A traditional Chinese medicine composition for preventing and treating feline urological disease, and a preparation method and application thereof

Abstract

This invention discloses a traditional Chinese medicine formula for preventing and treating feline urinary tract diseases, its preparation method, and its application. The formula consists of the following components in parts by weight: 15-25 parts of Psoralea corylifolia, 15-25 parts of Alpinia oxyphylla, 10-20 parts of Trigonella foenum-graecum, 5-15 parts of Zea mays, 5-15 parts of Juncus effusus, 10-20 parts of Dioscorea hypoglauca, 10-20 parts of Phellodendron chinense, 10-20 parts of Lonicera japonica, 5-15 parts of Paeonia lactiflora, and 5-15 parts of Glycyrrhiza uralensis. The traditional Chinese medicine formula provided by this invention has diuretic and urinary tract mucosal repairing effects. It can effectively relieve symptoms such as urinary stones, painful urination, hematuria, or gravel in the urine caused by damp-heat in the lower abdomen. It promotes the repair of the urinary tract mucosa in animals with urinary tract diseases, alleviates inflammatory responses, and prevents the formation of crystals in the urine.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine for dogs and cats, specifically to a traditional Chinese medicine formula for the prevention and treatment of feline urinary tract diseases, its preparation method, and its application. Background Technology

[0002] With the increasing popularity of companion pets in households, the health and welfare of cats are receiving more and more attention. Among various clinical diseases in cats, Feline Lower Urinary Tract Disease (FLUTD) is an extremely common health problem that troubles many pet owners. This disease not only causes cats great pain and stress, but its recurrent nature also brings long-term management challenges and a heavy financial burden.

[0003] Feline urinary tract diseases are a group of syndromes with similar clinical symptoms, mainly including idiopathic cystitis, urolithiasis (such as struvite, calcium oxalate crystals), urinary tract infections, and urethral plugs. Affected animals often exhibit symptoms such as urinary frequency, difficulty urinating, hematuria, and not urinating in the litter box. In severe cases, complete urethral obstruction can occur, leading to acute post-renal renal failure and endangering life. The etiology is complex and closely related to multiple factors such as diet, water intake, environmental stress, endocrine function, and autoimmunity. Idiopathic cystitis accounts for the largest proportion, and its pathogenesis involves abnormalities of the neuroendocrine system.

[0004] Currently, conventional treatments for FLUTD primarily focus on symptomatic management and control of secondary complications. These mainly include: 1) using antispasmodics and analgesics (such as meloxicam and butorphanol) to relieve pain and spasms; 2) using antibiotics to control secondary bacterial infections; 3) managing urolithiasis through prescription diets (such as urine acidification and dissolution-promoting prescriptions); and 4) catheterization and flushing in cases of urethral obstruction, with surgical interventions such as urethrostomy considered for severe or recurrent cases. However, these methods have significant limitations. Long-term reliance on nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics can lead to gastrointestinal and renal damage; antibiotic overuse easily leads to drug resistance and is ineffective against most non-bacterial causes; while prescription diets can dissolve specific types of crystals, they require long-term or even lifelong consumption and cannot address the core inflammation and stress issues; and surgery is invasive, with associated anesthesia risks and potential postoperative complications. Overall, existing therapies largely focus on symptomatic relief, with limited effectiveness in reducing recurrence rates, regulating overall condition, and addressing the root cause.

[0005] Therefore, there is a clinical need for a safer alternative or complementary treatment that can comprehensively regulate multiple targets and effectively prevent recurrence. Traditional Chinese medicine (TCM) emphasizes a holistic view and syndrome differentiation, and has a long history of treating urinary system diseases. TCM compound formulas are characterized by multi-component and multi-target effects, and can exert a synergistic effect through multiple pathways such as clearing heat and dampness, promoting blood circulation and removing blood stasis, promoting diuresis and relieving strangury, and tonifying the kidney and replenishing qi, thereby exerting comprehensive effects such as anti-inflammation, analgesia, antibacterial, anti-stone formation, relieving smooth muscle spasms, and regulating the body's immune and stress states. Compared with chemical drugs, mild TCM preparations have potential advantages in the long-term management of chronic and recurrent diseases, such as relatively fewer toxic side effects, less likelihood of developing drug resistance, and emphasis on restoring the body's balance. This provides a clear research direction and solid theoretical basis for developing a dedicated TCM formula for the prevention and treatment of feline urinary tract diseases, aiming to reduce recurrence and improve quality of life. Based on this, this invention aims to provide a TCM formula for urinary tract diseases, its preparation method, and its application, providing a new approach to the treatment of feline urinary tract diseases. Summary of the Invention

[0006] 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 formula for the prevention and treatment of feline urinary tract diseases, its preparation method and application.

[0007] To solve the above-mentioned technical problems, the present invention discloses the following technical solution:

[0008] In a first aspect, the present invention discloses a traditional Chinese medicine composition for preventing and treating feline urinary tract diseases.

[0009] The combination consists of the following components: Psoralea corylifolia, Alpinia oxyphylla, Trigonella foenum-graecum, Zea mays, Juncus effusus, Dioscorea hypoglauca, Phellodendron chinense, Lonicera japonica, Paeonia lactiflora, and Glycyrrhiza uralensis.

[0010] The pharmacological properties of each herbal component in the herbal composition are as follows:

[0011] (1) Psoralea corylifolia: sweet, cold. It enters the liver, kidney, lung, and small intestine meridians. It clears heat, promotes urination, cools the blood, and detoxifies.

