CN113368198B - Pharmaceutical composition for treating wind-heat affecting lung and preparation method and application thereof - Google Patents
Pharmaceutical composition for treating wind-heat affecting lung and preparation method and application thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/78—Saururaceae (Lizard's-tail family)
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/35—Caprifoliaceae (Honeysuckle family)
- A61K36/355—Lonicera (honeysuckle)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
- A61K36/484—Glycyrrhiza (licorice)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/534—Mentha (mint)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/538—Schizonepeta
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/60—Moraceae (Mulberry family), e.g. breadfruit or fig
- A61K36/605—Morus (mulberry)
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
- A61K36/634—Forsythia
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/736—Prunus, e.g. plum, cherry, peach, apricot or almond
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
Abstract
The invention belongs to the field of traditional Chinese medicine compositions and application thereof, and particularly relates to a pharmaceutical composition for treating wind-heat affecting lung syndrome and a preparation method and application thereof. The pharmaceutical composition for treating wind-heat affecting lung is prepared from the following raw materials in parts by weight: 1-5 parts of houttuynia cordata, 1-4 parts of scutellaria baicalensis, 1-5 parts of fructus forsythiae, 1-4 parts of honeysuckle, 1-4 parts of folium mori, 1-4 parts of schizonepeta, 0.5-2 parts of mint, 1-4 parts of bitter almond, 1-5 parts of reed rhizome and 0.1-1.5 parts of liquorice. The pharmaceutical composition is used for treating the syndrome of wind-heat affecting the lung, namely the symptoms of abnormal dispersing and descending of lung qi and lung defense diseases caused by wind-heat affection or long-lasting lung stagnation and heat transformation due to wind-cold affection, has good curative effect, and has the advantages of convenient administration, simple process and low cost.
Description
Technical Field
The invention belongs to the field of traditional Chinese medicine compositions and application thereof, and particularly relates to a pharmaceutical composition for treating wind-heat affecting lung and a preparation method and application thereof.
Background
The pattern of wind-heat invading the lung refers to the condition of wind-heat affection or chronic wind-cold transforming into heat, which causes the failure of the lung qi to descend and disperse, and the lung defense and defense diseases. The traditional Chinese medicine considers that the body has poor immunity, which causes the exogenous wind-heat or the wind-cold to be stagnated in the body for a long time and generate heat, and causes the disorder of the dispersion and descending of the lung-qi, thereby leading to a series of symptoms. The symptoms of the common patients are mild aversion to cold and severe fever, and the cough is the most obvious, the patients have phlegm but are not easy to cough, the phlegm produced by the cough is yellow and thick, and the symptoms of red tongue, floating and rapid pulse, pharyngalgia, dysphoria and the like can also be presented. If the clinical symptoms are mild and the physique is good, more water can be drunk, proper rest can be realized, the labor and the rest can be combined, the diet is light, and the pungency and the stimulation to food can be avoided; for patients with severe symptoms and weak constitution, the Chinese medicine can be taken orally. The traditional Chinese medicine considers that the patients with wind-heat affecting the lung should adopt the medicines for dispelling wind and clearing heat, and relieving exterior syndrome with pungent and cool natured drugs. At present, a lot of medicines for treating wind-heat affecting lung have certain curative effect, but the effect is not ideal.
The 'a traditional Chinese medicine composition for treating wind-heat affecting lung' patent with the grant number CN103463536B discloses a traditional Chinese medicine formula for treating wind-heat affecting lung, which comprises, by weight, 10-40 parts of honeysuckle, 5-2 parts of fructus forsythiae, 5-20 parts of almond, 5-20 parts of platycodon grandiflorum, 10-40 parts of houttuynia cordata, 5-25 parts of scutellaria baicalensis, 5-20 parts of schizonepeta, 5-20 parts of divaricate saposhnikovia root, 5-20 parts of periostracum cicadae, 5-20 parts of stiff silkworm, 5-20 parts of oroxylum indicum, 5-20 parts of myrobalan meat, 5-25 parts of adenophora stricta, 10-40 parts of rhizoma phragmitis, 2-10 parts of bulbus fritillariae cirrhosae, 5-20 parts of radix stemonae, 5-20 parts of common coltsfoot flower, 5-20 parts of aster, 10-40 parts of radix peucedani, and 5-15 parts of liquorice. The patent has better curative effect, the formula of the medicine contains 20 traditional Chinese medicine components, the components are complex, the cost is high, and the medicine needs to be decocted twice and the decoction is not convenient to take. The patent of 'a traditional Chinese medicine for treating lung diseases with syndrome of wind-heat invading lung' with No. CN103656414B discloses a traditional Chinese medicine formula for treating lung diseases with syndrome of wind-heat invading lung, which comprises, by weight, 12-15 parts of burdock, 10-12 parts of lily, 15-20 parts of kudzu root, 10-15 parts of chrysanthemum, 15-20 parts of stemona, 12-15 parts of magnolia flower, 10-12 parts of pine nodular branch, 15-20 parts of sweet wormwood herb, 8-10 parts of indigo naturalis, 15-20 parts of dwarf lilyturf tuber and 25-30 parts of fructus viticis. The medicine has good treatment effect and high effective rate, and the dosage form is granules which are convenient to take, but the treatment period is long.
