include at least pharmaceuticals, food, or health products.

[0017] Furthermore, the product achieves a diuretic effect through Poria triterpenes; furthermore, the product regulates the intestinal flora through the fermentation products of Poria hydrolysate and whole fecal bacteria, promoting the growth of beneficial bacteria and inhibiting the growth of harmful bacteria.

[0018] The beneficial effects of the present invention include, but are not limited to: This invention is the first to combine fecal microbiota transplantation and microbial fermentation. Whole fecal microbiota are added to Poria cocos enzymatic hydrolysate to prepare fecal microbiota capsules. While providing prebiotic carbohydrates, the fermentation process by the fecal microbiota increases the content of Poria cocos triterpenes in the hydrolysate, enhancing the diuretic effect of the fecal microbiota capsules and assisting their uric acid-lowering effect. The fecal microbiota capsules of this invention achieve uric acid-lowering effects through direct uric acid reduction, inhibition of harmful bacteria growth, diuresis, and anti-inflammation. Furthermore, since the fecal microbiota in this invention is derived from the human body, it has fewer side effects, providing a new approach to uric acid reduction. Detailed Implementation

[0019] The present invention is described in detail below with reference to the embodiments, but the present invention is not limited to these embodiments. Unless otherwise specified, the raw materials and catalysts in the embodiments of the present invention are all purchased through commercial channels.

[0020] Example 1: Preparation of Poria cocos enzymatic hydrolysate The dried Poria cocos pieces were pulverized using a grinder and sieved (80-100 mesh) to obtain uniform Poria cocos powder. The Poria cocos powder was mixed with an acetate-sodium acetate buffer solution with a pH of ~5.0 to prepare a 5%~10% Poria cocos suspension. β-glucanase was added to the Poria cocos suspension and the mixture was stirred and reacted at 50-60°C and pH=4.5-5.5 for 2-4 hours. After the reaction, the mixture was boiled at high temperature (above 95°C for 10 minutes) to inactivate the enzyme. After cooling, the mixture was centrifuged at 10000g for 20 minutes at 4°C to remove undissolved residue, yielding a clear Poria cocos enzymatic hydrolysate. The hydrolysate was filtered through a 0.22μm filter membrane for sterilization to avoid introducing contaminating bacteria. It was stored at 4°C for later use.

[0021] Example 2: Fecal microbial isolation (1) Donor Healthy donors or autologous transplant donors who meet the screening criteria for fecal microbiota transplantation (FMT) donors. Healthy donors are defined as adolescents and children under 24 years of age who meet the GB18467—2011 criteria and do not have any of the following: clear or suspected bacterial, fungal, or viral infections; history of gastrointestinal polyps; abnormal bowel habits and stool shape; stool volume less than 50 g / time; rough skin, abnormal skin luster, or acute or chronic skin diseases; antibiotic use within the past 3 months; body mass index exceeding the healthy range (overweight or underweight); history of sexual activity within the past 3 months; unhealthy diet; smoking, drinking, or tattoos; insufficient sleep at night; clear or suspected mental health abnormalities; living or working in high-temperature or high-pollution risk environments; or a family history of tumors, metabolic diseases, or mental illnesses.

[0022] (2) Fecal collection The donor's stool sample is collected in a dedicated stool sampling room. A sufficient amount of stool (not less than 100g) should be collected, with characteristics of type III and type IV according to the Bristol stool classification. The sample is placed in a disposable sterile stool sampling container and immediately enters the laboratory preparation procedure, while the stool weight and donor number are recorded.

[0023] (3) Homogenization and preliminary separation In the anaerobic workstation, add 100-200g of fecal sample to 1000-1400mL of physiological saline and mix well. Homogenize under anaerobic conditions using a tapping homogenizer for 2-5 minutes to break up fecal particles. Filter through an 80-100 mesh sieve to remove coarse fiber impurities, retaining the homogenate.