[0012] (2) Alpinia oxyphylla: Sweet, bland, and cold. It enters the heart, stomach, and small intestine meridians. It clears heat and drains fire, relieves irritability, and promotes urination.

[0013] (3) Fenugreek: Sweet, bland, neutral. It enters the heart, lung, spleen, and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind.

[0014] (4) Corn silk: sweet, neutral. Enters the bladder, liver, and gallbladder meridians. Promotes diuresis and reduces swelling, eliminates dampness and relieves jaundice;

[0015] (5) Juncus effusus: Sweet, bland, slightly cold. It enters the heart, lung, and small intestine meridians. It promotes urination and clears heart fire;

[0016] (6) Dioscorea hypoglauca: Bitter, neutral. Enters the kidney and stomach meridians. It promotes diuresis and removes turbidity;

[0017] (7) Phellodendron bark: Bitter, slightly cold. Enters the liver meridian. Clears heat and cools blood, disperses blood stasis and relieves pain;

[0018] (8) Honeysuckle vine: sweet, cold. Enters the lung and stomach meridians. Clears heat and detoxifies, dispels wind and unblocks the meridians;

[0019] (9) Red peony root: Bitter, slightly cold. Enters the liver meridian. Clears heat and cools the blood, disperses blood stasis and relieves pain;

[0020] (10) Licorice: Sweet, neutral. It enters the heart, lung, spleen, and stomach meridians. It tonifies the spleen and replenishes qi, clears heat and detoxifies, eliminates phlegm and stops cough, relieves spasms and pain, and harmonizes the effects of other herbs.

[0021] This invention is formulated according to the principles of traditional Chinese veterinary medicine. Cats are docile but have a constitution that tends towards coldness, making them prone to fright and stress that can damage their kidneys. Therefore, irregular eating habits or stress can easily lead to problems such as nephritis, urinary tract infections, urinary tract stones, and urinary retention. This invention uses Psoralea corylifolia, Alpinia oxyphylla, and Trigonella foenum-graecum as the principal herbs to warm the kidneys, invigorate yang, dispel cold, and relieve pain; corn silk, Juncus effusus, and Dioscorea hypoglauca as the assistant herbs to promote diuresis and eliminate dampness; and Phellodendron amurense, Lonicera japonica, Paeonia lactiflora, and Glycyrrhiza uralensis as adjuvant herbs to clear heat, dry dampness, cool the blood, and detoxify. This formula has shown good efficacy in treating feline urinary tract diseases through clinical application.

[0022] In some embodiments, the weight parts of each component are: 15-25 parts of Psoralea corylifolia, 15-25 parts of Alpinia oxyphylla, 10-20 parts of Fenugreek, 5-15 parts of Zea mays, 5-15 parts of Juncus effusus, 10-20 parts of Dioscorea hypoglauca, 10-20 parts of Phellodendron chinense, 10-20 parts of Lonicera japonica, 5-15 parts of Paeonia lactiflora, and 5-15 parts of Glycyrrhiza uralensis.

[0023] In some embodiments, the weight parts of each component are as follows: 18-22 parts of Psoralea corylifolia, 18-22 parts of Alpinia oxyphylla, 13-17 parts of Fenugreek, 8-12 parts of Zea mays, 8-12 parts of Juncus effusus, 13-17 parts of Dioscorea hypoglauca, 13-17 parts of Phellodendron chinense, 13-17 parts of Lonicera japonica, 8-12 parts of Paeonia lactiflora, and 8-12 parts of Glycyrrhiza uralensis.

[0024] In some embodiments, the weight parts of each component are: 20 parts of Psoralea corylifolia, 20 parts of Alpinia oxyphylla, 15 parts of Fenugreek, 10 parts of Zea mays, 10 parts of Juncus effusus, 15 parts of Dioscorea hypoglauca, 15 parts of Phellodendron chinense, 15 parts of Lonicera japonica, 10 parts of Paeonia lactiflora, and 10 parts of Glycyrrhiza uralensis.

[0025] In some embodiments, the mass of each component is: 20g of Psoralea corylifolia, 20g of Alpinia oxyphylla, 15g of Fenugreek, 10g of Zea mays, 10g of Juncus effusus, 15g of Dioscorea hypoglauca, 15g of Phellodendron chinense, 15g of Lonicera japonica, 10g of Paeonia lactiflora, and 10g of Glycyrrhiza uralensis.

[0026] Secondly, this invention discloses a traditional Chinese medicine extract for the prevention and treatment of feline urinary tract diseases.

[0027] In some embodiments, the herbal extract is made from the following components in parts by weight: 15-25 parts of Psoralea corylifolia, 15-25 parts of Alpinia oxyphylla, 10-20 parts of Trigonella foenum-graecum, 5-15 parts of Zea mays, 5-15 parts of Juncus effusus, 10-20 parts of Dioscorea hypoglauca, 10-20 parts of Phellodendron chinense, 10-20 parts of Lonicera japonica, 5-15 parts of Paeonia lactiflora, and 5-15 parts of Glycyrrhiza uralensis.

[0028] In some embodiments, the herbal extract is made from the following components in parts by weight: 18-22 parts of Psoralea corylifolia, 18-22 parts of Alpinia oxyphylla, 13-17 parts of Trigonella foenum-graecum, 8-12 parts of Zea mays, 8-12 parts of Juncus effusus, 13-17 parts of Dioscorea hypoglauca, 13-17 parts of Phellodendron chinense, 13-17 parts of Lonicera japonica, 8-12 parts of Paeonia lactiflora, and 8-12 parts of Glycyrrhiza uralensis.

