Rhinitis lotion containing traditional Chinese medicine extract and preparation method thereof

Abstract

The invention provides a rhinitis lotion containing traditional Chinese medicine extracts of mint, houttuynia cordata, sea salt, fructus lycii and dandelion and a preparation method of the rhinitis lotion. The traditional Chinese medicine composition is stable in quality and can effectively treat allergic rhinitis.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparations, specifically to a nasal wash containing extracts of traditional Chinese medicine and its preparation method, and more specifically to a nasal wash containing extracts of traditional Chinese medicine such as peppermint, houttuynia cordata, wolfberry, and dandelion and its preparation method. Background Technology

[0002] Rhinitis is an inflammatory condition of the nose, with main symptoms including nasal congestion, itching, runny nose, and frequent sneezing. The causes are complex, commonly including viral infections (such as during a cold), bacterial infections, contact with allergens (like pollen), or inhalation of irritating gases. Additionally, certain systemic diseases can also trigger rhinitis.

[0003] Among the many types, allergic rhinitis is the most common, usually manifesting as sudden, continuous sneezing upon exposure to pollen, dust, or similar substances. It's important to note that the "allergens" mentioned here refer to substances that some people are overly sensitive to; while most people may have no symptoms upon contact, allergy sufferers will experience a strong reaction. The severity of symptoms varies considerably among patients; some may only experience occasional runny nose, while others may suffer from chronic nasal congestion that affects their breathing.

[0004] Relevant data shows that major air pollutants such as PM2.5, ozone, nitrogen dioxide, sulfur dioxide, and vehicle exhaust can all induce allergic rhinitis. Although allergic rhinitis is not a serious disease, severe allergic rhinitis can affect sleep in 70% of cases and affect daily life and work in 94% of cases. Furthermore, allergic rhinitis may be accompanied by multiple diseases such as otitis media, sinusitis, nasal polyps, and asthma, posing a greater threat to health.

[0005] Currently, the treatment of allergic rhinitis mainly involves desensitization, hormones, and immunotherapy. These methods usually provide significant short-term relief, but the effects are difficult to maintain after discontinuation. Furthermore, hormone medications cannot be used long-term to maintain treatment effectiveness and are prone to side effects such as dry mucous membranes, nosebleeds, bad taste, and headaches.

[0006] Traditional Chinese medicine (TCM) has a history of treating allergic rhinitis for thousands of years. During the Tang Dynasty, Sun Simiao treated the disease based on the differentiation of syndromes related to lung and kidney deficiency; during the Jin and Yuan Dynasties, Liu Hejian treated it based on the theory of heat and fire; and during the Ming and Qing Dynasties, physicians treated it from the perspective of lung and spleen qi deficiency. Modern TCM has also proposed various treatment plans for allergic rhinitis from different angles, including the application of ancient prescriptions with modifications and the development of new formulas. Feng Rongchang's application of Yupingfeng Powder to treat allergic rhinitis has yielded excellent results; Cang Er Zi Powder, recorded in Volume 5 of *Ji Sheng Fang* as a treatment for nasal congestion and persistent nasal discharge, composed of Magnolia biondii, Xanthium sibiricum, Angelica dahurica, Ligusticum chuanxiong, Mentha haplocalyx, Fritillaria cirrhosa, fermented soybean, Chrysanthemum morifolium, and Glycyrrhiza uralensis, has also achieved good results in treating allergic rhinitis. Li Ming, using a randomized controlled trial, proposed a decoction made from ingredients such as Rubia cordifolia, Lithospermum erythrorhizon, Saposhnikovia divaricata, Cicadae periostracum, Pheretima aspergillum, Cynanchum paniculatum, and Prunus mume to treat allergic rhinitis, concluding that it was significantly more effective than Western medicine.

[0007] The inventors of this application have developed a traditional Chinese medicine composition wash for the effective treatment of rhinitis, especially allergic rhinitis, based on long-term clinical practice. This composition has a simple formula, easy manufacturing process, convenient administration, and few toxic side effects. It can effectively improve the rhinitis symptoms of patients and is not prone to recurrence. Summary of the Invention

[0008] The purpose of this invention is to provide a nasal wash containing extracts of traditional Chinese medicine, including peppermint, houttuynia cordata, sea salt, wolfberry, and dandelion, and its preparation method. This traditional Chinese medicine composition is stable in quality and can effectively treat allergic rhinitis.

[0009] To achieve the objectives of this invention, the following technical solution is adopted: A nasal wash containing extracts of traditional Chinese medicine, composed of extracts of peppermint, houttuynia cordata, and wolfberry, sea salt, dandelion extract, and pharmaceutical excipients.

[0010] In some embodiments of the present invention, the weight ratio of the peppermint, houttuynia cordata, wolfberry extract, sea salt, and dandelion extract is 2~5:9:6~10.

[0011] In some embodiments of the present invention, the weight ratio of the peppermint, houttuynia cordata, wolfberry extract, sea salt, and dandelion extract is 3~4:9:7~8.

[0012] In some embodiments of the present invention, the weight ratio of the peppermint, houttuynia cordata, wolfberry extract, sea salt, and dandelion extract is 3.5:9:7.5.

