Traditional Chinese medicine composition for preventing or treating prostatitis and preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for preventing or treating prostatitis and a preparation method and application thereof, and belongs to the technical field of health care medicines. The traditional Chinese medicine composition is prepared from the following components: semen plantaginis, herba taraxaci, radix sophorae flavescentis, cortex phellodendri, radix salviae miltiorrhizae, radix et rhizoma rhei, radix rehmanniae praeparata, fructus ligustri lucidi, semen cuscutae, herba cistanche, fructus lycii extract, longan extract, membrane of hen egg, fructus ziziphi jujubae extract, honey and rice fermentation filtrate. The traditional Chinese medicine composition is in a liquid dosage form prepared by a process including fermentation treatment. The traditional Chinese medicine composition prepared by the invention can relieve prostate tissue edema of a prostatitis model rat in a dose-dependent manner and reduce a prostate wet weight index, so that the traditional Chinese medicine composition has a certain improvement effect on prostate tissue hyperplasia and inflammatory swelling caused by chronic abacterial prostatitis.

Description

Technical Field

[0001] This application relates to the field of health care products technology, and in particular to a traditional Chinese medicine composition for the prevention or treatment of prostatitis, its preparation method and application. Background Technology

[0002] Currently, prostate health products mostly focus on improving a single pathological aspect, such as clearing heat, tonifying the kidneys, or promoting blood circulation, making it difficult to address the complex pathogenesis of "damp-heat stagnation combined with kidney deficiency" commonly seen in clinical practice. Existing technologies mainly suffer from the following shortcomings: 1) The formulation is simply a collection of ingredients, lacking clarity regarding the principal, assistant, and adjuvant herbs, and the synergistic effects between components have not been thoroughly explored and verified; 2) The preparation process often uses single water or alcohol extraction, making it difficult to ensure the full dissolution of effective components with different polarities, and prolonged high-temperature processing can easily lead to the inactivation of heat-sensitive components (such as some glycosides and volatile components). Therefore, providing a comprehensive prostate conditioning and health care liquid with a scientifically formulated, advanced process, significant synergistic effects, and easy absorption is of significant practical importance. Summary of the Invention

[0003] This application is made in view of the above-mentioned problems, and its purpose is to provide a traditional Chinese medicine composition for the prevention or treatment of prostatitis, a method for its preparation and application.

[0004] Specifically, the first aspect of this application provides a traditional Chinese medicine composition for the prevention or treatment of prostatitis, comprising the following components: The heat-clearing and dampness-eliminating group includes Plantago seed, dandelion, Sophora flavescens, and Phellodendron bark; The blood-activating and stasis-removing group includes salvia miltiorrhiza and rhubarb; The kidney-tonifying and foundation-strengthening group contains extracts of Rehmannia glutinosa, Ligustrum lucidum, Cuscuta chinensis, Cistanche deserticola, Lycium barbarum, and Longan. Moisturizing and Nourishing Mask Set: Contains phoenix shell, jujube extract and honey; Biological fermentation carrier: contains rice fermentation filtrate; The traditional Chinese medicine composition is a liquid dosage form prepared through a process including fermentation.

[0005] Furthermore, the following components are included in parts by mass: Plantain seed 80-120 parts, dandelion 80-120 parts, sophora flavescens 60-90 parts, phellodendron bark 60-90 parts; Salvia miltiorrhiza 50-80 parts, rhubarb 30-50 parts; 70-100 parts of Rehmannia glutinosa, 50-75 parts of Ligustrum lucidum, 50-75 parts of Cuscuta chinensis, 50-75 parts of Cistanche deserticola, 20-35 parts of Lycium barbarum extract, and 15-25 parts of Longan extract. 10-20 parts of phoenix skin, 20-30 parts of jujube extract, and 150-250 parts of honey; 300-500 portions of rice fermentation filtrate.

[0006] Furthermore, the blood-activating and stasis-removing group also includes Kochia scoparia and Cnidium monnieri, with Kochia scoparia comprising 40-60 parts and Cnidium monnieri comprising 40-60 parts.

[0007] Furthermore, the fermentation process is carried out using Lactobacillus plantarum.

[0008] A second aspect of the present invention provides a method for preparing a traditional Chinese medicine composition for the prevention or treatment of prostatitis, comprising the following steps: (1) The raw medicinal materials are grouped and processed according to their differences in properties to obtain extracts or pastes; (2) Mix the extracts or pastes obtained in step (1), add the rice fermentation filtrate, honey, wolfberry extract, longan extract, jujube extract, dodder seed and cistanche, adjust the pH and carry out probiotic fermentation. (3) Inactivate, separate, and finely filter the fermentation broth, add the micro powder of phoenix skin, homogenize, adjust the volume, and sterilize to obtain the final product.