[0029] In some embodiments, the herbal extract is made from the following components in parts by weight: 20 parts of Psoralea corylifolia, 20 parts of Alpinia oxyphylla, 15 parts of Trigonella foenum-graecum, 10 parts of Zea mays, 10 parts of Juncus effusus, 15 parts of Dioscorea hypoglauca, 15 parts of Phellodendron chinense, 15 parts of Lonicera japonica, 10 parts of Paeonia lactiflora, and 10 parts of Glycyrrhiza uralensis.

[0030] In some embodiments, the herbal extract is made from the following components in parts by weight: 20g of Psoralea corylifolia, 20g of Alpinia oxyphylla, 15g of Trigonella foenum-graecum, 10g of Zea mays, 10g of Juncus effusus, 15g of Dioscorea hypoglauca, 15g of Phellodendron chinense, 15g of Lonicera japonica, 10g of Paeonia lactiflora, and 10g of Glycyrrhiza uralensis.

[0031] Thirdly, the present invention discloses a method for preparing the traditional Chinese medicine extract described in the second aspect above.

[0032] In some embodiments, the preparation method includes weighing each Chinese herbal medicine component according to the formula ratio, pulverizing and extracting each component to obtain an extract; concentrating the obtained extract to obtain a paste; and drying the obtained paste to obtain the final product.

[0033] In some embodiments, all components are pulverized to pass through 24-35 mesh, such as 30 mesh.

[0034] In some embodiments, the extraction solvent is water; in some embodiments, the mass fraction ratio of the solvent to the medicinal material is 8-12:1; and in some embodiments, it is 10:1.

[0035] In some embodiments, the extraction temperature is 70-90°C, and in some embodiments it is 80°C; the extraction time is 1-3 hours, and in some embodiments it is 2 hours.

[0036] In some embodiments, the concentration is achieved using a double-effect concentrator, with the vacuum degree and evaporation temperature of each effect being: first effect -0.06MPa, 85℃; second effect -0.08MPa, 60℃.

[0037] In some embodiments, the concentration is to concentrate to a relative density of 0.9-1.3, and in some embodiments 1.20.

[0038] Fourthly, this invention discloses a product for preventing and treating feline urinary tract diseases.

[0039] The product includes the traditional Chinese medicine composition described in the first aspect above or the traditional Chinese medicine extract described in the second aspect above.

[0040] The product is in the form of an oral medication, including but not limited to granules, powders, pills, tablets or capsules.

[0041] The product uses the above-mentioned traditional Chinese medicine composition as its active ingredient and also includes commonly used excipients or auxiliary ingredients.

[0042] The products mentioned include veterinary drugs, feed additives, or feed.

[0043] The product has any one or more of the following functions;

[0044] i. Promotes the repair of bladder mucosa in animals with urinary tract diseases;

[0045] ii. To alleviate urinary difficulties and painful urination in animals suffering from urinary tract diseases;

[0046] iii. To prevent the formation of crystals in cat urine or to promote the expulsion of existing stones in the urinary system.

[0047] In this invention, the urinary tract diseases include stones and cystitis; the stones include bladder stones.

[0048] In this invention, when the product is feed, the composition is made into a commonly used dosage form (veterinary drug or feed additive) and then added to the feed to make a basic daily ration suitable for daily feeding.

[0049] Beneficial effects: Compared with the prior art, the present invention has the following advantages:

[0050] The traditional Chinese medicine composition provided by this invention targets the pathological characteristics of urinary tract diseases and has comprehensive effects of clearing heat and dampness, promoting diuresis and relieving strangury, promoting blood circulation and removing blood stasis, and soothing the liver and relieving depression. It can regulate the body's water metabolism from multiple targets, relieve urinary tract smooth muscle spasm, inhibit inflammatory response and crystal formation, and achieve both symptomatic and radical treatment.

[0051] The traditional Chinese medicine composition provided by this invention has significant therapeutic effects in a rat model of bladder stones. It can effectively reduce the saturation of crystalline substances in urine, inhibit the formation and aggregation of stone cores, and promote the excretion of stones.

[0052] The traditional Chinese medicine composition provided by this invention has significant therapeutic effects in a rat model of cystitis, reducing bladder mucosal inflammation, congestion and edema induced by chemical factors, and significantly improving urodynamic parameters and pain behavior in experimental animals.

[0053] The traditional Chinese medicine composition provided by this invention has a significant therapeutic effect on cats with cystitis, significantly improving their urinary frequency, urgency, and pain, and restoring their mental state and appetite.

[0054] The traditional Chinese medicine composition provided by this invention has a wide range of raw material sources, a stable preparation process, low cost, and is easy to industrialize. Attached Figure Description

[0055] Figure 1 The image shows the formation of crystals in the urine of rats with bladder stones in Example 2; where A: control group; B: stone model group; C: positive drug group; D: low-dose group; E: medium-dose group; F: high-dose group.

[0056] Figure 2 The following is a description of the urination status (size and quantity of litter clumps) of a cat with cystitis in Example 4; where A and B represent the litter status of the cat with cystitis; and C and D represent the litter status of the cat with cystitis 15 days after treatment. Detailed Implementation

[0057] The present invention can be better understood from the following embodiments. However, those skilled in the art will readily understand that the descriptions in the embodiments are for illustrative purposes only and should not, and will not, limit the invention as detailed in the claims.

