Traditional Chinese medicine preparation for treating urinary system infection

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, and discloses a traditional Chinese medicine preparation for treating urinary system infection. The invention discloses a traditional Chinese medicine preparation for treating urinary system infection. The traditional Chinese medicine preparation is prepared from the following raw materials in parts by mass: 20-30 parts of herba desmodii styracifolii, 5-15 parts of rhizoma alismatis, 20-30 parts of folium pyrrosiae, 4-6 parts of lygodium japonicum, 10-20 parts of semen plantaginis, 5-15 parts of endothelium corneum gigeriae galli, 0.5-1.5 parts of shiny cattle, 3-5 parts of amber, 5-15 parts of vinegar-processed rhizoma corydalis, 5-15 parts of radix astragali and The prepared traditional Chinese medicine preparation for treating urinary system infection has good antibacterial activity and good anti-inflammatory effect, and has remarkable advantages in the aspects of controlling infection, relieving inflammation and protecting target organs.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparations, and more specifically, to a traditional Chinese medicine preparation for treating urinary tract infections. Background Technology

[0002] Urinary tract infection (UTI) is a common clinical disease caused by pathogenic microorganisms such as bacteria and fungi invading the urinary tract. It is more common in women, the elderly, and people with weakened immune systems. Common pathogens include Escherichia coli, Staphylococcus aureus, and Proteus mirabilis. Clinical manifestations include urinary frequency, urgency, dysuria, fever, and even back pain. If left untreated, it can develop into serious complications such as pyelonephritis and sepsis, significantly impacting the patient's quality of life.

[0003] Currently, the main clinical treatment for urinary tract infections is the use of antibiotics, such as quinolones, cephalosporins, and sulfonamides. While antibiotics are highly effective in the acute phase, their overuse and prolonged use have led to increasingly prominent bacterial resistance problems, resulting in higher treatment failure rates, longer treatment courses, and increased medical costs. Furthermore, antibiotics also have side effects such as intestinal flora imbalance and liver and kidney toxicity.

[0004] Traditional Chinese medicine (TCM) exhibits unique advantages in treating urinary tract infections due to its multi-component, multi-target, and holistic regulatory characteristics. TCM theory classifies this disease as falling under the categories of "Lin syndrome" and "urinary retention," often caused by damp-heat accumulation and spleen-kidney deficiency. Treatment should focus on clearing heat and dampness, promoting urination, and strengthening the body's resistance. While numerous TCM compound preparations exist, they still have some shortcomings: many traditional compound preparations have slow onset of action and limited antibacterial and anti-inflammatory efficacy, particularly against infections caused by complex or drug-resistant bacteria, failing to fully meet clinical needs; most existing preparations use single extraction methods such as water or alcohol extraction, or simple mixed extraction processes. This crude extraction method makes it difficult to fully and selectively extract all effective components, and the optimal extraction conditions vary for different medicinal materials. Mixed extraction may destroy or under-extract some heat-sensitive or specific polar components, affecting the final efficacy; extracts prepared by traditional processes often have high impurity content and low concentrations of effective components, affecting the stability and bioavailability of the preparation.

[0005] Therefore, there is an urgent need for a new type of traditional Chinese medicine preparation with scientific formulation, advanced preparation process, definite efficacy and controllable quality, so as to more effectively treat urinary tract infections and overcome the shortcomings of existing technologies. Summary of the Invention

[0006] The purpose of this invention is to provide a traditional Chinese medicine preparation for treating urinary tract infections.

[0007] To achieve the above objectives, the present invention provides the following technical solution: One of the technical solutions of this invention: A traditional Chinese medicine preparation for treating urinary tract infections, comprising the following raw materials in parts by weight: 20-30 parts of Lysimachia christinae, 5-15 parts of Alisma plantago-aquatica, 20-30 parts of Pyrrosia lingua, 4-6 parts of Lygodium japonicum, 10-20 parts of Plantago asiatica, 5-15 parts of chicken gizzard lining, 0.5-1.5 parts of Aralia elata, 3-5 parts of amber, 5-15 parts of vinegar-processed Corydalis yanhusuo, 5-15 parts of Astragalus membranaceus, and 1-3 parts of Glycyrrhiza uralensis.

[0008] The second technical solution of this invention: The preparation method of the above-mentioned traditional Chinese medicine preparation for treating urinary tract infections includes the following steps: 1) Mix Lysimachia christinae, Alisma plantago-aquatica, Pyrrosia lingua, Lygodium japonicum and Plantago asiatica to obtain Chinese herbal powder A. Then, place Chinese herbal powder A in water and extract it by subcritical water-ultrasound coupling. After filtration, obtain Chinese herbal extract A. 2) Mix chicken gizzard lining, sand absinthe, amber, and vinegar-processed corydalis to obtain Chinese medicine powder B. Then, place Chinese medicine powder B in 85% ethanol, extract by supercritical CO2, filter, and obtain Chinese medicine extract B. 3) Mix Astragalus membranaceus and Glycyrrhiza uralensis to obtain Chinese medicine powder C. Then disperse Chinese medicine powder C in water to obtain Chinese medicine powder C dispersion. 4) Place the compound enzyme in the dispersion of Chinese herbal powder C obtained in step 3), perform enzymatic hydrolysis, ultrasonic treatment, and filtration to obtain Chinese herbal extract C; 5) Mix the Chinese herbal extract A obtained in step 1), the Chinese herbal extract B obtained in step 2), and the Chinese herbal extract C obtained in step 4), adsorb and decolorize, and filter to obtain a preliminary purified extract; 6) Concentrate the preliminary purified extract obtained in step 5) into a clear paste, then slowly add 95% ethanol to the clear paste. After the ethanol is added, let it stand, filter, and distill under reduced pressure to obtain the purified extract. 7) Add soluble starch to the purified extract obtained in step 6), stir evenly, and then spray dry to obtain the traditional Chinese medicine preparation for treating urinary tract infections.