[0009] Further, in step (1), the herbs Plantago asiatica, Taraxacum mongolicum, Kochia scoparia, Ligustrum lucidum, and Rehmannia glutinosa were extracted by decoction. For Salvia miltiorrhiza, Sophora flavescens, Phellodendron chinense, and Cnidium monnieri, ethanol reflux extraction was used for alcohol extraction. For rhubarb, a method combining low-temperature ethanol maceration and ultrasonic extraction was used for extraction.

[0010] Furthermore, the ethanol concentration used in the alcohol extraction is 65%-70%; And / or, the ethanol concentration for ethanol soaking of rhubarb is 50%-55%, and the ultrasonic extraction temperature is 30-40℃.

[0011] Further, in step (2), the pH of the mixture is adjusted to 5.8-6.2, Lactobacillus plantarum is inoculated, and fermentation is carried out at 36.5-37.5℃ for 40-56 hours, with the final pH of fermentation being 4.0-4.5.

[0012] Furthermore, in step (3), the micronized powder of the phoenix coat has a particle size D90≤10μm; the sterilization is low-temperature pasteurization, which is carried out at 72-75℃ for 15-20 seconds.

[0013] The third aspect of this application provides an application of a traditional Chinese medicine composition for the prevention or treatment of prostatitis, wherein the traditional Chinese medicine composition is used to prepare a health product with the effects of improving prostate health, clearing heat and dampness, promoting urination and / or promoting blood circulation and removing blood stasis.

[0014] The present invention has the following beneficial effects: The principal herbs in this invention are Plantago asiatica, Taraxacum mongolicum, Sophora flavescens, and Phellodendron chinense. These herbs powerfully clear damp-heat from the lower burner, but are bitter and cold in nature. The adjuvant herbs are a large group of kidney-tonifying and essence-replenishing herbs, including Rehmannia glutinosa, Ligustrum lucidum, Cuscuta chinensis, and Cistanche deserticola. On the one hand, they tonify the kidneys and strengthen the body to treat deficiency; on the other hand, they counteract the bitter and cold nature of the principal herbs, preventing excessive clearing and damage to Yang Qi and Yin fluids. The assistant herbs are Salvia miltiorrhiza, which invigorates blood and removes blood stasis, and Rheum palmatum, which invigorates blood and guides damp-heat downwards. In cases of damp-heat stagnation in the prostate, blood stasis makes it even more difficult to dissipate dampness. These two herbs improve local microcirculation in the gland, facilitating the penetration of the effective components of the principal herbs that clear heat and promote diuresis, as well as the excretion of metabolic products, achieving a synergistic effect of improved blood circulation leading to improved water metabolism. The adjuvant herbs, including jujube, longan, and wolfberry extracts, and the guiding herb honey, are sweet and moistening, which not only improve the taste but also moderate the bitter, cold, and drying properties of the principal and assistant herbs, protecting the gastrointestinal and urethral mucosa. Phoenix skin is rich in keratin, which can form a protective colloid in solution, further enhancing the stability and mucosal affinity of the preparation. This invention uses rice fermentation filtrate instead of pure water as the main solvent and carrier. It is rich in small molecule peptides, amino acids, organic acids and prebiotics. It not only has nutritional and mild anti-inflammatory effects, but also acts as a natural transdermal absorption promoter and stabilizer. It forms a complex system with traditional Chinese medicine extracts to improve the overall bioavailability. Detailed Implementation

[0015] To make the objectives, technical solutions, and advantages of this application clearer, the following description and illustration are provided in conjunction with embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of this application. All other embodiments obtained by those skilled in the art based on the embodiments provided in this application without inventive effort are within the scope of protection of this application.

[0016] Obviously, the following description is merely some examples or embodiments of this application. Those skilled in the art can apply this application to other similar scenarios without any inventive effort. Furthermore, it is understood that although the effort involved in such development may be complex and lengthy, for those skilled in the art related to the content disclosed in this application, any changes to design, manufacturing, or production based on the technical content disclosed in this application are merely conventional technical means and should not be construed as insufficient disclosure of the content of this application.