[0058] Unless otherwise specified, the experimental methods described in the following examples are conventional methods; unless otherwise specified, the reagents and materials are commercially available.

[0059] In this invention, except where expressly stated, any matters or issues not mentioned herein are directly applicable to those known in the art without any modification. Furthermore, any implementation described herein can be freely combined with one or more other implementations described herein, and the resulting technical solutions or concepts are considered part of the original disclosure or original record of this invention, and should not be regarded as new content not disclosed or anticipated herein, unless those skilled in the art consider the combination clearly unreasonable.

[0060] All features disclosed in this invention can be combined arbitrarily, and such combinations should be understood as the contents disclosed or recorded in this invention, unless those skilled in the art consider such combinations to be obviously unreasonable.

[0061] The numerical points disclosed in this specification include not only the numerical points specifically disclosed in the embodiments, but also the endpoints of each numerical range in the specification. Any combination of these numerical points should be regarded as the range disclosed or recorded in this invention.

[0062] In this invention, the technical and scientific terms that are given a definition shall be used as defined thereon, and those that are not given a definition shall be understood according to their common meaning in the art.

[0063] Example 1: Preparation of Traditional Chinese Medicine Compound

[0064] Formula: 20g of Psoralea corylifolia, 20g of Alpinia oxyphylla, 15g of Trigonella foenum-graecum, 10g of Corn silk, 10g of Juncus effusus, 15g of Dioscorea hypoglauca, 15g of Phellodendron chinense, 15g of Lonicera japonica, 10g of Paeonia lactiflora, and 10g of Glycyrrhiza uralensis.

[0065] The preparation method is as follows: Weigh the above-mentioned medicinal materials according to the weight ratio, screen and wash them; pulverize the medicinal materials to pass through a 30-mesh sieve; extract using a dynamic countercurrent reflux extraction method, with drinking water as the extraction solvent, a solvent-to-raw material mass fraction ratio of 10:1, a heating temperature of 80℃, and an extraction time of 2 hours to obtain the extract; concentrate the obtained extract using a double-effect concentrator, with the vacuum degree and evaporation temperature for each effect being: first effect -0.06MPa, 85℃; second effect -0.08MPa, 60℃. Concentrate the liquid to a relative density of 1.20 to obtain the extract; spray dry the obtained extract to obtain the final product.

[0066] Example 2

[0067] Thirty-six healthy male Wistar rats (body weight 230±20 g) around 8 weeks old were randomly divided into a control group, a stone group, a positive drug group (hydrochlorothiazide), a low-dose traditional Chinese medicine compound group, a medium-dose traditional Chinese medicine compound group, and a high-dose traditional Chinese medicine compound group (the traditional Chinese medicine compound prepared in Example 1, with low dose 250 mg / kg, medium dose 500 mg / kg, and high dose 750 mg / kg), with 6 rats in each group. They were given standard growth and reproduction feed and free access to food and water for a feeding experiment lasting 4 weeks.

[0068] Starting from the first day of the formal experiment, except for the control group, rats in all other groups were administered a 20% ethylene glycol solution by gavage every morning to prepare a stone model. The low, medium, and high dose groups of the traditional Chinese medicine compound were administered a traditional Chinese medicine compound aqueous solution by gavage every afternoon at doses of 250 mg / kg, 500 mg / kg, and 750 mg / kg (calculated as traditional Chinese medicine compound), respectively. The corresponding concentrations of the traditional Chinese medicine compound aqueous solution were 50 mg / mL, 100 mg / mL, and 150 mg / mL, respectively. The positive control group was administered a hydrochlorothiazide aqueous solution by gavage every afternoon at a dose of 1.5 mg / kg (calculated as hydrochlorothiazide). The corresponding concentration of the hydrochlorothiazide aqueous solution was 0.3 mg / mL. The control group and the stone group were administered the same amount of distilled water by gavage. The intervention was continued for 4 weeks. During the experiment, water intake was recorded every 2 days; weight changes were recorded every 4 days; fresh urine from rats in each group was collected 24 hours before the end of the experiment using the metabolic cage method for urine pH testing and urine sediment microscopic examination; at the end of the experiment, rat blood was collected to detect serum urea (UREA), creatinine (CREA), calcium (Ca), and phosphorus (P) levels, as well as the expression levels of inflammatory factors TNF-α and IL-1β, and kidney tissue was collected to detect changes in the expression levels of inflammation-related genes.

[0069] Experimental results

[0070] 1. Changes in rat body weight

[0071] The effects of the traditional Chinese medicine compound on the growth of rats with gallstones are shown in Table 1. At the end of the experiment, compared with the control group, the body weight of rats in the gallstone group and each dose group of the traditional Chinese medicine compound was lower. During the entire experiment, the control group showed the greatest increase in body weight, while the increase in body weight in the gallstone group was significantly lower than that in the control group (P < 0.01). These results indicate that the establishment of the gallstone model significantly inhibited the growth of rat body weight, and the intervention of the traditional Chinese medicine compound, especially at medium and high doses, alleviated this growth inhibition to a certain extent.

[0072] Table 1. Changes in rat body weight

[0073]

[0074] Note: Data are expressed as mean ± SEM, # indicates comparison with the control group. # P < 0.05 ## P < 0.01, ### P < 0.001; * indicates that compared with the stone group, * P < 0.05 ** P < 0.01, *** P < 0.001.

