Traditional Chinese medicine inulin gel as well as preparation method and application thereof

Abstract

The invention relates to the field of pet food, in particular to traditional Chinese medicine inulin gel as well as a preparation method and application thereof. The traditional Chinese medicine inulin gel comprises a traditional Chinese medicine composition extract, a bilberry extract and inulin. The traditional Chinese medicine composition extract is obtained by extracting poria cocos, plantain herb, rhizoma alismatis and lalang grass rhizome, and the inulin is soluble dietary fibers and prebiotics. The traditional Chinese medicine inulin gel has the advantages that the gel has good palatability, traditional Chinese medicine can be continuously released in the intestinal tract through the intestinal tract retention effect, and the effective treatment time is prolonged; besides, the inulin has a certain health-care function, and the treatment effect on the cat interstitial cystitis is enhanced, so that the treatment effect can be ensured even if the feeding frequency is reduced, and the workload of pet owners and clinical care can be reduced.

Description

Technical Field

[0001] This invention relates to the field of pet food, and more particularly to a traditional Chinese medicine inulin gel, its preparation method, and its application. Background Technology

[0002] Feline interstitial cystitis (FIC) is a common chronic urinary tract disease that primarily affects adult domestic cats. Clinical manifestations are mainly abnormal urination behaviors, including urinary frequency, painful dribbling, and hematuria. In severe cases, it can lead to urinary tract obstruction and even acute kidney injury. The specific pathogenesis is not fully understood. Pathological observation shows that the bladder tissue of cats with FIC often exhibits significant edema, hemorrhage, vascular congestion, and interstitial inflammatory cell infiltration, with a significant increase in the number of mast cells in the urothelium and lamina propria.

[0003] Current Western medicine treatments primarily employ symptomatic treatments such as anti-inflammatory drugs, analgesics, and behavioral interventions, with limited long-term efficacy and certain side effects. Traditional Chinese veterinary medicine offers a unique perspective on the treatment of urinary incontinence (FIC). Traditional Chinese veterinary medicine theory collectively refers to clinical symptoms such as frequent urination, urgency, urinary obstruction, or painful urination as "Lin syndrome," whose etiology and pathogenesis are mainly related to damp-heat accumulation, kidney deficiency with dampness, or impaired bladder function. Based on syndrome differentiation, Lin syndrome can be divided into heat-induced Lin, stone-induced Lin, blood-induced Lin, chyluria, and fatigue-induced Lin. FIC clinically manifests as blood-induced Lin and heat-induced Lin. The treatment principle focuses on clearing heat and dampness, promoting urination and relieving pain, supplemented by tonifying the kidneys and strengthening the body's foundation.

[0004] The formula described in this invention is mainly composed of Poria cocos, Plantago asiatica, Alisma plantago-aquatica, Imperata cylindrica root, and bilberry extract. Compared with Western medicine treatments, traditional Chinese medicine compound formulas are inexpensive, have a mild and long-lasting stable effect, and relatively few side effects. They are characterized by multi-target and holistic conditioning, focusing on restoring the body's overall function while improving symptoms. The various components in the compound formula work synergistically and complement each other, exhibiting unique advantages in regulating constitution and improving overall bodily function.

[0005] However, the frequent use of traditional Chinese medicine (TCM) makes it difficult to administer to pets, thus reducing the frequency of medication is crucial for the development of TCM products for pets. The palatability of different dosage forms of TCM varies considerably. Decoctions typically have a strong taste, which pets generally won't readily consume; granules and capsules have a milder taste, but artificial feeding can easily cause stress in cats; gels and pastes, such as pet nutritional pastes, are highly palatable, and pets will readily eat them.

[0006] Inulin, primarily derived from plants such as Jerusalem artichoke, chicory, peony, and thistle, is a soluble dietary fiber and prebiotic with biocompatibility, biodegradability, and structural multifunctionality, making it an ideal functional food ingredient. Through heating and cooling, inulin solution can be transformed into inulin gel (IG). IG can be used as an oral delivery carrier, exhibiting good colonic retention, promoting the proliferation of beneficial intestinal bacteria, exerting a sustained-release effect, and improving therapeutic efficacy. However, whether inulin gel can improve the palatability of this traditional Chinese medicine compound and reduce the frequency of administration remains unknown. This patent has conducted animal model experiments and clinical verification in this regard. Summary of the Invention

[0007] Purpose of the invention: The technical problem to be solved by the present invention is to address the shortcomings of the prior art by providing a traditional Chinese medicine inulin gel, its preparation method and application.

