Traditional Chinese medicine composition with anti-inflammatory and diuretic effects, preparation method and application thereof

Abstract

The application provides a traditional Chinese medicine composition with anti-inflammatory and diuretic effects, a preparation method and application, and relates to the technical field of traditional Chinese medicines.The traditional Chinese medicine composition is prepared from the following components in parts by weight: 25-55 parts of honeysuckle, 20-45 parts of dandelion, 10-30 parts of cattail, 5-15 parts of wormwood, 1.5-5 parts of stoneve extract and 5-15 parts of scutellaria; the stoneve extract is prepared by ethanol reflux extraction, alkali immersion and acid precipitation.The preparation method of the traditional Chinese medicine composition comprises the following steps: S1, mixing dandelion, wormwood and scutellaria, and decocting them in water to obtain filtrate A and residue A; S2, reflux extracting residue A, honeysuckle and cattail with 20%-40% ethanol to obtain filtrate B and residue B; and S3, mixing filtrate B, filtrate A and stoneve extract.The six components cooperate with each other to bring excellent diuretic, anti-inflammatory and urinary tract infection treatment effects, and can improve the urine output, reduce the content of inflammatory factors and bacterial load.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition with anti-inflammatory and diuretic effects, its preparation method, and its application. Background Technology

[0002] Urinary tract infection (UTI) is an infection of the urinary system caused primarily by bacteria, mainly manifesting as symptoms such as urinary frequency, urgency, and dysuria. It is one of the most common urinary system diseases in clinical practice. Traditional treatment mainly relies on cephalosporins and quinolone antibiotics; however, long-term use can lead to antibiotic resistance. Clinical practice and related research have confirmed that traditional Chinese medicine can prevent and treat UTIs through its antibacterial and anti-inflammatory effects.

[0003] The traditional Chinese medicine formula Yinhua Miyanling Tablet (YMT) originates from the Bazheng San formula in the *Taiping Huimin Heji Jufang* (Formulary of the Bureau of Imperial Medical Services for the Benefit of the People). It consists of ten herbs: Polygonum aviculare, Juncus effusus, Lophatherum gracile, Scutellaria barbata, Akebia trifoliata, Pyrrosia lingua, Lonicera japonica, Dianthus superbus, Taxillus chinensis, and Plantago asiatica. Its main functions include clearing heat and detoxifying, and promoting diuresis and relieving strangury. It is widely used to treat acute cystitis, acute pyelonephritis, and damp-heat syndrome in the lower jiao (lower burner), with clinical symptoms including frequent and urgent urination, urethral stinging or hematuria, fever and chills, and lower back pain. While Yinhua Miyanling Tablet has anti-inflammatory and diuretic effects, its anti-inflammatory potency is relatively weak, its onset of action is slow, and it requires a large dosage. Generally, it needs to be taken continuously for 7-14 days to see results. Furthermore, the formula contains a large number of cold-natured herbs, and long-term use can easily damage the spleen and stomach's yang energy. Therefore, its anti-inflammatory and diuretic effects still need further improvement.

[0004] Chinese invention patent CN106237162A discloses a traditional Chinese medicine composition for treating acute pyelonephritis and its preparation method. Even though this composition, based on Yin Hua Mi Yan Ling tablets, adds four diuretic and urinary tract-clearing ingredients—talc, gardenia, rhubarb, and licorice—it still requires three consecutive courses of treatment to eliminate symptoms in clinical diagnosis and treatment of patients with acute pyelonephritis (accompanied by inflammation of the bladder or urethra), and the composition contains numerous ingredients. Therefore, further research and improvement of the traditional Chinese medicine formulation are needed to enhance its anti-inflammatory and diuretic effects.

[0005] Chinese invention patent CN101940733A discloses a traditional Chinese medicine composition for nephritis and its preparation method. The effective components of this traditional Chinese medicine composition are made from raw materials including Atractylodes lancea, Poria cocos, Imperata cylindrica, Stephania tetrandra, Panax ginseng, Polygonatum sibiricum, Cuscuta chinensis, Lycium barbarum, Lonicera japonica, Taraxacum mongolicum, Astragalus membranaceus, Epimedium brevicornu, Atractylodes macrocephala, and Citrus reticulata. The prepared medicine has the effects of tonifying the kidney and spleen, promoting diuresis and reducing edema. It can be used to treat chronic nephritis with stable efficacy and a total effective rate of over 86.0% in treating nephritis. Chinese invention patent CN116688070A records a traditional Chinese medicine composition, a traditional Chinese medicine preparation, its preparation method, and its application. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Astragalus membranaceus 5-50 parts, Lonicera japonica 5-50 parts, Forsythia suspensa 0-30 parts, Ailanthus altissima bark 0-15 parts, Rheum palmatum 3-15 parts, Magnolia officinalis 3-15 parts, Caesalpinia sappan 3-15 parts, and Smilax glabra 3-30 parts. It can replenish qi and blood, strengthen the body's resistance, eliminate pathogens, detoxify, and promote urination; it is used to treat urinary tract infections caused by damp-heat accumulation in the lower body, and effectively prevents and treats recurrent urinary tract infections. Although numerous traditional Chinese medicine (TCM) compositions for improving urinary tract infections and promoting diuresis have emerged, most of these compositions have complex components and do not demonstrate synergistic effects between the components; furthermore, there is a need to shorten the treatment course and improve the anti-inflammatory and diuretic effects. Summary of the Invention

[0006] This invention addresses the problems existing in the prior art by providing a traditional Chinese medicine composition with anti-inflammatory and diuretic effects, along with its preparation method and application. The six components—honeysuckle, dandelion, rush pith, artemisia capillaris, pyrrosia lingua extract, and scutellaria baicalensis—work together to deliver excellent diuretic, anti-inflammatory, and urinary tract infection treatment effects, increase urine output, and reduce the content of inflammatory factors and the number of bacteria.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows: First, the present invention provides a traditional Chinese medicine composition with anti-inflammatory and diuretic effects, which is made of the following components by weight: 25-55 parts honeysuckle, 20-45 parts dandelion, 10-30 parts rush pith, 5-15 parts artemisia capillaris, 1.5-5 parts pyrrosia lingua extract and 5-15 parts scutellaria baicalensis.