[0017] An embodiment of the first aspect of this application provides a traditional Chinese medicine composition for the prevention or treatment of prostatitis, comprising the following components: The heat-clearing and dampness-eliminating group includes Plantago seed, dandelion, Sophora flavescens, and Phellodendron bark; The blood-activating and stasis-removing group includes salvia miltiorrhiza and rhubarb; The kidney-tonifying and foundation-strengthening group contains extracts of Rehmannia glutinosa, Ligustrum lucidum, Cuscuta chinensis, Cistanche deserticola, Lycium barbarum, and Longan. Moisturizing and Nourishing Mask Set: Contains phoenix shell, jujube extract and honey; Biological fermentation carrier: contains rice fermentation filtrate; The traditional Chinese medicine composition is a liquid dosage form prepared through a process including fermentation.

[0018] In the aforementioned traditional Chinese medicine composition, the heat-clearing and dampness-eliminating group is based on Plantago seed, dandelion, Sophora flavescens, and Phellodendron amurense. These four herbs work together to clear heat, eliminate dampness, detoxify, and promote urination, targeting the fundamental pathogenesis of damp-heat accumulation in prostatitis. Plantago seed is sweet, cold, and slippery, clearing heat, promoting urination, eliminating dampness, and stopping diarrhea, guiding damp-heat out through urination, making it one of the principal herbs. Dandelion is bitter and cold, clearing heat, detoxifying, reducing swelling and dissipating nodules, especially effective in clearing damp-heat in the lower burner, significantly relieving urinary dribbling and painful urination caused by damp-heat. Sophora flavescens is bitter, cold, and descending, clearing heat, drying dampness, killing parasites, and promoting urination. Its active ingredient, matrine, has broad-spectrum antibacterial and anti-inflammatory activities, which can inhibit inflammatory reactions in the prostate. Phellodendron amurense is bitter and cold, clearing heat, drying dampness, purging fire, and detoxifying, effectively clearing damp-heat in the lower burner, and when used in conjunction with Sophora flavescens, it enhances the heat-clearing and dampness-drying effects. The blood-activating and stasis-removing group mainly consists of Salvia miltiorrhiza and rhubarb. Salvia miltiorrhiza is bitter and slightly cold, and it activates blood circulation, removes blood stasis, unblocks meridians, and relieves pain. It can improve local blood circulation in the prostate and promote the absorption of inflammatory substances. Modern pharmacological studies have shown that its components, such as tanshinone, have anti-inflammatory and anti-fibrotic effects. Rhubarb is bitter and cold, and it can eliminate stagnation, remove blood stasis, and unblock meridians. It can both activate blood circulation to promote blood flow and clear heat and fire to guide damp-heat downward. Its anthraquinone components can enhance intestinal peristalsis, promote toxin excretion, and reduce the inflammatory burden of the prostate. If the blood-activating and stasis-removing group further includes Kochia scoparia and Cnidium monnieri, Kochia scoparia clears heat and dampness, dispels wind and relieves itching, while Cnidium monnieri dries dampness, dispels wind, kills parasites and relieves itching. The two complement each other to enhance the effects of clearing heat and dampness, drying dampness and relieving itching, which is especially suitable for prostatitis patients with symptoms such as genital itching and dampness. The kidney-tonifying and foundation-strengthening group treats the root cause. Rehmannia glutinosa (processed) is sweet and warm, nourishing blood and yin, replenishing essence and marrow, making it a key herb for tonifying kidney yin. Ligustrum lucidum (purple privet fruit) is sweet, bitter, and cool, nourishing the liver and kidneys, improving eyesight and darkening hair, and can nourish kidney yin and benefit liver blood. Cuscuta chinensis (dodder seed) is pungent, sweet, and neutral, tonifying the kidneys and replenishing essence, nourishing the liver and improving eyesight, making it a good herb for gently tonifying the liver and kidneys without being drying or greasy. Cistanche deserticola (cistanche deserticola) is sweet, salty, and warm, tonifying kidney yang, replenishing essence and blood, and moistening the intestines to relieve constipation. Its warming and tonifying properties are not drying or hot, and it can help kidney yang and replenish essence and blood to strengthen the foundation. Lycium barbarum extract is rich in Lycium barbarum polysaccharides and other components, nourishing the liver and kidneys, replenishing essence and improving eyesight, and enhancing the body's immunity. Longan extract tonifies the heart and spleen, nourishes blood and calms the mind. Combined with other kidney-tonifying herbs, it works synergistically to nourish kidney yin, tonify kidney yang, and replenish essence and blood, thus strengthening kidney qi and regulating bladder qi transformation, thereby relieving symptoms such as frequent and urgent urination and preventing repeated invasion of damp-heat pathogens. In the moisturizing and protective film group, phoenix skin is sweet and neutral in nature, and can nourish yin and moisten the lungs, astringe sores and protect the mucous membrane. When its micro powder is added to the preparation, it can form a protective film on the mucous membrane surface, reduce inflammatory stimulation, and promote mucous membrane repair. Jujube extract replenishes qi and blood, and calms the mind. Its polysaccharides, vitamins and other components can enhance the body's resistance and moderate the effects of the medicine. Honey is sweet and neutral, replenishes the middle jiao and moistens dryness, relieves pain and detoxifies. It can not only correct the taste and improve the taste of the preparation, but also moderate the properties of bitter and cold medicines in the formula and protect the gastrointestinal mucosa. At the same time, its viscosity can enhance the stability of the preparation.The rice fermentation filtrate, a bio-fermentation carrier, provides a good matrix environment for the entire composition. Its rich content of small molecule peptides, amino acids, organic acids, B vitamins, and prebiotics not only provides nutrition for probiotic fermentation but also has certain nutritional and health benefits and mild anti-inflammatory effects. It can promote the dissolution and absorption of the effective components of traditional Chinese medicine, improve the bioavailability of the preparation, and work synergistically with the extracts of traditional Chinese medicine.