[0075] 2. Changes in water intake

[0076] The effects of the traditional Chinese medicine compound on water intake in each group of rats were evaluated. The results are shown in Table 2. Compared with the control group, the average daily water intake of rats in the stone group was significantly increased (P < 0.001). Compared with the model group, the water intake of the low-dose group was significantly decreased (P < 0.01), indicating that the traditional Chinese medicine compound can significantly regulate the polydipsia caused by stones.

[0077] Table 2 Changes in water intake in rats

[0078]

[0079] Note: Data are expressed as mean ± SEM, # indicates comparison with the control group. # P < 0.05 ## P < 0.01, ### P < 0.001; * indicates that compared with the stone group, * P < 0.05 ** P < 0.01, *** P < 0.001.

[0080] 3. Urine pH level and urine sediment

[0081] The pH level of rat urine in each group was measured to assess the effect of the traditional Chinese medicine compound on alleviating urinary acidity. The results are shown in Table 3. The normal urine pH value of rats is usually between 6.5 and 7.5. Compared with the control group, the urine pH value of the stone group was significantly reduced (P < 0.01), which is consistent with the common biochemical characteristics of the calcium oxalate stone model. The pH value of the positive control group and the medium and high dose groups of the traditional Chinese medicine compound showed a trend of returning to the normal range, and the high dose group had a significant effect.

[0082] Urine sediment microscopy Figure 1 As shown, the control group ( Figure 1 -A) A small amount of scattered crystals in the field of vision is a normal physiological phenomenon. (Gardeniasis group) Figure 1 -B) Numerous typical calcium oxalate crystals are visible, exhibiting characteristic envelope-like, dumbbell-shaped, short columnar, and irregular polyhedral forms, as indicated by the black arrows in the figure. Compared to the stone group, the calcium oxalate crystals in all other treatment groups were reduced to varying degrees (CF), with the high-dose traditional Chinese medicine compound group ( Figure 1 -F) Calcium oxalate crystals are almost invisible in the field of view.

[0083] Table 3. Urine pH Levels

[0084]

[0085] Note: Data are expressed as mean ± SEM, # indicates comparison with the control group. # P < 0.05 ## P < 0.01, ### P < 0.001; * indicates that compared with the stone group,* P < 0.05 ** P < 0.01, *** P < 0.001.

[0086] 4. Organ Index

[0087] The results of detecting the kidney and bladder indices of rats in each group are shown in Table 4. Compared with the control group, the kidney and bladder indices of the stone group were significantly increased, indicating pathological changes such as edema, inflammatory cell infiltration, and tissue hyperplasia. Compared with the stone group, the bladder index of the positive drug group was significantly decreased (P<0.001). After intervention with the traditional Chinese medicine compound, the organ indices of each dosage group showed varying degrees of decline, indicating that the compound has a certain alleviating effect on the pathological damage to the kidney and bladder caused by the stone model.

[0088] Table 4. Organ Index of Rats

[0089]

[0090] Note: Data are expressed as mean ± SEM, # indicates comparison with the control group. # P < 0.05 ## P < 0.01, ### P < 0.001; * indicates that compared with the stone group, * P < 0.05 ** P < 0.01, *** P < 0.001.

[0091] 5. Serum biochemical indicators

[0092] Serum biochemical indicators of rats were detected to evaluate the effects of traditional Chinese medicine compound on their renal function indicators. The results are shown in Table 5. Compared with the control group, the serum urea, creatinine and calcium levels in the stone model group were significantly increased (P<0.001 or P<0.01). Compared with the stone model group, the serum urea level in the low-dose group was significantly decreased (P<0.05), the serum urea, creatinine and calcium levels in the medium-dose group were significantly decreased (P<0.05), and the serum urea, creatinine and calcium levels in the high-dose group were significantly decreased (P<0.01 or P<0.05). There was no significant difference in serum phosphorus levels among the groups.

[0093] Table 5 Serum Biochemical Indicators

[0094]

[0095] Note: Data are expressed as mean ± SEM, # indicates comparison with the control group. # P < 0.05 ## P < 0.01, ### P < 0.001; * indicates that compared with the stone group, * P < 0.05 **P < 0.01, *** P < 0.001.

[0096] 6. Expression levels of inflammatory factor-related genes

[0097] The relative expression levels of inflammatory factor mRNAs in the kidney tissues of rats in each group were detected to assess the effect of the traditional Chinese medicine compound on the local inflammatory response of the kidney induced by the establishment of a stone model. The results are shown in Table 6. Compared with the control group, the relative expression levels of TNF-α and IL-6 mRNAs in the kidney tissues of the stone group were significantly increased (P < 0.05). Compared with the stone group, the relative expression level of TNF-α mRNAs in the medium-dose group was significantly decreased (P < 0.05), and the relative expression levels of TNF-α and IL-6 mRNAs in the kidney tissues of the high-dose group were significantly decreased (P < 0.001 or P < 0.05). No significant changes were observed in the mRNA expression level of IL-1β in each group.

[0098] Table 6. mRNA expression levels of inflammatory factor-related genes in kidney tissue

[0099]

[0100] Note: Data are expressed as mean ± SEM, # indicates comparison with the control group. # P < 0.05 ## P < 0.01, ### P < 0.001; * indicates that compared with the stone group, * P < 0.05 ** P < 0.01, *** P < 0.001.