[0009] Further, in step 1), the water-to-powder ratio of the herbal powder A to water is (10-20) mL:1g.

[0010] Further, in step 1), the parameters of the subcritical water-ultrasonic coupling are: Preparatory stage: 90~110℃, 5~15min, synchronous ultrasonic power 200W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; Main extraction stage: 65~75℃, 20~30min, synchronous ultrasonic power 300W, frequency 40kHz, ultrasonic operation 30s, interval 10s; Deep extraction stage: 70-90℃, 10-20min, synchronous ultrasonic power 400W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s.

[0011] Further, in step 2), the ratio of the herbal powder B to 85% ethanol is (4-6) mL: 1g.

[0012] Further, in step 2), the parameters for supercritical CO2 extraction are: pressure 30 MPa, temperature 45–55 °C, time 2–3 h, and CO2 flow rate 20 L / h.

[0013] Further, in step 3), the water-to-powder ratio of the Chinese herbal powder C to water is (15-25) mL:1g.

[0014] Further, in step 4), the complex enzyme is composed of cellulase, pectinase and trypsin mixed in a mass ratio of 1:(1-3):(0.1-0.3).

[0015] Further, in step 4), the ratio of the compound enzyme to the dispersion of the traditional Chinese medicine powder C is (15-25) mL:1g.

[0016] Further, in step 4), the enzymatic hydrolysis specifically involves enzymatic hydrolysis at pH 5.0 and 45°C for 1–3 hours.

[0017] Further, in step 4), the ultrasonic treatment specifically involves controlling the ultrasonic power to be 400W and the frequency to be 40kHz, and performing ultrasonic treatment for 30 minutes.

[0018] Further, in step 5), the adsorption decolorization specifically involves using 1%wt activated carbon for adsorption decolorization.

[0019] Further, in step 5), the filtration specifically involves: sequentially using a ceramic membrane with a pore size of 0.1 μm and a nanofiltration membrane with a molecular weight cutoff of 200–300 Da.

[0020] Furthermore, in step 6), the relative density of the ointment is 1.10.

[0021] Further, in step 6), the step of slowly adding 95% ethanol to the clear paste specifically involves controlling the stirring speed to 50 rpm and slowly adding 95% ethanol to the clear paste according to a final ethanol concentration of 60% (v / v).

[0022] Further, in step 6), the standing period specifically refers to standing at 4°C for 12 to 36 hours.

[0023] Further, in step 6), the vacuum distillation specifically involves distilling the filtrate under reduced pressure at 55°C and 0.5 MPa.

[0024] Further, in step 7), the amount of soluble starch added is 10%wt.

[0025] Further, in step 7), the parameters for spray drying are: inlet air temperature 140-160℃, outlet air temperature 75-85℃, and powder moisture content 3-5%.

[0026] The third technical solution of this invention: The above-mentioned traditional Chinese medicine preparation for treating urinary tract infections is used in the treatment of urinary tract infections.

[0027] Compared with the prior art, the beneficial effects of the present invention are as follows: The traditional Chinese medicine preparation prepared by this invention for treating urinary tract infections has a minimum inhibitory concentration (MIC) of 16.6 μg / mL against Escherichia coli and a MIC of 10.8 μg / mL against Staphylococcus aureus, demonstrating good antibacterial activity. The traditional Chinese medicine preparation prepared by this invention for treating urinary tract infections showed an inhibition rate of 89.5% against tumor necrosis factor-α, 85.2% against interleukin-6, and 82.7% against interleukin-1β, demonstrating good anti-inflammatory effects. The traditional Chinese medicine preparation prepared according to this invention for treating urinary tract infections, after 7 days of treatment, showed that the urine white blood cell count was 15 Cells / μL, the urine protein count was 8 mg / dL, and the urine bacterial count was 10. 2.1 CFU / mL, white blood cell count 8.5 × 10⁻⁶ 9 / L, with a kidney pathology score of 1.2, has significant advantages in controlling infection, reducing inflammation, and protecting target organs. Detailed Implementation

[0028] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention. It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the present invention.

[0029] Furthermore, regarding the numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Every smaller range between any stated value or intermediate value within a stated range, and any other stated value or intermediate value within said range, is also included within this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0030] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0031] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be obvious to those skilled in the art. This specification and embodiments are merely exemplary.