[0019] In this embodiment, the components are described in parts by mass as follows: Plantain seed 80-120 parts, dandelion 80-120 parts, sophora flavescens 60-90 parts, phellodendron bark 60-90 parts; Salvia miltiorrhiza 50-80 parts, rhubarb 30-50 parts; 70-100 parts of Rehmannia glutinosa, 50-75 parts of Ligustrum lucidum, 50-75 parts of Cuscuta chinensis, 50-75 parts of Cistanche deserticola, 20-35 parts of Lycium barbarum extract, and 15-25 parts of Longan extract. 10-20 parts of phoenix skin, 20-30 parts of jujube extract, and 150-250 parts of honey; 300-500 portions of rice fermentation filtrate.

[0020] In this embodiment, the blood-activating and stasis-removing group also includes Kochia scoparia and Cnidium monnieri, wherein Kochia scoparia is 40-60 parts and Cnidium monnieri is 40-60 parts.

[0021] Furthermore, the fermentation process is carried out using Lactobacillus plantarum PS128.

[0022] A second aspect of the present invention provides a method for preparing a traditional Chinese medicine composition for the prevention or treatment of prostatitis, comprising the following steps: (1) The raw medicinal materials are grouped and processed according to their differences in properties to obtain extracts or pastes; (2) Mix the extracts or pastes obtained in step (1), add the rice fermentation filtrate, honey, wolfberry extract, longan extract, jujube extract, dodder seed and cistanche, adjust the pH and carry out probiotic fermentation. (3) Inactivate, separate, and finely filter the fermentation broth, add the micro powder of phoenix skin, homogenize, adjust the volume, and sterilize to obtain the final product.

[0023] In this embodiment, in step (1), Plantago seed, dandelion, Kochia scoparia fruit, Ligustrum lucidum fruit, and Rehmannia glutinosa are mixed and soaked in purified water at 10 times the total weight of the herbs for 30 minutes. A stepped heating method is used for decoction: first, the temperature is maintained at 85-90℃ for 40 minutes, then the temperature is increased to 95-100℃ and gently boiled for 50 minutes. The mixture is filtered, and the filtrate is collected. The residue is then added to 8 times the amount of purified water and decocted at 95-100℃ for 40 minutes. The two filtrates are combined.

[0024] The herbs, including Salvia miltiorrhiza, Sophora flavescens, Phellodendron chinense, and Cnidium monnieri, were extracted by refluxing with 70% v / v ethanol solution (6 times their total weight) for 1 hour; the mixture was filtered, and the filtrate was collected. The residue was then extracted by refluxing with 65% v / v ethanol solution (4 times their total weight) for 45 minutes; the filtrates from the two extractions were combined, and the ethanol was recovered under reduced pressure at 60℃ and -0.08MPa to obtain a concentrated ethanol extract.

[0025] Rhubarb was pulverized into coarse powder (passed through a 20-mesh sieve) and soaked in 50% v / v ethanol solution at room temperature (25±3℃) for 24 hours in a sealed container. Subsequently, ultrasonic-assisted extraction was performed: ultrasonic frequency 40kHz, power 300W, ultrasonic treatment at 35℃ for 20 minutes, followed by filtration, and the filtrate was reserved.

[0026] In step (2), the water extract filtrate and the alcohol extract concentrate are stirred and mixed evenly at 45-50℃. Then, the rhubarb extract obtained in step (1) is slowly added and stirred continuously. Then, the proportions of Cuscuta chinensis, Cistanche deserticola (crushed through an 80-mesh sieve), Lycium barbarum extract, Longan extract, and Jujube extract are added to the mixture in sequence and stirred until completely dissolved.

