Pediatric ephedra, apricot kernel, gypsum and licorice mixture

Abstract

The invention discloses a children Maxingshigan mixture, which relates to the technical field of traditional Chinese medicine pharmacy, and has the technical key points that the children Maxingshigan mixture is prepared into an oral liquid dosage form by mixing ephedra, bitter apricot kernel, gypsum, liquorice, folium isatidis, houttuynia cordata, trichosanthes peel and scutellaria baicalensis according to a specific weight ratio and adding auxiliary materials. The preparation method comprises the following steps: pretreating the raw materials, decocting and extracting twice, merging filtrate, refrigerating and finely filtering, concentrating in vacuum, preparing liquid to a constant volume, filtering and filling at a terminal, sterilizing and the like. The mixture disclosed by the invention has the effects of diffusing lung, depressing qi, clearing heat and eliminating phlegm, is mainly used for treating heat cough and asthma syndromes caused by exogenous evil entering the interior and transforming heat in children, and is particularly suitable for patients with acute bronchitis with the syndromes. The dosage form is convenient for children to take, stable in quality and exact in curative effect.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine pharmaceutical technology, specifically to a pediatric ephedra, apricot kernel, and licorice compound. Background Technology

[0002] Pneumonia in children is a common respiratory illness characterized by rapid onset, severe symptoms, and rapid progression, posing a serious threat to children's health. Globally, it is one of the leading causes of death in children. Traditional treatments for childhood pneumonia primarily rely on antibiotics, but their effectiveness is gradually decreasing due to increasing antibiotic resistance. Therefore, finding and developing new treatments, especially those that reduce the risk of resistance and side effects, has become particularly urgent. Traditional Chinese medicine (TCM) has a long history and unique advantages in treating childhood pneumonia. Its treatment principles mainly focus on regulating the body's internal balance and enhancing its self-repair capabilities by promoting lung function, relieving cough, clearing heat, resolving phlegm, and calming asthma.

[0003] Currently, the treatment of pediatric pneumonia mainly relies on Western medicine's antibiotic therapy and traditional Chinese medicine's herbal remedies. While Western medicine treatments show significant effects in the short term, long-term or inappropriate use can lead to side effects such as increased drug resistance and intestinal flora imbalance. Traditional Chinese medicine treatment focuses on adjusting the body's overall condition, using a combination of herbs to treat the disease. Traditional Chinese medicine treatment plans for pediatric pneumonia typically include combinations of various herbs, such as ephedra, apricot kernel, gypsum, and licorice, which are believed in traditional Chinese medicine to have the effects of clearing the lungs, clearing heat, resolving phlegm, and relieving asthma. However, traditional Chinese herbal remedies suffer from problems such as complex preparation, inconvenient administration, and unstable efficacy, limiting their widespread application in the modern medical system.

[0004] Therefore, the present invention provides a pediatric ephedrine-amygium compound. Summary of the Invention

[0005] The purpose of this invention is to solve the above-mentioned problems by providing a pediatric ephedra, apricot kernel, stone and licorice mixture. This addresses the current situation where pediatric respiratory diseases such as pneumonia and bronchitis mainly rely on antibiotics for treatment, but long-term or irrational use can easily lead to increased bacterial resistance, decreased efficacy, and potential side effects such as intestinal flora imbalance.

[0006] To achieve the above objectives, the technical solution of the present invention is as follows: A pediatric ephedra, apricot kernel, gypsum, and licorice compound, made from the following raw materials in the indicated weight ratios: ephedra 50–70 g, bitter apricot kernel 50–70 g, gypsum 160–200 g, licorice 25–35 g, indigo leaf 40–50 g, houttuynia cordata 40–50 g, trichosanthes peel 40–50 g, scutellaria baicalensis 40–50 g, and excipients.

[0007] Furthermore, the weight ratio of the raw materials is as follows: Ephedra 60 g, Bitter Almond 60 g, Gypsum 180 g, Licorice 30 g, Isatis Leaf 45 g, Houttuynia Cordata 45 g, Trichosanthes Peel 45 g, and Scutellaria baicalensis 45 g.

[0008] Furthermore, the compound is an oral liquid dosage form.

[0009] Furthermore, the preparation method of the compound includes the following steps:

[0010] a) Pretreatment of the active pharmaceutical ingredient;

[0011] b) Extract by decoction in two stages;

[0012] c) Combine the filtrates, refrigerate to allow precipitation, and then perform fine filtration;

[0013] d) Vacuum concentration to a concentrate with a relative density of 1.10–1.15;

[0014] e) Prepare the solution, add excipients, and adjust the volume;

[0015] f) Terminal filtration, filling, and sterilization.