[0032] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0033] In the following examples and comparative examples, all raw materials used were commercially available. All Chinese herbal raw materials were ground into powder and passed through an 80-mesh sieve.

[0034] The following embodiments illustrate a method for preparing a traditional Chinese medicine preparation for treating urinary tract infections, comprising the following steps: 1) Weigh each raw material according to the following mass proportions: 20-30 parts of Lysimachia christinae, 5-15 parts of Alisma plantago-aquatica, 20-30 parts of Pyrrosia lingua, 4-6 parts of Lygodium japonicum, 10-20 parts of Plantago asiatica, 5-15 parts of chicken gizzard lining, 0.5-1.5 parts of Arisaema heterophyllum, 3-5 parts of amber, 5-15 parts of vinegar-processed Corydalis yanhusuo, 5-15 parts of Astragalus membranaceus, and 1-3 parts of Glycyrrhiza uralensis. 2) Mix the herbs weighed in step 1) such as Lysimachia christinae, Alisma plantago-aquatica, Pyrrosia lingua, Lygodium japonicum and Plantago asiatica to obtain Chinese herbal powder A. Then, according to the water-to-powder ratio of Chinese herbal powder A to water of (10-20) mL:1g, place Chinese herbal powder A in water and perform subcritical water-ultrasonic coupling extraction. After filtration, obtain Chinese herbal extract A. The parameters of the subcritical water-ultrasonic coupling are as follows: Preparatory stage: 90~110℃, 5~15min, synchronous ultrasonic power 200W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; Main extraction stage: 65~75℃, 20~30min, synchronous ultrasonic power 300W, frequency 40kHz, ultrasonic operation 30s, interval 10s; Deep extraction stage: 70-90℃, 10-20min, synchronous ultrasonic power 400W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; 3) Mix the chicken gizzard lining, sand amber, amber and vinegar-processed corydalis weighed in step 1) to obtain Chinese medicine powder B. Then, according to the material-liquid ratio of Chinese medicine powder B to 85% ethanol of (4-6) mL:1g, place Chinese medicine powder B in 85% ethanol, extract by supercritical CO2, filter, and obtain Chinese medicine extract B. The parameters for supercritical CO2 extraction are: pressure 30 MPa, temperature 45–55 °C, time 2–3 h, and CO2 flow rate 20 L / h. 4) Mix the Astragalus membranaceus and Glycyrrhiza uralensis weighed in step 1) to obtain Chinese medicine powder C. Then, according to the water-to-powder ratio of Chinese medicine powder C to water of (15-25) mL:1g, disperse Chinese medicine powder C in water to obtain Chinese medicine powder C dispersion. 5) According to the material-liquid ratio of compound enzyme and Chinese herbal powder C dispersion of (15-25) mL:1g, place the compound enzyme in the Chinese herbal powder C dispersion obtained in step 4), and enzymatically hydrolyze it at pH 5.0 and 45℃ for 1-3 hours. Then, control the ultrasonic power to be 400W and the frequency to be 40kHz, and ultrasonically treat for 30 minutes. Filter to obtain Chinese herbal extract C. The complex enzyme is composed of cellulase, pectinase and trypsin mixed in a mass ratio of 1:(1-3):(0.1-0.3); 6) Mix the herbal extract A obtained in step 2), the herbal extract B obtained in step 3), and the herbal extract C obtained in step 5), and then sequentially use 1%wt activated carbon for adsorption and decolorization, a ceramic membrane with a pore size of 0.1μm for filtration, and a nanofiltration membrane with a molecular weight cutoff of 200-300Da for filtration to obtain a preliminary purified extract. 7) Concentrate the preliminary purified extract obtained in step 6) into a clear paste with a relative density of 1.10 (60℃). Then, control the stirring speed at 50 rpm and slowly add 95% ethanol to the clear paste with a final ethanol concentration of 60% (v / v). After the ethanol is added, let it stand at 4℃ for 12-36 hours, filter, and distill the filtrate under reduced pressure at 55℃ and 0.5 MPa to obtain the purified extract. 8) Add 10%wt of soluble starch to the purified extract obtained in step 7), stir evenly, and then spray dry to obtain the traditional Chinese medicine preparation for treating urinary tract infections; The parameters for spray drying are: inlet air temperature 140-160℃, outlet air temperature 75-85℃, and powder moisture content 3-5%.

