A traditional Chinese medicine rhinitis bacteriostatic solution

Abstract

This invention relates to the field of traditional Chinese medicine antibacterial liquid technology, and particularly to a traditional Chinese medicine antibacterial liquid for nasal use, made from the following raw materials: Xanthium sibiricum, Centipeda minima, Magnolia biondii, Asarum heterotropoides, Acorus tatarinowii, Akebia trifoliata, Atractylodes lancea, Indigo naturalis, Mentha haplocalyx, and polyhexamethylene biguanide. This invention combines nine traditional Chinese medicines—Xanthium sibiricum, Centipeda minima, Magnolia biondii, Asarum heterotropoides, Acorus tatarinowii, Akebia trifoliata, Atractylodes lancea, Indigo naturalis, and Mentha haplocalyx—with polyhexamethylene biguanide. The traditional Chinese medicine components are an improvement on the ancient formula of Xanthium sibiricum powder, synergistically exerting the effects of clearing the lungs and nasal passages, dispelling wind and cold, and anti-inflammatory and anti-allergic properties. Polyhexamethylene biguanide provides broad-spectrum antibacterial efficacy. By changing the traditional oral dosage form to a nasal drop, the liquid acts directly on the nasal mucosa lesion site, avoiding the first-pass effect of the liver and the metabolic burden on the kidneys associated with oral medications, significantly improving drug safety. Skin irritation, eye irritation, and allergy tests all showed no irritation or sensitization.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine antibacterial liquid technology, and in particular to a traditional Chinese medicine antibacterial liquid for rhinitis. Background Technology

[0002] Allergic rhinitis (AR), also known as hay fever, is a chronic, non-infectious inflammatory disease of the nasal mucosa, characterized by nasal congestion, itching, sneezing, and runny nose, which occurs in susceptible individuals after exposure to allergens. Recent research indicates that AR affects 5% to 50% of the world's population, with nearly 250 million patients in my country.

[0003] Modern medicine commonly uses antihistamines, steroids, and anticholinergic drugs for treatment, but these have drawbacks such as unstable efficacy, easy relapse, and long-term use can lead to adverse reactions such as gastrointestinal discomfort, drowsiness, fatigue, and even anaphylactic shock. Immunotherapy has a long treatment course and great individual differences, while surgical treatment carries the risk of nasal adhesions or even loss of smell.

[0004] Traditional Chinese medicine (TCM) treatment for rhinitis rhinitis (AR) has advantages such as improving the body's immunity, providing long-lasting and stable efficacy, reducing recurrence rates, and having fewer toxic side effects. However, traditional Chinese medicine is mostly administered as oral decoctions, which have disadvantages such as inconvenience in administration, poor taste, potential first-pass effects on the liver and kidneys, and low patient compliance. Existing topical products lack innovative formulations, do not fully utilize modern antibacterial technology, or need improvement in terms of direct targeting of the lesion and ease of use. Therefore, a TCM-based antibacterial nasal spray is needed to address these issues. Summary of the Invention

[0005] The purpose of this invention is to solve the problems mentioned in the background section.

[0006] To achieve the above objectives, the present invention adopts the following technical solution: A traditional Chinese medicine antibacterial solution for nasal use is made from the following ingredients: Xanthium sibiricum, Centipeda minima, Magnolia biondii, Asarum heterotropoides, Acorus tatarinowii, Akebia trifoliata, Atractylodes lancea, Indigo naturalis, Mentha haplocalyx, and polyhexamethylene biguanide.

[0007] Preferably, the polyhexamethylene biguanide has a mass percentage content of 0.03%-0.05%.

[0008] Preferably, the weight ratio of Xanthium sibiricum, Centipeda minima, Magnolia biondii, Asarum heterotropoides, Acorus tatarinowii, Akebia trifoliata, Atractylodes lancea, Indigo naturalis, and Mentha haplocalyx is as follows: Xanthium sibiricum 10-20 parts, Centipeda minima 5-15 parts, Magnolia biondii 5-15 parts, Asarum heterotropoides 3-10 parts, Acorus tatarinowii 5-12 parts, Akebia trifoliata 5-12 parts, Atractylodes lancea 5-12 parts, Indigo naturalis 3-8 parts, and Mentha haplocalyx 3-10 parts.

[0009] Preferably, the antibacterial solution is a liquid dosage form for use as nasal drops or sprays.

