Dropping liquid for treating rhinitis and otitis media and production process thereof

Abstract

The invention relates to the technical field of Chinese herbal medicines, and particularly discloses a dropping liquid for treating rhinitis and otitis media and a production process thereof. The dropping liquid is prepared from 10-15 parts of rhizoma cimicifugae, 10-15 parts of radix astragali, 10-15 parts of herba ephedrae, 10-15 parts of flos caryophylli, 8-10 parts of radix saposhnikoviae, 8-10 parts of radix puerariae, 8-10 parts of rhizoma seu radix notopterygii, 8-10 parts of honey-fried liquorice root, 8-10 parts of herba houttuyniae, 8-10 parts of flos lonicerae and 20 parts of rhizoma coptidis. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 15-18 parts of radix scutellariae, 15-18 parts of radix isatidis, 15-18 parts of chrysanthemum morifolium, 15-18 parts of acorus calamus, 15-18 parts of bothriospermum chinense, 15-18 parts of rhizoma phragmitis, 15-18 parts of fructus piperis longi, 15-18 parts of poria cocos, 18-20 parts of semen trichosanthis, 18-20 parts of centipeda minima, 18-20 parts of herba violae, 18-20 parts of cortex moutan, 18-20 parts of wax gourd kernels and 18-20 parts of radices stellariae dichotomae. The side effects of drug resistance, mucosal lesion, decline of immunity and the like easily caused by long-term use of antibiotics, glucocorticoid and other components in western medicines are avoided. The traditional Chinese medicine emphasizes overall conditioning, has relatively small side effects, and is more suitable for long-term use by patients with chronic and recurrent rhinitis and otitis media.

Description

Technical Field

[0001] The invention belongs to the technical field of Chinese herbal medicines, and particularly relates to drops for treating rhinitis and otitis media and a production process thereof. Background Art

[0002] Rhinitis and otitis media are common ENT diseases, with high incidence rates worldwide and high rates of recurrence, severely impacting patients' quality of life. Rhinitis presents with nasal congestion, runny nose, itching, and sneezing. Long-term untreated symptoms can lead to complications such as sinusitis and pharyngitis. Otitis media presents with ear pain, pus discharge from the ear canal, and hearing loss. If untreated, it can lead to serious consequences such as perforated eardrums and permanent hearing loss.

[0003] Currently, there is a lack of simple, easy-to-use medications for treating acute and chronic suppurative otitis media both domestically and internationally. Clinical treatments for rhinitis and otitis media primarily fall into two categories: Western medicine and traditional Chinese medicine. Western medicine, often using antibiotics and glucocorticoids, can provide short-term symptom relief, but long-term use can lead to drug resistance, damage to the nasal or ear canal mucosa, and decreased immunity. Furthermore, their effectiveness is limited for chronic, recurring cases.

[0004] Among the existing traditional Chinese medicine preparations, there are many single or compound medicines for rhinitis or otitis media, but there are few preparations that can treat both diseases at the same time. In addition, there are many similar drop treatment products on the market that have a pungent smell and are not popular with patients.

[0005] Or some of the current preparations have simple formulas, and have single effects such as anti-inflammatory, orifice-opening, and detoxification, which are difficult to cope with complex pathogenesis. The effective ingredients are difficult to fully penetrate into the lesion site, affecting the treatment effect. Summary of the Invention

[0006] The object of the present invention is to provide a drop for treating rhinitis and otitis media and a production process thereof, so as to solve the problems raised in the above background technology.

[0007] To achieve the above object, the present invention provides the following technical solutions:

[0008] A drop for treating rhinitis and otitis media, comprising the following raw materials in parts by weight:

[0009] 10-15 parts of Cimicifuga heracleifolia, 10-15 parts of Astragalus membranaceus, 10-15 parts of Ephedra sinica, 10-15 parts of Clove, 8-10 parts of Saposhnikovia divaricata, 8-10 parts of Pueraria root, 8-10 parts of Notopterygium wilfordii, 8-10 parts of Honey-fried Licorice root, 8-10 parts of Houttuynia cordata, 8-10 parts of Double Flower, 20 parts of Lianchao, 15-18 parts of Scutellaria baicalensis, 15-18 parts of Isatis root, 15-18 parts of Hangju, 15-18 parts of Acorus calamus, 15-18 parts of Toad Grass, 15-18 parts of Phragmites australis, 15-18 parts of Bibo, 15-18 parts of Poria cocos, 18-20 parts of Trichosanthes root, 18-20 parts of Goose Not Food Grass, 18-20 parts of Anti-white Grass, 18-20 parts of Moutan Bark, 18-20 parts of Winter Melon Seed, 18-20 parts of Bupleurum chinense, 18-20 parts of Flower 18-20 parts of powder, 15-18 parts of Chuanxiong, 15-18 parts of Xanthium sibiricum, 15-18 parts of Schisandra chinensis, 15-18 parts of Magnolia Flos, 15-18 parts of Fritillaria thunbergii, 15-18 parts of Squama manis, 15-18 parts of Loofah vine / network, 10-13 parts of Sophora flavescens, 10-13 parts of Terminalia chebula, 10-13 parts of Angelica dahurica, 10-13 parts of White Peony Root, 10-13 parts of Platycodon grandiflorum, 8-10 parts of Angelica dahurica, 8-10 parts of Angelica dahurica, 8-10 parts of Radix Angelicae Pubescentis, 8-10 parts of Schizonepeta tenuifolia, 8-10 parts of Asarum, 8-10 parts of Sinapis alba, 8-10 parts of Sichuan pepper, 8-10 parts of Morus alba, 8-10 parts of Patchouli, 8-10 parts of Pinellia ternata, 8-10 parts of Polygonatum sibiricum, 15-16 parts of Prunus mume, and 15-16 parts of Coix seed.