[0013] In some embodiments of the present invention, the weight ratio of the peppermint, houttuynia cordata, wolfberry extract, sea salt, and dandelion extract is 3:9:7.

[0014] In some embodiments of the present invention, the weight ratio of the peppermint, houttuynia cordata, wolfberry extract, sea salt, and dandelion extract is 4:9:8.

[0015] The pharmaceutical excipient is HS-15, water for injection.

[0016] Furthermore, the weight ratio of the peppermint, houttuynia cordata, and wolfberry extract to HS-15 is 1:5~8, preferably 1:5~7; more preferably 1:6.

[0017] In some embodiments of the present invention, the preparation method of the peppermint, houttuynia cordata, and wolfberry extract includes the following steps: (1) Wash the mint, houttuynia cordata and wolfberry in a weight ratio of 0.5:2:1, dry them and set aside.

[0018] (2) Extraction 1: Take peppermint, houttuynia cordata and wolfberry, add 8-10 times the amount of water, adjust the pH to 5-6 with citric acid, soak for 2-4 hours, extract at 90-100℃ for 1-3 hours under ultrasonic assistance, filter to obtain residue 1 and extract A; freeze-dry extract A to obtain peppermint, houttuynia cordata and wolfberry extract 1.

[0019] (3) Extraction 2: Take the filter residue 1, add 5-6 times the amount of ethyl acetate and n-heptane mixed solvent, extract at 40-50℃ for 1-3h, separate solid and liquid, remove solvent under reduced pressure to obtain peppermint, houttuynia cordata and wolfberry extract 2.

[0020] (4) Refining: Using the crude extract of peppermint, houttuynia cordata and wolfberry 2 obtained in step (3) as the starting material, add 1-3 times the amount of ethyl acetate and let stand for 24 hours; take the supernatant and remove the solvent under reduced pressure to obtain peppermint, houttuynia cordata and wolfberry extract 3.

[0021] (5) Mix peppermint, houttuynia cordata and wolfberry extract 1 and peppermint, houttuynia cordata and wolfberry extract 3 to obtain peppermint, houttuynia cordata and wolfberry extract.

[0022] Furthermore, in step (3), the volume ratio of ethyl acetate to n-heptane in the mixed solvent of ethyl acetate and n-heptane is 5~6:1.

[0023] In some embodiments of the present invention, the preparation method of the dandelion extract includes the following steps: (1) Take dandelion, add 10-12 times the amount of a mixed solvent of petroleum ether and ethyl acetate, extract at 40-50℃ for 1-2 hours, separate, and obtain filter residue 2. (2) Add 7-8 times the amount of 40%-50% ethanol to the filter residue 2 and extract at 70-80℃ for 3-4 hours. Separate the solid and liquid to obtain extract B. (3) Add 1-2 times the amount of anhydrous ethanol to extract B, let stand for 15-20 hours, take the supernatant, freeze dry, and obtain dandelion extract.

[0024] Furthermore, in step (3), the volume ratio of petroleum ether to ethyl acetate in the mixed solvent of petroleum ether and ethyl acetate is 2 to 4:1, preferably 3:1.

[0025] Secondly, the present invention provides a method for preparing a nasal wash containing extracts of traditional Chinese medicine.

[0026] A method for preparing a nasal wash containing traditional Chinese medicine extracts includes the following steps: Add peppermint, houttuynia cordata, wolfberry extract, dandelion extract, and HS-15 to water for injection, heat to 30-40℃, stir for 1-2 hours until a clear light brown solution is obtained, add sea salt; filter (0.45μm), sterilize, and obtain a nasal wash containing traditional Chinese medicine extracts.

[0027] Compared with the prior art, the present invention has the following advantages: 1. It can effectively treat rhinitis or allergic rhinitis, with significant results.

[0028] 2. After being left to stand for 12 months, the effect showed no significant change and the quality remained stable. Detailed Implementation

[0029] This invention discloses a nasal wash containing extracts of traditional Chinese medicine, including peppermint, houttuynia cordata, sea salt, wolfberry, and dandelion, and its preparation method. Those skilled in the art can refer to the content of this invention and, combined with the relevant principles of traditional Chinese medicine preparations and drug extraction, appropriately modify the process parameters to achieve the same result. It is particularly important to note that all similar substitutions and modifications are obvious to those skilled in the art and are considered to be included within the scope of this invention. The application of this invention has been described through preferred embodiments, and those skilled in the art can obviously make modifications or appropriate changes and combinations to the methods and applications described herein without departing from the content, spirit, and scope of this invention to realize and apply the technology of this invention.

[0030] To better understand the invention and not to limit its scope, all figures indicating amounts, percentages, and other numerical values ​​used in this application should, in all cases, be understood to be modified by the word "approximately." Each numerical parameter should at least be considered as obtained based on reported significant figures and through conventional rounding methods.

[0031] The present invention will be further illustrated by the following examples, but the examples do not limit the present invention in any way.

[0032] Preparation Example 1: Peppermint, Houttuynia cordata, and Lycium barbarum extracts (1) Wash the mint, houttuynia cordata and wolfberry in a weight ratio of 0.5:2:1, dry them and set aside.

