Traditional Chinese medicine composition for improving urinary tract infection, preparation method and application

Through a traditional Chinese medicine composition containing a variety of traditional Chinese medicine ingredients, the drug resistance and recurrence problems that Chinese and Western medicines cannot effectively solve in urinary tract infection are solved, and the effect of improving the symptoms of urinary tract infection and reducing the recurrence rate is achieved, providing a safe and effective alternative and supplementary treatment option.

CN119818595APending Publication Date: 2025-04-15WANGJING HOSPITAL OF CHINA ACAD OF CHINESE MEDICAL SCI
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Patent Information

Application Number
CN202510099432.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-01-22
Publication Date
2025-04-15

AI Technical Summary

Technical Problem

Existing Western medicines cannot effectively solve the drug resistance, recurrence and adverse reactions of urinary tract infections, especially in postmenopausal, elderly and immunodeficient patients, where recurrence and drug resistance are serious.

Method used

A traditional Chinese medicine composition is provided, including Bupleurum, Scutellaria baicalensis, Raw Astragalus, Salvia miltiorrhiza, Baitou, Pyramid, Malase, Malase, Aconite, Cinnamon and Rush, and is prepared into an oral preparation through a specific mass ratio and preparation method to improve the symptoms of urinary tract infection.

Benefits of technology

This traditional Chinese medicine composition significantly improves the symptoms of urinary tract infection, has a low recurrence rate and no obvious toxic side effects, is safe, and has better efficacy in clearing drug-resistant bacteria than antibiotics, providing an effective antibiotic replacement and supplementary treatment option.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to the technical field of traditional Chinese medicine composition preparation and application, and discloses a traditional Chinese medicine composition for improving urinary tract infection and a preparation method and application thereof.The traditional Chinese medicine composition is prepared from radix bupleuri, radix scutellariae, raw radix astragali, radix salviae miltiorrhizae, the root of Chinese pulsatilla, herba patriniae, polygonum aviculare, chingma abutilon seeds, the root of three-nerved spicebush, fennel, cinnamon and juncus roemerianus. The traditional Chinese medicine composition comprises the following components in parts by mass: 14-16g of radix bupleuri; 9 to 11 g of radix scutellariae; 19 to 21 g of raw radix astragali; 29 to 31 g of red sage root; 13-17g of Chinese pulsatilla root; 28-32 g of herba patriniae; 14-16 g of polygonum aviculare; 13 to 16 g of chingma abutilon seeds; 7-9g of combined spicebush root; 7-9g of fennel; 5-7g of cinnamon; according to the traditional Chinese medicine composition for strengthening the body resistance, clearing heat and promoting diuresis, the clearing curative effect on RUTI drug-resistant bacteria is better than that of antibiotics, the symptoms of a patient are obviously improved, the recurrence rate is lower than that of an antibiotic group, and the treatment principle and purpose of traditional Chinese medicine are completely different from those of antibiotic treatment; the traditional Chinese medicine composition disclosed by the invention considers recovery and improvement of the overall functional state of a patient instead of purely removing pathogenic bacteria.
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Description

Technical Field

[0001] The present invention relates to the technical field of preparation and application of Chinese medicine compositions, and in particular to a Chinese medicine composition for improving urinary tract infection, a preparation method and application thereof. Background Art

[0002] Urinary tract infection is the second most common infectious disease after respiratory tract infection, and often causes severe sepsis or septic shock. Recurrent urinary tract infection refers to urinary tract infection occurring ≥2 times within 6 months or ≥3 times within 12 months. It is a common but difficult to cure disease in clinical practice. The susceptible population of RUTI is mostly postmenopausal, elderly, and immunocompromised patients, and the recurrence rate exceeds 50%. Its repeated attacks require a large amount of antibiotics, leading to increasingly serious drug resistance. Finding alternative antibiotic therapies has always been a hot spot and difficulty in the field of infection. RUTI is different from other infectious diseases. It is characterized by lingering and recurrent attacks. The main drugs in the clinical prevention and treatment guidelines are currently antibiotics. Generally, a large dose of antibiotics is taken orally or intravenously during the attack period, and a low dose of long-term antibiotics is taken orally during the remission period.