[0010] A production process for treating rhinitis and otitis media drops, comprising the following steps:

[0011] S1. Pretreatment of medicinal materials

[0012] Take Cimicifuga heracleifolia, Astragalus membranaceus, Ephedra sinica, Clove, Saposhnikovia divaricata, Pueraria root, Notopterygium wilfordii, Honey-fried Licorice, Houttuynia cordata, Shuanghua, Lianchao, Scutellaria baicalensis, Isatis root, Chrysanthemum indicum, Acorus calamus, Toad grass, Phragmites australis, Bibo, Poria cocos, Trichosanthes root, Ebushica oleracea, Anti-white grass, Cortex Moutan, Wax gourd seed, Bupleurum chinense, Pollen, Chuanxiong, Xanthium sibiricum, Schisandra chinensis, Magnolia officinalis, Fritillaria thunbergii, Rinse each of the following herbs: Luffa vine / network, Soapberry, Terminalia chebula, Angelica dahurica, White peony root, Platycodon grandiflorum, Angelica pubescens, Peppermint, Schizonepeta tenuifolia, Asarum sieboldii, Sinapis alba, Sichuan pepper, Morus alba, Patchouli, Pinellia ternata, Polygonatum sibiricum, Plum, Coix seed, Rinse each herb with 30-40℃ warm water for 2-3 times to remove impurities, soil and residual roots and dead bark of non-medicinal parts on the surface of the woody herbs, drain the water and set aside;

[0013] S2. First decoction

[0014] Add purified water in a ratio of 1:3.5 to the total weight of the medicinal materials, stir until the medicinal materials are fully immersed, cover and soak for 2.5 hours, stirring once every 30 minutes;

[0015] After soaking, place the container on the heating device, boil over high heat, then reduce the heat and maintain a simmer for 15 minutes, stirring constantly to prevent the herbs from sticking to the pot;

[0016] After decoction is completed, filter immediately with an 80-mesh filter and collect the first filtrate into a clean container; retain the medicinal residue;

[0017] S3, second decoction

[0018] Add purified water to the remaining medicinal residue at a ratio of 1:2.5 of the total weight of the medicinal materials, stir evenly, cover, bring to a boil over high heat, then reduce heat and simmer for 20 minutes, stirring continuously to prevent sticking to the pan.

[0019] After decoction is completed, filter with an 80-mesh filter, collect the second filtrate, and combine it with the first filtrate to obtain a mixed medicinal solution;

[0020] S4. Preliminary processing and adjustment

[0021] The mixed liquid was coarsely filtered through a 100-mesh filter to remove larger particles of impurities and obtain a clear liquid; 1.5% of the volume of the coarsely filtered liquid was added with preservatives and protective agents, stirred until completely dissolved, and simmered on low heat for 5-8 minutes. During this period, the pH value of the liquid was monitored with pH test paper to ensure that it was between 6.8 and 7.0;

[0022] S5. Low temperature precipitation and filtration

[0023] Stop heating, wait for the liquid to cool naturally to room temperature, transfer it to a clean sealed container, and place it in a constant temperature incubator at 5-8°C overnight for 12-16 hours to allow impurities to fully precipitate;

[0024] The next day, take out the container and filter the liquid with a 120-mesh filter to remove the sediment at the bottom and collect the clear filtrate;

[0025] S6. Alcohol purification

[0026] Add 95% medical alcohol to the clarified filtrate at a volume ratio of 3:1, stir evenly, and boil over high heat for 5 minutes to promote the precipitation of fibrin. Stir continuously to prevent local overheating.

[0027] Stop heating, wait for the mixture to cool naturally to room temperature, transfer it to a clean sealed container, and place it in a 5-8°C constant temperature incubator overnight to allow the fibrin to fully precipitate;

[0028] S7, fine filtration

[0029] The next day, the container was removed and filtered using a vacuum filtration device with a 0.45 μm filter membrane to collect the filtrate;

[0030] S8, Alcohol Recovery

[0031] The collected filtrate is used for alcohol recovery: using a rotary evaporator or distillation apparatus, distill the alcohol at 60-70°C until there is no obvious alcohol smell in the liquid;

[0032] S9. Sterilization

[0033] Dispense the dark brown liquid into clean glass containers, seal them and sterilize them:

[0034] Day 1: sterilize at 100℃ for 1 hour and cool naturally to room temperature;

[0035] The next day: Repeat the sterilization at 100℃ for 1 hour and cool naturally to room temperature;

[0036] Day 3: Sterilize again at 100℃ for 1 hour and cool naturally to room temperature;

[0037] S10, sterile packaging

[0038] The sterilized liquid medicine is packaged in sterile spray bottles on a sterile operating table. The capacity of each bottle is determined according to demand. During the packaging process, avoid the liquid medicine from contacting the outside of the bottle mouth to prevent contamination. After the packaging is completed, immediately seal the spray bottle, label it, and store it in a cool and dry place.