[0101] 7. Serum inflammatory factor levels

[0102] The results of detecting serum inflammatory factor levels in rats are shown in Table 7. Compared with the control group, the serum IL-1β level in the stone group was significantly increased (P < 0.05), indicating that the establishment of the stone model induced a systemic inflammatory response to some extent. In contrast, the high-dose traditional Chinese medicine compound group significantly reduced serum IL-1β levels (P < 0.05), suggesting that the traditional Chinese medicine compound has the effect of inhibiting systemic inflammation and regulating the body's immune response. There was no significant difference in serum TNF-α levels among the groups.

[0103] Table 7 Serum inflammatory factor levels

[0104]

[0105] Note: Data are expressed as mean ± SEM, # indicates comparison with the control group. # P < 0.05 ## P < 0.01, ###P < 0.001; * indicates that compared with the stone group, * P < 0.05 ** P < 0.01, *** P < 0.001.

[0106] The results of this case study indicate that the traditional Chinese medicine compound significantly alleviated the inhibition of weight gain caused by kidney stones and effectively regulated abnormal drinking behavior, helping to restore the body's normal physiological metabolism and growth and development. Furthermore, the traditional Chinese medicine compound intervention reversed the excessive acidification of urine caused by the kidney stone model, significantly reduced abnormally elevated serum urea, creatinine, and calcium levels, and significantly reduced the increase in organ indices caused by inflammation or hyperplasia, thus inhibiting local and systemic inflammatory responses to a certain extent.

[0107] Example 3

[0108] Thirty-six healthy female Wistar rats (body weight 170±20 g) around 6 weeks old were randomly divided into a control group, a cystitis group, a positive drug group (hydrochlorothiazide), a low-dose traditional Chinese medicine compound group, a medium-dose traditional Chinese medicine compound group, and a high-dose traditional Chinese medicine compound group (the traditional Chinese medicine compound prepared in Example 1, with low dose 250 mg / kg, medium dose 500 mg / kg, and high dose 750 mg / kg), with 6 rats in each group. They were given standard growth and reproduction feed and allowed free access to food and water for a feeding experiment lasting 1 week.

[0109] On days 1, 4, and 7 of the experiment, except for the control group, rats in all other groups were intraperitoneally injected with 75 mg / kg cyclophosphamide solution daily to establish a cystitis model. The positive control group was treated daily by gavage with hydrochlorothiazide aqueous solution at a dose of 1.5 mg / kg (calculated as hydrochlorothiazide). The low, medium, and high dose groups of the traditional Chinese medicine compound were treated daily by gavage with traditional Chinese medicine compound aqueous solution at doses of 250 mg / kg, 500 mg / kg, and 750 mg / kg (calculated as traditional Chinese medicine compound), respectively. The drug concentrations in each group were the same as in Example 2. The control group and the model group were given the same volume of physiological saline orally. The intervention was continued for 1 week. Changes in rat body weight were recorded during the experiment. Changes in urination behavior of rats in each group within 4 hours were recorded the day before the end of the experiment. At the end of the experiment, rat blood was collected to detect the expression level of the inflammatory factor TNF-α in serum, fresh urine was collected to detect the level of histamine in urine, and bladder tissue was collected to detect changes in the expression level of genes related to the mucosal barrier.

[0110] Experimental results

[0111] 1. Changes in rat body weight

[0112] The effects of the traditional Chinese medicine compound on reducing body weight in rats with cystitis are shown in Table 8. Compared with the control group, the body weight of rats in the other groups decreased sharply (P < 0.001). Compared with the cystitis group, the high dose of the traditional Chinese medicine compound effectively alleviated the body weight loss caused by the cystitis model.

[0113] Table 8. Changes in rat body weight

[0114]

[0115] Note: Data are expressed as mean ± SEM, # indicates comparison with the control group. # P < 0.05 ## P < 0.01, ### P < 0.001; * indicates that compared with the cystitis group, * P < 0.05 ** P < 0.01, *** P < 0.001.

[0116] 2. Changes in urination behavior

[0117] The effects of traditional Chinese medicine (TCM) compound on the urination behavior of rats in each group were evaluated. The results are shown in Table 9. The cystitis group showed a significantly higher urination frequency than the control group (P < 0.01) and a significantly lower single urine volume than the control group (P < 0.001), exhibiting typical cystitis symptoms such as urinary urgency and frequency. After intervention with the TCM compound, the urination frequency of rats in the low- and high-dose groups was significantly lower than that in the cystitis group (P < 0.05), and while there was no significant difference in single urine volume between the treatment groups and the cystitis group, all groups showed a certain degree of increase. The urination frequency of rats in the positive control group was also significantly lower than that in the cystitis group (P < 0.05), and the single urine volume was increased compared to the cystitis group.

[0118] Table 9 Changes in urination behavior in rats over 4 hours

[0119]

[0120] Note: Data are expressed as mean ± SEM, # indicates comparison with the control group. # P < 0.05 ## P < 0.01, ### P < 0.001; * indicates that compared with the cystitis group, * P < 0.05 ** P < 0.01, *** P < 0.001.

[0121] 3. Bladder Index

[0122] The results of the bladder index of each group of rats are shown in Table 10. The bladder index of the cystitis group was significantly increased, indicating that the establishment of the cystitis model induced bladder wall thickening and tissue edema. Compared with the cystitis group, the bladder index of each drug administration group was significantly reduced, and the improvement effect of the medium and high dose groups was extremely significant, indicating that it has stronger anti-inflammatory, edema-reducing and hyperplasia-inhibiting effects.