[0008] To address the aforementioned technical problems, this invention discloses a traditional Chinese medicine inulin gel, its preparation method, and its application. This invention designs a traditional Chinese medicine inulin gel composed of Poria cocos, Plantago asiatica, Alisma plantago-aquatica, Imperata cylindrica root, bilberry extract, and inulin. All the traditional Chinese medicinal materials in this invention are both medicinal and edible, and inulin is a soluble dietary fiber and prebiotic. After being prepared into an inulin gel, the palatability of this traditional Chinese medicine compound is improved, making it easier to feed and reducing the frequency of feeding. At the same time, it enhances the effects of strengthening the spleen, removing dampness, and promoting diuresis. This traditional Chinese medicine inulin gel is a functional pet food gel used to enhance the treatment of feline interstitial cystitis. The specific technical solution of this invention is as follows:

[0009] In a first aspect, the present invention provides a traditional Chinese medicine inulin gel, comprising a traditional Chinese medicine composition extract, bilberry extract, and inulin; wherein the traditional Chinese medicine composition extract is obtained by solvent extraction of the traditional Chinese medicine composition; the traditional Chinese medicine composition comprises the following components in parts by weight: 1-3 parts Poria cocos, 1-3 parts Plantago asiatica, 1-3 parts Alisma plantago-aquatica, and 1-3 parts Imperata cylindrica. Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 2 parts Poria cocos, 2 parts Plantago asiatica, 2 parts Alisma plantago-aquatica, and 1 part Imperata cylindrica.

[0010] The solvent is water, and the extract of the traditional Chinese medicine composition is prepared by the following method: Each component of the traditional Chinese medicine composition is weighed according to the weight ratio, soaked in water, and then decocted to obtain an extract. The extract is then dried to obtain the extract of the traditional Chinese medicine composition. Preferably, the extract of the traditional Chinese medicine composition is prepared by the following method: Each component of the traditional Chinese medicine composition is weighed according to the weight ratio, soaked in 8-12 times its weight of deionized water for 20-40 minutes, brought to a boil over high heat, then simmered over low heat for 0.5-2 hours, and filtered. 6-8 times its weight of deionized water is added to the residue, and the mixture is decocted for 0.5-2 hours. The residue is removed, the two filtrates are combined and concentrated to obtain an extract. The extract is then freeze-dried to obtain the extract of the traditional Chinese medicine composition.

[0011] Preferably, the blueberry extract was purchased from Shaanxi Ruilin Pal Biotechnology Co., Ltd., batch number H240809-12. The inulin, CAS number 9005-80-5, was purchased from Shanghai Titan Technology Co., Ltd.

[0012] In the aforementioned inulin gel, the bilberry extract comprises 0.2% to 0.5% of the total mass of the extract in the herbal composition. Preferably, it comprises 0.2% to 0.3%.

[0013] In the aforementioned inulin gel, the mass concentration of the herbal composition extract is 30%–45%, preferably 30%–40%.

[0014] In the inulin gel, the mass concentration of inulin is 30% to 40%, preferably 30%.

[0015] The medicinal properties of each component in the traditional Chinese medicine inulin gel of this invention are as follows:

[0016] Poria cocos is neutral in nature and sweet and bland in taste. It enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and eliminating dampness, and strengthens the spleen to remove dampness. It belongs to the category of diuretic and edema-reducing drugs under the subclass of diuretic and dampness-eliminating drugs. Modern pharmacological studies have shown that it has anti-inflammatory, antioxidant, and diuretic effects.

[0017] Plantain, cold in nature and sweet in taste, enters the liver, kidney, lung, and small intestine meridians. It clears heat and promotes diuresis, resolves phlegm, cools the blood, and detoxifies. It belongs to the diuretic and urinary tract clearing herbs category under the subclass of diuretic and dampness-draining herbs. Modern pharmacological studies have shown that it possesses antibacterial, anti-inflammatory, and antitumor activities.

[0018] Alisma plantago-aquatica, cold in nature, sweet and bland in taste. It enters the kidney and bladder meridians. It promotes urination and clears damp-heat. It belongs to the diuretic and urinary tract clearing herbs under the subclass of diuretic and dampness-draining herbs. Its main active ingredients are triterpenoids, which have diuretic, anti-calculous, and hepatoprotective and kidney-protective pharmacological effects.

[0019] Imperata cylindrica root is cold in nature and sweet in taste. It enters the lung, stomach, and bladder meridians. It cools the blood and stops bleeding, clears heat and promotes diuresis. It belongs to the category of blood-cooling and hemostatic drugs under the hemostatic drug category. Modern pharmacological studies have shown that its rich flavonoids and triterpenoids have significant antioxidant and anti-inflammatory effects.

[0020] Blueberries are neutral in nature and sweet in taste. They have anti-inflammatory and diuretic properties, and the anthocyanins in their extracts have antioxidant and vascular protective effects.

[0021] Inulin, primarily derived from plants such as Jerusalem artichoke, chicory, patina, and thistle, is a soluble dietary fiber and prebiotic with biocompatibility, biodegradability, and structural multifunctionality, making it an ideal functional food ingredient. Through heating and cooling, inulin solutions can be transformed into inulin gel (IG). IG can be used as an oral delivery carrier to improve the palatability of medications.