[0010] Preferably, the antibacterial solution is used in the preparation of products for the prevention and treatment of allergic rhinitis.

[0011] A method for preparing a traditional Chinese medicine antibacterial solution for nasal cavity, comprising the following steps: The first step involves extracting Xanthium sibiricum, Centipeda minima, Magnolia biondii, Asarum heterotropoides, Acorus tatarinowii, Akebia trifoliata, Atractylodes lancea, Indigo naturalis, and Mentha haplocalyx with water or alcohol to obtain an extract. The second step is to mix the extract with polyhexamethylene biguanide evenly.

[0012] Preferably, the antibacterial solution is used in the preparation of products for the prevention and treatment of allergic rhinitis.

[0013] Preferably, the product is a disinfectant nasal antibacterial solution, which is applied directly to the nasal cavity by dripping or spraying.

[0014] This invention has at least the following beneficial effects: 1. This study combines nine traditional Chinese medicines—Xanthium sibiricum, Centipeda minima, Magnolia biondii, Asarum heterotropoides, Acorus tatarinowii, Akebia trifoliata, Atractylodes lancea, Indigo naturalis, and Mentha haplocalyx—with polyhexamethylene biguanide. The herbal components are an improvement on the ancient formula of Xanthium sibiricum powder, synergistically exerting the effects of clearing the lungs and orifices, dispelling wind and cold, and anti-inflammatory and anti-allergic properties. Polyhexamethylene biguanide provides broad-spectrum antibacterial efficacy. Antibacterial experiments show that the antibacterial rate against Staphylococcus aureus, Escherichia coli, and Candida albicans is >99.5%, significantly better than using herbal extracts alone, demonstrating the synergistic effect of combining traditional Chinese and Western medicine.

[0015] 2. By changing the traditional oral dosage form to nasal drops, the medication acts directly on the lesion site of the nasal mucosa, avoiding the first-pass effect of the liver and the metabolic burden on the kidneys of oral medications, which greatly improves the safety of medication. Skin irritation, eye irritation and allergy tests all showed no irritation or no sensitization reaction. It has good safety for long-term use and high patient compliance.

[0016] 3. By rationally controlling the content of polyhexamethylene biguanide to 0.03%-0.05% and designing a gradient of traditional Chinese medicine proportions, the product achieves optimal antibacterial and anti-allergic effects while ensuring safety. Human trial results show that the overall effective rate for patients with allergic rhinitis reaches 73.3%-86.7%, the total score of nasal symptoms decreases by more than 56%, and the incidence of adverse reactions is low, with no significant rebound of symptoms after discontinuation of the drug.

[0017] 4. By positioning the product as a disinfectant nasal antibacterial solution, it combines the dual functions of traditional Chinese medicine conditioning and physical antibacterial action. It can be used for daily care and adjunctive treatment of allergic rhinitis, as well as for antibacterial cleaning of the nasal mucosa. It has a wide range of applications. Compared with existing technologies, this invention avoids the dependence of hormone nasal sprays and the drowsiness side effects of antihistamines, providing patients with a safe, effective and convenient over-the-counter option. Attached Figure Description

[0018] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the following description of the embodiments will be briefly introduced. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is a comparison chart of the raw material ratios in different embodiments of the present invention; Figure 2 This is a flowchart of the preparation method of the present invention. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0021] Basic scheme composition; Reference Figure 1-2 A traditional Chinese medicine antibacterial nasal spray, made from the following ingredients: Xanthium sibiricum, Centipeda minima, Magnolia biondii, Asarum heterotropoides, Acorus tatarinowii, Akebia trifoliata, Atractylodes lancea, Indigo naturalis, Mentha haplocalyx, and polyhexamethylene biguanide.

[0022] The mass percentage of polyhexamethylene biguanide is 0.03%-0.05%.

[0023] The weight ratio of Xanthium sibiricum, Centipeda minima, Magnolia biondii, Asarum heterotropoides, Acorus tatarinowii, Akebia trifoliata, Atractylodes lancea, Indigo naturalis, and Mentha haplocalyx is as follows: Xanthium sibiricum 10-20 parts, Centipeda minima 5-15 parts, Magnolia biondii 5-15 parts, Asarum heterotropoides 3-10 parts, Acorus tatarinowii 5-12 parts, Akebia trifoliata 5-12 parts, Atractylodes lancea 5-12 parts, Indigo naturalis 3-8 parts, and Mentha haplocalyx 3-10 parts.