[0033] (2) Extraction 1: Take peppermint, houttuynia cordata and wolfberry, add 9 times the amount of water, adjust the pH to 5-6 with citric acid, soak for 3 hours, extract at 90-100℃ for 2 hours under 500W ultrasonic assistance, filter to obtain residue 1 and extract A; freeze-dry extract A to obtain peppermint, houttuynia cordata and wolfberry extract 1.

[0034] (3) Extraction 2: Take filter residue 1 and add 6 times the amount of a mixed solvent of ethyl acetate and n-heptane (V 乙 V 正 Extracted at 40-50℃ for 2 hours (ratio 6:1), followed by solid-liquid separation and solvent removal under reduced pressure to obtain peppermint, houttuynia cordata, and wolfberry extract 2.

[0035] (4) Refining: Using the crude extract of peppermint, houttuynia cordata and wolfberry 2 obtained in step (3) as the starting material, add 2 times the amount of ethyl acetate and let stand for 24 hours; take the supernatant and remove the solvent under reduced pressure to obtain peppermint, houttuynia cordata and wolfberry extract 3.

[0036] (5) Mix peppermint, houttuynia cordata and wolfberry extract 1 and peppermint, houttuynia cordata and wolfberry extract 3 to obtain peppermint, houttuynia cordata and wolfberry extract.

[0037] Preparation Example 2: Peppermint, Houttuynia cordata, and Lycium barbarum extracts (1) Wash the mint, houttuynia cordata and wolfberry in a weight ratio of 0.5:2:1, dry them and set aside.

[0038] (2) Extraction 1: Take peppermint, houttuynia cordata and wolfberry, add 8 times the amount of water, adjust the pH to 5-6 with citric acid, soak for 2 hours, extract at 90-100℃ for 1 hour under 500W ultrasonic assistance, filter to obtain residue 1 and extract A; freeze-dry extract A to obtain peppermint, houttuynia cordata and wolfberry extract 1.

[0039] (3) Extraction 2: Take filter residue 1 and add 5 times the amount of a mixed solvent of ethyl acetate and n-heptane (V 乙 V 正 Extraction was carried out at 40-50℃ for 1 hour (ratio = 6:1), followed by solid-liquid separation and solvent removal under reduced pressure to obtain peppermint, houttuynia cordata and wolfberry extract 2.

[0040] (4) Refining: Using the crude extract of peppermint, houttuynia cordata and wolfberry 2 obtained in step (3) as the starting material, add 2 times the amount of ethyl acetate and let stand for 24 hours; take the supernatant and remove the solvent under reduced pressure to obtain peppermint, houttuynia cordata and wolfberry extract 3.

[0041] (5) Mix peppermint, houttuynia cordata and wolfberry extract 1 and peppermint, houttuynia cordata and wolfberry extract 3 to obtain peppermint, houttuynia cordata and wolfberry extract.

[0042] Preparation Example 3: Peppermint, Houttuynia cordata, and Lycium barbarum extracts (1) Wash the mint, houttuynia cordata and wolfberry in a weight ratio of 0.5:2:1, dry them and set aside.

[0043] (2) Extraction 1: Take peppermint, houttuynia cordata and wolfberry, add 10 times the amount of water, adjust the pH to 5-6 with citric acid, soak for 4 hours, extract at 90-100℃ for 3 hours under 600W ultrasonic assistance, filter to obtain residue 1 and extract A; freeze-dry extract A to obtain peppermint, houttuynia cordata and wolfberry extract 1.

[0044] (3) Extraction 2: Take filter residue 1 and add 6 times the amount of a mixed solvent of ethyl acetate and n-heptane (V 乙 V 正 Extraction was carried out at 40-50℃ for 3 hours (ratio = 6:1), followed by solid-liquid separation and solvent removal under reduced pressure to obtain peppermint, houttuynia cordata and wolfberry extract 2.

[0045] (4) Refining: Using the crude extract of peppermint, houttuynia cordata and wolfberry 2 obtained in step (3) as the starting material, add 3 times the amount of ethyl acetate and let stand for 24 hours; take the supernatant, remove the solvent under reduced pressure to obtain peppermint, houttuynia cordata and wolfberry 3.

[0046] (5) Mix peppermint, houttuynia cordata and wolfberry extract 1 and peppermint, houttuynia cordata and wolfberry extract 3 to obtain peppermint, houttuynia cordata and wolfberry extract.

[0047] Preparation Example 4: Peppermint, Houttuynia cordata, and Lycium barbarum extracts (1) Wash the mint, houttuynia cordata and wolfberry in a weight ratio of 0.5:2:1, dry them and set aside.

[0048] (2) Extraction 1: Take peppermint, houttuynia cordata and wolfberry, add 9 times the amount of water, adjust the pH to 5-6 with citric acid, soak for 3 hours, extract at 90-100℃ for 2 hours under 500W ultrasonic assistance, filter to obtain residue 1 and extract A; freeze-dry extract A to obtain peppermint, houttuynia cordata and wolfberry extract 1.