[0024] (4) Fine filtration and centrifugal enrichment The microorganisms were filtered stepwise through stainless steel mesh in a nitrogen fume hood, passing through 10-mesh, 18-mesh, 35-mesh, and 100-mesh filters in sequence to remove residual impurities and host cells. The mixture was then centrifuged at 3000-10000g for 10-30 minutes at 4℃ to precipitate the microorganisms. After discarding the supernatant, a 3.5% trehalose solution was added and stirred thoroughly to obtain a high-concentration whole-fecal microbial sludge solution.

[0025] (5) Identification of fungal sludge Culture medium: Use a synthetic culture medium with uric acid or hypoxanthine / xanthine as the sole nitrogen source.

[0026] Culture conditions: Cultured under strict anaerobic conditions at 37°C with shaking.

[0027] Subculture: Every 48 hours, transfer the culture to fresh culture medium of the same type, repeating this process 3-5 times. Collect fecal bacteria with uric acid-lowering effects.

[0028] DNA and RNA of fecal bacteria that lower uric acid were extracted, and a biotechnology company was commissioned to perform next-generation sequencing on the extracted DNA and RNA to obtain raw sequencing data. After removing the host genes from the raw sequencing data, the data was compared with the NCBI microbial database and identified using 16S microbial identification to obtain the genus or species of fecal bacteria.

[0029] The results showed that fecal bacteria included at least *Lactobacillus fermentatus*, *Lactobacillus johnsonii*, *Lactobacillus paracasei*, *Lactobacillus plantarum*, and *Pseudomonas dignetus*.

[0030] Example 3: Preparation of fecal microbial capsules 1) Preparation of core material Preparation of freeze-drying protectant: Dissolve 10-15 parts by weight of trehalose, 5-10 parts by weight of skim milk powder, and 2-5 parts by weight of yeast extract in 0.9% physiological saline solution to prepare freeze-drying protectant.

[0031] Optimization of the proportion of Poria cocos enzymatic hydrolysate: fix the concentration of fecal microbial sludge (the number of viable bacteria should be maintained at 2.5*10). 12 (CFU / g). Different concentrations of Poria cocos enzymatic hydrolysate were diluted with PBS, mixed, and anaerobically incubated at 37°C for 2-4 hours. Uric acid degradation efficiency was then assessed to determine the optimal mixing ratio. The specific steps are as follows: Sodium urate was added to simulated intestinal fluid (potassium dihydrogen phosphate (KH2PO4): 6.8 g, pancreatic enzyme 10 g, distilled water: added to 1000 mL, pH value: adjusted to 6.8 ± 0.1 with 0.1 mol / L sodium hydroxide (NaOH) solution) to prepare a 2 mmol / L "uric acid substrate solution".

[0032] Set up the following groups in sterile EP tubes or 96-well plates, with 3 replicates per group: Blank control group: 900 μL uric acid substrate solution + 100 μL sterile PBS; Enzymatic hydrolysate group: 900 μL uric acid substrate solution + 100 μL Poria cocos enzymatic hydrolysate; Microbial sludge group: 900 μL uric acid substrate solution + 100 μL functional microbial sludge suspension; Mixed group: 900 μL uric acid substrate solution + 100 μL bacterial sludge-enzyme hydrolysate mixture; Prebiotic group: 900 μL uric acid substrate solution + 100 μL bacterial sludge-oligomanganese mixture, wherein the oligomanganese concentration is 15%; Control group of inactivated bacteria: 900 μL uric acid substrate solution + 100 μL fecal microbial sludge that has been heat-inactivated (121°C, 20 min).

[0033] Test 1 detects uric acid degradation rate Incubate each reaction tube in a 37°C shaker to simulate in vivo temperature. After 24 hours of reaction, remove one reaction tube from each group. Immediately centrifuge the sample tube at 12,000 rpm for 5 minutes to precipitate bacterial cells and insoluble matter. Carefully aspirate the supernatant and determine the uric acid concentration according to the instructions for use of the uric acid assay kit. Calculate the uric acid degradation rate.