[0039] Preferably, the preservative in S4 includes sodium benzoate, and the protective agent includes propylene glycol.

[0040] Preferably, the pH value in S4 is adjusted by adding citric acid or sodium hydroxide solution for fine adjustment.

[0041] Preferably, the fine filtration method in S7 further includes performing normal pressure filtration using slow filter paper, repeating the filtration twice until the filtrate is clear, and collecting the filtrate.

[0042] Preferably, the alcohol recovery method in S8 further includes placing the filtrate in a stainless steel container, heating over a low heat to evaporate the alcohol, and constantly stirring during the process until no bubbles are generated on the surface of the liquid, thereby obtaining a dark brown liquid.

[0043] Compared with the prior art, the present invention has the following beneficial effects:

[0044] The present invention selects multiple Chinese medicinal herbs such as Cimicifuga heracleifolia, Astragalus membranaceus, and Ephedra sinica, which work in conjunction with each other to achieve multiple benefits, including clearing away heat and detoxifying, dispelling wind and opening the orifices, promoting blood circulation and reducing swelling, and drying dampness and healing sores. The various herbs in the formula work synergistically to effectively improve symptoms such as nasal congestion, runny nose, and nasal itching caused by rhinitis, as well as earache, pus discharge from the ear canal, and hearing loss caused by otitis media. Through holistic conditioning, not only can surface symptoms be alleviated, but local inflammation and systemic function can also be improved, fundamentally conditioning the body to achieve the effect of treating both the symptoms and the root cause, thereby reducing the recurrence of the disease.

[0045] This product uses a purely traditional Chinese medicine formula, avoiding the side effects of Western medicine, such as antibiotics and glucocorticoids, which can lead to drug resistance, mucosal damage, and decreased immunity with long-term use. Traditional Chinese medicine focuses on overall health and has relatively few side effects, making it more suitable for long-term use by patients with chronic, recurrent rhinitis and otitis media.

[0046] The present invention provides a fully purified medicinal solution in its production process, reducing impurities and the possibility of local irritation. The prepared drops are suitable for administration to the nasal cavity and the ear canal, are easy to use, and can be administered by the patient themselves. Whether patients suffer from rhinitis, otitis media, or both, the drops can be used for treatment, thus having a wide range of applications. DETAILED DESCRIPTION

[0047] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the embodiments described 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 making creative efforts are within the scope of protection of the present invention.

[0048] Example 1:

[0049] Drops for treating rhinitis and otitis media

[0050] 1. Raw materials and dosage

[0051] 12 parts of Cimicifuga heracleifolia, 13 parts of Astragalus membranaceus, 11 parts of Ephedra sinica, 14 parts of Clove, 9 parts of Saposhnikovia divaricata, 8 parts of Pueraria root, 10 parts of Notopterygium wilfordii, 9 parts of honey-fried Licorice root, 9 parts of Houttuynia cordata, 8 parts of Double Flower, 20 parts of Lianchao, 16 parts of Scutellaria baicalensis, 17 parts of Isatis indigotica, 15 parts of Chrysanthemum morifolium, 16 parts of Acorus calamus, 17 parts of Toad Herb, 16 parts of Phragmites australis, 15 parts of Bibo, 17 parts of Poria, 19 parts of Trichosanthes root, 18 parts of E. sutchuenensis, 19 parts of Radix Rehmanniae, 20 parts of Cortex Moutan, 18 parts of Wax Gourd Seed, 19 parts of Bupleurum chinense , 20 parts of pollen, 16 parts of Rhizoma Chuanxiong, 17 parts of Fructus Xanthii, 15 parts of Fructus Schisandrae Chinensis, 16 parts of Flos Magnoliae, 17 parts of Fritillariae Thunbergii, 15 parts of Squama Manis, 16 parts of Luffa vine / network, 11 parts of Spina Gleditsiae, 12 parts of Fructus Terminaliae Terminaliae, 10 parts of Angelicae Dahuricae, 11 parts of White Peony Roots, 12 parts of Platycodon Grandiflorum, 9 parts of Angelicae Pubescentis, 8 parts of Tenebrio worms, 10 parts of Mentha, 9 parts of Herba Schizonepetae, 8 parts of Asarum, 10 parts of Semen Sinapis, 9 parts of Zanthoxylum bungeanum, 8 parts of Cortex Mori, 10 parts of Patchouli, 9 parts of Rhizoma Pinelliae, 8 parts of Polygonatum sibiricum, 15 parts of Plum Blossoms, 16 parts of Semen Coicis.