[0024] The antibacterial solution is a liquid dosage form, used for nasal drops or sprays.

[0025] Application of antibacterial solution in the preparation of products for the prevention and treatment of allergic rhinitis.

[0026] The antibacterial solution is a disinfectant-grade nasal antibacterial solution, which can be directly dripped into or sprayed into the nasal cavity for use.

[0027] The antibacterial solution also contains pharmaceutically acceptable solvents or excipients, such as water or ethanol.

[0028] The antibacterial solution has antibacterial effects against Candida albicans, Staphylococcus aureus, and Escherichia coli.

[0029] The antibacterial solution is prepared by the following method: water extraction or alcohol extraction of Xanthium sibiricum, Centipeda minima, Magnolia biondii, Asarum heterotropoides, Acorus tatarinowii, Akebia quinata, Atractylodes lancea, Indigo naturalis, and Mentha haplocalyx to obtain an extract, which is then mixed evenly with polyhexamethylene biguanide.

[0030] The following description is based on examples and experimental data; Example 1; Raw material composition: 10 parts of stir-fried cocklebur, 5 parts of centipeda minima, 5 parts of magnolia flower, 3 parts of asarum, 5 parts of calamus, 5 parts of akebia, 5 parts of atractylodes, 3 parts of indigo naturalis, and 3 parts of mint.

[0031] Polyhexamethylene biguanide (purity ≥99%, average molecular weight 1100-1600): accounts for 0.03% of the total mass of the final antibacterial solution.

[0032] Preparation method: Step 1: After cleaning and selecting the above nine Chinese medicinal herbs, dry them at 60℃ to constant weight, pulverize them through a 20-mesh sieve to obtain coarse powder. Take the coarse powder, add 10 times its weight (w / w) of purified water, soak for 1 hour, heat to a gentle boil and reflux for extraction twice, each time for 1.5 hours (temperature 98±2℃). Combine the extracts and coarsely filter through a 200-mesh sieve.

[0033] Step 2: The filtrate is concentrated under reduced pressure at a vacuum of -0.08 to -0.09 MPa and a water bath temperature of 60±2℃. The relative density is measured at 60℃ to obtain a concentrated Chinese medicine solution.

[0034] Step 3: Take polyhexamethylene biguanide, add 10 times its weight of purified water, stir to dissolve into a 10% mother liquor, add the mother liquor to the concentrated Chinese medicine solution while stirring, add purified water to the final total weight, adjust the pH to 6.0-7.0 with 0.1mol / L NaOH or HCl, continue stirring for 15 minutes, and let stand for 12 hours.

[0035] Step 4: Take the supernatant and filter it sequentially through 0.45μm and 0.22μm microporous membranes. After passing the test, fill it into medical polyethylene nasal drop bottles, 10mL per bottle.

[0036] Example 2; Raw material composition: 15 parts of stir-fried cocklebur, 10 parts of centipeda minima, 10 parts of magnolia flower, 6 parts of asarum, 8 parts of calamus, 8 parts of akebia, 8 parts of atractylodes, 5 parts of indigo naturalis, and 6 parts of mint.

[0037] Polyhexamethylene biguanide (purity ≥99%, average molecular weight range 1100-1600, source same as in Example 1): accounts for 0.04% (w / w) of the total mass of the final antibacterial solution.

[0038] Preparation method: first step: After cleaning and selecting the above nine Chinese medicinal herbs, dry them in an oven at 60℃ until constant weight, then pulverize them through a 20-mesh sieve to obtain coarse powder. Take the coarse powder, add 10 times the amount (w / w, i.e., 10 times the weight of the medicinal materials) of purified water, soak for 1 hour, heat to a gentle boil and reflux for extraction twice, each extraction time is 1.5 hours, and the extraction temperature is controlled at 98±2℃. The two extracts are coarsely filtered through a 200-mesh stainless steel sieve, and the filtrates are combined.

[0039] The second step, concentration: The combined filtrates were concentrated under reduced pressure at a vacuum of -0.08 MPa to -0.09 MPa and a water bath temperature of 60 ± 2 °C until the relative density was 1.05 to 1.10 (measured at 60 °C), while controlling the volume of the concentrated liquid to be approximately 1.5 to 2.0 times the weight of the medicinal materials. This yielded a concentrated traditional Chinese medicine solution.