[0123] Table 10 Rat Bladder Index

[0124] Note: Data are expressed as mean ± SEM, # indicates comparison with the control group. # P < 0.05 ## P < 0.01, ### P < 0.001; * indicates that compared with the cystitis group, * P < 0.05 ** P < 0.01, *** P < 0.001.

[0125] 4. Urinary histamine levels

[0126] The results of urine histamine level detection are shown in Table 11. The urine histamine level in the cystitis group was significantly higher than that in the control group (P < 0.001), indicating the presence of mast cell activation and neurogenic inflammation in the model. After intervention with traditional Chinese medicine compound, the urine histamine levels in the medium and high dose groups were significantly lower than those in the model group (P < 0.001).

[0127] Table 11 Histamine levels in rat urine

[0128]

[0129] Note: Data are expressed as mean ± SEM, # indicates comparison with the control group. # P < 0.05 ## P < 0.01, ### P < 0.001; * indicates that compared with the cystitis group, * P < 0.05 ** P < 0.01, *** P < 0.001.

[0130] 5. Serum inflammatory factor levels

[0131] Serum TNF-α levels in rats were measured, and the results are shown in Table 12. Compared with the control group, serum TNF-α levels in the cystitis group were significantly increased (P < 0.01); compared with the cystitis group, serum TNF-α levels in each dose of the traditional Chinese medicine compound group were significantly decreased (P < 0.01), indicating that the compound can effectively inhibit the systemic inflammatory response caused by cystitis.

[0132] Table 12 Serum TNF-α levels in rats

[0133]

[0134] Note: Data are expressed as mean ± SEM, # indicates comparison with the control group. # P < 0.05 ## P < 0.01, ### P < 0.001; * indicates that compared with the cystitis group,* P < 0.05 ** P < 0.01, *** P < 0.001.

[0135] 6. Expression levels of mucosal barrier-related genes

[0136] The results of detecting the relative mRNA expression levels of key tight junction protein genes in bladder tissue are shown in Table 13. The relative mRNA expression levels of ZO-1, Occludin, and Claudin in the cystitis model group were significantly lower than those in the control group, indicating that the integrity of the bladder epithelial barrier structure was disrupted. The expression of the three genes in each dose group of the traditional Chinese medicine compound was restored to varying degrees, with the high dose group showing particularly significant effects.

[0137] Table 13. mRNA expression levels of mucosal barrier-related genes in bladder tissue.

[0138]

[0139] Note: Data are expressed as mean ± SEM, # indicates comparison with the control group. # P < 0.05 ## P < 0.01, ### P < 0.001; * indicates that compared with the cystitis group, * P < 0.05 ** P < 0.01, *** P < 0.001.

[0140] The results of this case study demonstrate that this traditional Chinese medicine compound can significantly reverse severe weight loss caused by cystitis and regulate the resulting urinary urgency and frequency, significantly reduce the bladder index, and effectively alleviate bladder wall thickening and edema. In terms of systemic anti-inflammatory and local barrier repair, it can significantly reduce serum levels of the pro-inflammatory factor TNF-α and significantly reduce urinary levels of histamine, a key pain-inducing and sensitizing mediator, while upregulating gene expression of tight junction proteins in bladder tissue. It provides a comprehensive treatment for cystitis through synergistic anti-inflammatory, barrier repair, neuromodulation, and organ protection mechanisms.

[0141] Example 4

[0142] The experimental animals were cats with cystitis diagnosed in Jiangning District, Nanjing City, between May and June 2025. Cases deemed suitable for standard treatment were selected from all affected cats for the experiment. The traditional Chinese medicine compound prepared according to Example 1 was added to the basal diet of the affected cats (2g / kg). Data from confirmed cystitis cases were collected and recorded, and changes in relevant indicators before and after treatment were compared.

[0143] Experimental results

[0144] 1. Changes in food intake in cats with cystitis

[0145] During the trial, the daily food intake of the affected cats was recorded and the average daily food intake was calculated to assess the cats' appetite and the palatability of the cat food. The results are shown in Table 14. In the later stage of treatment, the average daily food intake of the affected cats increased significantly (P<0.001), indicating that the cats' initiative to eat was enhanced and their appetite improved.

[0146] Table 14 Average daily food intake of affected cats

[0147]

[0148] Note: Data are expressed as Mean±SEM, * indicates comparison with day 1 of treatment. * P < 0.05 ** P < 0.01, *** P < 0.001.

[0149] 2. Clinical manifestations of cystitis in cats

[0150] During the trial, the cats' mental state, body temperature, respiration, heart rate, and defecation were observed and recorded daily. In the early stage of treatment, the cats' mental state was generally poor, and their respiration and heart rate were high. As the treatment progressed, the cats' mental state improved, and their respiration and heart rate returned to the normal range.

[0151] Table 15 Clinical Manifestations of Affected Cats

[0152]

[0153] 3. Changes in urination behavior in cats with cystitis

[0154] During the experiment, the number of times the cats urinated daily and the amount of litter clumping were observed and recorded to assess changes in their urination behavior. The results are shown in Table 16 and... Figure 2 Before treatment, the cats exhibited frequent, urgent, and painful urination, characterized by frequent attempts to urinate but small amounts of urine, occasionally accompanied by painful howling or dribbling, and a long time required to empty their bladders. After 15 days of treatment, the frequency of urination decreased significantly (P<0.01), and the amount of urine increased significantly, mainly manifested as larger and fewer litter clumps, and a significantly shorter time required for each urination (P<0.05 or P<0.01).