[0052] The production process includes the following steps:

[0053] S1. Pretreatment of medicinal materials

[0054] Take the above amount of Cimicifuga, Astragalus, Ephedra, Clove, Saposhnikovia, Pueraria, Notopterygium, Honey-fried Licorice, Houttuynia, Shuanghua, Lianchao, Scutellaria, Isatis, Hangchrysanthemum, Acorus, Toad Grass, Phragmites, Big Bo, Poria, Trichosanthes, Goose Does Not Eat Grass, Anti-white Grass, Moutan Bark, Wax Melon Seed, Bupleurum, Pollen, Chuanxiong, Xanthium sibiricum, Schisandra, Magnolia, Fritillaria thunbergii, Rinse with 35℃ warm water twice respectively to remove impurities, soil and residual roots and dead skin of non-medicinal parts on the surface of woody medicinal materials, drain the water and set aside.

[0055] S2. First decoction

[0056] After weighing, the total mass of the medicinal materials is 1000g. 3500g of purified water is added at a ratio of 1:3.5, and stirred to fully immerse the medicinal materials. Cover and soak for 2.5 hours, stirring once every 30 minutes.

[0057] After soaking, place the container on the heating device, boil it over high heat, then turn to low heat and maintain a simmer for 15 minutes, stirring constantly to prevent the herbs from sticking to the pot.

[0058] After decoction is completed, filter immediately with an 80-mesh filter and collect the first filtrate into a clean container; retain the residue.

[0059] S3, second decoction

[0060] Add 2500g of purified water to the retained medicinal residue at a ratio of 1:2.5 of the total mass of the medicinal materials, stir evenly and cover, boil over high heat and then simmer over low heat for 20 minutes, stirring continuously to prevent sticking to the pan.

[0061] After decoction is completed, filter with an 80-mesh filter, collect the second filtrate, and combine it with the first filtrate to obtain a mixed medicinal solution.

[0062] S4. Preliminary processing and adjustment

[0063] The mixed liquid was coarsely filtered through a 100-mesh filter to remove larger impurities and obtain a clear liquid. Measurements showed that the volume of the liquid after coarse filtration was 4000 ml. 60 g of a preservative (sodium benzoate) and a protective agent (propylene glycol) were added at a rate of 1.5%. After stirring until completely dissolved, the mixture was simmered over low heat for 6 minutes. During this time, the pH of the liquid was monitored with pH test paper and found to be 6.7. A small amount of sodium hydroxide solution was added to fine-tune the pH to between 6.8 and 7.0.

[0064] S5. Low temperature precipitation and filtration

[0065] Stop heating, wait for the drug solution to cool naturally to room temperature, transfer it to a clean sealed container, and place it in a 6°C constant temperature incubator overnight for 14 hours to allow impurities to fully precipitate.

[0066] The next day, take out the container, filter the liquid medicine with a 120-mesh filter, remove the sediment at the bottom, and collect the clarified filtrate.

[0067] S6. Alcohol purification

[0068] After measurement, the volume of the clarified filtrate is 3000ml. Add 1000ml of 95% medical alcohol at a volume ratio of 3:1, stir evenly and boil over high heat for 5 minutes to promote the precipitation of fibrin. Continue stirring during the process to prevent local overheating.

[0069] Stop heating, wait for the mixture to cool naturally to room temperature, transfer it to a clean sealed container, and place it in a 7°C constant temperature incubator overnight to allow the fibrin to fully precipitate.

[0070] S7, fine filtration

[0071] The next day, remove the container and filter using a vacuum filtration device with a 0.45 μm filter membrane to collect the filtrate. Alternatively, filter at normal pressure using slow filter paper. Repeat the filtration twice until the filtrate is clear and collect the filtrate.

[0072] S8, Alcohol Recovery

[0073] The collected filtrate is then distilled using a rotary evaporator at 65°C to recover the alcohol until no noticeable alcohol odor remains in the solution. Alternatively, the filtrate can be placed in a stainless steel container and heated over low heat to evaporate the alcohol, stirring continuously, until no bubbles form on the surface of the solution, resulting in a dark brown liquid.

[0074] S9. Sterilization

[0075] Dispense the dark brown liquid into clean glass containers, seal them and sterilize them:

[0076] Day 1: sterilize at 100℃ for 1 hour and cool naturally to room temperature;

[0077] The next day: Repeat the sterilization at 100℃ for 1 hour and cool naturally to room temperature;

[0078] Day 3: Sterilize again at 100℃ for 1 hour and cool naturally to room temperature.

[0079] S10, sterile packaging

[0080] The sterilized liquid medicine is packaged in sterile spray bottles on a sterile operating table. The capacity of each bottle is 10 ml. During the packaging process, avoid the liquid medicine from contacting the outside of the bottle mouth to prevent contamination. After the packaging is completed, immediately seal the spray bottle, label it, and store it in a cool and dry place.