[0008] Preferably, the traditional Chinese medicine composition is made from the following components in parts by weight: 30-50 parts honeysuckle, 24-40 parts dandelion, 15-25 parts rush pith, 8-12 parts artemisia capillaris, 2-4 parts pyrrosia lingua extract and 8-13 parts scutellaria baicalensis.

[0009] More preferably, the traditional Chinese medicine composition is made from the following components in parts by weight: 40 parts honeysuckle, 30 parts dandelion, 20 parts rush pith, 10 parts artemisia capillaris, 3 parts pyrrosia lingua extract and 10 parts scutellaria baicalensis.

[0010] Preferably, the preparation method of the Pyrrosia lingua extract includes the following steps: (1) The medicinal material of Pyrrosia lingua was extracted by reflux with ethanol of 80%-95% by volume, filtered, and filtrate 1 and residue 1 were obtained. (2) Filter residue 1 was extracted with alkaline solution and filtered to obtain filtrate 2; (3) Adjust the pH of filtrate 2 to 4.5-5.5 to obtain precipitate; (4) The filtrate 1 is concentrated to obtain a concentrate, which is mixed with the precipitate from step (3) and dried to obtain the Pyrrosia extract.

[0011] In this invention, the medicinal material *Pyrrosia lingua* (Thunb.) Farw. is the dried leaf of *Pyrrosia lingua*, *Pyrrosia lingua*, or *Pyrrosia petiolate*, all belonging to the Polypodiaceae family.

[0012] More preferably, in step (1), the Pyrrosia lingua herb is first pulverized before reflux extraction, and the particle size is 10-100 mesh.

[0013] More preferably, the particle size of the pulverized material is 50 mesh.

[0014] More preferably, in step (1), the volume concentration of the ethanol is 90%.

[0015] More preferably, in step (1), the temperature of the reflux extraction is 50-65℃.

[0016] More preferably, in step (1), the reflux extraction temperature is 60°C.

[0017] More preferably, in step (1), the reflux extraction time is 1.5-3 hours.

[0018] More preferably, in step (1), the reflux extraction time is 2 hours.

[0019] More preferably, in step (1), the solid-liquid ratio of the reflux extraction is 1g:15-25mL.

[0020] More preferably, in step (1), the solid-liquid ratio of the reflux extraction is 1g:20mL.

[0021] More preferably, in step (2), the alkaline solution is an alkaline solution with a mass concentration of 0.5%-3%.

[0022] More preferably, in step (2), the alkaline solution is an alkaline solution with a mass concentration of 2%.

[0023] More preferably, in step (2), the alkaline solution is selected from at least one of sodium hydroxide solution, potassium hydroxide solution, ammonia solution, and sodium carbonate solution.

[0024] More preferably, in step (2), the alkaline solution is a sodium hydroxide solution.

[0025] More preferably, in step (2), the extraction temperature is 60-80℃.

[0026] More preferably, in step (2), the extraction temperature is 70°C.

[0027] More preferably, in step (2), the extraction is performed 1-3 times; even more preferably, in step (2), the extraction is performed 2 times.

[0028] More preferably, in step (2), the extraction time is 2-3 hours each time; even more preferably, in step (2), the extraction time is 2.5 hours each time.

[0029] More preferably, in step (2), the ratio of material to liquid for each extraction is 1g:10-20mL; even more preferably, in step (2), the ratio of material to liquid for each extraction is 1g:15mL.

[0030] More preferably, in step (3), the pH is adjusted to 5.0.

[0031] More preferably, in step (3), an acidic component is used to adjust the pH, wherein the acidic component is selected from at least one of malic acid, citric acid, and acetic acid.

[0032] More preferably, in step (3), adjusting the pH can achieve the technical effect described in this invention by using either diluted or undiluted acidic components.

[0033] More preferably, in step (3), after adjusting the pH, the mixture needs to stand for 1-3 hours.

[0034] More preferably, in step (4), the concentration is selected from vacuum concentration until ethanol is removed, to obtain a concentrate with a relative density of 1.1-1.3 (50°C).

[0035] More preferably, in step (4), the reduced pressure concentration is performed by concentrating the filtrate 1 under reduced pressure to obtain a concentrate with a relative density of 1.2 (50°C).

[0036] More preferably, in step (4), the drying is freeze drying for 12-36 hours; even more preferably, in step (4), the freeze drying time is 24 hours.

[0037] Furthermore, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: S1. Dandelion, Artemisia capillaris and Scutellaria baicalensis are mixed, decocted in water, filtered, and filtrate A and residue A are obtained. S2, filter residue A is mixed with honeysuckle and rush pith, and extracted by reflux with ethanol of 20%-40% by volume. After filtration, filtrate B and filter residue B are obtained. S3. Concentrate filtrate B, then mix it with filtrate A, and dry to obtain a mixture; S4, the mixture and the Pyrrosia lingua extract are mixed to obtain a traditional Chinese medicine composition.

[0038] Preferably, in step S1, the dandelion, artemisia capillaris, and scutellaria baicalensis are pulverized before decoction, with a particle size of 10-100 mesh.

[0039] More preferably, in step S1, the particle size of the pulverized material is 50 mesh.

[0040] Preferably, in step S1, the decoction specifically involves adding 15-25 times the total mass of dandelion, artemisia capillaris, and scutellaria baicalensis to water, and boiling and decocting for 1-3 hours.