[0040] Step 3: Preparation Accurately weigh the prescribed amount of polyhexamethylene biguanide (PHMB), add purified water equivalent to 10 times the weight of PHMB, stir to dissolve, and prepare a 10% PHMB stock solution. Slowly add the stock solution to the concentrated traditional Chinese medicine solution while stirring, and add purified water to the final total weight (calculated based on the total mass of the final antibacterial solution). Continue stirring for 15 minutes until homogeneous. Adjust the pH to 6.0–7.0 (measured using a pH meter) with 0.1 mol / L sodium hydroxide solution or 0.1 mol / L hydrochloric acid solution. Let stand for 12 hours to allow the insoluble precipitate to settle completely.

[0041] Step 4, filtration and filling: The supernatant was collected and filtered through a two-stage process using a 0.45 μm microporous membrane and a 0.22 μm microporous membrane. The filtrate was tested for pH, relative density, polyhexamethylene biguanide content (HPLC), and microbial limits (aerobic bacteria count ≤100 CFU / mL, mold and yeast count ≤10 CFU / mL, and no Staphylococcus aureus or Pseudomonas aeruginosa). After passing the tests, the filtrate was filled into 10 mL medical polyethylene nasal drop vials.

[0042] Quality control indicators: Appearance: Brownish-yellow to yellowish-brown clear liquid, with a small amount of sediment that disperses easily when shaken.

[0043] pH value: 6.0~7.0.

[0044] Relative density (20℃): 1.02~1.08.

[0045] Polyhexamethylene biguanide content: 0.036%~0.044% (90%~110% of the labeled amount of 0.04%).

[0046] Antibacterial efficacy: According to the 2020 edition of the Chinese Pharmacopoeia, Part IV, General Chapter 1121, the antibacterial rate against Staphylococcus aureus, Escherichia coli, and Candida albicans is ≥99.5%.

[0047] Example 3; Raw material composition: 20 parts of stir-fried cocklebur, 15 parts of centipeda minima, 15 parts of magnolia flower, 10 parts of asarum, 12 parts of calamus, 12 parts of akebia stem, 12 parts of atractylodes rhizome, 8 parts of indigo naturalis, and 10 parts of mint.

[0048] Polyhexamethylene biguanide (purity ≥99%, average molecular weight range 1100-1600, source same as in Example 1): accounts for 0.05% (w / w) of the total mass of the final antibacterial solution.

[0049] Preparation method: first step: After cleaning and selecting the above nine Chinese medicinal herbs, dry them in an oven at 60℃ until constant weight, then pulverize them through a 20-mesh sieve to obtain coarse powder. Take the coarse powder and add 10 times the amount (w / w, i.e., 10 times the weight of the medicinal materials) of purified water, and soak for 1 hour. Heat to a gentle boil and reflux for extraction twice, each extraction time being 1.5 hours, with the extraction temperature controlled at 98±2℃. Filter the two extracts coarsely through a 200-mesh stainless steel sieve, and combine the filtrates.

[0050] Step Two: The combined filtrate was concentrated under reduced pressure at a vacuum of -0.08 MPa to -0.09 MPa and a water bath temperature of 60 ± 2 °C until the relative density was 1.05 to 1.10 (measured at 60 °C). At the same time, the volume of the concentrated liquid was controlled to be about 1.5 to 2.0 times the weight of the medicinal materials to obtain the Chinese herbal medicine concentrate.

[0051] Step 3: Accurately weigh the prescribed amount of polyhexamethylene biguanide and add purified water equivalent to 10 times the weight of polyhexamethylene biguanide. Stir to dissolve and prepare a 10% polyhexamethylene biguanide stock solution. Slowly add the stock solution to the concentrated traditional Chinese medicine solution while stirring, and add purified water to the final total weight (calculated based on the total mass of the final antibacterial solution). Continue stirring for 15 minutes until homogeneous. Adjust the pH to 6.0–7.0 using 0.1 mol / L sodium hydroxide solution or 0.1 mol / L hydrochloric acid solution (measured with a pH meter). Let stand for 12 hours to allow the insoluble precipitate to settle completely.

[0052] Step 4: The supernatant was filtered through a two-stage filter system, first through a 0.45 μm microporous membrane and then through a 0.22 μm microporous membrane. The filtrate was tested for pH, relative density, polyhexamethylene biguanide content (HPLC), and microbial limits (aerobic bacteria count ≤100 CFU / mL, mold and yeast count ≤10 CFU / mL, and no Staphylococcus aureus or Pseudomonas aeruginosa). After passing the tests, the solution was filled into 10 mL medical polyethylene nasal drop vials.