[0081] Embodiment 2;

[0082] Drops for treating rhinitis and otitis media

[0083] Raw materials and dosage

[0084] 10 parts of Cimicifuga heracleifolia, 15 parts of Astragalus, 15 parts of Ephedra, 10 parts of Clove, 8 parts of Saposhnikovia divaricata, 10 parts of Pueraria root, 8 parts of Notopterygium wilfordii, 10 parts of honey-fried Licorice root, 10 parts of Houttuynia cordata, 10 parts of Double Flower, 20 parts of Lianchao, 15 parts of Scutellaria baicalensis, 18 parts of Isatis root, 18 parts of Chrysanthemum, 15 parts of Acorus calamus, 18 parts of Toad Herb, 15 parts of Phragmites australis, 18 parts of Bibo, 15 parts of Poria, 18 parts of Trichosanthes, 20 parts of E. cochinchinensis, 18 parts of Radix Rehmanniae, 18 parts of Radix Rehmanniae, 20 parts of Cortex Moutan, 20 parts of Wax Gourd Seed, 18 parts of Bupleurum chinense, 20 parts of pollen, 15 parts of Rhizoma Chuanxiong, 18 parts of Fructus Xanthii, 18 parts of Fructus Schisandrae Chinensis, 15 parts of Flos Magnoliae, 18 parts of Fritillariae Thunbergii, 18 parts of Squama Manis, 15 parts of Luffa vine / network, 13 parts of Spina Gleditsiae, 10 parts of Fructus Terminaliae Terminaliae, 13 parts of Radix Angelicae Dahuricae, 10 parts of Radix Paeoniae Albae, 13 parts of Platycodon Grandiflori, 10 parts of Radix Angelicae Pubescentiss, 10 parts of Schizonepeta Tenuifoliae, 10 parts of Semen Sinapis, 10 parts of Fructus Zanthoxyli, 10 parts of Cortex Mori, 8 parts of Patchouli, 10 parts of Rhizoma Pinelliae, 10 parts of Rhizoma Polygonati, 16 parts of Plums Mume, 15 parts of Semen Coicis.

[0085] A production process for drops for treating rhinitis and otitis media;

[0086] S1. Pretreatment of medicinal materials

[0087] Take the above amount of various medicinal materials, rinse them quickly three times with 30℃ warm water to remove impurities, soil and residual roots and dead bark of non-medicinal parts on the surface of woody medicinal materials, drain the water and set aside.

[0088] S2. First decoction

[0089] After weighing, the total mass of the medicinal materials is 1200g. 4200g of purified water is added at a ratio of 1:3.5, and stirred to fully immerse the medicinal materials. Cover and soak for 2.5 hours, stirring once every 30 minutes.

[0090] After soaking, place the container on the heating device, boil it over high heat, then turn to low heat and maintain a simmer for 15 minutes, stirring constantly to prevent the herbs from sticking to the pot.

[0091] After decoction is completed, filter immediately with an 80-mesh filter and collect the first filtrate into a clean container; retain the residue.

[0092] S3, second decoction

[0093] Add 3000g of purified water to the retained medicinal residue at a ratio of 1:2.5 of the total mass of the medicinal materials, stir evenly and cover, boil over high heat and then simmer over low heat for 20 minutes, stirring continuously to prevent sticking to the pan.

[0094] After decoction is completed, filter with an 80-mesh filter, collect the second filtrate, and combine it with the first filtrate to obtain a mixed medicinal solution.

[0095] S4. Preliminary processing and adjustment

[0096] The mixed liquid was coarsely filtered through a 100-mesh filter to remove larger impurities and obtain a highly clear liquid. Measurements showed that the volume of the liquid after coarse filtration was 5000 ml. 75 g of a preservative (sodium benzoate) and a protective agent (propylene glycol) were added at a 1.5% concentration. After stirring until completely dissolved, the mixture was simmered over low heat for 5 minutes. During this time, the pH of the liquid was monitored with pH test paper and found to be 7.1. A small amount of citric acid was added to fine-tune the pH to between 6.8 and 7.0.

[0097] S5. Low temperature precipitation and filtration

[0098] Stop heating and allow the solution to cool naturally to room temperature. Transfer the solution to a clean, sealed container and place it in a 5°C incubator overnight for 16 hours to allow impurities to fully settle. The next day, remove the container and filter the solution through a 120-mesh filter to remove the sediment at the bottom. Collect the clarified filtrate.

[0099] S6. Alcohol purification

[0100] After measurement, the volume of the clarified filtrate is 3600ml. 1200ml of 95% medical alcohol is added at a volume ratio of 3:1. After stirring evenly, boil over high heat for 5 minutes to promote the precipitation of fibrin. Stir continuously during the process to prevent local overheating.

[0101] Stop heating, wait for the mixture to cool naturally to room temperature, transfer it to a clean sealed container, and place it in a 5°C constant temperature incubator overnight to allow the fibrin to fully precipitate.

[0102] S7, fine filtration

[0103] The next day, remove the container and filter using a vacuum filtration device with a 0.45 μm filter membrane to collect the filtrate. Simultaneously, filter using slow filter paper at normal pressure, repeating the filtration twice until the filtrate is clear, and collect the filtrate.

[0104] S8, Alcohol Recovery

[0105] The collected filtrate is distilled and the alcohol is recovered using a rotary evaporator at 60°C until there is no noticeable alcohol odor in the liquid. Alternatively, the filtrate can be placed in a stainless steel container and heated over low heat to evaporate the alcohol, stirring continuously, until no bubbles form on the surface of the liquid, resulting in a dark brown liquid.