[0003] Existing western medicines cannot solve the problems of drug resistance, secondary infection, adverse reactions, etc. Recent studies have shown that traditional Chinese medicine has multiple advantages in anti-infection, such as safety, effectiveness, and low resistance, and is the trend of alternative antibiotic treatment in the future. To this end, a traditional Chinese medicine composition, preparation method and application for improving urinary tract infection are proposed. Summary of the invention

[0004] The purpose of the present invention is to provide a Chinese medicine composition for improving urinary tract infection, a preparation method and application thereof, so as to solve the problems raised in the above background technology.

[0005] To achieve the above object, the present invention provides the following technical scheme: a Chinese medicine composition for improving urinary tract infection, the Chinese medicine composition comprising bupleurum, scutellaria, raw astragalus, salvia miltiorrhiza, pulsatilla, patrinia, scutellaria baicalensis, malt seed, lindera striata, fennel, cinnamon bark and rush;

[0006] The composition weight ratio of the Chinese medicine composition is:

[0007] Bupleurum 14-16g;

[0008] Scutellaria baicalensis 9-11g;

[0009] Raw Astragalus 19-21g;

[0010] Salvia miltiorrhiza 29-31g;

[0011] Pulsatilla 13-17g;

[0012] Patrinia 28-32g;

[0013] Polygonum multiflorum 14-16g;

[0014] Winter mallow seeds 13-16g;

[0015] Linderae 7-9g;

[0016] Fennel 7-9g;

[0017] Cinnamon 5-7g;

[0018] 2-4g of rush.

[0019] Preferably, the above comprises the following steps:

[0020] S1. Selecting raw materials of Chinese medicine composition;

[0021] S2, after mixing the Chinese medicines, adding water or ethanol to extract, to obtain an extract;

[0022] S3, mixing the extracts;

[0023] S4, performing a reduced pressure concentration process on the mixed extract;

[0024] S5, drying the condensed extract to obtain an extract powder;

[0025] S6. Mixing the obtained dry powder of the extract with a pharmaceutically acceptable carrier to prepare an oral preparation.

[0026] Preferably, in the above-mentioned S2, the weight of the water or ethanol is 5-15 times that of the traditional Chinese medicine composition.

[0027] Preferably, the above-mentioned ethanol has a concentration of 10%-60%.

[0028] Preferably, the Chinese medicine composition is extracted 1-3 times.

[0029] Preferably, the extraction time is 0.5-2 hours each time.

[0030] Preferably, in the above-mentioned S4, the reduced pressure concentration treatment may be one of air drying, vacuum drying or spray drying.

[0031] Preferably, in the above: in S6, the oral preparation includes tablets, dispersible tablets, effervescent tablets, orally disintegrating tablets, lozenges, chewable tablets, hard capsules, soft capsules, granules, pills, powders, pellets or oral liquid preparations.

[0032] Preferably, the above-mentioned: use of the traditional Chinese medicine composition in treating urinary tract infection.

[0033] Compared with the prior art, the present invention adopts the above technical solution and has the following technical effects:

[0034] 1. The Chinese medicine compound composition provided by the present invention has a good effect of improving the symptoms of urinary tract infection, can be used to treat urinary tract infection, is convenient to take clinically, and no obvious toxic and side effects were found in the Chinese medicine composition provided by the present invention during the experiment, and has good safety.

[0035] Second, the Fuzheng Qingre Lishi formula in the Chinese medicine composition of the present invention has a better effect on the elimination of RUTI resistant bacteria than antibiotics, and the patient's symptoms are significantly improved and the recurrence rate is lower than that of the antibiotic group. The treatment principles and purposes of traditional Chinese medicine are completely different from those of antibiotic treatment. The Chinese medicine composition of the present invention considers restoring and improving the overall functional state of the patient, rather than simply eliminating pathogenic bacteria. Therefore, Chinese medicine is a good alternative and supplementary treatment option. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0037] Figure 1 This is a schematic diagram of the UPEC clearance rate of spleen and kidney in the high-dose, long-course Chinese medicine intervention group of the present invention;

[0038] Figure 2 This is a schematic diagram of the CFU index of spleen and kidney organs after the intervention of the traditional Chinese medicine group of the present invention;

[0039] Figure 3 It is a schematic diagram of the in vitro antibacterial effect of the Chinese medicine monomer / compound of the present invention;

[0040] Figure 4 It is a schematic diagram of the in vitro antibacterial effect of the Chinese medicine-containing serum of the present invention. DETAILED DESCRIPTION

[0041] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0042] It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the conditions under which this application can be implemented. Therefore, they have no substantive technical significance. Any structural modification, change in proportional relationship or adjustment of size should still fall within the scope of the technical content disclosed in this application without affecting the effects and purposes that can be achieved by this application.