[0049] (3) Extraction 2: Take filter residue 1 and add 6 times the amount of a mixed solvent of ethyl acetate and n-heptane (V 乙 V 正 Extracted at 40-50℃ for 2 hours (ratio 6:1), followed by solid-liquid separation and solvent removal under reduced pressure to obtain peppermint, houttuynia cordata, and wolfberry extract 2.

[0050] (4) Mix peppermint, houttuynia cordata and wolfberry extract 1 and peppermint, houttuynia cordata and wolfberry extract 2 to obtain peppermint, houttuynia cordata and wolfberry extract.

[0051] Preparation Example 5: Peppermint and Houttuynia cordata Extract (1) Wash and dry the mint and houttuynia cordata in a weight ratio of 0.5:2 and set aside.

[0052] (2) Extraction 1: Take mint and houttuynia cordata, add 9 times the amount of water, adjust the pH to 5-6 with citric acid, soak for 3 hours, extract at 90-100℃ for 2 hours under 500W ultrasonic assistance, filter to obtain filter residue 1 and extract A; freeze-dry extract A to obtain mint and houttuynia cordata extract 1.

[0053] (3) Extraction 2: Take filter residue 1 and add 6 times the amount of a mixed solvent of ethyl acetate and n-heptane (V 乙 V 正 Extracted at 40-50℃ for 2 hours (ratio 6:1), followed by solid-liquid separation and solvent removal under reduced pressure to obtain peppermint and houttuynia cordata extract 2.

[0054] (4) Refining: Using the crude peppermint and houttuynia cordata extract 2 obtained in step (3) as the starting material, add 2 times the amount of ethyl acetate and let stand for 24 hours; take the supernatant and remove the solvent under reduced pressure to obtain peppermint and houttuynia cordata extract 3.

[0055] (5) Mix peppermint and houttuynia cordata extract 1 and peppermint and houttuynia cordata extract 3 to obtain peppermint and houttuynia cordata extract.

[0056] Preparation Example 6: Houttuynia cordata and Lycium barbarum extract (1) Wash and dry the houttuynia cordata and wolfberry in a weight ratio of 2:1 and set aside.

[0057] (2) Extraction 1: Take houttuynia cordata and wolfberry, add 9 times the amount of water, adjust the pH to 5-6 with citric acid, soak for 3 hours, extract at 90-100℃ for 2 hours under 500W ultrasonic assistance, filter to obtain residue 1 and extract A; freeze-dry extract A to obtain houttuynia cordata and wolfberry extract 1.

[0058] (3) Extraction 2: Take filter residue 1 and add 6 times the amount of a mixed solvent of ethyl acetate and n-heptane (V 乙 V 正 Extraction was carried out at 40-50℃ for 2 hours (ratio 6:1), followed by solid-liquid separation and solvent removal under reduced pressure to obtain Houttuynia cordata and Lycium barbarum extract 2.

[0059] (4) Refining: Using the crude extract of houttuynia cordata and wolfberry 2 obtained in step (3) as the starting material, add 2 times the amount of ethyl acetate and let stand for 24 hours; take the supernatant and remove the solvent under reduced pressure to obtain extract of houttuynia cordata and wolfberry 3.

[0060] (5) Mix Houttuynia cordata and wolfberry extract 1 and Houttuynia cordata and wolfberry extract 3 to obtain Houttuynia cordata and wolfberry extract.

[0061] Preparation Example 7: Peppermint and Goji Berry Extract (1) Wash and dry the mint and wolfberry in a weight ratio of 0.5:1 and set aside.

[0062] (2) Extraction 1: Take peppermint and wolfberry, add 9 times the amount of water, adjust the pH to 5-6 with citric acid, soak for 3 hours, extract at 90-100℃ for 2 hours under 500W ultrasonic assistance, filter to obtain residue 1 and extract A; freeze-dry extract A to obtain peppermint and wolfberry extract 1.

[0063] (3) Extraction 2: Take filter residue 1 and add 6 times the amount of a mixed solvent of ethyl acetate and n-heptane (V 乙 V 正 Extracted at 40-50℃ for 2 hours (ratio 6:1), followed by solid-liquid separation and solvent removal under reduced pressure to obtain peppermint and wolfberry extract 2.

[0064] (4) Refining: Using the crude peppermint and wolfberry extract 2 obtained in step (3) as the starting material, add 2 times the amount of ethyl acetate and let stand for 24 hours; take the supernatant and remove the solvent under reduced pressure to obtain peppermint and wolfberry extract 3.

[0065] (5) Mix peppermint and wolfberry extract 1 and peppermint, houttuynia cordata and wolfberry extract 3 to obtain peppermint and wolfberry extract.

[0066] Preparation Example 8: Peppermint, Houttuynia cordata, and Lycium barbarum extracts (1) Wash the mint, houttuynia cordata and wolfberry in a weight ratio of 0.5:2:1, dry them and set aside.

[0067] (2) Extraction 1: Take peppermint, houttuynia cordata and wolfberry, add 9 times the amount of water, extract at 90-100℃ for 2h, filter to obtain residue 1 and extract A; freeze-dry extract A to obtain peppermint, houttuynia cordata and wolfberry extract 1.