[0041] More preferably, in step S1, the decoction specifically involves adding 20 times the total mass of dandelion, artemisia capillaris, and scutellaria baicalensis to water, and boiling and decocting for 2 hours.

[0042] Preferably, in step S2, the volume concentration of the ethanol is 30%.

[0043] Preferably, in step S2, the reflux extraction temperature is 65-80℃.

[0044] More preferably, in step S2, the reflux extraction temperature is 75°C.

[0045] Preferably, in step S2, the material-to-liquid ratio of the reflux extraction is 1g:15-25mL.

[0046] More preferably, in step S2, the material-to-liquid ratio of the reflux extraction is 1g:20mL.

[0047] Preferably, in step S2, the reflux extraction time is 0.5-2 hours.

[0048] More preferably, in step S2, the reflux extraction time is 1 hour.

[0049] Preferably, in step S2, before mixing, the honeysuckle and rush pith are first chopped or crushed into coarse powder.

[0050] Preferably, in step S3, the concentration is vacuum concentration, which is carried out at 60°C to a relative density of 1.1-1.3 to remove ethanol.

[0051] More preferably, in step S3, the concentration is vacuum concentration, concentrated to a relative density of 1.2 at 60°C.

[0052] Preferably, in step S3, the drying process involves a second concentration before drying, where the concentration is carried out at 60°C to a relative density of 1.1-1.3.

[0053] More preferably, in step S3, the secondary concentration is carried out at 60°C to a relative density of 1.2.

[0054] Preferably, in step S3, the drying is freeze-drying for 12-36 hours; more preferably, in step S3, the freeze-drying time is 24 hours.

[0055] Finally, the present invention provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of drugs with anti-inflammatory, diuretic and / or urinary tract infection prevention and treatment effects.

[0056] Preferably, the drug further includes a drug carrier.

[0057] More preferably, the drug carrier may be a solid carrier, a liquid carrier, or a gaseous carrier. Examples of solid carriers include lactose, kaolin, sucrose, talc, gelatin, agar, pectin, gum arabic, magnesium stearate, and stearic acid. Examples of liquid carriers include syrup, peanut oil, olive oil, and water. Examples of gaseous carriers include carbon dioxide and nitrogen.

[0058] In preparing compositions for oral dosage forms, any convenient pharmaceutical medium can be used. For example, water, ethanol, oils, alcohols, flavoring agents, preservatives, coloring agents, etc., can be used to form oral liquid dosage forms, such as suspensions and solutions; while carriers, such as starch, sugars, microcrystalline cellulose, diluents, granulators, emulsifiers, lubricants, binders, and disintegrants, can be used to form oral solid dosage forms, such as powders, capsules, and tablets. Tablets and capsules are preferred oral dosage units using solid pharmaceutical carriers due to their ease of administration. Tablets can be coated using standard aqueous or non-aqueous techniques.

[0059] Tablets containing the herbal composition or extract of the present invention can be prepared by compression or molding, optionally using one or more excipients or adjuvants. The active ingredient can be compressed in a free-flowing form (e.g., powder or granules) in a suitable machine, optionally mixed with binders, lubricants, inert diluents, surfactants, or dispersants. Molded tablets can be molded in a suitable machine, i.e., a mixture of powdered compounds moistened with an inert liquid diluent. Each tablet preferably contains about 0.05 mg to about 5 g of active ingredient, and each sachet or capsule preferably contains about 0.05 mg to about 5 g of active ingredient. For example, a formulation intended for oral administration to humans may contain about 0.5 mg to about 5 g of active pharmaceutical ingredient, mixed with a suitable and convenient carrier material, which may comprise about 5% to 95% of the total composition. Unit dosage forms typically contain about 1 mg to about 2 g of active ingredient, typically in doses of 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg, or 1000 mg.

[0060] The pharmaceutical compositions of this invention suitable for parenteral administration can be prepared as aqueous solutions or suspensions of the active compound. Suitable surfactants, such as hydroxypropyl cellulose, may be included. Dispersions can also be prepared in mixtures of glycerol, liquid polyethylene glycol, and their oils. Furthermore, preservatives may be added to prevent harmful microbial growth.

[0061] The medicaments of the present invention can be in forms suitable for topical use, such as aerosols, creams, ointments, lotions, powders, or the like. Furthermore, the compositions can be in suitable forms for transdermal drug delivery devices. These formulations can be prepared using the traditional Chinese medicine compositions of the present invention through conventional processing methods. For example, a cream or ointment with a desired consistency can be prepared by mixing a hydrophilic material and water, and about 5 wt% to about 10 wt% of the compound.

[0062] The medicament of the present invention can be in a form suitable for rectal administration, wherein the carrier is solid. It is preferable to formulate the mixture into a single-dose suppository. Suitable carriers include cocoa butter and other materials commonly used in the art. Suppositories can be made by first forming a mixture containing a softened or melted carrier, followed by cooling and shaping in a mold.

[0063] In addition to the carrier components described above, the pharmaceutical formulations may include (if applicable) one or more additional carrier components, such as diluents, buffers, flavoring agents, binders, surfactants, thickeners, lubricants, preservatives (including antioxidants), etc. Furthermore, other excipients may be added, such as lactose, starch, cellulose derivatives, magnesium stearate, stearic acid, etc., colorants, and flavoring agents, etc., to make the formulation isotonic with the blood of the intended receptor. Components containing the traditional Chinese medicine composition of this invention can also be prepared in powder or concentrated form.

[0064] Preferably, the dosage form of the drug is not limited to dosage forms for administration such as pills, capsules, granules, oral liquids, powders, tablets, lozenges, ointments, etc., and suitable pharmaceutical carriers in the art can be selected for different dosage forms.