[0016] Furthermore, in step b), the amount of water used for the first decoction is 8 times the total weight of the medicinal materials, and for the second decoction it is 6 times.

[0017] Furthermore, the compound is used to treat feverish cough and asthma in children caused by external pathogens entering the body and transforming into heat, with symptoms including cough, shortness of breath, thick yellow phlegm, fever, and thirst.

[0018] Furthermore, the compound is suitable for acute bronchitis patients with the above-mentioned symptoms.

[0019] The pharmacological properties of the drug of this invention are as follows:

[0020] Ephedra: pungent, slightly bitter, warm, enters the lung and bladder meridians, promotes lung function and relieves asthma, induces sweating to release the exterior, promotes diuresis and reduces swelling, used to treat cough and asthma, colds due to wind-cold, edema and scanty urine.

[0021] Almonds: bitter, slightly warm, slightly toxic, enter the lung and large intestine meridians, lower qi, stop cough and relieve asthma, moisten the intestines and promote bowel movement, used to treat cough and asthma, chest fullness and phlegm, dry intestines and constipation.

[0022] Gypsum: sweet and pungent, very cold, enters the lung and stomach meridians, clears heat and drains fire, relieves irritability and quenches thirst, used to treat high fever and thirst, lung heat cough, and stomach fire toothache.

[0023] Licorice: Sweet, neutral, enters the heart, lung, spleen, and stomach meridians. It tonifies the spleen and replenishes qi, clears heat and detoxifies, relieves spasms and pain, and harmonizes other herbs. It is used to treat spleen and stomach weakness, palpitations and shortness of breath, cough with excessive phlegm, and abdominal cramps and pain.

[0024] Isatis leaf: bitter, cold, enters the heart and stomach meridians, clears heat and detoxifies, cools blood and eliminates spots, used to treat febrile diseases with high fever, heat toxicity causing spots, sore throat, mumps, erysipelas, and sores.

[0025] Houttuynia cordata: pungent, slightly cold, enters the lung meridian, clears heat and detoxifies, eliminates carbuncles and drains pus, promotes urination and relieves strangury, used to treat lung abscess with purulent sputum, phlegm-heat cough and wheezing, and strangury due to heat.

[0026] Trichosanthes peel: sweet and cold, enters the lung and stomach meridians, clears heat and resolves phlegm, relieves chest congestion and dissipates nodules, moistens the intestines and promotes bowel movement. It is used to treat cough due to lung heat, chest pain, chest congestion and fullness, and constipation due to intestinal dryness.

[0027] Scutellaria baicalensis: bitter, cold, enters the lung, gallbladder, spleen, large intestine and small intestine meridians. It clears heat and dries dampness, drains fire and detoxifies, cools blood and stops bleeding, and calms the fetus. It is used to treat damp-heat syndrome, chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung heat cough, high fever and thirst, blood heat vomiting and nosebleeds, carbuncles and boils, and threatened abortion.

[0028] The therapeutic mechanism of this invention is as follows:

[0029] Ephedra, gypsum, and apricot kernel are the principal herbs, which promote lung function, relieve cough and asthma, and clear heat.

[0030] Ephedra, gypsum, and apricot kernel are the principal ingredients of the pediatric Ephedra-Apricot Kernel-Gypsum Compound of this invention, which have the effects of relieving cough and asthma, and clearing heat. Ephedra can relieve lung inflammation and edema by inducing sweating and relieving exterior symptoms, while gypsum clears heat and drains fire with its pungent and cold properties, and apricot kernel lowers lung qi and relieves cough and asthma. The three ingredients work synergistically to effectively relieve symptoms such as cough and asthma in children with pneumonia, while clearing lung heat and reducing inflammatory response.

[0031] Isatis leaf, houttuynia cordata, and trichosanthes peel are used as assistant herbs to clear heat, detoxify, resolve phlegm, and regulate qi.

[0032] Isatis leaf, houttuynia cordata, and trichosanthes peel are the auxiliary herbs in this invention, possessing the functions of clearing heat and detoxifying, resolving phlegm and regulating qi. Isatis leaf can inhibit certain bacteria and viruses, houttuynia cordata has antibacterial and anti-inflammatory effects, and trichosanthes peel clears heat, resolves phlegm, regulates qi, and relieves chest tightness. The combined use of these herbs can enhance the body's anti-infection ability, reduce phlegm production, improve respiratory function, and promote the expulsion of phlegm from the lungs.

[0033] Scutellaria baicalensis is used as an adjuvant herb, possessing antibacterial, antifungal, and anti-allergic properties.