[0034] The above operations must be performed inside the anaerobic workstation.

[0035] The results are shown in Table 1.

[0036] Table 1

[0037] Table 1 shows that when the concentration of Poria cocos enzymatic hydrolysate is 5%–20%, the efficiency of uric acid degradation is significantly higher than that of other groups. Furthermore, among prebiotics and Poria cocos enzymatic hydrolysate at the same concentration, Poria cocos enzymatic hydrolysate has a better effect on promoting uric acid reduction by fecal microorganisms. It is speculated that this may be because the fermentation process of the whole fecal microorganism solution in Poria cocos enzymatic hydrolysate produces certain secretions that further promote uric acid degradation.

[0038] Test 2: Detect the bacterial community composition in each group. The changes in the species and abundance of fecal bacteria in the precipitate after the reaction in step 1 were tested using the 16s baseline assay. The results are shown in Table 2.

[0039] Table 2

[0040] As shown in Table 2, the mixture of bacterial sludge and enzymatic hydrolysate promotes the growth of beneficial bacteria and inhibits the growth of harmful bacteria during the process of lowering uric acid, and the effect is significantly better than that of the prebiotic group. It is speculated that some new antibacterial substances are produced during the fermentation of Poria cocos.

[0041] Test 3: Detection of Poria cocos triterpenes in the enzymatic hydrolysate group and the mixed group Previous studies have shown that Poria triterpenes have a good diuretic effect (Zhao Yuhui, Tang Dandan, Chen Danqian, et al. Research progress on chemical constituents and diuretic mechanism of diuretics Poria, Poria peel, Polyporus umbellatus and Alisma plantago-aquatica [J]. Chinese Journal of Pharmacology and Toxicology, 2014(4):594-599. DOI:10.3867 / j.issn.1000-3002.2014.04.24.) The content of triterpenic acids in Poria cocos was determined by pre-column derivatization-gas chromatography-mass spectrometry (Chen Fei, Li Huihua, Chen Chun, et al. Simultaneous determination of soluble sugars and triterpenic acids in Poria cocos by pre-column derivatization-gas chromatography-mass spectrometry [J]. Journal of Xiamen University (Natural Science Edition), 2024, 63(03):532-540.). The detection conditions are as follows: The supernatant after the reaction in Test 1 was extracted with pure methanol.

[0042] Chromatographic column: Reversed-phase C18 column (column length is usually 100-150 mm, inner diameter is 2.1-4.6 mm, and particle size is 1.7-5 μm).

[0043] Mobile phase: Phase A: Deionized water containing 0.1% formic acid; Phase B: Acetonitrile containing 0.1% formic acid.

[0044] Column temperature: 38℃; flow rate: 0.5 mL / min; injection volume: 5 μL.

[0045] Ion source: Electrospray ionization (ESI).

[0046] The gradient elution procedure is shown in Table 3.

[0047] Table 3

[0048] The results are shown in Table 4.

[0049] As shown in Table 4, the content of Poria cocos triterpenes in the mixed group was significantly increased.

[0050] Optimization of freeze-drying protectant ratio Prepare multiple identical mixtures of bacterial sludge and enzymatic hydrolysate (enzymatic hydrolysate ratio 15%, viable cell concentration 2.5*10⁻⁶). 12 CFU / g).

[0051] Different concentration gradients of lyophilization protectants were prepared (2.5%, 5%, 7.5%, 10%, 12.5%, 15% v / v).

[0052] After freezing at -80°C for 24-48 hours, the cryopreservation-thawing cycle is performed by thawing in a 37°C water bath.

[0053] The viable cell survival rate of different groups was calculated using the plate count method (number of viable cells after thawing / number of viable cells before freezing × 100%).

[0054] The results are shown in Table 5.

[0055] Table 5

[0056] As shown in Table 5, when the concentration of the freeze-drying protectant is between 7.5% and 12.5%, the survival rate of live bacteria is relatively high, exceeding 80%.