[0053] Quality control indicators: Appearance: Brownish-yellow to yellowish-brown clear liquid, with a small amount of sediment that disperses easily when shaken.

[0054] pH value: 6.0~7.0.

[0055] The relative density selected at 20℃ is 1.02~1.08.

[0056] Polyhexamethylene biguanide content: 0.045%~0.055% (90%~110% of the labeled amount of 0.05%).

[0057] Antibacterial efficacy: According to the 2020 edition of the Chinese Pharmacopoeia, Part IV, General Chapter 1121, the antibacterial rate against Staphylococcus aureus, Escherichia coli, and Candida albicans is ≥99.5%.

[0058] Example 4; Raw material composition: 15 parts of stir-fried cocklebur, 10 parts of centipeda minima, 10 parts of magnolia flower, 6 parts of asarum, 8 parts of acorus tatarinowii, 8 parts of akebia quinata, 8 parts of atractylodes lancea, 5 parts of indigo naturalis, and 6 parts of mint (same as in Example 2).

[0059] Polyhexamethylene biguanide (purity ≥99%, average molecular weight range 1100-1600, source same as in Example 1): accounts for 0.04% (w / w) of the total mass of the final antibacterial solution.

[0060] Preparation method: first step: After cleaning and selecting the above nine Chinese medicinal herbs, dry them in a 60℃ oven to constant weight, pulverize them through a 20-mesh sieve to obtain coarse powder. Take the coarse powder and add 8 times its weight (w / w, i.e., 8 times the weight of the medicinal materials) of a 70% v / v ethanol aqueous solution (i.e., 70 parts by volume of ethanol mixed with 30 parts by volume of purified water), and soak for 30 minutes. Extract twice by heating and reflux, each time for 1 hour, with the extraction temperature controlled at 78±2℃ (near the boiling point of ethanol). Filter the two extracts coarsely through a 200-mesh stainless steel sieve, and combine the filtrates.

[0061] Step Two: The combined filtrates were subjected to reduced pressure to recover ethanol under vacuum conditions of -0.06 MPa to -0.08 MPa and a water bath temperature of 50 ± 2 °C until no alcohol odor was detected (ethanol residue ≤ 0.5% as determined by gas chromatography). The remaining aqueous solution was further concentrated under reduced pressure conditions of -0.08 MPa to -0.09 MPa and a water bath temperature of 60 ± 2 °C until the relative density reached 1.05 to 1.10 (measured at 60 °C), while simultaneously controlling the volume of the concentrated solution to be approximately 1.5 to 2.0 times the weight of the medicinal materials. This yielded a concentrated traditional Chinese medicine solution.

[0062] Step 3: Accurately weigh the prescribed amount of polyhexamethylene biguanide (PHMB), add purified water equivalent to 10 times the weight of PHMB, stir to dissolve, and prepare a 10% PHMB stock solution. Slowly add the stock solution to the concentrated traditional Chinese medicine solution while stirring, and add purified water to the final total weight (calculated based on the total mass of the final antibacterial solution). Continue stirring for 15 minutes until homogeneous. Adjust the pH to 6.0–7.0 (measured using a pH meter) with 0.1 mol / L sodium hydroxide solution or 0.1 mol / L hydrochloric acid solution. Let stand for 12 hours to allow the insoluble precipitate to settle completely.

[0063] Step 4: The supernatant was collected and filtered through a two-stage filter system consisting of a 0.45 μm microporous membrane and a 0.22 μm microporous membrane. The filtrate was tested for pH, relative density, polyhexamethylene biguanide content (HPLC), ethanol residue (GC, limit ≤0.5%), and microbial limits (aerobic bacteria count ≤100 CFU / mL, mold and yeast count ≤10 CFU / mL, Staphylococcus aureus and Pseudomonas aeruginosa not detectable). After passing the tests, the solution was filled into 10 mL medical polyethylene nasal drop vials.

[0064] Quality control indicators: Appearance: Brownish-yellow to yellowish-brown clear liquid, with a small amount of sediment that disperses easily when shaken.

[0065] pH value: 6.0~7.0.

[0066] Relative density (20℃): 1.02~1.08.

[0067] Polyhexamethylene biguanide content: 0.036%~0.044% (90%~110% of the labeled amount of 0.04%).