[0106] S9. Sterilization

[0107] Dispense the dark brown liquid into clean glass containers, seal them and sterilize them:

[0108] Day 1: sterilize at 100℃ for 1 hour and cool naturally to room temperature;

[0109] The next day: Repeat the sterilization at 100℃ for 1 hour and cool naturally to room temperature;

[0110] Day 3: Sterilize again at 100℃ for 1 hour and cool naturally to room temperature.

[0111] S10, sterile packaging

[0112] The sterilized liquid medicine is packaged in sterile spray bottles on a sterile operating table. The capacity of each bottle is 15 ml. During the packaging process, avoid the liquid medicine from contacting the outside of the bottle mouth to prevent contamination. After the packaging is completed, immediately seal the spray bottle, label it, and store it in a cool and dry place.

[0113] Embodiment 3;

[0114] A drop for treating rhinitis and otitis media;

[0115] Raw materials and dosage

[0116] 15 parts of Cimicifuga heracleifolia, 10 parts of Astragalus, 13 parts of Ephedra, 12 parts of Clove, 10 parts of Saposhnikovia divaricata, 9 parts of Pueraria root, 9 parts of Notopterygium wilfordii, 8 parts of honey-fried Licorice root, 8 parts of Houttuynia cordata, 9 parts of Double Flower, 20 parts of Lianchao, 18 parts of Scutellaria baicalensis, 15 parts of Isatis root, 16 parts of Chrysanthemum, 18 parts of Acorus calamus, 15 parts of Toadgrass, 18 parts of Phragmites australis, 16 parts of Bibo, 18 parts of Poria, 20 parts of Trichosanthes, 19 parts of E. sutchuenensis, 20 parts of Radix Rehmanniae, 18 parts of Cortex Moutan, 19 parts of Wax Gourd Seed, 20 parts of Bupleurum chinense 18 parts of angelica sinensis leaves, 18 parts of angelica dahurica leaves, 15 parts of fructus xanthii, 16 parts of schisandrae fruits, 18 parts of flos magnoliae, 15 parts of fritillary thunbergii, 16 parts of pangolins, 18 parts of luffa vine vine / network, 10 parts of galangal, 13 parts of chebula, 11 parts of the angelica dahurica leaves, 13 parts of the white paeoniae alba, 10 parts of platycodon grandiflorum, 8 parts of angelica dahurica leaves, 9 parts of schizonepeta tenuifolia leaves, 9 parts of asarum, 9 parts of white sinapine seeds, 8 parts of chuanxiong, 9 parts of white mulberry barks, 9 parts of patches of patches, 8 parts of pinellia tubers, 9 parts of polygonatum, 15 parts of ume plums, 16 parts of coix seeds.

[0117] A production process for drops for treating rhinitis and otitis media;

[0118] S1. Pretreatment of medicinal materials

[0119] Take the above amount of various medicinal materials, rinse them quickly three times with 40℃ warm water to remove impurities, soil and residual roots and dead bark of non-medicinal parts on the surface of woody medicinal materials, drain the water and set aside.

[0120] S2. First decoction

[0121] After weighing, the total mass of the medicinal materials is 1100g. 3850g of purified water is added at a ratio of 1:3.5, and stirred to fully immerse the medicinal materials. Cover and soak for 2.5 hours, stirring once every 30 minutes.

[0122] After soaking, place the container on the heating device, boil it over high heat, then turn to low heat and maintain a simmer for 15 minutes, stirring constantly to prevent the herbs from sticking to the pot.

[0123] After decoction is completed, filter immediately with an 80-mesh filter and collect the first filtrate into a clean container; retain the residue.

[0124] S3, second decoction

[0125] Add 2750g of purified water to the retained medicinal residue at a ratio of 1:2.5 to the total mass of the medicinal materials, stir evenly and cover, boil over high heat and then simmer over low heat for 20 minutes, stirring continuously to prevent sticking to the pan.

[0126] After decoction is completed, filter with an 80-mesh filter, collect the second filtrate, and combine it with the first filtrate to obtain a mixed medicinal solution.

[0127] S4. Preliminary processing and adjustment

[0128] The mixed liquid was coarsely filtered through a 100-mesh filter to remove larger impurities and obtain a clear liquid. The volume of the liquid after coarse filtration was measured to be 4500 ml. 67.5 g of a preservative (sodium benzoate) and a protective agent (propylene glycol) were added at a 1.5% concentration. After stirring until completely dissolved, the mixture was simmered over low heat for 8 minutes. During this time, the pH of the liquid was monitored with pH test paper and found to be 6.6. A small amount of sodium hydroxide solution was added to fine-tune the pH to between 6.8 and 7.0.

[0129] S5. Low temperature precipitation and filtration

[0130] Stop heating, wait for the liquid to cool naturally to room temperature, transfer it to a clean sealed container, and place it in an 8°C constant temperature incubator overnight for 12 hours to allow impurities to fully precipitate.

[0131] The next day, take out the container, filter the liquid medicine with a 120-mesh filter, remove the sediment at the bottom, and collect the clarified filtrate.