[0022] Poria cocos and Plantago asiatica are the principal herbs, playing a crucial role in clearing heat from the upper body and promoting its downward flow in this formula. Alisma plantago-aquatica, as the assistant herb, enhances the formula's diuretic, dampness-removing, heat-clearing, and turbidity-resolving effects. The various herbs work synergistically, with the principal, assistant, adjuvant, and guiding herbs complementing each other to achieve the effect of clearing heat and promoting urination. Inulin gel serves as the drug delivery system. On one hand, it facilitates the sustained release of the herbal compound in the intestines through intestinal retention, increasing the effective treatment time for cystitis; on the other hand, it selectively promotes the proliferation of probiotics through fermentation by the intestinal microbiota.

[0023] Secondly, the present invention provides a method for preparing the traditional Chinese medicine inulin gel described in the first aspect, comprising the following steps: dissolving the traditional Chinese medicine composition extract, bilberry extract, and inulin in water, heating and mixing, and then allowing it to stand to obtain the traditional Chinese medicine inulin gel. Preferably, the traditional Chinese medicine composition extract and bilberry extract are first mixed and dissolved in water, shaken at 70°C for 5-10 minutes to completely dissolve them, obtaining a traditional Chinese medicine formulation solution, then inulin is added and fully dissolved, heated to 70°C and shaken for 5-10 minutes to completely dissolve them, and allowed to stand at room temperature for 10-20 hours to obtain the traditional Chinese medicine inulin gel.

[0024] Thirdly, this invention provides the application of the traditional Chinese medicine inulin gel described in the first aspect in the preparation of a drug for treating cystitis. The cystitis referred to is pet cystitis, including cyclophosphamide-induced cystitis in rats or interstitial cystitis in cats.

[0025] The dosage of the Chinese herbal inulin gel in pets is 1-2 g / kg every 1-2 days.

[0026] Beneficial effects:

[0027] This invention discloses an inulin gel complex loaded with extracts of Poria cocos, Plantago asiatica, Alisma plantago-aquatica, Imperata cylindrica, and Bilberry. The inulin gel serves as the drug delivery system, loading a traditional Chinese medicine formula with spleen-strengthening, dampness-draining, diuretic, and urinary tract-clearing properties. The use of inulin gel, on the one hand, facilitates the sustained release of the traditional Chinese medicine formula in the intestines through intestinal retention, thereby increasing the effective treatment time for cystitis; on the other hand, it selectively promotes the proliferation of probiotics through fermentation of the intestinal microbiota. Specifically, it has the following beneficial effects:

[0028] ① Compared to pure traditional Chinese medicine formulas, this gel has a sweet and bland taste, and is in the form of a semi-solid ointment, making it more palatable, easier to feed, and reducing stress on sick animals.

[0029] ② All the traditional Chinese medicines in this invention are food-grade materials, and inulin is a functional food ingredient that can enhance the spleen-strengthening, dampness-removing, diuretic, and urination-relieving effects of traditional Chinese medicines. At the same time, inulin selectively promotes the proliferation of probiotics through fermentation of the intestinal microbiota, enhancing the therapeutic effect on feline interstitial cystitis. Therefore, even with reduced feeding frequency, the therapeutic effect can be guaranteed, which can reduce the workload of pet owners and clinical medical staff.

[0030] ③ The inulin gel of traditional Chinese medicine described in this invention has good gelling properties and stability, has intestinal retention properties, can exert a sustained-release effect, and prolongs the drug residence time.

[0031] ④ The traditional Chinese medicine inulin gel prepared by this invention has a simple preparation method, mild reaction conditions, low production cost, and good biosafety.

[0032] ⑤ The inulin gel prepared by this invention has been shown in animal model experiments to have a significant therapeutic effect on cyclophosphamide-induced cystitis in rats. It can effectively alleviate kidney damage, reduce kidney inflammation, relieve urinary tract infection and urinary tract bleeding, reduce urine specific gravity, and alleviate liver damage in rats. Clinical treatment has verified that the gel can effectively treat interstitial cystitis in cats. Compared with traditional Chinese medicine alone, the gel can significantly reduce the number of administrations and improve the cure rate.

[0033] In summary, the inulin gel prepared by this invention has broad prospects for clinical application and functional food development. Attached Figure Description

[0034] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments, and the advantages of the present invention in the above and / or other aspects will become clearer.

[0035] Figure 1 These are inulin gels containing different amounts of inulin from traditional Chinese medicine. From left to right, they represent 25%, 30%, 35%, and 40%.

[0036] Figure 2Scanning electron microscope (SEM) images of inulin gels containing 30%, 35%, and 40% inulin content from traditional Chinese medicine are shown. Image A is a 30% inulin gel with a scale bar of 1 μm; image B is a 30% inulin gel with a scale bar of 500 nm; image C is a 35% inulin gel with a scale bar of 1 μm; image D is a 35% inulin gel with a scale bar of 500 nm; image E is a 40% inulin gel with a scale bar of 1 μm; and image F is a 40% inulin gel with a scale bar of 500 nm.