[0068] (3) Extraction 2: Take filter residue 1 and add 6 times the amount of a mixed solvent of ethyl acetate and n-heptane (V 乙 V 正 Extracted at 40-50℃ for 2 hours (ratio 6:1), followed by solid-liquid separation and solvent removal under reduced pressure to obtain peppermint, houttuynia cordata, and wolfberry extract 2.

[0069] (4) Refining: Using the crude extract of peppermint, houttuynia cordata and wolfberry 2 obtained in step (3) as the starting material, add 2 times the amount of ethyl acetate and let stand for 24 hours; take the supernatant and remove the solvent under reduced pressure to obtain peppermint, houttuynia cordata and wolfberry extract 3.

[0070] (5) Mix peppermint, houttuynia cordata and wolfberry extract 1 and peppermint, houttuynia cordata and wolfberry extract 3 to obtain peppermint, houttuynia cordata and wolfberry extract.

[0071] Preparation Example 9: Peppermint, Houttuynia cordata, and Lycium barbarum extracts (1) Wash the mint, houttuynia cordata and wolfberry in a weight ratio of 0.5:2:1, dry them and set aside.

[0072] (2) Extraction 1: Take peppermint, houttuynia cordata and wolfberry, add 9 times the amount of water, adjust the pH to 5-6 with citric acid, soak for 3 hours, extract at 90-100℃ for 2 hours under 500W ultrasonic assistance, filter to obtain residue 1 and extract A; freeze-dry extract A to obtain peppermint, houttuynia cordata and wolfberry extract 1.

[0073] (3) Extraction 2: Take the filter residue 1, add 6 times the amount of ethyl acetate solvent, extract at 40-50℃ for 2h, separate the solid and liquid, remove the solvent under reduced pressure, and obtain peppermint, houttuynia cordata and wolfberry extract 2.

[0074] (4) Refining: Using the crude extract of peppermint, houttuynia cordata and wolfberry 2 obtained in step (3) as the starting material, add 2 times the amount of ethyl acetate and let stand for 24 hours; take the supernatant and remove the solvent under reduced pressure to obtain peppermint, houttuynia cordata and wolfberry extract 3.

[0075] (5) Mix peppermint, houttuynia cordata and wolfberry extract 1 and peppermint, houttuynia cordata and wolfberry extract 3 to obtain peppermint, houttuynia cordata and wolfberry extract.

[0076] Preparation Example 10: Peppermint, Houttuynia cordata, and Lycium barbarum extracts (1) Wash the mint, houttuynia cordata and wolfberry in a weight ratio of 0.5:2:1, dry them and set aside.

[0077] (2) Extraction 1: Take peppermint, houttuynia cordata and wolfberry, add 9 times the amount of water, adjust the pH to 5-6 with citric acid, soak for 3 hours, extract at 90-100℃ for 2 hours under 500W ultrasonic assistance, filter to obtain residue 1 and extract A; freeze-dry extract A to obtain peppermint, houttuynia cordata and wolfberry extract 1.

[0078] (3) Extraction 2: Take the filter residue 1, add 6 times the amount of n-heptane solvent, extract at 40-50℃ for 2h, separate the solid and liquid, remove the solvent under reduced pressure, and obtain peppermint, houttuynia cordata and wolfberry extract 2.

[0079] (4) Refining: Using the crude extract of peppermint, houttuynia cordata and wolfberry 2 obtained in step (3) as the starting material, add 2 times the amount of ethyl acetate and let stand for 24 hours; take the supernatant and remove the solvent under reduced pressure to obtain peppermint, houttuynia cordata and wolfberry extract 3.

[0080] (5) Mix peppermint, houttuynia cordata and wolfberry extract 1 and peppermint, houttuynia cordata and wolfberry extract 3 to obtain peppermint, houttuynia cordata and wolfberry extract.

[0081] Preparation Example 11: Dandelion Extract (1) Take dandelion and add 11 times the amount of a mixed solvent of petroleum ether and ethyl acetate (V 石 V 乙Extraction was carried out at 40-50℃ for 2 hours (ratio 3:1), followed by separation to obtain filter residue 2. (2) Add 7 times the amount of 45% ethanol to the filter residue 2 and extract at 70-80℃ for 3h. Separate the solid and liquid to obtain extract B. (3) Add 2 times the amount of anhydrous ethanol to extract B, let stand for 15-20 hours, take the supernatant, freeze dry, and obtain dandelion extract.

[0082] Preparation Example 12: Dandelion Extract (1) Take dandelion and add 10 times the amount of a mixed solvent of petroleum ether and ethyl acetate (V 石 V 乙 Extraction was carried out at 40-50℃ for 2 hours (ratio 3:1), followed by separation to obtain filter residue 2. (2) Add 8 times the amount of 40% ethanol to the filter residue 2 and extract at 70-80℃ for 4 hours. Separate the solid and liquid to obtain extract B. (3) Add 2 times the amount of anhydrous ethanol to extract B, let stand for 15-20 hours, take the supernatant, freeze dry, and obtain dandelion extract.