[0027] Adjust the pH of the mixture to 5.8-6.2 with lactic acid, add the appropriate amount of rice fermentation filtrate, and then add purified water to a total volume of approximately 800 L. Stir well, and inoculate with activated *Lactobacillus plantarum* seed culture at an inoculation rate of 3% v / v of the mixture volume. Ferment at 36.5-37.5℃ under anaerobic conditions for 48 hours. During this period, sample and monitor pH and total acidity every 12 hours. The pH should stabilize at 4.0-4.5 at the end of fermentation.

[0028] In step (3), the fermentation broth is rapidly heated to 80°C and kept for 10 minutes to terminate fermentation and sterilize; then it is immediately cooled to below 10°C and centrifuged at 4°C and 8000 rpm for 15 minutes to obtain the supernatant; the supernatant is then filtered through 0.45 μm and 0.22 μm microporous membranes to obtain a clear filtrate.

[0029] Add the specified amount of honey to the filtrate and stir well. Then, pulverize the phoenix skin (particle size D90≤10μm), slowly add it, and disperse it using high-speed shearing (3000rpm, 10 minutes). Finally, add purified water to a final volume of 1000L and perform high-pressure homogenization (pressure 20MPa, 2 cycles). Use low-temperature pasteurization, holding at 72-75℃ for 15-20 seconds. After cooling, fill and seal under aseptic conditions.

[0030] An embodiment of the third aspect of this application provides an application of a traditional Chinese medicine composition for the prevention or treatment of prostatitis, wherein the traditional Chinese medicine composition is used to prepare a health product having the effects of improving prostate health, clearing heat and dampness, promoting urination and / or promoting blood circulation and removing blood stasis.

[0031] Example The following examples describe the disclosure of this invention in more detail. These examples are merely illustrative, as various modifications and variations will be apparent to those skilled in the art within the scope of this disclosure. Unless otherwise stated, all parts, percentages, and ratios reported in the following examples are based on weight. Unless otherwise stated, all reagents used in the examples are available commercially or synthesized using conventional methods and are ready for use without further processing. Unless otherwise stated, all instruments used in the examples are available commercially.

[0032] Example 1 A traditional Chinese medicine composition for the prevention or treatment of prostatitis, comprising the following components in parts by weight: Plantain seed 1050 parts, dandelion 100 parts, sophora flavescens 75 parts, phellodendron bark 80 parts; Salvia miltiorrhiza 70 parts, rhubarb 45 parts, Kochia scoparia 55 parts, and Cnidium monnieri 50 parts; 80 parts of Rehmannia glutinosa, 65 parts of Ligustrum lucidum, 65 parts of Cuscuta chinensis, 60 parts of Cistanche deserticola, 25 parts of Lycium barbarum extract, and 20 parts of Longan extract. 15 parts of phoenix skin, 20 parts of jujube extract, and 180 parts of honey; 450 portions of rice fermentation filtrate.