[0068] Ethanol residue: ≤0.5% (complies with General Chapter 0861 of Part IV of the 2020 edition of the Chinese Pharmacopoeia).

[0069] Antibacterial efficacy: According to the 2020 edition of the Chinese Pharmacopoeia, Part IV, General Chapter 1121, the antibacterial rate against Staphylococcus aureus, Escherichia coli, and Candida albicans is ≥99.5%.

[0070] The following is a test table for antibacterial efficacy;

[0071] The antibacterial solution of this invention has an inhibition rate of >99.5% against three indicator bacteria, which meets the criteria for strong antibacterial effect in the "Disinfection Technical Specification".

[0072] The following is a table of security test conclusions;

[0073] The antibacterial solution of this invention meets the relevant national standards for safety.

[0074] Ninety volunteers diagnosed with allergic rhinitis were randomly divided into three groups of 30 each.

[0075] The antibacterial solutions prepared in Examples 1, 2, and 3 were used respectively. Two drops were applied to each nostril twice a day, morning and evening, for 14 consecutive days. The four symptoms of nasal congestion, runny nose, sneezing, and nasal itching were assessed using the Visual Analogue Scale (VAS), with a score of 0-10. The higher the score, the more severe the symptoms. The overall effectiveness rate was calculated, and a decrease in symptom score of ≥50% was considered effective.

[0076] A randomized, single-blind, self-controlled pre- and post-treatment trial was conducted. Ninety volunteers diagnosed with persistent allergic rhinitis at the Department of Otolaryngology of a tertiary hospital between March 2024 and February 2025 were selected. Inclusion criteria: age 18-65 years, no use of other rhinitis medications in the past two weeks. They were randomly divided into three groups of 30 each. The antibacterial solutions prepared in Examples 1, 2, and 3 were used respectively. Two drops were administered to each nostril twice daily, morning and evening, for 14 consecutive days.

[0077] Treatment efficacy assessment: The total nasal symptom score (TNSS, including four items: nasal congestion, runny nose, sneezing, and nasal itching, with each item scored from 0 to 3 points and the total score from 0 to 12 points) was used.

[0078] Effective was defined as a decrease of ≥50% in TNSS after treatment; markedly effective was defined as a decrease of ≥75%; ineffective was defined as a decrease of <50%. Adverse events were also recorded.

[0079] The following figures illustrate the improvement of allergic rhinitis symptoms in each embodiment;

[0080] There was no statistically significant difference between Example 2 and Example 1 (P=0.12), indicating that increasing the concentration of traditional Chinese medicine may help improve efficacy, but no dose-dependent enhancement was observed between the contents of 0.04% and 0.05% polyhexamethylene biguanide.

[0081] Adverse events: Example 1: One patient experienced mild nasal stinging during the first use, which disappeared spontaneously after about 30 seconds and did not recur during subsequent use.

[0082] Example 2 group: No adverse events reported.

[0083] Example 3 group: 2 patients experienced mild nasal dryness, which did not affect continued use; 1 patient experienced brief sneezing (considered to be caused by drug irritation), which subsided after 1 minute.

[0084] All adverse events were mild and did not lead to discontinuation of medication or require medical intervention.

[0085] Typical case: Case 1: Ms. Zhang, female, 32 years old, had a 5-year history of pollen allergic rhinitis, with flare-ups every spring and autumn. At enrollment, her TNSS score was 9 (nasal congestion 3, runny nose 3, sneezing 2, nasal itching 1). On the 3rd day of using the product in Example 2, she reported a significant reduction in nasal congestion; on the 5th day, the runny nose decreased; and on the 10th day, her TNSS score dropped to 2. After discontinuing the medication, she was followed up for 2 weeks. Her symptoms did not completely recur, but she still had mild nasal congestion (score 1).

[0086] Case 2: Mr. Li, male, 45 years old, suffers from perennial allergic rhinitis (dust mite allergy). He had previously used nasal corticosteroids but had poor compliance. After using the product in Example 1, the frequency of sneezing decreased from about 20 times a day to 8 times a day on the 4th day. The nasal itching disappeared on the 7th day. On the 14th day, the TNSS score decreased from 8 points before treatment to 3 points. The patient reported that it was milder than the corticosteroid spray, but the onset of action was slower.