[0083] Preparation Example 13: Dandelion Extract (1) Take dandelion and add 12 times the amount of a mixed solvent of petroleum ether and ethyl acetate (V 石 V 乙 Extraction was performed at a ratio of 3:1 (equal to 1 part density) at 40-50℃ for 1 hour, followed by separation to obtain filter residue 2. (2) Add 7 times the amount of 50% ethanol to the filter residue 2 and extract at 70-80℃ for 3h. Separate the solid and liquid to obtain extract B. (3) Add 2 times the amount of anhydrous ethanol to extract B, let stand for 15-20 hours, take the supernatant, freeze dry, and obtain dandelion extract.

[0084] Preparation Example 14: Dandelion Extract (1) Take dandelion, add 11 times the amount of petroleum ether solvent, extract at 40-50℃ for 2h, separate, and obtain filter residue 2; (2) Add 7 times the amount of 45% ethanol to the filter residue 2 and extract at 70-80℃ for 3h. Separate the solid and liquid to obtain extract B. (3) Add 2 times the amount of anhydrous ethanol to extract B, let stand for 15-20 hours, take the supernatant, freeze dry, and obtain dandelion extract.

[0085] Preparation Example 15: Dandelion Extract (1) Take dandelion, add 11 times the amount of ethyl acetate solvent, extract at 40-50℃ for 2 hours, separate, and obtain filter residue 2; (2) Add 7 times the amount of 45% ethanol to the filter residue 2 and extract at 70-80℃ for 3h. Separate the solid and liquid to obtain extract B; (3) Add 2 times the amount of anhydrous ethanol to extract B, let stand for 15-20 hours, take the supernatant, freeze dry, and obtain dandelion extract.

[0086] Preparation Example 16: Dandelion Extract (1) Take dandelion, add 7 times the amount of 45% ethanol, extract at 70-80℃ for 3h, separate, and obtain extract B by solid-liquid separation; (2) Add 2 times the amount of anhydrous ethanol to extract B, let stand for 15-20 hours, take the supernatant, freeze dry, and obtain dandelion extract.

[0087] Preparation Example 17: Dandelion Extract (1) Take dandelion, add 11 times the amount of a mixed solvent of petroleum ether and ethyl acetate, extract at 40-50℃ for 2 hours, separate, and obtain filter residue 2. (2) Add 7 times the amount of water to the filter residue 2 and extract at 70-80℃ for 3 hours. Separate the solid and liquid to obtain extract B; (3) Add 2 times the amount of anhydrous ethanol to extract B, let stand for 15-20 hours, take the supernatant, freeze dry, and obtain dandelion extract.

[0088] Preparation Example 18: Dandelion Extract (1) Take dandelion, add 11 times the amount of a mixed solvent of petroleum ether and ethyl acetate, extract at 40-50℃ for 2 hours, separate, and obtain filter residue 2. (2) Add 7 times the amount of 10% ethanol to the filter residue 2 and extract at 70-80℃ for 3h. Separate the solid and liquid to obtain extract B. (3) Add 2 times the amount of anhydrous ethanol to extract B, let stand for 15-20 hours, take the supernatant, freeze dry, and obtain dandelion extract.

[0089] Examples 1-15: Traditional Chinese Medicine Compositions for Treating Rhinitis

[0090] Preparation method: Add peppermint, houttuynia cordata, wolfberry extract, dandelion extract, and HS-15 to water for injection, heat to 30-40℃, stir for 1-2 hours until a clear light brown solution is obtained, add sea salt; make up to volume with water for injection, continue stirring for 1-2 hours, filter (0.45μm), sterilize, and obtain a nasal wash containing traditional Chinese medicine extracts.

[0091] Examples 16-18: Traditional Chinese Medicine Compositions for Treating Rhinitis

[0092] Preparation method: Example 16: Add peppermint, houttuynia cordata and wolfberry extract and HS-15 to water for injection, heat to 30-40℃, stir for 1-2 hours until a clear light brown solution is obtained, add sea salt; make up to volume with water for injection, continue stirring for 1-2 hours, filter (0.45μm), sterilize, and obtain a nasal wash containing traditional Chinese medicine extract.

[0093] Example 17: Dandelion extract and HS-15 were added to water for injection, the temperature was raised to 30-40℃, and the mixture was stirred for 1-2 hours until a clear light brown solution was obtained. Sea salt was added; the volume was adjusted with water for injection, and stirring was continued for 1-2 hours. The solution was filtered (0.45μm) and sterilized to obtain a nasal wash containing traditional Chinese medicine extract.

[0094] Example 18: Add peppermint, houttuynia cordata, wolfberry extract and dandelion extract to water for injection, heat to 30-40℃, stir for 1-2 hours until a clear light brown solution is obtained, add sea salt; make up to volume with water for injection, continue stirring for 1-2 hours, filter (0.45μm), sterilize to obtain a nasal wash containing traditional Chinese medicine extracts.