[0033] The method for preparing the traditional Chinese medicine composition for the prevention or treatment of prostatitis includes the following steps: (1) Mix Plantago asiatica, Taraxacum mongolicum, Kochia scoparia, Ligustrum lucidum, and Rehmannia glutinosa, add 10 times the total weight of the herbs in purified water, and soak for 30 minutes; use a step-by-step heating method to decoct: first maintain at 90℃ for 40 minutes, then raise the temperature to 100℃ and maintain a gentle boil for 50 minutes. Filter and collect the filtrate; add 8 times the amount of purified water to the dregs and decoct at 100℃ for 40 minutes; combine the two filtrates; The herbs, including Salvia miltiorrhiza, Sophora flavescens, Phellodendron chinense, and Cnidium monnieri, were extracted by reflux with 70% v / v ethanol solution, which was 6 times their total weight, for 1 hour. The mixture was filtered, and the filtrate was collected. The residue was then extracted by reflux with 65% v / v ethanol solution, which was 4 times its total weight, for 45 minutes. The filtrates from the two extractions were combined, and the ethanol was recovered under reduced pressure at 60℃ and -0.08MPa to obtain a concentrated extract. Rhubarb was pulverized into coarse powder (passed through a 20-mesh sieve) and soaked in 50% v / v ethanol solution at room temperature (25°C) for 24 hours in a sealed container. Subsequently, ultrasonic-assisted extraction was performed: ultrasonic frequency 40kHz, power 300W, ultrasonic treatment at 35°C for 20 minutes, followed by filtration. The filtrate was then reserved. (2) Mix the water extract filtrate and the alcohol extract concentrate at 50°C until homogeneous; then slowly add the rhubarb extract obtained in step (1) and continue stirring. Then add the appropriate amounts of Cuscuta chinensis, Cistanche deserticola (crushed through an 80-mesh sieve), Lycium barbarum extract, Longan extract, and Jujube extract to the mixture in sequence and stir until completely dissolved. Adjust the pH of the mixture to 6.2 with lactic acid, add the appropriate amount of rice fermentation filtrate, and add purified water to a total volume of approximately 800L. Stir well, and inoculate with activated Lactobacillus plantarum seed culture at an inoculation rate of 3% v / v of the mixture volume. Ferment at 37.5℃ under anaerobic conditions for 48 hours. During this period, sample and monitor pH and total acidity every 12 hours. The pH should stabilize at 4.5 at the end of fermentation. (3) The fermentation broth is rapidly heated to 80°C and kept for 10 minutes to terminate fermentation and sterilize; then it is immediately cooled to below 10°C and centrifuged at 4°C and 8000 rpm for 15 minutes to collect the supernatant; the supernatant is then filtered through 0.45 μm and 0.22 μm microporous membranes to obtain a clear filtrate. Add the specified amount of honey to the filtrate and stir well. Then, pulverize the phoenix skin into ultrafine particles (particle size D90≤10μm), slowly add it, and disperse it under high-speed shear (3000rpm, 10 minutes). Finally, add purified water to a final volume of 1000L and perform high-pressure homogenization (pressure 20MPa, 2 cycles). Use low-temperature pasteurization to maintain the temperature at 75℃ for 15 seconds. After cooling, fill and seal under aseptic conditions.

[0034] Example 2 A traditional Chinese medicine composition for the prevention or treatment of prostatitis, comprising the following components in parts by weight: Plantain seed 100 parts, dandelion 100 parts, sophora flavescens 80 parts, phellodendron bark 70 parts; Salvia miltiorrhiza 60 parts, rhubarb 40 parts, Kochia scoparia 50 parts, Cnidium monnieri 50 parts; 80 parts of Rehmannia glutinosa, 60 parts of Ligustrum lucidum, 60 parts of Cuscuta chinensis, 60 parts of Cistanche deserticola, 30 parts of Lycium barbarum extract, and 20 parts of Longan extract; 15 parts of phoenix skin, 25 parts of jujube extract, and 200 parts of honey; 400 portions of rice fermentation filtrate.

[0035] The method for preparing the traditional Chinese medicine composition for the prevention or treatment of prostatitis includes the following steps: (1) Mix Plantago asiatica, Taraxacum mongolicum, Kochia scoparia, Ligustrum lucidum, and Rehmannia glutinosa, add 10 times the total weight of the herbs in purified water, and soak for 30 minutes; use a step-by-step heating method to decoct: first maintain at 85℃ for 40 minutes, then raise the temperature to 95℃ and maintain for 50 minutes. Filter and collect the filtrate; add 8 times the amount of purified water to the dregs and decoct at 95℃ for 40 minutes; combine the two filtrates; The herbs, including Salvia miltiorrhiza, Sophora flavescens, Phellodendron chinense, and Cnidium monnieri, were extracted by reflux with 70% v / v ethanol solution, which was 6 times their total weight, for 1 hour. The mixture was filtered, and the filtrate was collected. The residue was then extracted by reflux with 65% v / v ethanol solution, which was 4 times its total weight, for 45 minutes. The filtrates from the two extractions were combined, and the ethanol was recovered under reduced pressure at 60℃ and -0.08MPa to obtain a concentrated extract. Rhubarb was pulverized into coarse powder (passed through a 20-mesh sieve) and soaked in 50% v / v ethanol solution at room temperature (25°C) for 24 hours in a sealed container. Subsequently, ultrasonic-assisted extraction was performed: ultrasonic frequency 40kHz, power 300W, ultrasonic treatment at 35°C for 20 minutes, followed by filtration. The filtrate was then reserved. (2) Mix the water extract filtrate and the alcohol extract concentrate at 45°C until homogeneous; then slowly add the rhubarb extract obtained in step (1) and continue stirring. Then add the appropriate amounts of Cuscuta chinensis, Cistanche deserticola (crushed through an 80-mesh sieve), Lycium barbarum extract, Longan extract, and Jujube extract to the mixture in sequence and stir until completely dissolved. Adjust the pH of the mixture to 6 with lactic acid, add the appropriate amount of rice fermentation filtrate, and add purified water to a total volume of approximately 800L. Stir well, inoculate with activated Lactobacillus plantarum seed liquid at an inoculation rate of 3% v / v of the mixture volume, and ferment at 37℃ under anaerobic conditions for 48 hours. During this period, sample and monitor pH and total acidity every 12 hours. The pH should stabilize at 4.2 at the end of fermentation. (3) The fermentation broth is rapidly heated to 80°C and kept for 10 minutes to terminate fermentation and sterilize; then it is immediately cooled to below 10°C and centrifuged at 4°C and 8000 rpm for 15 minutes to collect the supernatant; the supernatant is then filtered through 0.45 μm and 0.22 μm microporous membranes to obtain a clear filtrate. Add the specified amount of honey to the filtrate and stir well; then, pulverize the phoenix skin into ultrafine particles (particle size D90≤10μm), slowly add it and disperse it at high speed (3000rpm, 10 minutes); finally, add purified water to a final volume of 1000L and perform high-pressure homogenization (pressure 20MPa, 2 cycles); use low-temperature pasteurization, holding at 73℃ for 15 seconds; after cooling, fill and seal under aseptic conditions.