[0065] In the present invention, the honeysuckle (Lonicera japonica Thunb.) is the dried flower buds or the flowers with initial opening of the plant Lonicera japonica in the Caprifoliaceae family, also known as double flower and honeysuckle flower; it is harvested before the flowers bloom in summer and dried for use in medicine; the medicinal material is in the shape of a rod, thick at the top and thin at the bottom, slightly curved, and the surface is yellowish-white or greenish-white. Properties and flavors: sweet and cold, with the efficacy of clearing heat and detoxifying, and is used to treat febrile diseases caused by warm pathogens, dysentery with heat-toxin, carbuncles, sores, furuncles, throat obstruction, and various infectious diseases.

[0066] In the present invention, the dandelion (Lonicera japonica Thunb.) is the dried whole herb of the plant Taraxacum mongolicum in the Compositae family, also known as: dandelion, dandelion herb, and milkwort; it has the effects of clearing heat and detoxifying, dissipating swelling and resolving masses, and promoting diuresis and relieving stranguria, and is commonly used to treat furuncles, carbuncles, breast abscess, sore throat and other symptoms.

[0067] In the present invention, the rush (Juncus effusus L.) is the dried pith of the stem of the plant Juncus effusus in the Juncaceae family. It has the effects of promoting diuresis and relieving stranguria, clearing the heart and reducing fire. It is mainly used to treat stranguria syndrome, restlessness and insomnia, and sores and ulcers on the tongue.

[0068] In the present invention, the Artemisia capillaris Thunb. is the dried aerial part of the plant Artemisia scoparia Waldst. & Kit. or Artemisia capillaris Thunb. in the Compositae family; also known as: Artemisia capillaris, and cottony Artemisia capillaris; it is mainly used to treat jaundice with less urine, damp-warm syndrome in summer heat, and itching of moist sores, and can play the role of clearing and promoting dampness-heat, and promoting bile drainage and subsiding jaundice.

[0069] In the present invention, the Pyrrosia lingua (Thunb.) Farw. is the dried leaf of the plant Pyrrosia sheareri (Bak.) Ching, Pyrrosia lingua (Thunb.) Farw. or Pyrrosia petiolosa (Christ) Ching in the Polypodiaceae family. It has the effects of promoting diuresis and relieving stranguria, clearing the lung and relieving cough, and cooling blood and stopping bleeding, and is commonly used to relieve symptoms such as difficult urination, cough due to lung heat, and bleeding due to blood heat.

[0070] In the present invention, the Scutellaria baicalensis Georgi is the dried root of the plant Scutellaria baicalensis Georgi in the Lamiaceae family. It has the effects of purging fire and detoxifying, clearing heat and reducing inflammation, antibacterial and anti-inflammatory, lowering blood pressure, promoting diuresis, lowering blood lipid, antiplatelet aggregation, and stopping bleeding.

[0071] Compared with the prior art, the present invention has the following beneficial effects: 1. In the traditional Chinese medicine composition of the present invention, the six components of honeysuckle, dandelion, rush pith, artemisia capillaris, pyrrosia lingua extract and scutellaria baicalensis work together to significantly enhance diuresis, increase urine output, reduce inflammation, rapidly reduce urinary leukocytes and bacterial load, and rapidly reduce serum inflammatory factor content.

[0072] 2. Under specific ratio conditions, the six components in the traditional Chinese medicine composition of the present invention further increase urine output and reduce the expression levels of Renin, ALD and AngII in serum; further rapidly reduce the number of leukocytes and bacteria in urine, rapidly reduce the content of serum inflammatory factors and bacterial load in urine.

[0073] 3. Under the conditions of the specific extraction method of the Pyrrosia lingua extract and the specific preparation method of the traditional Chinese medicine composition, the traditional Chinese medicine composition obtained by the present invention has better diuretic, anti-inflammatory, faster reduction of urinary leukocyte and bacterial count, and faster reduction of serum inflammatory factor content and urinary bacterial load. Detailed Implementation

[0074] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following content is merely an exemplary description of the scope of protection claimed by the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, and such changes should also fall within the scope of protection claimed by the present invention.

[0075] When numerical ranges are given in the embodiments, it should be understood that, unless otherwise stated in the invention, both endpoints of each numerical range and any value between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0076] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all chemical reagents used in the embodiments of the present invention are obtained through conventional commercial channels. Products from different manufacturers do not have a significant impact on the effectiveness.

[0077] Example 1 A method for preparing a Pyrrosia lingua extract is as follows: (1) Pyrrosia lingua was pulverized to 50 mesh and extracted by reflux at 60°C for 2 hours using 90% ethanol at a solid-liquid ratio of 1g:20mL. After filtration, filtrate 1 and filter residue 1 were obtained. (2) Filter residue 1 was extracted twice with a 2% sodium hydroxide solution at 70°C, each time with a material-to-liquid ratio of 1g:15mL for 2.5h. After filtration, the extracts from the two extractions were combined to obtain filtrate 2. (3) The pH of filtrate 2 was adjusted to 5.0 with malic acid and allowed to stand for 2 hours to obtain a precipitate; (4) Filtrate 1 was concentrated under reduced pressure to obtain a concentrate with a relative density of 1.2 (50°C), which was mixed with the precipitate from step (3) and freeze-dried for 24 hours to obtain the Pyrrosia extract.

[0078] Example 2 A method for preparing a Pyrrosia lingua extract is as follows: (1) Pyrrosia lingua was pulverized to 10 mesh and extracted by reflux at 65°C for 1.5 h using 95% ethanol at a solid-liquid ratio of 1 g: 25 mL. After filtration, filtrate 1 and residue 1 were obtained. (2) Filter residue 1 was extracted once with a 3% sodium hydroxide solution at 80°C for 3 hours with a material-to-liquid ratio of 1g:20mL. After filtration, filtrate 2 was obtained. (3) The pH of filtrate 2 was adjusted to 5.5 with citric acid and allowed to stand for 3 hours to obtain a precipitate; (4) Filtrate 1 was concentrated under reduced pressure to obtain a concentrate with a relative density of 1.2 (50°C), which was mixed with the precipitate from step (3) and freeze-dried for 24 hours to obtain the Pyrrosia extract.