[0087] Conclusion: The antibacterial solution of the present invention has a clear effect on improving the symptoms of allergic rhinitis, with a total effective rate of 73.3%-86.7%. The effects of Examples 2 and 3 are better. Compared with chemical drugs, it has a slightly slower onset of action but is well tolerated and is suitable for long-term use or as an adjunct therapy.

[0088] Stability testing; The product from Example 2 was placed under accelerated conditions at 40℃±2℃ and 75%±5% relative humidity for 6 months. Samples were taken at 0, 1, 2, 3, and 6 months to test the polyhexamethylene biguanide content, pH value, and inhibition rate against Staphylococcus aureus. Each time point was tested three times, and the average value was taken.

[0089]

[0090] After 6 months of accelerated testing, the content of polyhexamethylene biguanide decreased by about 10%, but remained within the range of 90%-110% of the labeled amount (labeled amount 0.04%); the antibacterial rate was still >99.5%, meeting the standard requirements; the pH value decreased slightly but remained within the acceptable range (5.5-7.0).

[0091] The product's various indicators remained stable within 6 months under accelerated conditions. Based on the Arrhenius equation, the shelf life at room temperature (25°C) can be tentatively set at 18 months. It is recommended that long-term stability testing be continued for up to 24 months to confirm this.

[0092] Explanation of differences from Example 2;

[0093] Alcohol extraction can more fully extract fat-soluble components, such as volatile oils from Magnolia biondii and fat-soluble glycosides from Akebia trifoliata, and the resulting product may have stronger anti-inflammatory activity; however, it increases the number of process steps and slightly raises the cost. Both methods can yield antibacterial solutions that meet quality standards.

[0094] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the claimed invention. The scope of protection claimed by the appended claims and their equivalents is defined.

Claims

1. A traditional Chinese medicine antibacterial solution for nasal inflammation, characterized in that: It is made from the following ingredients: Xanthium sibiricum, Centipeda minima, Magnolia biondii, Asarum heterotropoides, Acorus tatarinowii, Akebia trifoliata, Atractylodes lancea, Indigo naturalis, Mentha haplocalyx, and polyhexamethylene biguanide.

2. The traditional Chinese medicine antibacterial nasal spray according to claim 1, characterized in that, The mass percentage of the polyhexamethylene biguanide is 0.03%-0.05%.

3. The traditional Chinese medicine antibacterial nasal spray according to claim 1, characterized in that, The weight ratio of Xanthium sibiricum, Centipeda minima, Magnolia biondii, Asarum heterotropoides, Acorus tatarinowii, Akebia trifoliata, Atractylodes lancea, Indigo naturalis, and Mentha haplocalyx is as follows: Xanthium sibiricum 10-20 parts, Centipeda minima 5-15 parts, Magnolia biondii 5-15 parts, Asarum heterotropoides 3-10 parts, Acorus tatarinowii 5-12 parts, Akebia trifoliata 5-12 parts, Atractylodes lancea 5-12 parts, Indigo naturalis 3-8 parts, and Mentha haplocalyx 3-10 parts.

4. The traditional Chinese medicine antibacterial nasal spray according to claim 1, characterized in that, The antibacterial solution is a liquid dosage form for use as nasal drops or sprays.

5. The traditional Chinese medicine antibacterial solution for nasal inflammation according to claim 1, characterized in that, The antibacterial solution is used in the preparation of products for the prevention and treatment of allergic rhinitis.

6. The traditional Chinese medicine antibacterial solution for nasal inflammation according to claim 1, characterized in that, The antibacterial solution is a disinfectant-grade nasal antibacterial solution, which can be directly dripped into or sprayed into the nasal cavity for use.

7. The traditional Chinese medicine antibacterial nasal spray according to claim 6, characterized in that, The antibacterial solution also contains pharmaceutically acceptable solvents or excipients, wherein the solvent is water or ethanol.

8. The traditional Chinese medicine antibacterial nasal spray according to claim 7, characterized in that, The antibacterial solution has antibacterial effects against Candida albicans, Staphylococcus aureus, and Escherichia coli.

9. The traditional Chinese medicine antibacterial solution for nasal inflammation according to claim 6, characterized in that, The antibacterial solution is prepared by the following method: water extraction or alcohol extraction of Xanthium sibiricum, Centipeda minima, Magnolia biondii, Asarum heterotropoides, Acorus tatarinowii, Akebia trifoliata, Atractylodes lancea, Indigo naturalis, and Mentha haplocalyx to obtain an extract, which is then mixed evenly with polyhexamethylene biguanide.

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