[0037] Figure 3 Rheological diagram of inulin gel containing 30% inulin content.

[0038] Figure 4 The results of routine urine tests in rats with cystitis were obtained 7 days after administration of the drug. Among them, A is the urinary protein:creatinine ratio (UPC), B is protein (PRO), C is albumin (ALB), D is urinary creatinine (CRE), E is blood occult blood (BLD), F is leukocytes (LEU), and G is specific gravity of urine (SG).

[0039] Figure 5 Serum biochemical results were obtained from rats with a cystitis model 7 days after administration of the drug. A represents alanine aminotransferase (ALT), B represents aspartate aminotransferase (AST), C represents alkaline phosphatase (ALP), D represents serum albumin (ALB), E represents creatinine (CREA), and F represents blood urea nitrogen (BUN). Detailed Implementation

[0040] To make the above-mentioned objectives, features and advantages of the present invention more apparent and understandable, the specific embodiments of the present invention will be described in detail below with reference to the embodiments. These embodiments are implemented on the premise of the technical solution of the present invention, and provide detailed implementation methods and specific operation processes. However, the protection scope of the present invention is not limited to the following embodiments.

[0041] In the following examples, the Poria cocos, Plantago asiatica, Alisma plantago-aquatica, and Imperata cylindrica were all purchased from Nanjing Tongrentang Pharmacy. The Bilberry Extract was purchased from Shaanxi Ruilin Pal Biotechnology Co., Ltd., batch number H240809-12. The Inulin, CAS number 9005-80-5, was purchased from Shanghai Titan Technology Co., Ltd.

[0042] Example 1: Preparation of Traditional Chinese Medicine Formula Solution

[0043] This embodiment prepares the traditional Chinese medicine formula solution according to the following method:

[0044] (1) Weigh out 50g of Poria cocos, 50g of Plantago asiatica, 50g of Alisma plantago-aquatica and 25g of Imperata cylindrica root, wash them and put them into a container;

[0045] (2) Add 10 times the mass of deionized water and soak for 30 minutes. Bring to a boil over high heat, then simmer over low heat for 1 hour. Filter.

[0046] (3) Add 8 times the mass of deionized water to the filter residue, decoct for 1 hour, remove the residue, combine the two filtrates and concentrate to obtain a crude drug weight of 1 g·mL. -1 Aqueous decoction (extract);

[0047] (4) Using a freeze dryer, the decoction is freeze-dried into powder to obtain a traditional Chinese medicine composition extract;

[0048] (5) Add 0.25% w / w blueberry extract, mix well, and obtain the traditional Chinese medicine formula powder;

[0049] (6) Dissolve the Chinese herbal medicine powder in sterile water to prepare a 0.5 g / mL solution. -1 The aqueous solution of the traditional Chinese medicine was heated to 70°C in a water bath and shaken for 5-10 minutes to completely dissolve it, thus obtaining the traditional Chinese medicine formula solution for subsequent experiments.

[0050] Example 2: Screening of Gels

[0051] To screen for gels with good stability and palatability, this example selected six food gels, including gelatin, pectin, carrageenan, sodium alginate, mesona powder, and inulin gels, for testing. Different gel powders were added to the traditional Chinese medicine formula solution prepared in Example 1 to create different gels.

[0052] 1. Preparation of traditional Chinese medicine gelatin gel (GG):

[0053] (1) Dissolving: Add 5g of gelatin powder to 50mL of distilled water and let stand for 5min (pre-swelling). Then use a water bath to heat at 60℃ until completely dissolved.

[0054] (2) Mixing: Pour the dissolved gelatin solution into the Chinese medicine formula solution, totaling 200mL, and stir well;

[0055] (3) Cooling: Refrigerate at 4℃ for 1-3 hours to solidify and obtain Chinese medicine GG.

[0056] 2. Preparation of traditional Chinese medicine pectin gel (PG):

[0057] (1) Dry mixing: Mix 1g of pectin powder with 3 times the amount of dry sugar beforehand to prevent clumping.

[0058] (2) Dissolving: Slowly sprinkle the mixture into 50g of 80-90℃ traditional Chinese medicine formula solution and stir for 2-3 minutes until completely dissolved.

[0059] (3) Add sugar to adjust the acidity: Add another 50g of sugar, boil and then cool to 95℃, add citric acid (or lactic acid) to adjust the pH to 2.8-3.5.

[0060] (4) Cooling: After being placed at room temperature for 10 minutes, it is refrigerated at 4℃ for 1 hour to obtain the Chinese medicine PG.

[0061] 3. Preparation of traditional Chinese medicine carrageenan gel (CG):

[0062] (1) Dissolving: Add 3g of carrageenan powder to 50mL of traditional Chinese medicine formula solution, stir with a magnetic stirrer until it is evenly dissolved, and allow it to swell for 1 hour.