[0079] Example 3 A method for preparing a Pyrrosia lingua extract is as follows: (1) Pyrrosia lingua was pulverized to 100 mesh and extracted by reflux at 50°C for 3 hours using 80% ethanol at a solid-liquid ratio of 1g:15mL. After filtration, filtrate 1 and residue 1 were obtained. (2) Filter residue 1 was extracted three times at 60°C with a 0.5% sodium hydroxide solution, each time with a material-to-liquid ratio of 1g:10mL for 2 hours. After filtration, the extracts from the three extractions were combined to obtain filtrate 2. (3) The pH of filtrate 2 was adjusted to 4.5 with acetic acid and allowed to stand for 1 hour to obtain the precipitate; (4) Filtrate 1 was concentrated under reduced pressure to obtain a concentrate with a relative density of 1.2 (50°C), which was mixed with the precipitate from step (3) and freeze-dried for 24 hours to obtain the Pyrrosia extract.

[0080] Example 4 A traditional Chinese medicine composition with anti-inflammatory and diuretic effects is made from the following components by weight: 40 parts honeysuckle, 30 parts dandelion, 20 parts rush pith, 10 parts artemisia capillaris, 3 parts pyrrosia extract (Example 1) and 10 parts scutellaria baicalensis.

[0081] The preparation method of the traditional Chinese medicine composition is as follows: S1. Mix dandelion, artemisia capillaris and scutellaria baicalensis, grind to 50 mesh, add 20 times the weight of water, boil and decoct for 2 hours, filter to obtain filtrate A and residue A; S2, filter residue A, and honeysuckle and rush pith powdered into coarse powder are mixed and extracted by reflux for 1 hour at a material-to-liquid ratio of 1g:20mL and 75℃ using 30% ethanol. After filtration, filtrate B and filter residue B are obtained. S3. Filtrate B was concentrated under reduced pressure at 60°C to a relative density of 1.2, and then mixed with filtrate A; it was further concentrated at 60°C to a relative density of 1.2, and then freeze-dried for 24 hours to obtain a mixture. S4, the mixture and the Pyrrosia lingua extract are mixed to obtain a traditional Chinese medicine composition.

[0082] Example 5 A traditional Chinese medicine composition with anti-inflammatory and diuretic effects is made from the following components by weight: 30 parts honeysuckle, 40 parts dandelion, 15 parts rush pith, 12 parts artemisia capillaris, 2 parts pyrrosia extract (Example 2) and 13 parts scutellaria baicalensis.

[0083] The preparation method of the traditional Chinese medicine composition is the same as in Example 4.

[0084] Example 6 A traditional Chinese medicine composition with anti-inflammatory and diuretic effects is made from the following components by weight: 50 parts honeysuckle, 24 parts dandelion, 25 parts rush pith, 8 parts artemisia capillaris, 4 parts pyrrosia lingua extract (Example 3) and 8 parts scutellaria baicalensis.

[0085] The preparation method of the traditional Chinese medicine composition is the same as in Example 4.

[0086] Example 7 A traditional Chinese medicine composition with anti-inflammatory and diuretic effects is made from the following components in parts by weight: 55 parts honeysuckle, 45 parts dandelion, 10 parts rush pith, 5 parts artemisia capillaris, 1.5 parts pyrrosia lingua extract (Example 1) and 5 parts scutellaria baicalensis.

[0087] The preparation method of the traditional Chinese medicine composition is as follows: S1, dandelion, artemisia capillaris and scutellaria baicalensis are mixed and crushed to 10 mesh, 25 times the weight of water is added, boiled and decocted for 1 hour, filtered to obtain filtrate A and residue A; S2, filter residue A, and honeysuckle and rush pith powdered into coarse powder are mixed and extracted by reflux for 2 hours using 20% ​​ethanol at a material-to-liquid ratio of 1g:15mL and 80℃. After filtration, filtrate B and filter residue B are obtained. S3. Filtrate B was concentrated under reduced pressure at 60°C to a relative density of 1.2, and then mixed with filtrate A; it was further concentrated at 60°C to a relative density of 1.2, and then freeze-dried for 24 hours to obtain a mixture. S4, the mixture and the Pyrrosia lingua extract are mixed to obtain a traditional Chinese medicine composition.

[0088] Example 8 A traditional Chinese medicine composition with anti-inflammatory and diuretic effects is made from the following components in parts by weight: 25 parts honeysuckle, 20 parts dandelion, 30 parts rush pith, 15 parts artemisia capillaris, 5 parts pyrrosia extract (Example 1) and 15 parts scutellaria baicalensis.

[0089] The preparation method of the traditional Chinese medicine composition is as follows: S1, dandelion, artemisia capillaris and scutellaria baicalensis are mixed and pulverized to 100 mesh, 15 times the weight of water is added, boiled and decocted for 3 hours, filtered to obtain filtrate A and residue A; S2, filter residue A, and honeysuckle and rush pith powdered into coarse powder are mixed and extracted by reflux for 0.5 h using 40% ethanol at a material-to-liquid ratio of 1 g:25 mL and 65 °C. The mixture is then filtered to obtain filtrate B and filter residue B. S3. Filtrate B was concentrated under reduced pressure at 60°C to a relative density of 1.2, and then mixed with filtrate A; it was further concentrated at 60°C to a relative density of 1.2, and then freeze-dried for 24 hours to obtain a mixture. S4, the mixture and the Pyrrosia lingua extract are mixed to obtain a traditional Chinese medicine composition.