[0095] Example 19: Efficacy test of the nasal wash of the present invention 1. Model preparation and group treatment Triamcinolone acetonide nasal spray (a corticosteroid, manufactured by Jiangxi Zhenshiming Pharmaceutical Co., Ltd.), ovalbumin (OVA), rat IgE enzyme-linked immunosorbent assay kit, and Mucin5AC antibody (Abcam, UK). Rats: 210, half male and half female, weighing 200g±30g; after one week of acclimatization feeding, the rats were divided into half male and half female.

[0096] Two hundred rats were randomly selected for sensitization: 1 mL of OVA suspension (0.9% sodium chloride, 20 mg OVA, 30 mg aluminum hydroxide) was injected intraperitoneally every other day for a total of 8 times (15 days) to induce basal sensitization. Starting on day 16, 50 μL of 10% OVA saline solution was instilled into each of the rats' anterior nostrils once daily for 10 consecutive days to induce allergic rhinitis. After successful modeling, rats were randomly assigned to the model group, positive control group, and groups described in Examples 1-18 (rhinitis wash prepared in Examples 1-18); each group consisted of 10 rats. Another 10 animals were placed in the normal control group and received intraperitoneal injection and nasal drops as before, but the medication administered was saline solution.

[0097] The normal group and the model group were given nasal washes with physiological saline, and the positive control group was given triamcinolone acetonide nasal spray. The nasal washes prepared in Examples 1-18 were used for nasal washes. Each group was given 2 ml each time, twice a day, for 3 consecutive weeks.

[0098] 2. Detection indicator: Serum IgE content detection After administration, blood was collected from the celiac artery of the rats after anesthesia, serum was separated, and enzyme-linked immunosorbent assay (ELISA) was performed according to the kit instructions.

[0099] 3. Statistical Analysis Methods Data were processed using SPSS software and analyzed using one-way ANOVA. Data are expressed as mean ± standard deviation. P < 0.05 was considered statistically significant.

[0100] 4. Results Results of IgE levels in the blood of rats in each group

[0101] Note: Compared with the normal group, *P<0.05, **P<0.01 Compared with the model group, #P < 0.05 and ##P < 0.01; Compared with Example 1 group, ·P < 0.05 and ·&P < 0.01 Example 20: Efficacy test of the nasal wash of the present invention after 3 months of accelerated storage 1. Test samples: The nasal washes in Examples 1-4, 9-12, 14-15, and 18 were placed under accelerated conditions for 3 months (temperature 40℃±2℃, humidity 60%±5%), and the efficacy was tested.

[0102] 2. Model preparation was the same as in Example 19. Rats were divided into 13 groups, randomly assigned as the model group, Examples 1-4, 9-12, 14-15, and 18 (the prepared nasal wash was aged for 3 months); each group contained 10 rats. Another 10 were selected as the normal group and administered intraperitoneal injection and nasal irrigation as before, but the medication given was physiological saline.

[0103] The normal group and the model group were given nasal washes with physiological saline, and the nasal washes prepared by the example group were given 2 ml each time, twice a day, for 3 consecutive weeks.

[0104] 3. The detection indicators and statistical analysis methods are the same as in Example 19.

[0105] 4. Results:

[0106] Note: Compared with the normal group, *P<0.05, **P<0.01 Compared with the model group, #P < 0.05 and ##P < 0.01; Compared with Example 1 group, ·P < 0.05 and ·&P < 0.01 (1) Compared with the normal group, the level of IgE, the allergy mediator, in the model group increased significantly, and the two groups showed a very significant difference (P<0.01), indicating that the modeling was successful.

[0107] (2) Compared with the model group, the nasal wash prepared in Examples 1-3 can significantly reduce the content of allergy mediator IgE, and all have very significant differences (P<0.01). After 3 months of accelerated storage, the efficacy did not change significantly, and still had very significant differences (P<0.01), indicating that the nasal wash prepared in Examples 1-3 can treat allergic rhinitis and has stable quality.

[0108] Compared with the positive control group, the nasal washes prepared in Examples 1-3 significantly reduced the content of the allergy mediator IgE, with very high differences (P<0.05), indicating that the nasal washes prepared in Examples 1-3 are superior to the corticosteroid triamcinolone acetonide (positive control group) in reducing the main allergy mediator IgE.

[0109] (3) Compared with Example 1, Example 4 had the same effect at the beginning of preparation. However, after 3 months of accelerated storage, the efficacy was significantly worse than that of Example 1 (P<0.05).

[0110] (4) Compared with the model group, the nasal washes prepared in Examples 5-7 can significantly reduce the content of allergy mediator IgE, and all have significant differences (P<0.05). However, compared with Example 1, the content of allergy mediator IgE is significantly increased (P<0.05), indicating that the efficacy of the nasal washes prepared in Examples 5-7 is significantly worse than that of Example 1.

[0111] (5) Compared with the model group, the nasal wash prepared in Example 8 can significantly reduce the content of allergy mediator IgE, and there are significant differences (P<0.05). However, compared with Example 1, the content of allergy mediator IgE is significantly increased (P<0.05), indicating that Example 1 achieved unexpected technical effects.

[0112] (6) Compared with Example 1, Examples 9-10 had similar effects at the beginning of preparation. However, after 3 months of accelerated storage, the efficacy was significantly worse than that of Example 1 (P<0.05).