[0034] Scutellaria baicalensis, used as an adjuvant in this invention, possesses antibacterial or bacteriostatic, anti-inflammatory, and anti-allergic effects. Components in Scutellaria baicalensis, such as baicalin, can effectively inhibit the growth of various bacteria and viruses, reduce the release of inflammatory mediators, alleviate bronchospasm, thereby reducing capillary permeability, alleviating pulmonary congestion and organ bleeding, and playing an important role in the anti-infective and anti-inflammatory treatment of pediatric pneumonia.

[0035] Licorice is used as an adjuvant to harmonize the effects of other herbs and to clear heat and detoxify.

[0036] Licorice, as the adjuvant in this invention, has the functions of harmonizing various medicines and clearing heat and detoxifying. The glycyrrhizic acid and other components in licorice can harmonize the properties and flavors of various medicinal materials, enhancing the overall efficacy of the compound. At the same time, licorice also has anti-inflammatory and detoxifying effects, which can reduce the toxic side effects of drugs, protect the liver and kidney function of children, and ensure the safety and effectiveness of the drug.

[0037] The main indications for this invention are: pediatric pneumonia; symptoms include persistent high fever, cough and wheezing, copious yellow phlegm, chest pain and tightness, difficulty breathing, dry mouth and thirst, red tongue with yellow coating, and slippery and rapid pulse. It has the effects of relieving cough, clearing heat and resolving phlegm, and relieving asthma.

[0038] Compared with existing technologies, the beneficial effects of this solution are as follows: The Pediatric Ephedra, Gypsum, and Apricot Kernel Compound of this invention, through the synergistic effect of the principal herbs Ephedra, Gypsum, and Apricot Kernel, effectively relieves cough and asthma, while clearing lung heat and reducing inflammatory responses. The assistant herbs Isatis Leaf, Houttuynia Cordata, and Trichosanthes Peel enhance the body's anti-infection ability, reduce sputum production, improve respiratory function, and promote sputum expectoration. The adjuvant herb Scutellaria baicalensis exerts antibacterial, anti-inflammatory, and anti-allergic effects, reducing bronchospasm and pulmonary congestion. The guiding herb Glycyrrhiza uralensis harmonizes the various herbs, enhancing the overall efficacy while reducing drug toxicity and protecting children's liver and kidney function. This Pediatric Ephedra, Gypsum, and Apricot Kernel Compound of this invention not only treats the symptoms of pediatric pneumonia but also promotes health recovery by enhancing the body's overall disease resistance. The antibacterial, anti-inflammatory, and anti-allergic effects of Scutellaria baicalensis, combined with the harmonizing and detoxifying effects of Glycyrrhiza uralensis, enhance the therapeutic effect of the compound while reducing drug toxicity and ensuring medication safety. Detailed Implementation

[0039] To enable those skilled in the art to better understand the present invention, the technical solution of the present invention will be described in further detail below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0040] It should be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other. The present invention will now be described in detail with reference to the embodiments.

[0041] Example 1: Preparation of Pediatric Ephedra, Apricot Kernel, and Glycyrrhiza Compound

[0042] I. Prescription Composition

[0043] The composition and proportions of the raw materials for this compound preparation, based on a yield of 1000ml, are as follows:

[0044]

[0045] II. Preparation Method

[0046] 1. Pre-treatment: Weigh the above eight medicinal slices, remove non-medicinal parts, impurities, and moldy products. Rinse quickly with drinking water and drain. Crush the gypsum into small pieces and decoct it first in a decoction vessel. Place the remaining medicinal materials in a clean container for later use.

[0047] 2. Decoction and Extraction: Place the processed gypsum in a multi-functional Chinese medicine extraction tank, add 8 times the amount (about 4.8L) of drinking water, turn on the heat, and maintain the boiling for 30 minutes (i.e., "first decoction"). Add the remaining seven herbs (ephedra, bitter almond, licorice, indigo leaf, houttuynia cordata, trichosanthes peel, and scutellaria baicalensis) to the extraction tank, add water to 8 times the total amount of herbs, soak for 30 minutes, turn on the heat to boiling, adjust the heat to maintain a gentle boil, and carry out the first decoction for 1.5 hours. After the decoction, filter through a 100-mesh sieve and collect the filtrate (A). Add 6 times the amount (about 3.6L) of drinking water to the residue again and carry out the second decoction for 1 hour. After the decoction, filter through a 100-mesh sieve again and collect the filtrate (B).

[0048] 3. Concentration: Combine the two filtrates (A+B) and let them stand in a cold storage (2-8℃) for 12 hours to allow impurities to settle completely. Take the supernatant and perform fine filtration using a plate and frame filter press with diatomaceous earth as a filter aid to obtain a clear extract. Transfer the clear extract to a vacuum concentration tank and concentrate it to a relative density of 1.10-1.15 under conditions of temperature ≤65℃ and vacuum degree -0.06~-0.08MPa.