[0036] Experimental Case The traditional Chinese medicine composition prepared in Example 1 for the prevention or treatment of prostatitis was used in the following tests: One hundred healthy male SD rats, weighing 200±20g, were randomly divided into 5 groups of 20 rats each after one week of acclimatization.

[0037] Grouping: Blank control group Model control group Example 1: Low-dose group of the product (0.5 mL / kg·bw) Example 1: Dosage group of the product (1.0 mL / kg·bw) Example 1: High-dose group of the product (2.0 mL / kg·bw) Modeling: Except for the blank control group, rats in the other groups were injected percutaneously into the dorsal lobe of the prostate with 1% carrageenan solution (0.1 mL / 100g) to prepare a chronic nonbacterial prostatitis model. The modeling period was 7 days.

[0038] Administration: Administration began after successful model establishment and continued for 28 days. The route of administration mimicked human use: rats were administered via rectal enema. Administered once daily at a fixed time. Rats were fasted for 4 hours prior to administration. Using a specialized thin tubing connected to a syringe, the test substance was slowly injected into the rat rectum to a depth of approximately 3-4 cm. After injection, the rats were kept upside down for a short time to prevent leakage. The control group and the model group received an equal volume of physiological saline. Twenty-four hours after the last administration, blood was collected from the abdominal aorta, the animals were euthanized, and the prostate tissue was completely harvested.

[0039] 1. The results of the prostate wet weight index (mg / 100g body weight) test are shown in Table 1.

[0040] Table 1 Results of prostate wet weight index test

[0041] 2. The results of the detection of inflammatory factor levels in prostate tissue (ELISA method, pg / mg prot) are shown in Tables 2 and 3.

[0042] Table 2 Results of Tumor Necrosis Factor-α (TNF-α) Detection

[0043] Table 3. Results of Interleukin-1β (IL-1β) Detection

[0044] The above experiments show that, compared with the blank control group, the prostate wet weight index of rats in the model control group was significantly increased (P<0.01), indicating that the chronic nonbacterial prostatitis model was successfully established. The prostate wet weight index of the low, medium, and high dose groups of the product in Example 1 all showed varying degrees of decrease. Specifically, the low-dose group showed a decrease in prostate wet weight index compared with the model control group, but the difference was not statistically significant (P>0.05); the medium-dose group showed a significant decrease in prostate wet weight index compared with the model control group (P<0.05), down to 204.3±17.2 mg / 100g body weight; the high-dose group further decreased the prostate wet weight index to 185.7±16.8 mg / 100g body weight, showing a highly significant difference compared with the model control group (P<0.01), and was closer to the level of the blank control group. This result indicates that the traditional Chinese medicine composition prepared in Example 1 of this invention can dose-dependently reduce prostate tissue edema and decrease the prostate wet weight index in prostatitis model rats, suggesting that it has a certain ameliorative effect on prostate tissue hyperplasia and inflammatory swelling caused by chronic nonbacterial prostatitis.

[0045] It should be noted that this application is not limited to the above-described embodiments. The above embodiments are merely examples, and any embodiments with the same structure and effect as the technical concept within the scope of this application are included in the technical scope of this application. Furthermore, various modifications that can be conceived by those skilled in the art to the embodiments, and other ways of constructing by combining some of the constituent elements of the embodiments, without departing from the spirit of this application, are also included in the scope of this application.