[0035] Example 1 1) Weigh each raw material according to the following mass proportions: 25 parts of Lysimachia christinae, 10 parts of Alisma plantago-aquatica, 25 parts of Pyrrosia lingua, 5 parts of Lygodium japonicum, 15 parts of Plantago asiatica, 10 parts of chicken gizzard lining, 1 part of Achyranthes bidentata, 4 parts of amber, 10 parts of vinegar-processed Corydalis yanhusuo, 10 parts of Astragalus membranaceus, and 2 parts of Glycyrrhiza uralensis. 2) Mix the herbs weighed in step 1) such as Lysimachia christinae, Alisma plantago-aquatica, Pyrrosia lingua, Lygodium japonicum and Plantago asiatica to obtain herbal powder A. Then, according to the water-to-powder ratio of herbal powder A to water of 15mL:1g, place herbal powder A in water and perform subcritical water-ultrasonic coupling extraction. After filtration, obtain herbal extract A. The parameters of the subcritical water-ultrasonic coupling are as follows: Preparatory stage: 100℃, 10min, synchronous ultrasonic power 200W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; Main extraction stage: 70℃, 25min, synchronous ultrasonic power 300W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; Deep extraction stage: 80℃, 15min, synchronous ultrasonic power 400W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; 3) Mix the chicken gizzard lining, sand amber, amber and vinegar-processed corydalis weighed in step 1) to obtain Chinese medicine powder B. Then, according to the material-liquid ratio of Chinese medicine powder B to 85% ethanol of 5mL:1g, place Chinese medicine powder B in 85% ethanol, extract by supercritical CO2, filter, and obtain Chinese medicine extract B. The parameters for the supercritical CO2 extraction are: pressure 30 MPa, temperature 50 °C, time 2.5 h, and CO2 flow rate 20 L / h. 4) Mix the Astragalus membranaceus and Glycyrrhiza uralensis weighed in step 1) to obtain Chinese medicine powder C. Then, according to the water-to-powder ratio of Chinese medicine powder C to water of 20mL:1g, disperse Chinese medicine powder C in water to obtain Chinese medicine powder C dispersion. 5) According to the material-liquid ratio of compound enzyme to Chinese herbal powder C dispersion of 20mL:1g, the compound enzyme is placed in the Chinese herbal powder C dispersion obtained in step 4), and enzymatically hydrolyzed at pH 5.0 and 45℃ for 2h. Then, the ultrasonic power is controlled at 400W and the frequency is 40kHz, and the ultrasonic treatment is carried out for 30min. After filtration, Chinese herbal extract C is obtained. The complex enzyme is composed of cellulase, pectinase and trypsin mixed in a mass ratio of 1:2:0.2. 6) Mix the herbal extract A obtained in step 2), the herbal extract B obtained in step 3), and the herbal extract C obtained in step 5), and then sequentially use 1%wt activated carbon for adsorption and decolorization, a ceramic membrane with a pore size of 0.1μm for filtration, and a nanofiltration membrane with a molecular weight cutoff of 200-300Da for filtration to obtain a preliminary purified extract. 7) Concentrate the preliminary purified extract obtained in step 6) into a clear paste with a relative density of 1.10 (60℃). Then, control the stirring speed at 50 rpm and slowly add 95% ethanol to the clear paste with a final ethanol concentration of 60% (v / v). After the ethanol is added, let it stand at 4℃ for 24 h, filter, and distill the filtrate under reduced pressure at 55℃ and 0.5 MPa to obtain the purified extract. 8) Add 10%wt of soluble starch to the purified extract obtained in step 7), stir evenly, and then spray dry to obtain the traditional Chinese medicine preparation for treating urinary tract infections; The parameters for spray drying are: inlet air temperature 150℃, outlet air temperature 80℃, and powder moisture content 3-5%.

[0036] Example 2 1) Weigh each raw material according to the following mass proportions: 20 parts of Lysimachia christinae, 5 parts of Alisma plantago-aquatica, 20 parts of Pyrrosia lingua, 4 parts of Lygodium japonicum, 10 parts of Plantago asiatica, 5 parts of chicken gizzard lining, 0.5 parts of Achyranthes bidentata, 3 parts of amber, 5 parts of vinegar-processed Corydalis yanhusuo, 5 parts of Astragalus membranaceus, and 1 part of Glycyrrhiza uralensis. 2) Mix the herbs weighed in step 1) such as Lysimachia christinae, Alisma plantago-aquatica, Pyrrosia lingua, Lygodium japonicum and Plantago asiatica to obtain herbal powder A. Then, according to the water-to-powder ratio of herbal powder A to water of 10 mL: 1 g, place herbal powder A in water and perform subcritical water-ultrasonic coupling extraction. After filtration, obtain herbal extract A. The parameters of the subcritical water-ultrasonic coupling are as follows: Preparatory stage: 90℃, 5min, synchronous ultrasonic power 200W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; Main extraction stage: 65℃, 20min, synchronous ultrasonic power 300W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; Deep extraction stage: 70℃, 10min, synchronous ultrasonic power 400W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; 3) Mix the chicken gizzard lining, sand amber, amber and vinegar-processed corydalis weighed in step 1) to obtain Chinese medicine powder B. Then, according to the material-liquid ratio of Chinese medicine powder B to 85% ethanol of 4mL:1g, place Chinese medicine powder B in 85% ethanol, extract by supercritical CO2, filter, and obtain Chinese medicine extract B. The parameters for the supercritical CO2 extraction are: pressure 30 MPa, temperature 45 °C, time 2 h, and CO2 flow rate 20 L / h. 4) Mix the Astragalus membranaceus and Glycyrrhiza uralensis weighed in step 1) to obtain Chinese medicine powder C. Then, according to the water-to-powder ratio of Chinese medicine powder C to water of 15mL:1g, disperse Chinese medicine powder C in water to obtain Chinese medicine powder C dispersion. 5) According to the material-liquid ratio of compound enzyme to Chinese herbal powder C dispersion of 15mL:1g, place compound enzyme in the Chinese herbal powder C dispersion obtained in step 4), and enzymatically hydrolyze at pH 5.0 and 45℃ for 1h. Then control the ultrasonic power to be 400W and the frequency to be 40kHz, and sonicate for 30min. Filter to obtain Chinese herbal extract C. The complex enzyme is composed of cellulase, pectinase and trypsin mixed in a mass ratio of 1:1:0.1. 6) Mix the herbal extract A obtained in step 2), the herbal extract B obtained in step 3), and the herbal extract C obtained in step 5), and then sequentially use 1%wt activated carbon for adsorption and decolorization, a ceramic membrane with a pore size of 0.1μm for filtration, and a nanofiltration membrane with a molecular weight cutoff of 200-300Da for filtration to obtain a preliminary purified extract. 7) Concentrate the preliminary purified extract obtained in step 6) into a clear paste with a relative density of 1.10 (60℃). Then, control the stirring speed at 50 rpm and slowly add 95% ethanol to the clear paste with a final ethanol concentration of 60% (v / v). After the ethanol is added, let it stand at 4℃ for 12 h, filter, and distill the filtrate under reduced pressure at 55℃ and 0.5 MPa to obtain the purified extract. 8) Add 10%wt of soluble starch to the purified extract obtained in step 7), stir evenly, and then spray dry to obtain the traditional Chinese medicine preparation for treating urinary tract infections; The parameters for spray drying are: inlet air temperature 140℃, outlet air temperature 75℃, and powder moisture content 3-5%.