[0057] 2) Preparation of core material After mixing 10% freeze-drying protectant, bacterial sludge, and 15% enzymatic hydrolysate, the mixture was dispensed into freeze-drying bottles. After being frozen at -20℃ for 2 hours to set the shape, the mixture was then frozen in a freeze dryer at -50℃ and 20KPa for 24 hours to prepare the core material.

[0058] 3) Repackaging capsules Capsules were prepared by filling the core material into an enteric-coated capsule shell in a biosafety cabinet. The capsule shell material was pharmaceutical-grade gelatin (C...). 576 H 819 O 142 N 102 S2) n Example 4: Experiment on the reduction of uric acid by fecal microbiota capsules Experimental animals: Male SPF grade C57BL / 6 mice, 6-8 weeks old, are usually selected.

[0059] Test substance: Experimental group: Suspension of contents of fecal microbiota capsules (a mixture of microbial sludge and Poria cocos enzymatic hydrolysate).

[0060] Positive control group: allopurinol (10-15 mg / kg).

[0061] Solvent control group: PBS buffer.

[0062] Modeling agent: Potassium oxonate (PO): a uricase inhibitor, administered via intraperitoneal injection (250-300 mg / kg for mice).

[0063] Yeast Extract: Provides exogenous purines, usually mixed into feed (10-20% w / w).

[0064] Main reagents and instruments: Serum uric acid (SUA), creatinine (Cr), and blood urea nitrogen (BUN) detection kits; ELISA kits (such as IL-1β, TNF-α); Western blotting reagents (for detecting transport proteins); automated biochemical analyzer; PCR instrument, etc.

[0065] 1) Modeling SPF-grade male C57BL / 6 mice are typically selected. They are acclimatized for at least one week at a temperature of 22±2°C, humidity of 50±10%, and a 12 / 12-hour light / dark cycle. Uricase activity is inhibited by intraperitoneal injection of potassium oxonate (PO, 250-300 mg / kg), while simultaneously increasing uric acid production by feeding mice a diet containing 10-20% yeast extract, thus creating hyperuricemic mice.

[0066] 2) Grouped administration Fecal microbial capsule 1: 10% freeze-drying protectant and 10% live bacteria concentration. 8 CFU / mL; Fecal microbial capsule 2: 10% freeze-drying protectant, 15% enzyme hydrolysate, and 10% live bacteria concentration. 8 CFU / mL; Fecal microbiota capsule 3: 10% lyophilization protectant and 15% enzymatic hydrolysate; Fecal microbial capsule 4: 10% freeze-drying protectant, 15% oligomannose, and 10% live bacteria concentration. 8 CFU / mL The contents of the fecal microbial capsules (microbial sludge + Poria cocos enzymatic hydrolysate + lyophilization protectant) were resuspended in sterile PBS to prepare a microbial suspension of the required concentration for later use. The final concentration of live bacteria in the microbial sludge was 10. 8 CFU / mL.

[0067] Typically, 6 groups (n=5) are set up: blank control group (normal feed + physiological saline), model group (HUA modeling + physiological saline), fecal microbiota capsule group 1 (HUA modeling + fecal microbiota capsule 1), fecal microbiota capsule group 2 (HUA modeling + fecal microbiota capsule 2), fecal microbiota capsule group 3 (HUA modeling + fecal microbiota capsule 3), fecal microbiota capsule group 4 (HUA modeling + fecal microbiota capsule 4), and positive drug control group (HUA modeling + allopurinol (10-15 mg / kg)).

[0068] After successful modeling, each group of animals was administered gavage at a fixed time every day for two weeks.

[0069] 3) Indicator Testing (1) Serum biochemical marker detection: Following the last administration, patients were kept on a fasting schedule but allowed free access to water for 12 hours. Blood was collected after anesthesia, and serum was separated by centrifugation. Serum uric acid (SUA), creatinine (Cr), and blood urea nitrogen (BUN) levels were measured using an automated biochemical analyzer. The expression of inflammatory factors (NLRP3, IL-1β, TNF-α) was detected by qPCR. The results are shown in Table 6.