[0132] S6. Alcohol purification

[0133] After measurement, the volume of the clarified filtrate is 3300ml. 1100ml of 95% medical alcohol is added at a volume ratio of 3:1. After stirring evenly, boil over high heat for 5 minutes to promote the precipitation of fibrin. Stir continuously during the process to prevent local overheating.

[0134] Stop heating, wait for the mixture to cool naturally to room temperature, transfer it to a clean sealed container, and place it in an 8°C constant temperature incubator overnight to allow the fibrin to fully precipitate.

[0135] S7, fine filtration

[0136] The next day, remove the container and filter using a vacuum filtration device with a 0.45 μm filter membrane to collect the filtrate. Simultaneously, filter using slow filter paper at normal pressure, repeating the filtration twice until the filtrate is clear, and collect the filtrate.

[0137] S8, Alcohol Recovery

[0138] The collected filtrate is distilled using a rotary evaporator at 70°C to recover the alcohol until there is no noticeable alcohol odor in the solution. Alternatively, the filtrate can be placed in a stainless steel container and heated over low heat to evaporate the alcohol, stirring continuously, until no bubbles form on the surface of the solution, resulting in a dark brown liquid.

[0139] S9. Sterilization

[0140] Dispense the dark brown liquid into clean glass containers, seal them and sterilize them:

[0141] Day 1: sterilize at 100℃ for 1 hour and cool naturally to room temperature;

[0142] The next day: Repeat the sterilization at 100℃ for 1 hour and cool naturally to room temperature;

[0143] Day 3: Sterilize again at 100℃ for 1 hour and cool naturally to room temperature.

[0144] S10, sterile packaging

[0145] The sterilized liquid medicine is packaged in sterile spray bottles on a sterile operating table. The capacity of each bottle is 20 ml. During the packaging process, avoid the liquid medicine from contacting the outside of the bottle mouth to prevent contamination. After the packaging is completed, immediately seal the spray bottle, label it, and store it in a cool and dry place.

[0146] It will be appreciated that in the development of any actual embodiment, as in any engineering or design project, numerous implementation-specific decisions may be made. Such a development effort may be complex and time-consuming, but will, for those of ordinary skill having the benefit of this disclosure, be a routine undertaking of design, fabrication, and production without undue experimentation.

[0147] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the present invention may be modified or replaced by equivalents without departing from the spirit and scope of the technical solutions of the present invention, which should all be included in the scope of the claims of the present invention.

Claims

1. A drop for treating rhinitis and otitis media, characterized in that: It includes the following raw materials in parts by weight: 10-15 parts of Cimicifuga heracleifolia, 10-15 parts of Astragalus membranaceus, 10-15 parts of Ephedra sinica, 10-15 parts of Clove, 8-10 parts of Saposhnikovia divaricata, 8-10 parts of Pueraria root, 8-10 parts of Notopterygium wilfordii, 8-10 parts of Honey-fried Licorice root, 8-10 parts of Houttuynia cordata, 8-10 parts of Double Flower, 20 parts of Lianchao, 15-18 parts of Scutellaria baicalensis, 15-18 parts of Isatis root, 15-18 parts of Hangju, 15-18 parts of Acorus calamus, 15-18 parts of Toad Grass, 15-18 parts of Phragmites australis, 15-18 parts of Bibo, 15-18 parts of Poria cocos, 18-20 parts of Trichosanthes root, 18-20 parts of Goose Not Food Grass, 18-20 parts of Anti-white Grass, 18-20 parts of Moutan Bark, 18-20 parts of Winter Melon Seed, 18-20 parts of Bupleurum chinense, 18-20 parts of Flower 18-20 parts of powder, 15-18 parts of Chuanxiong, 15-18 parts of Xanthium sibiricum, 15-18 parts of Schisandra chinensis, 15-18 parts of Magnolia Flos, 15-18 parts of Fritillaria thunbergii, 15-18 parts of Squama manis, 15-18 parts of Loofah vine / network, 10-13 parts of Sophora flavescens, 10-13 parts of Terminalia chebula, 10-13 parts of Angelica dahurica, 10-13 parts of White Peony Root, 10-13 parts of Platycodon grandiflorum, 8-10 parts of Angelica dahurica, 8-10 parts of Angelica dahurica, 8-10 parts of Radix Angelicae Pubescentis, 8-10 parts of Schizonepeta tenuifolia, 8-10 parts of Asarum, 8-10 parts of Sinapis alba, 8-10 parts of Sichuan pepper, 8-10 parts of Morus alba, 8-10 parts of Patchouli, 8-10 parts of Pinellia ternata, 8-10 parts of Polygonatum sibiricum, 15-16 parts of Prunus mume, and 15-16 parts of Coix seed.