[0037] Example 3 1) Weigh each raw material according to the following mass proportions: 30 parts of Lysimachia christinae, 15 parts of Alisma plantago-aquatica, 30 parts of Pyrrosia lingua, 6 parts of Lygodium japonicum, 20 parts of Plantago asiatica, 15 parts of chicken gizzard lining, 1.5 parts of Achyranthes bidentata, 5 parts of amber, 15 parts of vinegar-processed Corydalis yanhusuo, 15 parts of Astragalus membranaceus, and 3 parts of Glycyrrhiza uralensis. 2) Mix the herbs weighed in step 1) such as Lysimachia christinae, Alisma plantago-aquatica, Pyrrosia lingua, Lygodium japonicum and Plantago asiatica to obtain herbal powder A. Then, according to the water-to-powder ratio of herbal powder A to water of 20mL:1g, place herbal powder A in water and perform subcritical water-ultrasonic coupling extraction. After filtration, obtain herbal extract A. The parameters of the subcritical water-ultrasonic coupling are as follows: Preparatory stage: 110℃, 15min, synchronous ultrasonic power 200W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; Main extraction stage: 75℃, 30min, synchronous ultrasonic power 300W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; Deep extraction stage: 90℃, 20min, synchronous ultrasonic power 400W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; 3) Mix the chicken gizzard lining, sand amber, amber and vinegar-processed corydalis weighed in step 1) to obtain Chinese medicine powder B. Then, according to the material-liquid ratio of Chinese medicine powder B to 85% ethanol of 6mL:1g, place Chinese medicine powder B in 85% ethanol, extract by supercritical CO2, filter, and obtain Chinese medicine extract B. The parameters for the supercritical CO2 extraction are: pressure 30 MPa, temperature 55 °C, time 3 h, and CO2 flow rate 20 L / h. 4) Mix the Astragalus membranaceus and Glycyrrhiza uralensis weighed in step 1) to obtain Chinese medicine powder C. Then, according to the water-to-powder ratio of Chinese medicine powder C to water of 25mL:1g, disperse Chinese medicine powder C in water to obtain Chinese medicine powder C dispersion. 5) According to the material-liquid ratio of compound enzyme to Chinese herbal powder C dispersion of 25mL:1g, the compound enzyme is placed in the Chinese herbal powder C dispersion obtained in step 4), and enzymatically hydrolyzed at pH 5.0 and 45℃ for 3h. Then, the ultrasonic power is controlled at 400W and the frequency is 40kHz, and the ultrasonic treatment is carried out for 30min. After filtration, Chinese herbal extract C is obtained. The complex enzyme is composed of cellulase, pectinase and trypsin mixed in a mass ratio of 1:3:0.3. 6) Mix the herbal extract A obtained in step 2), the herbal extract B obtained in step 3), and the herbal extract C obtained in step 5), and then sequentially use 1%wt activated carbon for adsorption and decolorization, a ceramic membrane with a pore size of 0.1μm for filtration, and a nanofiltration membrane with a molecular weight cutoff of 200-300Da for filtration to obtain a preliminary purified extract. 7) Concentrate the preliminary purified extract obtained in step 6) into a clear paste with a relative density of 1.10 (60℃). Then, control the stirring speed at 50 rpm and slowly add 95% ethanol to the clear paste with a final ethanol concentration of 60% (v / v). After the ethanol is added, let it stand at 4℃ for 36 h, filter, and distill the filtrate under reduced pressure at 55℃ and 0.5 MPa to obtain the purified extract. 8) Add 10%wt of soluble starch to the purified extract obtained in step 7), stir evenly, and then spray dry to obtain the traditional Chinese medicine preparation for treating urinary tract infections; The parameters for spray drying are: inlet air temperature 160℃, outlet air temperature 85℃, and powder moisture content 3-5%.