[0043] Example

[0044] See also Figure 1-4 The present invention provides a technical solution: a traditional Chinese medicine composition for improving urinary tract infection, the traditional Chinese medicine composition comprising bupleurum, scutellaria, raw astragalus, salvia miltiorrhiza, pulsatilla, patrinia, scutellaria baicalensis, malvaceae, lindera striata, fennel, cinnamon and rush;

[0045] The composition weight ratio of the Chinese medicine composition is:

[0046] 15g of Bupleurum chinense; 10g of Scutellaria baicalensis; 20g of raw Astragalus membranaceus; 30g of Salvia miltiorrhiza; 15g of Pulsatilla scabra; 30g of Patrinia scabra; 15g of Polygonum multiflorum; 15g of Malva ternata seed; 8g of Linderae scabra; 8g of fennel; 6g of cinnamon bark; 3g of Juncus effusus.

[0047] Bupleurum, Scutellaria, Raw Astragalus, Salvia miltiorrhiza, Pulsatilla, Patrinia and Polygonum multiflorum are used in combination, and the dosage of each medicinal material is determined based on the relationship between the effective components and functions, so that the components can work synergistically.

[0048] Bupleurum and Scutellariae can harmonize Shaoyang, clear the triple energizer, regulate the water channels, and distribute body fluids. When the pivot is opened, the rise and fall are clear, the distribution of body fluids is normal, and the water channels are unblocked.

[0049] Salvia miltiorrhiza, cinnamon bark, Pulsatilla chinensis, Patrinia chinensis, Polygonum multiflorum, and Fructus Malvae are used together as the assistant. Salvia miltiorrhiza can promote blood circulation and dissipate blood stasis, dredge the kidney meridians, prevent blood stasis from combining with dampness, and avoid aggravation of the condition.

[0050] Cinnamon enters the waist and abdomen, is good at warming the kidney yang and transforming dampness and turbidity, and can eliminate dampness and turbidity, relieve stranguria and treat symptoms;

[0051] Pulsatilla scabra and Patrinia scabra clear away heat, detoxify and cool the blood;

[0052] Polygonum multiflorum and Malus domestica seeds are diuretic and can relieve stranguria;

[0053] Linderae rutaecarpa and fennel are used together as adjuvants to promote qi and relieve pain, warm the kidney and dispel cold;

[0054] Juffure has diuretic, cooling, sedative and heat-clearing effects on the heart meridian.

[0055] The Chinese medicine compound composition provided by the present invention has a good effect of improving the symptoms of urinary tract infection, can be used to treat urinary tract infection, is convenient to take clinically, and no obvious toxic and side effects are found in the Chinese medicine compound composition provided by the present invention during the experiment, and has good safety.

[0056] The present invention also provides a method for preparing a Chinese medicine composition for improving urinary tract infection, comprising the following steps:

[0057] S1. Selecting raw materials of Chinese medicine composition;

[0058] S2, after mixing the Chinese medicines, adding water or ethanol to extract, to obtain an extract;

[0059] The weight of water or ethanol is 12 times that of the traditional Chinese medicine composition, the concentration of ethanol is 55%, the traditional Chinese medicine composition is extracted 3 times, and the extraction time for each time is 2 hours.

[0060] S3, mixing the extracts;

[0061] S4, performing a reduced pressure concentration treatment on the mixed extract; the reduced pressure concentration treatment may be one of air drying, vacuum drying or spray drying.

[0062] S5, drying the condensed extract to obtain an extract powder;

[0063] S6, mixing the obtained dry powder of the extract with a pharmaceutically acceptable carrier to prepare an oral preparation;

[0064] Oral preparations include tablets, dispersible tablets, effervescent tablets, orally disintegrating tablets, lozenges, chewable tablets, hard capsules, soft capsules, granules, pills, powders, pellets or oral liquid preparations.

[0065] The present invention also provides an application of a traditional Chinese medicine composition for improving urinary tract infection, and an application of the traditional Chinese medicine composition in treating urinary tract infection.