[0063] (2) Place the mixed solution in an 80℃ water bath and keep it at a constant temperature for 30 minutes;

[0064] (3) Cool to room temperature and store in a 4°C refrigerator for 16 hours to obtain Chinese medicine CG.

[0065] 4. Preparation of sodium alginate gel (AG) for traditional Chinese medicine:

[0066] (1) Dissolving: Add 3g of sodium alginate to 50mL of traditional Chinese medicine formula solution, stir with a magnetic stirrer until it is evenly dissolved, and allow it to swell for 1 hour.

[0067] (2) Place the mixed solution in an 80℃ water bath and keep it at a constant temperature for 30 minutes;

[0068] (3) Cool to room temperature and store in a 4°C refrigerator for 16 hours to obtain traditional Chinese medicine AG.

[0069] 5. Preparation of Mesona gel (MG):

[0070] (1) Dissolving: Take 10g of Mesona chinensis powder and dissolve it in 50g of traditional Chinese medicine formula solution. Stir well to obtain a thick solution.

[0071] (2) Heat to 100℃, add 200g of Chinese herbal medicine formula solution at 100℃, and stir evenly while heating.

[0072] (3) Place it in a refrigerator at 4℃ for more than 16 hours to obtain the Chinese medicine formula MG.

[0073] 6. Preparation of Inulin Gel (IG):

[0074] (1) Dissolving: Add 30g of inulin to 70g of traditional Chinese medicine formula solution, stir with a magnetic stirrer until it is evenly dissolved, and allow it to swell for 1 hour.

[0075] (2) Heat the mixed solution to 70°C and shake for 5-10 minutes to completely dissolve it;

[0076] (3) After standing at room temperature for 12 hours, a traditional Chinese medicine IG with an inulin mass concentration of 30% was obtained.

[0077] Stability evaluation: Equal amounts of the six gels were centrifuged at 3000 rpm for 30 min, and the gel properties were observed to test the centrifugal stability. The gels were then sealed and stored at 25±2℃ and 60±10% relative humidity for 6 months, and the gel properties were observed to test the time stability.

[0078] Palatability assessment: Ten healthy cats were selected, one cat per enclosure, to avoid any potential sources of stress and distraction (e.g., the presence of other specimens and / or new scents). Six identical stainless steel bowls were used, each containing one of six different gels, which were then thoroughly mixed with a liquid-like tuna cat food can. Two trials were conducted, with three bowls used in each trial, and the total number of feedings from each bowl was recorded.

[0079] Experimental Results: As shown in Table 1, both carrageenan gel (CG) and inulin gel (IG) maintained a stable gel state within six months, while other gels showed stratification and water separation. In the centrifugal stability test, carrageenan and inulin gels also exhibited good stability. In the palatability test, inulin showed the best palatability. Considering the stability, palatability, and health benefits of inulin, it was selected as the oral delivery carrier for the traditional Chinese medicine formulation in this application.

[0080] Table 1 Comparison of stability and palatability of six gel types

[0081]

[0082] Example 3 Morphological characterization of inulin gel from traditional Chinese medicine

[0083] Preparation of Chinese herbal inulin gel in this example: The preparation was carried out according to the steps of Example 2 to obtain Chinese herbal inulin gel with an inulin mass concentration of 30%.

[0084] For comparison, this embodiment also prepared traditional Chinese medicine inulin gels with inulin content of 25%, 35%, and 40% by mass. The preparation method was the same as that of the traditional Chinese medicine inulin gel with 30% inulin content, the only difference being the adjustment of the content of inulin and traditional Chinese medicine formula solution.

[0085] Figure 1 From left to right, the images show complexes with inulin contents of 25%, 30%, 35%, and 40%. The complex with 25% inulin content did not form a gel, while the complexes with 30%, 35%, and 40% inulin content all formed gels.

[0086] The gels with inulin contents of 30%, 35%, and 40% obtained in this embodiment were characterized by the following morphological characteristics:

[0087] This embodiment uses scanning electron microscopy for detection as follows:

[0088] (1) Instrument model: German ZEISS Sigma 360;

[0089] (2) Gels with inulin content of 30%, 35%, and 40% were freeze-dried into powder;

[0090] (3) The test sample must contain ≥10mg of lyophilized powder;

[0091] (4) Spray the powder with gold to increase its conductivity;

[0092] (5) The sample is attached to the conductive adhesive to prepare the sample, and the detection mode is secondary electron.

[0093] Figure 2 Scanning electron micrographs of traditional Chinese medicine gels with inulin content of 30%, 35%, and 40% are shown. The images reveal that all three gel complexes possess an ordered porous structure. The inulin gel with a high drug loading of 30% was selected for subsequent experiments.

[0094] Example 4: Performance Characterization of Inulin Gel

[0095] In this embodiment, the performance of the traditional Chinese medicine inulin gel prepared in Example 2 was characterized as follows:

[0096] In this embodiment, rheological testing is performed using the following method:

[0097] (1) Instrument model: American TADHR-2;

[0098] (2) Rheological samples require 5 mL of fluid;

[0099] (3) Required test system type: parallel board;

[0100] (4) Test mode: Modulus test (oscillation mode);

[0101] (5) Specific test items: temperature scan with fixed strain and frequency, with a test temperature of 0 to 100℃.