[0038] Comparative Example 1 Same as Example 1, except that: the Lysimachia christinae is replaced with Orthosiphon aristatus.

[0039] Comparative Example 2 Same as Example 1, except that: Pyrrosia lingua is replaced with Polygonum aviculare.

[0040] Comparative Example 3 Same as Example 1, except that amber is replaced with mother-of-pearl.

[0041] Comparative Example 4 Same as Example 1, except that vinegar-processed Corydalis is replaced with Ligusticum chuanxiong.

[0042] Comparative Example 5 1) Weigh each raw material according to the following mass proportions: 25 parts of Lysimachia christinae, 10 parts of Alisma plantago-aquatica, 25 parts of Pyrrosia lingua, 5 parts of Lygodium japonicum, 15 parts of Plantago asiatica, 10 parts of chicken gizzard lining, 1 part of Achyranthes bidentata, 4 parts of amber, 10 parts of vinegar-processed Corydalis yanhusuo, 10 parts of Astragalus membranaceus, and 2 parts of Glycyrrhiza uralensis. 2) Mix the herbs weighed in step 1) including Lysimachia christinae, Alisma plantago-aquatica, Pyrrosia lingua, Lygodium japonicum, Plantago asiatica, Gallus gallus domesticus gizzard lining, Achyranthes bidentata, amber, vinegar-processed Corydalis yanhusuo, Astragalus membranaceus, and Glycyrrhiza uralensis to obtain a Chinese herbal powder. Then, according to the water-to-powder ratio of Chinese herbal powder to water of 15 mL: 1 g, place the Chinese herbal powder in water and reflux extract at 100 °C for 2 h. Then, use 1% wt activated carbon for adsorption and decolorization, 0.1 μm pore size ceramic membrane filtration, and nanofiltration membrane with a molecular weight cutoff of 200-300 Da to obtain a preliminary purified extract. 3) Concentrate the preliminary purified extract obtained in step 2) into a clear paste with a relative density of 1.10 (60℃). Then, control the stirring speed at 50 rpm and slowly add 95% ethanol to the clear paste with a final ethanol concentration of 60% (v / v). After the ethanol is added, let it stand at 4℃ for 24 h, filter, and distill the filtrate under reduced pressure at 55℃ and 0.5 MPa to obtain the purified extract. 4) Add 10%wt of soluble starch to the purified extract obtained in step 3), stir evenly, and then spray dry to obtain the traditional Chinese medicine preparation for treating urinary tract infections; The parameters for spray drying are: inlet air temperature 150℃, outlet air temperature 80℃, and powder moisture content 3-5%.

[0043] Comparative Example 6 Same as Example 1, except that step 2) is: Mix the herbs weighed in step 1), including Lysimachia christinae, Alisma plantago-aquatica, Pyrrosia lingua, Lygodium japonicum, and Plantago asiatica, to obtain herbal powder A. Then, according to the water-to-powder ratio of herbal powder A to water of 15 mL: 1 g, place herbal powder A in water, perform subcritical water extraction, filter, and obtain herbal extract A. The parameters of the subcritical water are as follows: Preheating stage: 100℃, 10min; Main extraction stage: 70℃, 25min; Deep extraction stage: 80℃, 15min.

[0044] Comparative Example 7 Same as Example 1, except that step 2) is: Mix the herbs weighed in step 1), including Lysimachia christinae, Alisma plantago-aquatica, Pyrrosia lingua, Lygodium japonicum, and Plantago asiatica, to obtain herbal powder A. Then, according to the water-to-powder ratio of herbal powder A to water of 15 mL: 1 g, place herbal powder A in water and perform subcritical water-ultrasonic coupling extraction. After filtration, obtain herbal extract A. The parameters of the subcritical water-ultrasonic coupling are as follows: Main extraction stage: 70℃, 25min, synchronous ultrasonic power 300W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; Deep extraction stage: 80℃, 15min, synchronous ultrasonic power 400W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s.

[0045] Comparative Example 8 Same as Example 1, except that step 2) is: Mix the herbs weighed in step 1), including Lysimachia christinae, Alisma plantago-aquatica, Pyrrosia lingua, Lygodium japonicum, and Plantago asiatica, to obtain herbal powder A. Then, according to the water-to-powder ratio of herbal powder A to water of 15 mL: 1 g, place herbal powder A in water and perform subcritical water-ultrasonic coupling extraction. After filtration, obtain herbal extract A. The parameters of the subcritical water-ultrasonic coupling are as follows: Preparatory stage: 100℃, 10min, synchronous ultrasonic power 200W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; Main extraction stage: 70℃, 25min, synchronous ultrasonic power 300W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s.