[0070] Table 6

[0071] Wherein, ## indicates that compared with the blank control group, P<0.01; # indicates that compared with the blank control group, P<0.05; ** indicates that compared with the model group, P<0.01; * indicates that compared with the model group, P<0.05.

[0072] Table 6 shows that the fecal microbial capsules in group 3 exhibited a certain uric acid-lowering effect after fermentation by intestinal flora. Fecal microbial capsules group 2 showed better results than group 4, which is speculated to be due to the production of new secretions during the fermentation of Poria cocos, leading to its superior uric acid-lowering effect.

[0073] The above description is merely an embodiment of the present invention, and the scope of protection of the present invention is not limited to these specific embodiments, but is determined by the claims of the present invention. For those skilled in the art, the present invention can have various modifications and variations. Any modifications, equivalent substitutions, improvements, etc., made within the technical concept and principle of the present invention should be included within the scope of protection of the present invention.

Claims

1. A fecal microbial capsule, characterized in that, The fecal microbiota capsule comprises a wall material and a core material. The wall material is an enteric-coated capsule shell, and the core material comprises whole fecal microbiota and Poria cocos enzymatic hydrolysate. The effective live bacteria concentration in the whole fecal microbiota composite capsule is at least 2.5*10⁻⁶. 12 CFU / g.

2. The fecal microbial capsule according to claim 1, characterized in that, The concentration of Poria cocos hydrolysate in the fecal microbiota capsules is 5%~20%.

3. The fecal microbial capsule according to claim 1, characterized in that, The Poria cocos enzymatic hydrolysate is obtained by enzymatically hydrolyzing Poria cocos using at least one of β-glucanase, cellulase, pectinase, and amylase.

4. The fecal microbial capsule according to claim 1, characterized in that, The fecal microbial capsules also include a freeze-drying protectant.

5. The fecal microbial capsule according to claim 4, characterized in that, The freeze-drying protectant comprises at least 10-15 parts of trehalose, 5-10 parts of skim milk powder, and 2-5 parts of yeast extract.

6. The fecal microbial capsule according to claim 1, characterized in that, The enteric-coated capsule shell is selected from at least one of hydroxypropyl methylcellulose phthalate (HPMCP), hydroxypropyl methylcellulose acetate succinate (HPMCAS), azo polymer, gelatin, hydroxypropyl methylcellulose, and starch.

7. A method for preparing fecal microbiota capsules according to any one of claims 1-6, characterized in that, The method includes at least the following steps: S1. Add polysaccharide hydrolase to the Poria cocos suspension for enzymatic hydrolysis, and obtain Poria cocos hydrolysate after inactivation; S2. Collect feces from healthy individuals, homogenize them under anaerobic conditions, filter them in stages to remove impurities and host cells, centrifuge at 3000-10000g for 10-30 minutes to precipitate microorganisms, discard the supernatant, add a 3.5% trehalose solution, stir evenly, and obtain a high-concentration whole fecal microbial sludge. S3. Take 5%~20% of the Poria cocos enzymatic hydrolysate obtained from S1 and mix it with live bacteria at a concentration of 2.5*10. 12 The steps for preparing core material after mixing whole-culture sludge obtained from S2 with CFU / g; S4. Add the core material obtained in S3 into the enteric capsule shell to obtain fecal microbiota capsules.

8. The method according to claim 7, characterized in that, The core material in step S3 also includes 7.5% to 12.5% ​​of a freeze-drying protectant.

9. The use of the fecal microbiota capsule according to any one of claims 1-6 or the method according to claim 7 or 8 in any of the following aspects: A1. Applications in the preparation of diuretic products; A2. Applications in the preparation of uric acid-lowering products; A3. Applications in the preparation of anti-inflammatory products; A4. Applications in the preparation of products that regulate gut microbiota.

10. The application according to claim 9, characterized in that, The products mentioned include at least pharmaceuticals, food, or health products.

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