[0066] The Chinese medicine composition was used in the treatment of urinary tract infection. A parallel, randomized, controlled prospective clinical research method was adopted. A total of 74 RUTI patients were included, including 37 cases of Yin deficiency damp-heat syndrome in the Chinese medicine group and 17 cases in the Western medicine group; 13 cases of Yang deficiency dampness syndrome in the Chinese medicine group and 7 cases in the Western medicine group. The treatment course was 4 weeks and the follow-up was 6 months. The following is the recurrence data of the two groups during the treatment of the Chinese medicine composition and the clearance data of ESBLs-producing strains;

[0067] The following is a comparison of the recurrence data between the two groups:

[0068]

[0069] The following is the analysis data of the elimination of ESBLs-producing strains:

[0070]

[0071] The results showed that the Chinese medicine group was better at eliminating bacteria than the Western medicine group. At the end of the treatment, the bacterial elimination rates of the two groups were comparable. Chinese medicine was able to effectively eliminate extended-spectrum β-lactamase-producing Escherichia coli, methicillin-resistant coagulase-negative Staphylococcus aureus, and methicillin-resistant Staphylococcus epidermidis, while the Western medicine group was unable to do so.

[0072] Follow-up after 6 months showed that the recurrence rate of the Chinese medicine group was lower than that of the Western medicine group. There was a statistically significant difference between the Yin deficiency and damp-heat syndrome group and the Yang deficiency and dampness syndrome group (P<0.001). From the above data, it can be seen that the Fuzheng Qingre Lishi prescription of the present invention is better than antibiotics in eliminating drug-resistant bacteria, the patient's symptoms are significantly improved, and the recurrence rate of recurrent urinary tract infection is reduced.

[0073] At the same time, the present invention included 34 uncomplicated RUTI female patients, with an average age of 51.6±15.4 years old, who had received systemic antibiotic treatment but the effect was poor, the average annual incidence of UTI in the patients was 6.6±2.5, and the UPEC strains isolated from the urine of the patients were resistant to at least 8 antibiotics. The Chinese medicine composition of the present invention was used for treatment of Fuzheng Qingre Lishi for 4 weeks.

[0074] After 2 weeks, 25 cases (73.52%) had significant relief of symptoms.

[0075] At 4 weeks, 30 patients (88.23%) recovered from their symptoms.

[0076] Symptoms improved in 3 cases (7.5%).

[0077] After 6 months of follow-up, the recurrence rate was only 4 cases (11.76%), which was much lower than the recurrence rate after antibiotic treatment.

[0078] The present invention also adopted a randomized, double-blind, multicenter trial, which included 122 female RUTI patients. Participants were randomly assigned to receive Chinese medicine for 4 weeks or antibiotics for 1 week and placebo for 3 weeks.

[0079] The results showed that the cure rate was 90.2% in the Chinese medicine group and 82.0% in the antibiotic group.

[0080] The bacterial clearance rate in the Chinese medicine group was 88.5% (54 / 61), and that in the antibiotic group was 82.0% (50 / 61).

[0081] The recurrence rate after 6 months of follow-up was 9.1% in the traditional Chinese medicine group and 14.0% in the antibiotic group. The traditional Chinese medicine combination is a good alternative to antibiotics. The following data are the main treatment effect data, bacterial clearance rate and follow-up results of the patients.

[0082] The following are the main treatment effect data of patients:

[0083]

[0084] The following are the bacterial clearance rates and follow-up results:

[0085]

[0086] The Fuzheng Qingre Lishi formula in the Chinese medicine composition of the present invention has a better effect on the elimination of RUTI resistant bacteria than antibiotics, and the patient's symptoms are significantly improved and the recurrence rate is lower than that of the antibiotic group. The treatment principles and purposes of traditional Chinese medicine are completely different from those of antibiotic treatment. The Chinese medicine composition of the present invention considers the restoration and improvement of the patient's overall functional state, rather than simply eliminating pathogenic bacteria. Therefore, Chinese medicine is a good alternative and supplementary treatment option.

[0087] At the same time, the present invention carried out in vivo and in vitro experiments, screened out a UPEC-10 strain with all 7 virulence genes, pan-drug resistance, and a strong biofilm formation phenotype, infected Balb / c mice through the urethra, and used it to construct a mouse UTI model, and used the Chinese medicine composition of the Fuzheng Qingre Lishi recipe and the antibiotic imipenem as control treatments.