[0046] Comparative Example 9 Same as Example 1, except that step 2) is: Mix the herbs weighed in step 1), including Lysimachia christinae, Alisma plantago-aquatica, Pyrrosia lingua, Lygodium japonicum, and Plantago asiatica, to obtain herbal powder A. Then, according to the water-to-powder ratio of herbal powder A to water of 15 mL: 1 g, place herbal powder A in water and perform subcritical water-ultrasonic coupling extraction. After filtration, obtain herbal extract A. The parameters of the subcritical water-ultrasonic coupling are as follows: Preparatory stage: 100℃, 10min, synchronous ultrasonic power 200W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; Main extraction stage: 60℃, 25min, synchronous ultrasonic power 300W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; Deep extraction stage: 80℃, 15min, synchronous ultrasonic power 400W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s.

[0047] Comparative Example 10 Same as Example 1, except that step 2) is: Mix the herbs weighed in step 1), including Lysimachia christinae, Alisma plantago-aquatica, Pyrrosia lingua, Lygodium japonicum, and Plantago asiatica, to obtain herbal powder A. Then, according to the water-to-powder ratio of herbal powder A to water of 15 mL: 1 g, place herbal powder A in water and perform subcritical water-ultrasonic coupling extraction. After filtration, obtain herbal extract A. The parameters of the subcritical water-ultrasonic coupling are as follows: Preparatory stage: 100℃, 10min, synchronous ultrasonic power 200W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; Main extraction stage: 80℃, 25min, synchronous ultrasonic power 300W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; Deep extraction stage: 80℃, 15min, synchronous ultrasonic power 400W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s.

[0048] Comparative Example 11 Same as Example 1, except that step 5) is: The ultrasonic power was controlled at 400W and the frequency at 40kHz. The dispersion of Chinese herbal powder C obtained in step 4) was ultrasonically treated for 30 minutes, filtered, and Chinese herbal extract C was obtained.

[0049] Comparative Example 12 Same as Example 1, except that step 5) is: The compound enzyme and the dispersion of Chinese herbal powder C were in a material-liquid ratio of 20 mL: 1 g. The compound enzyme was placed in the dispersion of Chinese herbal powder C obtained in step 4), and enzymatically hydrolyzed at pH 5.0 and 45℃ for 2 h. After filtration, the Chinese herbal extract C was obtained. The complex enzyme is composed of cellulase, pectinase and trypsin mixed in a mass ratio of 1:2:0.2.

[0050] Effect verification I. Antibacterial activity test Referring to the CLSI guidelines, the minimum inhibitory concentrations of the traditional Chinese medicine preparations prepared in Examples 1-3 and Comparative Examples 1-12 against common pathogens of urinary tract infections were determined using the micro-broth dilution method. The results are shown in Table 1. Table 1 Minimum Inhibitory Concentration

[0051] As shown in Table 1, the traditional Chinese medicine preparation prepared by this invention for treating urinary tract infections has a minimum inhibitory concentration (MIC) of 16.6 μg / mL against Escherichia coli and a MIC of 10.8 μg / mL against Staphylococcus aureus, demonstrating good antibacterial activity.

[0052] II. Anti-inflammatory experiment A lipopolysaccharide (LPS)-induced inflammation model of mouse macrophages (RAW264.7) was constructed. The traditional Chinese medicine preparations prepared in Examples 1-3 and Comparative Examples 1-12 were administered to the cells, and the cell supernatants were collected. The concentrations of tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-1β (IL-1β) were detected by enzyme-linked immunosorbent assay (ELISA), and the inhibition rates of each inflammatory factor were calculated. The results are shown in Table 2. Table 2 Inhibition rate of inflammatory factors

[0053] As shown in Table 2, the traditional Chinese medicine preparation prepared by this invention for treating urinary tract infections showed an inhibition rate of 89.5% against tumor necrosis factor-α, 85.2% against interleukin-6, and 82.7% against interleukin-1β, demonstrating good anti-inflammatory effects.

[0054] III. Animal Model Experiments A mouse model of ascending urinary tract infection was established. The traditional Chinese medicine preparations prepared in Examples 1-3 and Comparative Examples 1-12 were administered for 7 days (1000 mg / kg / day). The therapeutic effect was evaluated after 7 days, and the results are shown in Table 3. Table 3 Treatment Efficacy

[0055] As shown in Table 3, the traditional Chinese medicine preparation for treating urinary tract infections prepared in this invention, after 7 days of treatment, resulted in a urine white blood cell count of 15 Cells / μL, a urine protein count of 8 mg / dL, and a urine bacterial count of 10. 2.1 CFU / mL, white blood cell count 8.5 × 10⁻⁶ 9 / L, with a kidney pathology score of 1.2, has significant advantages in controlling infection, reducing inflammation, and protecting target organs.

[0056] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the specific implementation of the present invention. Any modifications or equivalent substitutions that do not depart from the spirit and scope of the present invention should be covered within the scope of protection of the claims of the present invention.

Claims

1. A traditional Chinese medicine preparation for treating urinary tract infections, characterized in that, Includes the following quantities of raw materials: 20-30 parts of Lysimachia christinae, 5-15 parts of Alisma plantago-aquatica, 20-30 parts of Pyrrosia lingua, 4-6 parts of Lygodium japonicum, 10-20 parts of Plantago asiatica, 5-15 parts of chicken gizzard lining, 0.5-1.5 parts of Aralia elata, 3-5 parts of amber, 5-15 parts of vinegar-processed Corydalis yanhusuo, 5-15 parts of Astragalus membranaceus, and 1-3 parts of Glycyrrhiza uralensis.