[0090] Comparative Example 1 The following traditional Chinese medicine composition was prepared according to the components and weight parts described in Example 1 of CN106237162A: 20 parts of honeysuckle, 25 parts of Scutellaria barbata, 20 parts of talc, 13 parts of Polygonum aviculare, 15 parts of gardenia, 13 parts of Dianthus superbus, 13 parts of Pyrrosia lingua, 10 parts of rhubarb, 13 parts of Akebia trifoliata, 20 parts of Plantago asiatica, 20 parts of Lophatherum gracile, 25 parts of Taxillus chinensis, 4 parts of Juncus effusus, and 4 parts of Glycyrrhiza uralensis twig.

[0091] The preparation method of the traditional Chinese medicine composition is as follows: The above components were mixed and pulverized to 50 mesh. Water was added in 20 times the total mass of the above components and soaked for 0.5 hours. The mixture was then decocted and extracted twice, with the first extraction time being 2 hours and the second extraction time being 1 hour. After filtration, the mixture was concentrated at 60°C to a relative density of 1.2 and freeze-dried for 24 hours to obtain the traditional Chinese medicine composition.

[0092] Comparative Example 2 Unlike Example 4, dandelion was replaced with Lophatherum gracile Brongn. (dried stems and leaves of Lophatherum gracile Brongn., a plant of the genus Lophatherum in the family Poaceae). In the preparation method of the traditional Chinese medicine composition, the components of Example 4 were replaced with the components of Comparative Example 2, and all other aspects were the same as in Example 4.

[0093] Comparative Example 3 Unlike Example 4, Scutellaria baicalensis was replaced with Plantago asiatica (dried mature seeds of Plantago asiatica L., a plant in the Plantaginaceae family). In the preparation method of the traditional Chinese medicine composition, the components of Example 4 were replaced with the components of Comparative Example 3, and all other aspects were the same as in Example 4.

[0094] Comparative Example 4 Unlike Example 4, honeysuckle and dandelion were omitted. In the preparation method of the traditional Chinese medicine composition, the components of Example 4 were replaced with the components of Comparative Example 4, and all other aspects were the same as in Example 4.

[0095] Comparative Example 5 Unlike Example 4, the Artemisia capillaris component was omitted. In the preparation method of the traditional Chinese medicine composition, the components of Example 4 were replaced with the components of Comparative Example 5, and all other aspects were the same as in Example 4.

[0096] Comparative Example 6 Unlike Example 4, the preparation method of the Pyrrosia lingua extract is different.

[0097] The preparation method of Pyrrosia lingua extract is as follows: (1) Pyrrosia lingua was pulverized to 50 mesh and extracted by reflux at 60°C for 2 hours using 90% ethanol at a solid-liquid ratio of 1g:20mL. After filtration, filtrate 1 and filter residue 1 were obtained. (2) Filter residue 1 was extracted twice by reflux with 90% ethanol at 70°C, each time with a material-to-liquid ratio of 1g:15mL for 2.5h. After filtration, the extracts from the two reflux extractions were combined to obtain filtrate 2. (3) Filtrate 1 and Filtrate 2 were concentrated under reduced pressure to obtain a concentrate with a relative density of 1.2 (50℃), and then freeze-dried for 24 h to obtain Pyrrosia extract.

[0098] Comparative Example 7 The difference from Example 4 is that the preparation method of the traditional Chinese medicine composition is different. The 30% ethanol in step S2 is replaced with 80% ethanol. Everything else is the same as in Example 4.

[0099] Effect Test 1: Diuretic Effect Test 1. Laboratory animals Male SPF - grade Wistar rats (certificate number: SCXK(Ji)-2023-0002) that passed the urine screening were selected, with a body weight of 200g ± 20g. They were purchased from Yisi Experimental Animal Technology Co., Ltd. in Changchun City, Jilin Province. During the experiment, they were raised in the barrier environment of the Experimental Animal Center of the Basic Medical College of Jilin University. The temperature was controlled at 22 ± 4°C, the relative humidity was maintained at 40% - 60%, following a 12 - hour day - night alternating light cycle, and sufficient feed and drinking water were provided. They were adaptively raised for one week. During the experiment, all equipment such as cages, bedding, feed, and water bottles were strictly disinfected. The experimental protocol has passed the review of the Experimental Animal Ethics Committee of the Basic Medical College of Jilin University (ethical batch number: 2024 - 12007), and all animal operations strictly follow the Guidelines for the Care and Use of Laboratory Animals formulated by the National Institutes of Health of the United States.

[0100] 2. Screening of qualified animals by saline load Ninety male Wistar rats were selected. First, they were placed in standard cages for adaptive feeding for 1 week, and then transferred to metabolic cages for adaptive feeding for 2 days. Before the experiment, the rats were fasted for 24 hours without water restriction. The abdomen of the rats was gently pressed by hand to expel the residual urine in the bladder. Then, normal saline (0.9% NaCl solution) was administered by gavage at a dose of 25 mL / kg body weight, and the rats were immediately placed in metabolic cages (one rat per cage). The urine within 2 hours after gavage was collected. Rats with urine volume reaching more than 40% of the gavage volume were determined to meet the screening criteria for the saline - loaded Wistar rat model.

[0101] 3. Grouping and modeling of experimental animals Seventy - five of the above - mentioned qualified Wistar rats were randomly divided into 15 groups, with 5 rats in each group. The grouping is as follows: blank group (normal feeding, no treatment), model group (gavage with an equal volume of normal saline), positive drug group (gavage with 1.6 g / kg of Yinhuaminyanling tablets, Yinhuaminyanling tablets were purchased from Jilin Huakang Pharmaceutical Co., Ltd.), groups of Examples 4 - 8 (gavage with 0.2 g / kg of the traditional Chinese medicine composition), and groups of Comparative Examples 1 - 7 (gavage with 0.2 g / kg of the traditional Chinese medicine composition).