[0102] Figure 3 This is a rheological diagram of a traditional Chinese medicine inulin gel with a 30% inulin content. G′, the storage modulus (also known as the elastic modulus), represents the amount of energy stored during elastic (reversible) deformation of a material, reflecting its elasticity. G″, the loss modulus (also known as the viscous modulus), represents the amount of energy lost during viscous (irreversible) deformation of a material, reflecting its viscosity. When G′ and G″ are roughly equal, the material is semi-solid; gel is a typical semi-solid substance. G′ = G″ is the gel point, and the corresponding temperature is called the gel point temperature. The gel point temperature of the traditional Chinese medicine inulin gel prepared in this example is approximately 11.55℃.

[0103] Example 5: The therapeutic effect of inulin gel (a traditional Chinese medicine) on a rat model of cystitis.

[0104] The traditional Chinese medicine formula solution described in this embodiment was prepared according to the method described in Example 1, and the traditional Chinese medicine inulin gel was prepared according to the method described in Example 2. Animal model experiments for cystitis were conducted as follows:

[0105] Experimental animals: 24 female SPF-grade SD rats, 2-3 months old, weighing 200±20g, provided by Jiangsu Qinglongshan Biotechnology Co., Ltd., certificate number A202503270629, were housed in a standardized barrier environment animal room.

[0106] Animal grouping and treatment: Rats were randomly divided into a blank control group (Control), a cyclophosphamide model group (CTX), a traditional Chinese medicine treatment group (TCM), and a traditional Chinese medicine gel treatment group (IGTCM), as shown in Table 2.

[0107] On the first day of the experiment, rats in the CTX, TCM, and IGTCM groups were intraperitoneally injected with 87.5 mg / kg. -1A cyclophosphamide (CTX)-induced cystitis model was established. Rats in the Control group were intraperitoneally injected with the same volume of physiological saline. From day 1 to day 7 of the experiment, rats in the TCM group were administered a 2 g / kg traditional Chinese medicine formula solution by gavage daily, rats in the IGTCM group were administered a 2 g / kg traditional Chinese medicine inulin gel by gavage every two days, and rats in the Control and CTX groups were administered 2 g / kg physiological saline.

[0108] Table 2. Grouping and treatment of rats with cystitis model

[0109]

[0110] Testing: After drug administration, 24-hour urine was collected using a rat metabolic cage. A urine test strip was completely immersed in a urine tube for 2 seconds, then removed and placed on filter paper to absorb excess urine. The test strip was then placed in a urinalysis analyzer for 30 seconds to perform routine urine tests, including the urine protein-to-creatinine ratio (UPC), protein (PRO), albumin (ALB), creatinine (CRE), occult blood (BLD), white blood cells (LEU), and specific gravity (SG). After urine collection, rats were anesthetized by intraperitoneal injection of sodium pentobarbital and fixed supine on the operating table. The abdominal cavity was opened, and blood was collected from the abdominal aorta. 2 mL of non-anticoagulated blood was collected from each rat using a 4 mL non-anticoagulated blood collection tube. The blood was incubated at room temperature at an angle for 1 hour, and then analyzed at 3000 rpm. -1 Centrifuge for 15 min, aliquot the supernatant serum into 1.5 mL centrifuge tubes, and store at 4°C for later use in biochemical assays. The levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), serum albumin (ALB), creatinine (CREA), and blood urea nitrogen (BUN) in the serum were measured using a fully automated biochemical analyzer (BS-220). After blood collection, the bladder was dissected and rinsed three times with 1× phosphate buffered saline solution to remove blood stains. Photos were taken for recording.

[0111] All experimental data were analyzed using one-way ANOVA with GraphPad Prism 9.1 software for multiple comparisons. Data are expressed as mean ± SD. P < 0.05 indicates a significant difference, and the significance of the differences is expressed as *p < 0.05, **p < 0.01, and ***p < 0.001, respectively.