[0113] (7) Compared with Example 1, the effects of Examples 11-12 were slightly worse than those of Example 1 at the beginning of preparation, but there was no significant difference (P>0.05). However, after 3 months of accelerated storage, the efficacy was significantly worse than that of Example 1 (P<0.05).

[0114] (8) Compared with the model group, the nasal wash prepared in Example 13 can significantly reduce the content of allergy mediator IgE, showing a significant difference (P<0.05). However, compared with Example 1, the content of allergy mediator IgE is significantly increased (P<0.05), indicating that the efficacy of the nasal wash prepared in Example 13 is significantly worse than that of Example 1.

[0115] (9) Compared with Example 1, Examples 14-15 had similar effects at the beginning of preparation. However, after being placed for 3 months, the efficacy was significantly worse than that of Example 1 (P < 0.05).

[0116] (10) Compared with the model group, the nasal wash prepared in Examples 16-17 can slightly reduce the content of allergy mediator IgE, which is not significantly different (P>0.05). Compared with Example 1, the content of allergy mediator IgE is significantly increased (P<0.01), indicating that the nasal wash prepared in Examples 16-17 cannot treat rhinitis and the effect is significantly worse than that of Example 1.

[0117] (11) Compared with Example 1, Example 18 was slightly less effective than Example 1 at the beginning of preparation, but there was no significant difference (P>0.05). However, after 3 months of accelerated storage, the efficacy was significantly worse than Example 1 (P<0.05).

Claims

1. A nasal wash containing traditional Chinese medicine extracts, comprising peppermint, houttuynia cordata, and wolfberry extracts, sea salt, dandelion extract, and pharmaceutical excipients.

2. The nasal wash as described in claim 1, comprising the extracts of peppermint, houttuynia cordata, and wolfberry, is prepared by the following steps: (1) Wash and dry the mint, houttuynia cordata and wolfberry in a weight ratio of 0.5:2:1 and set aside; (2) Extraction 1: Take peppermint, houttuynia cordata and wolfberry, add 8-10 times the amount of water, adjust the pH to 5-6 with citric acid, soak for 2-4 hours, extract at 90-100℃ for 1-3 hours under ultrasonic assistance, filter to obtain residue 1 and extract A; freeze-dry extract A to obtain peppermint, houttuynia cordata and wolfberry extract 1. (3) Extraction 2: Take the filter residue 1, add 5-6 times the amount of ethyl acetate and n-heptane mixed solvent, extract at 40-50℃ for 1-3h, separate solid and liquid, remove solvent under reduced pressure to obtain peppermint, houttuynia cordata and wolfberry extract 2. (4) Refining: Using the crude extract of peppermint, houttuynia cordata and wolfberry 2 obtained in step (3) as the starting material, add 1-3 times the amount of ethyl acetate and let stand for 24 hours; take the supernatant and remove the solvent under reduced pressure to obtain peppermint, houttuynia cordata and wolfberry 3. (5) Mix peppermint, houttuynia cordata and wolfberry extract 1 and peppermint, houttuynia cordata and wolfberry extract 3 to obtain peppermint, houttuynia cordata and wolfberry extract.

3. The nasal wash as described in claim 1, wherein the dandelion extract is prepared by: (1) Take dandelion, add 10-12 times the amount of petroleum ether and ethyl acetate mixed solvent, extract at 40-50℃ for 1-2 hours, separate, and obtain filter residue 2; (2) Add 7-8 times the amount of 40%-50% ethanol to the filter residue 2 and extract at 70-80℃ for 3-4 hours. Separate the solid and liquid to obtain extract B. (3) Add 1-2 times the amount of anhydrous ethanol to extract B, let stand for 15-20 hours, take the supernatant, freeze dry, and obtain dandelion extract.

4. The nasal wash as described in claim 1, wherein the weight ratio of the peppermint, houttuynia cordata, and wolfberry extract, sea salt, and dandelion extract is 3~4:9:7~8.

5. The nasal wash as described in claim 1, wherein the weight ratio of the peppermint, houttuynia cordata, and wolfberry extract, sea salt, and dandelion extract is 3.5:9:7.

5.

6. The nasal wash as described in claim 1, wherein the weight ratio of the peppermint, houttuynia cordata, and wolfberry extract, sea salt, and dandelion extract is 3:9:

7.

7. The nasal wash as described in claim 1, wherein the weight ratio of the peppermint, houttuynia cordata, and wolfberry extract, sea salt, and dandelion extract is 4:9:

8.

8. The nasal wash as described in claim 1, wherein the pharmaceutical excipients are HS-15 and water for injection.

9. The nasal wash as described in claim 8, wherein the weight ratio of the peppermint, houttuynia cordata, and wolfberry extract to HS-15 is 1:5~7.

10. A method for preparing a nasal wash as described in claims 1-9, characterized in that, The process includes the following steps: Add peppermint, houttuynia cordata, wolfberry extract, dandelion extract, and HS-15 to water for injection, heat to 30-40℃, stir for 1-2 hours until a clear light brown solution is obtained, add sea salt; filter (0.45μm), sterilize, and obtain a nasal wash containing traditional Chinese medicine extracts.

Images