[0049] 4. Solution Preparation and Filling: Transfer the above-mentioned extract to a solution preparation tank. Add purified water to a final volume of 1000 ml and stir well. Add 0.3% (w / v) sodium benzoate as a preservative and 5% (w / v) honey or sucrose as a flavoring agent, and stir until completely dissolved. Perform terminal filtration using a 0.45 μm microporous membrane to ensure the clarity of the solution. Quantitatively fill the filtered solution into 150 ml brown oral liquid bottles using a liquid filling machine. Immediately cap and seal.

[0050] 5. Sterilization and Packaging: Place the filled mixture in a flowing steam sterilizer and sterilize at 100℃ for 30 minutes. After sterilization, wipe each bottle dry, label it, and pack it into a box to obtain the finished product.

[0051] III. Characteristics

[0052] This product is a clear, dark brownish-red liquid; it has a slightly fragrant odor and a sweet, slightly bitter taste.

[0053] IV. Indications

[0054] It promotes lung function, clears heat, and resolves phlegm. It is used for children with heat cough and asthma caused by external pathogens entering the body and transforming into heat, with symptoms such as cough, shortness of breath, thick yellow phlegm, fever, thirst, red tongue with yellow coating; and for acute bronchitis with the above symptoms.

[0055] V. Usage and Dosage

[0056] Oral administration, three times a day. Or as directed by your doctor.

[0057] Infants under 1 year old: 3-5 ml each time; children aged 1-3 years: 5 ml each time;

[0058] 3-5 years old: 5-7ml each time; 5 years and older: 10ml each time.

[0059] VI. Precautions

[0060] 1. This product is suitable for cough and asthma caused by lung heat. Use with caution if cough and asthma are caused by wind-cold attacking the lungs.

[0061] 2. Avoid spicy, cold, and greasy foods while taking this medication.

[0062] 3. If there is a small amount of sediment in this product, shake well before taking it; this will not affect the efficacy.

[0063] 4. Athletes should use with caution.

[0064] VII. Specifications

[0065] Each bottle contains 150ml.

[0066] VIII. Storage

[0067] Seal and store in a cool, dry place (not exceeding 20°C).

[0068] The above specific embodiments are merely explanations of the present invention and are not intended to limit the present invention. After reading this specification, those skilled in the art can make modifications to these embodiments without contributing any inventive step, but as long as they are within the scope of the claims of the present invention, they are protected by patent law.

Claims

1. A pediatric ephedrine-amygium-glycine mixture, characterized in that: It is made from the following raw materials in the indicated weight ratios: Ephedra 50–70 g, Bitter Almond 50–70 g, Gypsum 160–200 g, Licorice 25–35 g, Isatis Leaf 40–50 g, Houttuynia 40–50 g, Trichosanthes Peel 40–50 g, Scutellaria 40–50 g, and excipients.

2. The pediatric ephedrine-amygium-glycine mixture as described in claim 1, characterized in that: The weight ratio of the raw materials is as follows: Ephedra 60 g, Bitter Almond 60 g, Gypsum 180 g, Licorice 30 g, Isatis Leaf 45 g, Houttuynia Cordata 45 g, Trichosanthes Peel 45 g, Scutellaria baicalensis 45 g.

3. The pediatric ephedrine-amygium-glycine mixture as described in claim 1, characterized in that: The compound preparation is an oral liquid dosage form.

4. The pediatric ephedrine-amygium-glycine mixture as described in claim 1, characterized in that: The preparation method of the compound includes the following steps: a) Pretreatment of the active pharmaceutical ingredient; b) Extract by decoction in two stages; c) Combine the filtrates, refrigerate to allow precipitation, and then perform fine filtration; d) Vacuum concentration to a concentrate with a relative density of 1.10–1.15; e) Prepare the solution, add excipients, and adjust the volume; f) Terminal filtration, filling, and sterilization.

5. The pediatric ephedrine-amygium-glycine mixture as described in claim 1, characterized in that: In step b), the amount of water used for the first decoction is 8 times the total weight of the medicinal materials, and for the second decoction it is 6 times.

6. The pediatric ephedrine-amygium-glycine mixture as described in claim 1, characterized in that: The compound is used to treat feverish cough and asthma in children caused by external pathogens entering the body and transforming into heat, with symptoms such as cough, shortness of breath, thick yellow phlegm, fever and thirst.

7. The pediatric ephedrine-amygium-glycine mixture as described in claim 6, characterized in that: The compound is suitable for acute bronchitis with the above symptoms.

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