[0102] Except for the blank group, continuous gavage was performed once a day for 8 days. After the 8th administration, the rats were fasted for 24 hours without water restriction. The abdomen of the rats was gently pressed by hand to expel the residual urine in the bladder. Then, normal saline was administered by gavage to each group at a dose of 4 mL / 100 g body weight to establish a saline - loaded Wistar rat model.

[0103] 4. Collection and treatment of animal urine [[ID=1十七]] The rats after saline loading were immediately placed in metabolic cages, and the urine within 6 hours after gavage was collected to calculate the total urine output.

[0104] 5. ELISA method was used to detect the expression levels of Renin, ALD and AngII in rat serum. After urine collection, the patient was anesthetized with 10% chloral hydrate solution, blood was drawn from the abdominal aorta and injected into an anticoagulant tube. The blood was then centrifuged at 4°C (3000 r / min) for 15 min, and the supernatant was collected.

[0105] The levels of renin, aldosterone (ALD), and angiotensin II (AngII) in the serum samples of rats in each group were measured by enzyme-linked immunosorbent assay (ELISA). The detection kits for all three indicators were purchased from the same manufacturer (Wuhan GeneMei Technology Co., Ltd.), and the operating procedures were strictly followed according to their standard instructions.

[0106] 6. Effects of Traditional Chinese Medicine Combinations on Rat Urine The diuretic effect of the traditional Chinese medicine composition was evaluated by measuring the total urine output (mL / 100g body weight, urine output per 6 hours) of a saline-loaded Wistar rat model. The results are shown in Table 1.

[0107] Table 1. Results of total urine output

[0108] In Table 1, each group of data is compared with the model group. △ P≤0.05, △△ P≤0.01; Compared with Example 4, the comparative groups of each example group # P≤0.05, ## P≤0.01, indicating a significant difference.

[0109] As can be seen from Table 1, after gavage administration of the herbal composition of the present invention, Wistar rats experienced increased urine output and enhanced diuretic activity. Compared with the positive control group and the comparative control group, the present invention provides a greater urine output, indicating that the herbal composition obtained by the specific components, specific ratios and preparation method of the present invention has a significant effect on improving diuresis.

[0110] 7. Effects of traditional Chinese medicine composition on the expression levels of Renin, ALD and AngII in rat serum The levels of Renin, ALD and AngII in the serum of rats in each group were detected by ELISA (enzyme-linked immunosorbent assay). The results are shown in Table 2.

[0111] Table 2. Serum levels of Renin, ALD, and AngII in rats

[0112] In Table 2, each group of data is compared with the model group. △△ P≤0.01; Compared with Example 4, the comparative groups of each example group #P ≤ 0.05, ## P ≤ 0.01, showing significant differences.

[0113] As can be seen from Table 2, the traditional Chinese medicine composition of the present invention has a significant effect of reducing Renin, ALD and AngII; by regulating the levels of Renin, ALD and AngII, it further regulates signal pathways such as sodium absorption to exert a diuretic effect.

[0114] Effect Test 2 Clinical efficacy of urinary tract infection 1. Experimental method 1.1 Test animals and experimental materials 75 female C57BL / 6 mice, specific pathogen free (SPF) grade, purchased from Yisi Experimental Animal Technology Co., Ltd., Changchun City, Jilin Province, quality certificate number: SYXK(Ji)-2023-0010, body weight 18 - 22 g, 7 weeks old.

[0115] The mice were housed in a barrier environment in the Experimental Animal Center of the Basic Medical College of Jilin University, provided with free access to food and water, the light cycle was 12 - hour day and night alternation, the environmental temperature was maintained at 23 ± 5°C, and the relative humidity was controlled at 50 ± 10%. All experimental equipment (such as cages, bedding, feed, water bottles and drinking water) was strictly disinfected. This study has been approved by the Experimental Animal Ethics Committee of the Basic Medical College of Jilin University (approval number: 2023 - 503), and strictly follows the Guide for the Care and Use of Laboratory Animals of the National Institutes of Health.

[0116] Uropathogenic Escherichia coli (UPEC) CFT073 (NO.700928), purchased from the American Type Culture Collection (ATCC), and revived and preserved by the laboratory.

[0117] 1.2 Experimental grouping Divided into a sham operation group (n = 5) and an experimental group (n = 5 for each group). The mice were adaptively fed for 7 days, during which standard feed and distilled water were given.

[0118] Before modeling, the mice were deprived of water overnight. On the first day after adaptive feeding, the urethral orifice was disinfected in a biosafety cabinet and the mice were anesthetized with isoflurane. 50 μL of a bacterial suspension containing 1×10 8 CFU of UPEC CFT073 was injected into the bladder cavity through urethral catheterization. The sham operation group was injected with an equal amount of normal saline through the urethra.

[0119] After modeling, the dosage of drugs administered to the experimental groups was converted from human to mouse dosage: model group (0.25 mL / kg physiological saline by gavage), positive control group (2 g / kg Yin Hua Mi Yan Ling tablets purchased from Jilin Huakang Pharmaceutical Co., Ltd. by gavage), implementation group, and control group (0.25 g / kg by gavage); gavage was performed once daily for 5 consecutive days. Twelve hours after the last gavage, urine samples were collected to assess bacterial load; all mice were sacrificed, and blood serum was collected for inflammatory factor content detection according to the IL-1β and IL-6 kit requirements.