[0112] The results of routine urine tests in rats 7 days after administration are as follows: Figure 4 As shown, the urine protein-to-creatinine ratio (UPC) is a reliable indicator for assessing early impairment of kidney function. Figure 4As shown in Figure A, compared with the control group, CTX led to an increase in UPC in rats (P < 0.05); compared with the CTX group, both TCM and IGTCM decreased UPC (P > 0.05). Abnormally elevated urinary protein (PRO) is an important marker of renal impairment. Figure 4 B in the study showed that, compared with the control group, CTX significantly increased PRO in rats (P < 0.01); compared with the CTX group, both TCM and IGTCM effectively reduced PRO (P < 0.05). Urinary albumin (ALB) can serve as an indicator of renal function in systemic or local inflammatory responses. Figure 4 The results showed that CTX caused an increase in ALB levels in rats compared to the Control group (P > 0.05); both TCM and IGTCM decreased ALB levels compared to the CTX group (P > 0.05). Elevated urinary creatinine (CRE) suggests urinary tract infection and kidney damage. Figure 4 The results showed that, compared with the control group, CTX caused an increase in urinary CRE in rats (P < 0.05); compared with the CTX group, both TCM and IGTCM effectively reduced CRE (P < 0.05). A positive occult blood (BLD) result indicates urinary tract bleeding. Figure 4 The E-test showed that, compared with the control group, CTX caused a highly significant increase in BLD in rats (P < 0.001); compared with the CTX group, TCM significantly reduced CRE (P < 0.01), and IGTCM significantly reduced CRE (P < 0.001). A positive leukocyte (LEU) count also indicates urinary tract infection. Figure 4 The results showed that, compared with the control group, CTX caused a highly significant increase in LEU in rats (P < 0.001); compared with the CTX group, TCM significantly reduced LEU (P < 0.01), and IGTCM significantly reduced LEU (P < 0.001). Urine specific gravity (SG) depends on the concentration of dissolved substances in urine. Under pathological conditions, increases in urinary protein, glucose, ketone bodies, and cellular components can lead to elevated SG. Figure 4 The results showed that, compared with the control group, CTX significantly increased SG in rats (P < 0.01); compared with the CTX group, both TCM and IGTCM significantly decreased SG (P < 0.01).

[0113] Serum biochemical results of rats 7 days after administration are as follows Figure 5 As shown, elevated levels of both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are seen in acute and chronic liver injury. Figure 5Figures A and B show that, compared with the Control group, the CTX model group rats had significantly elevated ALT (P < 0.01) and significantly elevated AST (P < 0.05); compared with the CTX group, TCM significantly reduced ALT (P < 0.01) and AST (P < 0.05), while IGTCM significantly reduced ALT (P < 0.001) and significantly reduced AST (P < 0.01). Elevated alkaline phosphatase (ALP) suggests hepatobiliary disease involving hepatocellular parenchyma. Figure 5 The results showed that, compared with the control group, CTX caused a highly significant increase in ALP in rats (P < 0.001); compared with the CTX group, TCM effectively reduced ALP (P < 0.05), and IGTCM significantly reduced ALP (P < 0.001), with a significant difference between the TCM group and the IGTCM group (P < 0.05). Decreased serum albumin (ALB) suggests reduced ALP synthesis in the liver or decreased renal tubular reabsorption function. Figure 5 The results showed that, compared with the control group, CTX led to a decrease in serum ALB in rats (P < 0.05); compared with the CTX group, both TCM and IGTCM effectively increased ALB (P < 0.05). Elevated serum creatinine (CRE) indicated renal decompensation and moderate renal impairment. Figure 5 The results showed that, compared with the control group, CTX caused a highly significant increase in serum CRE in rats (P < 0.001). Compared with the CTX group, TCM significantly reduced CRE (P < 0.01), and IGTCM significantly reduced CRE (P < 0.001). Elevated blood urea nitrogen (BUN) reflects decreased glomerular filtration function. Figure 5 The F-values ​​in the study showed that BUN was significantly increased in the CTX model group compared with the control group (P < 0.05). Compared with the CTX group, TCM reduced BUN (P < 0.05), and IGTCM significantly reduced BUN (P < 0.01).

[0114] The above results indicate that TCM and IGTCM treatments have a certain protective effect against CTX-induced liver and kidney function damage in rats, can reduce the degree of urinary tract inflammation, and alleviate hematuria symptoms. Furthermore, IGTCM is more effective than TCM. Example 6: Evaluation of the effect of inulin gel on improving the palatability of traditional Chinese medicine.

[0115] The traditional Chinese medicine formula solution described in this embodiment was prepared according to the method described in Example 1, and the traditional Chinese medicine inulin gel was prepared according to the method described in Example 2.

[0116] In this embodiment, pure inulin gel was prepared using the following method:

[0117] (1) Take 140g of distilled water and heat it to 70℃ in a water bath;

[0118] (2) Add 60g of inulin, shake well for 5-10 minutes to dissolve it completely;

[0119] (3) Let stand at room temperature for 12 hours to prepare pure inulin gel (IG).

[0120] In this embodiment, palatability was evaluated using the following method:

[0121] Experimental Design: Ten healthy cats were selected, each with its own enclosure to avoid any potential sources of stress and distraction (e.g., the presence of other specimens and / or new scents). Three identical stainless steel bowls were used, each containing a simple inulin gel (IG), a traditional Chinese medicine formula solution (TCM), and an inulin gel (IGTCM), respectively. These three formulations were then mixed thoroughly with a liquid-like tuna cat food can. All three bowls were placed in the enclosures simultaneously, and feeding patterns were recorded.