[0155] Table 16 Urinating Behavior of Cats with Affected Cats

[0156]

[0157] Note: Data are expressed as Mean±SEM, * indicates comparison with day 1 of treatment. * P < 0.05 ** P < 0.01, *** P < 0.001.

[0158] The results of this implementation case show that adding the cat food product of this invention can effectively improve the appetite and mental state of cats with cystitis, relieve their pain and discomfort, correct the cat's urination pattern from frequent small amounts to healthy small amounts and more frequent urination, and promote their recovery.

[0159] The composition provided by this invention has the effects of promoting urination and repairing the urinary tract mucosa. It can effectively relieve urinary stones, painful urination, hematuria or sand in the urine caused by damp heat in the lower abdomen, promote the repair of urinary tract mucosa in animals with urinary tract diseases, relieve inflammatory response, and prevent the formation of crystals in the urine.

[0160] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention. Therefore, the scope of protection of this patent should be determined by the appended claims.

Claims

1. A traditional Chinese medicine composition for preventing and treating feline urinary tract diseases, characterized in that, It is composed of the following components in parts by weight: 15-25 parts of Psoralea corylifolia, 15-25 parts of Alpinia oxyphylla, 10-20 parts of Fenugreek, 5-15 parts of Zea mays, 5-15 parts of Juncus effusus, 10-20 parts of Dioscorea hypoglauca, 10-20 parts of Phellodendron chinense, 10-20 parts of Lonicera japonica, 5-15 parts of Paeonia lactiflora, and 5-15 parts of Glycyrrhiza uralensis.

2. A traditional Chinese medicine extract for the prevention and treatment of feline urinary tract diseases, characterized in that, It is made from the following components in parts by weight: 15-25 parts of Psoralea corylifolia, 15-25 parts of Alpinia oxyphylla, 10-20 parts of Fenugreek, 5-15 parts of Zea mays, 5-15 parts of Juncus effusus, 10-20 parts of Dioscorea hypoglauca, 10-20 parts of Phellodendron chinense, 10-20 parts of Lonicera japonica, 5-15 parts of Paeonia lactiflora, and 5-15 parts of Glycyrrhiza uralensis.

3. The traditional Chinese medicine composition according to claim 1 or the traditional Chinese medicine extract according to claim 2, characterized in that, The weight proportions of each component are as follows: Psoralea corylifolia 18-22 parts, Alpinia oxyphylla 18-22 parts, Trigonella foenum-graecum 13-17 parts, Zea mays 8-12 parts, Juncus effusus 8-12 parts, Dioscorea hypoglauca 13-17 parts, Phellodendron chinense 13-17 parts, Lonicera japonica 13-17 parts, Paeonia lactiflora 8-12 parts, and Glycyrrhiza uralensis 8-12 parts.

4. The traditional Chinese medicine composition according to claim 1 or the traditional Chinese medicine extract according to claim 2, characterized in that, The weight proportions of each component are as follows: 20 parts of Psoralea corylifolia, 20 parts of Alpinia oxyphylla, 15 parts of Fenugreek, 10 parts of Zea mays, 10 parts of Juncus effusus, 15 parts of Dioscorea hypoglauca, 15 parts of Phellodendron chinense, 15 parts of Lonicera japonica, 10 parts of Paeonia lactiflora, and 10 parts of Glycyrrhiza uralensis.

5. The traditional Chinese medicine composition according to claim 1 or the traditional Chinese medicine extract according to claim 2, characterized in that, The components are: 20g of Psoralea corylifolia, 20g of Alpinia oxyphylla, 15g of Trigonella foenum-graecum, 10g of Zea mays, 10g of Juncus effusus, 15g of Dioscorea hypoglauca, 15g of Phellodendron chinense, 15g of Lonicera japonica, 10g of Paeonia lactiflora, and 10g of Glycyrrhiza uralensis.

6. The method for preparing the traditional Chinese medicine extract according to claim 2, characterized in that, Weigh each Chinese herbal medicine component according to the formula ratio, pulverize and extract each component to obtain the extract; The obtained extract was concentrated to obtain a paste; the obtained paste was dried to obtain the final product.

7. A product for preventing and treating feline urinary tract diseases, characterized in that, It includes the traditional Chinese medicine composition of claim 1, the traditional Chinese medicine extract of claim 2, or the traditional Chinese medicine composition or extract of any one of claims 3-5.

8. The product according to claim 7, characterized in that, The products include veterinary drugs, feed additives, or feed.

9. The traditional Chinese medicine composition according to claim 1, the traditional Chinese medicine extract according to claim 2, or the product according to claim 7, characterized in that, The urinary tract diseases mentioned include stones and cystitis.

10. The traditional Chinese medicine composition according to claim 1, the traditional Chinese medicine extract according to claim 2, or the product according to claim 7, characterized in that, The prevention and treatment of feline urinary tract diseases includes any one or more of the following functions; i. Promotes the repair of bladder mucosa in animals with urinary tract diseases; ii. To alleviate urinary difficulties and painful urination in animals suffering from urinary tract diseases; iii. To prevent the formation of crystals in cat urine or to promote the expulsion of existing stones in the urinary system.

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