2. The method for preparing a traditional Chinese medicine preparation for treating urinary tract infections as described in claim 1, characterized in that, Includes the following steps: 1) Mix Lysimachia christinae, Alisma plantago-aquatica, Pyrrosia lingua, Lygodium japonicum and Plantago asiatica to obtain Chinese herbal powder A. Then, place Chinese herbal powder A in water and extract it by subcritical water-ultrasound coupling. After filtration, obtain Chinese herbal extract A. 2) Mix chicken gizzard lining, sand absinthe, amber and vinegar-processed corydalis to obtain Chinese medicine powder B. Then, place Chinese medicine powder B in 85% ethanol, extract by supercritical CO2, filter, and obtain Chinese medicine extract B. 3) Mix Astragalus membranaceus and Glycyrrhiza uralensis to obtain Chinese medicine powder C. Then disperse Chinese medicine powder C in water to obtain Chinese medicine powder C dispersion. 4) Place the compound enzyme in the dispersion of Chinese herbal powder C obtained in step 3), perform enzymatic hydrolysis, ultrasonic treatment, and filtration to obtain Chinese herbal extract C; 5) Mix the Chinese herbal extract A obtained in step 1), the Chinese herbal extract B obtained in step 2), and the Chinese herbal extract C obtained in step 4), adsorb and decolorize, and filter to obtain a preliminary purified extract; 6) Concentrate the preliminary purified extract obtained in step 5) into a clear paste, then slowly add 95% ethanol to the clear paste. After the ethanol is added, let it stand, filter, and distill under reduced pressure to obtain the purified extract. 7) Add soluble starch to the purified extract obtained in step 6), stir evenly, and then spray dry to obtain the traditional Chinese medicine preparation for treating urinary tract infections.

3. The method for preparing a traditional Chinese medicine preparation for treating urinary tract infections according to claim 2, characterized in that, In step 1), the water-to-material ratio of the herbal powder A to water is (10-20) mL:1g; the parameters of the subcritical water-ultrasound coupling are: pre-extraction stage: 90-110℃, 5-15min, synchronous ultrasonic power 200W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; main extraction stage: 65-75℃, 20-30min, synchronous ultrasonic power 300W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s; deep extraction stage: 70-90℃, 10-20min, synchronous ultrasonic power 400W, frequency 40kHz, ultrasonic operation for 30s, interval for 10s.

4. The method for preparing a traditional Chinese medicine preparation for treating urinary tract infections according to claim 2, characterized in that, In step 2), the ratio of the herbal powder B to 85% ethanol is (4-6) mL:1g; the parameters of the supercritical CO2 extraction are: pressure 30MPa, temperature 45-55℃, time 2-3h, and CO2 flow rate 20L / h.

5. The method for preparing a traditional Chinese medicine preparation for treating urinary tract infections according to claim 2, characterized in that, In step 3), the water-to-powder ratio of the Chinese herbal powder C to water is (15-25) mL:1g.

6. The method for preparing a traditional Chinese medicine preparation for treating urinary tract infections according to claim 2, characterized in that, In step 4), the composite enzyme is composed of cellulase, pectinase and trypsin mixed in a mass ratio of 1:(1-3):(0.1-0.3); the material-liquid ratio of the composite enzyme and the dispersion of the traditional Chinese medicine powder C is (15-25) mL:1g; the enzymatic hydrolysis is specifically performed at pH 5.0 and 45℃ for 1-3 hours; the ultrasonic treatment is specifically performed by controlling the ultrasonic power at 400W and the frequency at 40kHz for 30 minutes.

7. The method for preparing a traditional Chinese medicine preparation for treating urinary tract infections according to claim 2, characterized in that, In step 5), the adsorption decolorization specifically involves adsorption decolorization using 1%wt activated carbon; the filtration specifically involves sequential filtration using a ceramic membrane with a pore size of 0.1μm and a nanofiltration membrane with a molecular weight cutoff of 200-300Da.

8. The method for preparing a traditional Chinese medicine preparation for treating urinary tract infections according to claim 2, characterized in that, In step 6), the relative density of the clear extract is 1.10; the step of slowly adding 95% ethanol to the clear extract specifically involves controlling the stirring speed at 50 rpm and slowly adding 95% ethanol to the clear extract according to a final ethanol concentration of 60% (v / v); the step of settling specifically involves settling at 4°C for 12–36 h; the step of vacuum distillation specifically involves distilling the filtrate at 55°C and 0.5 MPa under reduced pressure.

9. A method for preparing a traditional Chinese medicine preparation for treating urinary tract infections according to claim 2, characterized in that, In step 7), the amount of soluble starch added is 10%wt; the parameters of the spray drying are: inlet air temperature 140-160℃, outlet air temperature 75-85℃, and powder moisture content 3-5%.

10. The application of the traditional Chinese medicine preparation for treating urinary tract infections as described in claim 1 in the treatment of urinary tract infections.

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