[0120] Bacterial load detection method: Collected urine samples were serially diluted with 0.9% sterile physiological saline: undiluted, 10... -1 10 -2 (Add 10 if necessary) -3 Diluents: Take 50 μL of each graded dilution and spread it onto agar medium using the crisscross pattern, covering the entire plate. Repeat the spreading at least 6 times to ensure uniform bacterial distribution and prevent colony aggregation. Incubate the agar plates at 37 ℃ for 24 h. Select plates with colony counts of 30-300 for counting and calculate the bacterial load in the urine samples.

[0121] 2. Effects of traditional Chinese medicine composition on IL-1β and IL-6 in animals with urinary tract infections The results of IL-1β and IL-6 levels are shown in Table 3.

[0122] Table 3 Results of IL-1β and IL-6 levels

[0123] Table 3 shows the comparison between each group of data and the model group. △ P≤0.05, △△ P≤0.01; Compared with Example 4, the comparative groups of each example group # P≤0.05, ## P≤0.01, indicating a significant difference.

[0124] As shown in Table 3, the traditional Chinese medicine composition of the present invention has a significant effect in reducing the content of inflammatory factors in mice with urinary tract infections; and the contents of IL-1β and IL-6 are lower than those in the positive control group and Comparative Example 1, indicating that the traditional Chinese medicine composition of the present invention has a superior anti-inflammatory effect compared with the prior art. In addition, the contents of IL-1β and IL-6 are significantly lower than those in the comparative example, indicating that the traditional Chinese medicine composition of the present invention uses specific components, proportions, and preparation methods to achieve a superior anti-inflammatory effect.

[0125] 3. Effects of traditional Chinese medicine composition on urinary bacteria in animals with urinary tract infections The results of urinary bacterial load are shown in Table 4.

[0126] Table 4

[0127] In Table 4, each group of data is compared with the model group. △ P≤0.05, △△ P≤0.01; Compared with Example 4, the comparative groups of each example group ## P≤0.01, indicating a significant difference.

[0128] As shown in Table 4, the traditional Chinese medicine composition of the present invention has a significant effect in reducing the bacterial load in urine; and the bacterial load in urine is significantly lower than that in the positive control group and Comparative Example 1, indicating that the traditional Chinese medicine composition of the present invention has a superior effect in preventing and treating urinary tract infections compared with the prior art. Furthermore, the significantly lower bacterial load in urine compared to the comparative example demonstrates that the traditional Chinese medicine composition of the present invention, using specific components, proportions, and preparation methods, results in a superior effect in preventing and treating urinary tract infections.

[0129] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition with anti-inflammatory and diuretic effects, characterized in that, It is made from the following components by weight: 25-55 parts honeysuckle, 20-45 parts dandelion, 10-30 parts rush pith, 5-15 parts artemisia capillaris, 1.5-5 parts pyrrosia lingua extract and 5-15 parts scutellaria baicalensis.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following components by weight: 30-50 parts honeysuckle, 24-40 parts dandelion, 15-25 parts rush pith, 8-12 parts artemisia capillaris, 2-4 parts pyrrosia lingua extract and 8-13 parts scutellaria baicalensis.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, It is made from the following components by weight: 40 parts honeysuckle, 30 parts dandelion, 20 parts rush pith, 10 parts artemisia capillaris, 3 parts pyrrosia lingua extract and 10 parts scutellaria baicalensis.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The preparation method of the Pyrrosia lingua extract includes the following steps: (1) The medicinal material of Pyrrosia lingua was extracted by reflux with ethanol of 80%-95% by volume, filtered, and filtrate 1 and residue 1 were obtained. (2) Filter residue 1 was extracted with alkaline solution and filtered to obtain filtrate 2; (3) Adjust the pH of filtrate 2 to 4.5-5.5 to obtain precipitate; (4) The filtrate 1 is concentrated to obtain a concentrate, which is mixed with the precipitate from step (3) and dried to obtain the Pyrrosia extract.

5. The traditional Chinese medicine composition according to claim 4, characterized in that, In step (1), the reflux extraction temperature is 50-65℃; the reflux extraction time is 1.5-3h; and the solid-liquid ratio is 1g:15-25mL. In step (2), the alkaline solution is an alkaline solution with a mass concentration of 0.5%-3%; In step (2), the extraction temperature is 60-80℃; the extraction is performed 1-3 times, the extraction time is 2-3 hours each time, and the material-to-liquid ratio is 1g:10-20mL each time. In step (3), after adjusting the pH, it needs to stand for 1-3 hours; In step (4), the drying process is freeze drying for 12-36 hours.

6. A method for preparing the traditional Chinese medicine composition according to any one of claims 1-5, characterized in that, Including the following steps: S1. Dandelion, Artemisia capillaris and Scutellaria baicalensis are mixed, decocted in water, filtered, and filtrate A and residue A are obtained. S2, filter residue A, honeysuckle and rush pith are mixed and extracted by reflux with ethanol of 20%-40% by volume, filtered to obtain filtrate B and filter residue B; S3. Concentrate filtrate B, then mix it with filtrate A, and dry to obtain a mixture; S4, the mixture and the Pyrrosia lingua extract are mixed to obtain a traditional Chinese medicine composition.

7. The preparation method according to claim 6, characterized in that, In step S1, the decoction process specifically involves adding 15-25 times the total mass of dandelion, artemisia capillaris, and scutellaria baicalensis to water, and boiling and simmering for 1-3 hours.

8. The preparation method according to claim 6, characterized in that, In step S2, the volume concentration of ethanol is 30%, the reflux extraction temperature is 65-80℃, the material-to-liquid ratio for reflux extraction is 1g:15-25mL, and the reflux extraction time is 0.5-2h.

9. The preparation method according to claim 6, characterized in that, In step S3, the drying process involves a second concentration before drying, concentrated at 60°C to a relative density of 1.1-1.3; the drying process is freeze drying for 12-36 hours.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-5 in the preparation of a medicament having anti-inflammatory, diuretic and / or anti-urinary tract infection effects.

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