[0088] The mouse model of UTI treated with the Fuzheng Qingre Lishi prescription of the present invention greatly reduced the number of bacteria in the kidney and bladder, wherein Figure 1 is the UPEC clearance rate of spleen and kidney in the high-dose, long-term Chinese medicine intervention group, Figure 2 is the CFU index of spleen and kidney organs after the intervention of the Chinese medicine group;

[0089] The Chinese medicine composition of the present invention has an in vitro antibacterial effect on UPEC10 strains, wherein: Figure 3 The in vitro antibacterial effect of Chinese medicine monomers / compounds, Figure 4 This is a graph showing the in vitro antibacterial effect of serum containing traditional Chinese medicine;

[0090] The traditional Chinese medicine composition of the present invention can up-regulate the expression of host immune-related cytokines such as IL6, IL8, MCP1, TRL4, and TGF-b.

[0091] In addition, animal experiments showed that the expression of virulence genes such as FyuA and RpoS in mice was inhibited after treatment with traditional Chinese medicine, indicating that the traditional Chinese medicine composition of the present invention can inhibit the expression of certain virulence genes of UPEC, providing theoretical scientific support for the application of the Fuzheng Qingre Lishi prescription.

[0092] It will be appreciated by those skilled in the art that the features described in the various embodiments and / or claims of the present invention may be combined and / or combined in various ways, even if such combinations and / or combinations are not explicitly described in the present invention. In particular, the features described in the various embodiments and / or claims of the present invention may be combined and / or combined in various ways without departing from the spirit and teachings of the present invention. All of these combinations and / or combinations fall within the scope of the present invention.

Claims

1. A Chinese medicine composition for improving urinary tract infection, characterized in that: The Chinese medicine composition comprises bupleurum, scutellaria, raw astragalus, salvia miltiorrhiza, pulsatilla, patrinia, scutellaria baicalensis, fructus malvae, lindera striata, fennel, cinnamon bark and rush; The composition weight ratio of the Chinese medicine composition is: Bupleurum 14-16g; Scutellaria baicalensis 9-11g; Raw Astragalus 19-21g; Salvia miltiorrhiza 29-31g; Pulsatilla 13-17g; Patrinia 28-32g; Polygonum multiflorum 14-16g; Winter mallow seeds 13-16g; Linderae 7-9g; Fennel 7-9g; Cinnamon 5-7g; 2-4g of rush.

2. The method for preparing a Chinese medicine composition for improving urinary tract infection according to claim 1, characterized in that: The following steps are involved: S1. Selecting raw materials of Chinese medicine composition; S2, after mixing the Chinese medicines, adding water or ethanol to extract, to obtain an extract; S3, mixing the extracts; S4, performing a reduced pressure concentration process on the mixed extract; S5, drying the condensed extract to obtain an extract powder; S6. Mixing the obtained dry powder of the extract with a pharmaceutically acceptable carrier to prepare an oral preparation.

3. A method for preparing a Chinese medicine composition for improving urinary tract infection according to claim 2, characterized in that: In S2, the weight of the water or ethanol is 5-15 times that of the traditional Chinese medicine composition.

4. A method for preparing a Chinese medicine composition for improving urinary tract infection according to claim 3, characterized in that: The concentration of the ethanol is 10%-60%.

5. A method for preparing a Chinese medicine composition for improving urinary tract infection according to claim 4, characterized in that: The Chinese medicine composition is extracted 1-3 times.

6. A method for preparing a Chinese medicine composition for improving urinary tract infection according to claim 5, characterized in that: The extraction time each time is 0.5-2 hours.

7. The method for preparing a Chinese medicine composition for improving urinary tract infection according to claim 2, characterized in that: In S4, the reduced pressure concentration treatment may be one of air drying, vacuum drying or spray drying.

8. The method for preparing a Chinese medicine composition for improving urinary tract infection according to claim 2, characterized in that: In S6, the oral preparation includes tablets, dispersible tablets, effervescent tablets, orally disintegrating tablets, lozenges, chewable tablets, hard capsules, soft capsules, granules, pills, powders, drop pills or oral liquid preparations.

9. The use of a Chinese medicine composition for improving urinary tract infection according to claim 1-2, characterized in that: Application of the traditional Chinese medicine composition in treating urinary tract infection.