[0122] Experimental Results: As shown in Table 3, the herbal formula solution had a strong odor. All 10 cats sniffed the herbal formula solution first, but none of them ate it after sniffing, resulting in a 0% active feeding rate. Eight cats ate the simple gel, and seven cats ate the herbal inulin gel. The herbal inulin gel in this application improved the palatability of the herbal formula, significantly increased the active feeding rate of the cats, and reduced the workload of pet owners and veterinarians in artificial feeding.

[0123] Table 3 Palatability Evaluation Results

[0124] Example 7: The therapeutic effect of traditional Chinese medicine inulin gel on feline interstitial cystitis

[0125] The traditional Chinese medicine formula solution described in this embodiment was prepared according to the method described in Example 1, and the traditional Chinese medicine inulin gel was prepared according to the method described in Example 2.

[0126] This embodiment describes the treatment of feline interstitial cystitis as follows:

[0127] Experimental Design: Cats clinically diagnosed with interstitial cystitis were selected, and their basic information is shown in Table 4. Taking into account factors such as sex, age, weight, and breed, the cats were randomly divided into three groups: a control group, a traditional Chinese medicine (TCM) formula solution group, and a traditional Chinese medicine inulin gel treatment group (IGTCM), as shown in Table 5. The control group was fed physiological saline. Both the TCM and IGTCM groups received the medication at a dose of 1 g / kg of the cat's body weight. TCM was administered twice daily, and IGTCM once daily, for 7 consecutive days.

[0128] Cure criteria: The cat's urinalysis and blood biochemistry indicators return to normal.

[0129] Trial results: As shown in Table 6, IGTCM treatment was more effective than TCM, and the cure rate was increased by 5% while reducing the frequency of medication.

[0130] The inulin gel prepared from this traditional Chinese medicine compound has a sweet and bland taste, and is a semi-solid ointment with good palatability, making it easy to feed and reducing stress responses in sick animals. It improves therapeutic efficacy while reducing the frequency of feeding. The main reasons are: ① Inulin, as a soluble dietary fiber and prebiotic, can promote the proliferation of beneficial intestinal bacteria. ② The gel formulation has a certain degree of stability, and its intestinal retention effect helps the traditional Chinese medicine compound to be continuously released in the intestines, increasing the effective treatment time.

[0131] Table 4 Basic Information of the Suffering Cats

[0132]

[0133] Table 5 Grouping and Treatment of Affected Cats

[0134]

[0135] Table 6 Clinical treatment efficacy of feline interstitial cystitis

[0136]

[0137] This invention discloses a food-grade inulin gel for enhancing the therapeutic effects of traditional Chinese medicine, and provides a method for preparing and applying this inulin gel. Many methods and approaches can be used to implement this technical solution; the above description is merely a preferred embodiment of the invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of this invention, and these improvements and modifications should also be considered within the scope of protection of this invention. All components not explicitly stated in this embodiment can be implemented using existing technologies.

Claims

1. A traditional Chinese medicine inulin gel, characterized in that, Including extracts of traditional Chinese medicine compositions, blueberry extract, and inulin; The extract of the traditional Chinese medicine composition is obtained by solvent extraction of the traditional Chinese medicine composition; The traditional Chinese medicine composition comprises the following components in parts by weight: 1-3 parts Poria cocos, 1-3 parts Plantago asiatica, 1-3 parts Alisma plantago-aquatica, and 1-3 parts Imperata cylindrica.

2. The traditional Chinese medicine inulin gel according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: 2 parts Poria cocos, 2 parts Plantago asiatica, 2 parts Alisma plantago-aquatica, and 1 part Imperata cylindrica.

3. The traditional Chinese medicine inulin gel according to claim 1, characterized in that, The solvent is water, and the extract of the traditional Chinese medicine composition is obtained by extraction as follows: each component of the traditional Chinese medicine composition is weighed according to the weight ratio, soaked in water, and then decocted to obtain an extract. The extract is then dried to obtain the extract of the traditional Chinese medicine composition.

4. The traditional Chinese medicine inulin gel according to claim 1, characterized in that, In the aforementioned Chinese herbal inulin gel, the mass of bilberry extract is 0.2% to 0.5% of the mass of the extract in the Chinese herbal composition.

5. The traditional Chinese medicine inulin gel according to claim 1, characterized in that, The inulin gel of the traditional Chinese medicine contains inulin at a mass concentration of 30% to 40%.

6. The method for preparing the traditional Chinese medicine inulin gel according to any one of claims 1 to 5, characterized in that, The process includes the following steps: dissolving the herbal composition extract, blueberry extract, and inulin in water, heating and mixing them, and then allowing them to stand to obtain the herbal inulin gel.

7. The use of the traditional Chinese medicine inulin gel according to any one of claims 1 to 5 in the preparation of a drug for treating cystitis.

8. The application according to claim 7, characterized in that, The cystitis mentioned refers to cystitis in pets.

9. The application according to claim 8, characterized in that, The dosage of the Chinese herbal inulin gel in pets is 1-2 g / kg every 1-2 days.

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