Claims

1. A traditional Chinese medicine composition for the prevention or treatment of prostatitis, characterized in that, Includes the following components: The heat-clearing and dampness-eliminating group includes Plantago seed, dandelion, Sophora flavescens, and Phellodendron bark; The blood-activating and stasis-removing group includes salvia miltiorrhiza and rhubarb; The kidney-tonifying and foundation-strengthening group contains extracts of Rehmannia glutinosa, Ligustrum lucidum, Cuscuta chinensis, Cistanche deserticola, Lycium barbarum, and Longan. Moisturizing and Nourishing Mask Set: Contains phoenix shell, jujube extract and honey; Biological fermentation carrier: contains rice fermentation filtrate; The traditional Chinese medicine composition is a liquid dosage form prepared through a process including fermentation.

2. The traditional Chinese medicine composition for the prevention or treatment of prostatitis according to claim 1, characterized in that, The following components are included in parts by mass: Plantain seed 80-120 parts, dandelion 80-120 parts, sophora flavescens 60-90 parts, phellodendron bark 60-90 parts; Salvia miltiorrhiza 50-80 parts, rhubarb 30-50 parts; 70-100 parts of Rehmannia glutinosa, 50-75 parts of Ligustrum lucidum, 50-75 parts of Cuscuta chinensis, 50-75 parts of Cistanche deserticola, 20-35 parts of Lycium barbarum extract, and 15-25 parts of Longan extract. 10-20 parts of phoenix skin, 20-30 parts of jujube extract, and 150-250 parts of honey; 300-500 portions of rice fermentation filtrate.

3. The traditional Chinese medicine composition for the prevention or treatment of prostatitis according to claim 1, characterized in that, The blood-activating and stasis-removing group also includes Kochia scoparia and Cnidium monnieri, with 40-60 parts of Kochia scoparia and 40-60 parts of Cnidium monnieri.

4. The traditional Chinese medicine composition for the prevention or treatment of prostatitis according to claim 1, characterized in that, The fermentation process is carried out using Lactobacillus plantarum.

5. A method for preparing a traditional Chinese medicine composition for the prevention or treatment of prostatitis, characterized in that, The preparation of the traditional Chinese medicine composition for the prevention or treatment of prostatitis according to any one of claims 1-4 comprises the following steps: (1) The raw medicinal materials are grouped and processed according to their differences in properties to obtain extracts or pastes; (2) Mix the extracts or pastes obtained in step (1), add the rice fermentation filtrate, honey, wolfberry extract, longan extract, jujube extract, dodder seed and cistanche, adjust the pH and carry out probiotic fermentation. (3) Inactivate, separate, and finely filter the fermentation broth, add the micro powder of phoenix skin, homogenize, adjust the volume, and sterilize to obtain the final product.

6. The method for preparing the traditional Chinese medicine composition for the prevention or treatment of prostatitis according to claim 5, characterized in that, Step (1) For Plantago asiatica, Taraxacum mongolicum, Kochia scoparia, Ligustrum lucidum and Rehmannia glutinosa, water extraction was carried out by decoction; For Salvia miltiorrhiza, Sophora flavescens, Phellodendron chinense, and Cnidium monnieri, ethanol reflux extraction was used for alcohol extraction. For rhubarb, a method combining low-temperature ethanol maceration and ultrasonic extraction was used for extraction.

7. The method for preparing the traditional Chinese medicine composition for the prevention or treatment of prostatitis according to claim 6, characterized in that, The ethanol concentration used in the alcohol extraction is 65%-70%; And / or, the ethanol concentration for ethanol soaking of rhubarb is 50%-55%, and the ultrasonic extraction temperature is 30-40℃.

8. The method for preparing the traditional Chinese medicine composition for the prevention or treatment of prostatitis according to claim 5, characterized in that, In step (2), the pH of the mixture is adjusted to 5.8-6.2, and Lactobacillus plantarum is inoculated. Fermentation is carried out at 36.5-37.5℃ for 40-56 hours, and the final pH of fermentation is 4.0-4.

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9. The method for preparing the traditional Chinese medicine composition for the prevention or treatment of prostatitis according to claim 5, characterized in that, In step (3), the micronized powder of the phoenix coat has a particle size D90≤10μm; the sterilization is low-temperature pasteurization, which is carried out at 72-75℃ for 15-20 seconds.

10. The application of a traditional Chinese medicine composition for the prevention or treatment of prostatitis, characterized in that, The traditional Chinese medicine composition is used to prepare health products with the effects of improving prostate health, clearing heat and dampness, promoting urination and / or promoting blood circulation and removing blood stasis.

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