2. The production process of the drops for treating rhinitis and otitis media according to claim 1, characterized in that: The following steps are included: S1. Pretreatment of medicinal materials Take Cimicifuga heracleifolia, Astragalus membranaceus, Ephedra sinica, Clove, Saposhnikovia divaricata, Pueraria root, Notopterygium wilfordii, Honey-fried Licorice, Houttuynia cordata, Shuanghua, Lianchao, Scutellaria baicalensis, Isatis root, Chrysanthemum indicum, Acorus calamus, Toad grass, Phragmites australis, Bibo, Poria cocos, Trichosanthes root, Ebushica oleracea, Anti-white grass, Cortex Moutan, Wax gourd seed, Bupleurum chinense, Pollen, Chuanxiong, Xanthium sibiricum, Schisandra chinensis, Magnolia officinalis, Fritillaria thunbergii, Rinse each of the following herbs: Luffa vine / network, Soapberry, Terminalia chebula, Angelica dahurica, White peony root, Platycodon grandiflorum, Angelica pubescens, Peppermint, Schizonepeta tenuifolia, Asarum sieboldii, Sinapis alba, Sichuan pepper, Morus alba, Patchouli, Pinellia ternata, Polygonatum sibiricum, Plum, Coix seed, Rinse each herb with 30-40℃ warm water for 2-3 times to remove impurities, soil and residual roots and dead bark of non-medicinal parts on the surface of the woody herbs, drain the water and set aside; S2. First decoction Add purified water in a ratio of 1:3.5 to the total weight of the medicinal materials, stir until the medicinal materials are fully immersed, cover and soak for 2.5 hours, stirring once every 30 minutes; After soaking, place the container on the heating device, boil over high heat, then reduce the heat and maintain a simmer for 15 minutes, stirring constantly to prevent the herbs from sticking to the pot; After decoction is completed, filter immediately with an 80-mesh filter and collect the first filtrate into a clean container; retain the medicinal residue; S3, second decoction Add purified water to the remaining medicinal residue at a ratio of 1:2.5 of the total weight of the medicinal materials, stir evenly, cover, bring to a boil over high heat, then reduce heat and simmer for 20 minutes, stirring continuously to prevent sticking to the pan. After decoction is completed, filter with an 80-mesh filter, collect the second filtrate, and combine it with the first filtrate to obtain a mixed medicinal solution; S4. Preliminary processing and adjustment The mixed liquid was coarsely filtered through a 100-mesh filter to remove larger particles of impurities and obtain a clear liquid; 1.5% of the volume of the coarsely filtered liquid was added with preservatives and protective agents, stirred until completely dissolved, and simmered on low heat for 5-8 minutes. During this period, the pH value of the liquid was monitored with pH test paper to ensure that it was between 6.8 and 7.0; S5. Low temperature precipitation and filtration Stop heating, wait for the liquid to cool naturally to room temperature, transfer it to a clean sealed container, and place it in a constant temperature incubator at 5-8°C overnight for 12-16 hours to allow impurities to fully precipitate; The next day, take out the container and filter the liquid with a 120-mesh filter to remove the sediment at the bottom and collect the clear filtrate; S6. Alcohol purification Add 95% medical alcohol to the clarified filtrate at a volume ratio of 3:1, stir evenly, and boil over high heat for 5 minutes to promote the precipitation of fibrin. Stir continuously to prevent local overheating. Stop heating, wait for the mixture to cool naturally to room temperature, transfer it to a clean sealed container, and place it in a 5-8°C constant temperature incubator overnight to allow the fibrin to fully precipitate; S7, fine filtration The next day, the container was removed and filtered using a vacuum filtration device with a 0.45 μm filter membrane to collect the filtrate; S8, Alcohol Recovery The collected filtrate is used for alcohol recovery: using a rotary evaporator or distillation apparatus, distill the alcohol at 60-70°C until there is no obvious alcohol smell in the liquid; S9. Sterilization Dispense the dark brown liquid into clean glass containers, seal them and sterilize them: Day 1: sterilize at 100℃ for 1 hour and cool naturally to room temperature; The next day: Repeat the sterilization at 100℃ for 1 hour and cool naturally to room temperature; Day 3: Sterilize again at 100℃ for 1 hour and cool naturally to room temperature; S10, sterile packaging The sterilized liquid medicine is packaged in sterile spray bottles on a sterile operating table. The capacity of each bottle is determined according to demand. During the packaging process, avoid the liquid medicine from contacting the outside of the bottle mouth to prevent contamination. After the packaging is completed, immediately seal the spray bottle, label it, and store it in a cool and dry place.

3. The production process of the drops for treating rhinitis and otitis media according to claim 2, characterized in that: The preservative in S4 includes sodium benzoate, and the protective agent includes propylene glycol.

4. The production process of the drops for treating rhinitis and otitis media according to claim 2, characterized in that: The pH value in S4 is adjusted by adding citric acid or sodium hydroxide solution for fine adjustment.

5. The production process of the drops for treating rhinitis and otitis media according to claim 2, characterized in that: The fine filtration method in S7 also includes filtering at normal pressure using slow filter paper, repeating the filtration twice until the filtrate is clear, and collecting the filtrate.

6. The production process of the drops for treating rhinitis and otitis media according to claim 2, characterized in that: The alcohol recovery method in S8 also includes placing the filtrate in a stainless steel container, heating over a low fire to evaporate the alcohol, and constantly stirring during the process until no bubbles are generated on the surface of the liquid, thereby obtaining a dark brown liquid.