Therefore, the invention aims to develop a traditional Chinese medicine prescription which has low cost, convenient taking, short treatment period and good curative effect and can be used for treating wind-heat affecting lung.
Disclosure of Invention
In order to overcome the technical problems, the invention provides the pharmaceutical composition for treating the wind-heat affecting lung syndrome, which has the advantages of simple process, low cost, convenient administration, short treatment period and good curative effect, and the preparation method and the application thereof.
In order to achieve the above purpose, the technical scheme provided by the invention is as follows:
the pharmaceutical composition for treatment is prepared from the following raw materials in parts by weight: 1-5 parts of heartleaf houttuynia herb, 1-4 parts of baical skullcap root, 1-5 parts of weeping forsythia, 1-4 parts of honeysuckle, 1-4 parts of mulberry leaf, 1-4 parts of fineleaf schizonepeta herb, 0.5-2 parts of mint, 1-4 parts of bitter almond, 1-5 parts of reed rhizome and 0.1-1.5 parts of liquorice.
Preferably, the pharmaceutical composition for treating wind-heat affecting lung is prepared from the following raw materials in parts by weight: 2-5 parts of heartleaf houttuynia herb, 1.5-4 parts of baical skullcap root, 2-5 parts of weeping forsythia, 2-4 parts of honeysuckle, 1.5-4 parts of mulberry leaf, 1.5-4 parts of fineleaf schizonepeta herb, 1-2 parts of mint, 1.5-4 parts of bitter apricot seed, 2-5 parts of reed rhizome and 0.3-1.5 parts of liquorice.
More preferably, the pharmaceutical composition for treating wind-heat affecting lung is prepared from the following raw materials in parts by weight: 3-5 parts of heartleaf houttuynia herb, 2-4 parts of baical skullcap root, 3-5 parts of weeping forsythia, 2.4-4 parts of honeysuckle, 2-4 parts of mulberry leaf, 2-4 parts of fineleaf schizonepeta herb, 1.2-2 parts of mint, 1.8-4 parts of bitter almond, 2.4-5 parts of reed rhizome and 0.6-1.5 parts of liquorice.
Preferably, the pharmaceutical composition for treating wind-heat affecting lung further comprises pharmaceutically acceptable auxiliary materials.
More preferably, the adjuvant of the pharmaceutical composition for treating wind-heat affecting lung is selected from any one or more of dextrin, maltodextrin, soluble starch and lactose.
The invention also aims to provide a preparation method of the pharmaceutical composition for treating wind-heat affecting lung, which comprises the following steps:
(1) weighing the Chinese medicinal materials respectively, decocting in water, filtering to obtain filtrate, decocting the filtered residue with water repeatedly, and mixing the filtrates;
(2) and concentrating the combined filtrate, adding auxiliary materials, and performing spray drying to obtain fine powder A, namely the pharmaceutical composition for treating wind-heat affecting lung.
Preferably, in the step (1), the amount of water added for decoction is 10-14 times of the amount of the medicinal materials, the number of times of repeated water adding for decoction is 1-2 times, and the decoction time is 0.5-1.5 h;
preferably, in step (2), the combined filtrates are concentrated to a relative density of 1.04-1.08(60 ℃).
The invention also aims to provide a preparation of the pharmaceutical composition.
Preferably, the dosage form of the preparation of the pharmaceutical composition is granules.
The invention also aims to provide a preparation method of the preparation of the pharmaceutical composition, which comprises the following steps: adding adjuvants into the fine powder A, mixing, granulating to obtain granule B, and drying.
The invention also relates to application of the pharmaceutical composition for treating wind-heat affecting lung or the preparation of the pharmaceutical composition in preparing a medicine for treating wind-heat affecting lung syndrome.
Compared with the prior art, the invention has the technical advantages that:
(1) the traditional Chinese medicine composition has good curative effect on wind-heat affecting lung by improving the types and the dosage of the traditional Chinese medicine raw materials in the traditional Chinese medicine composition, and has quick response and short treatment period.
The traditional Chinese medicine composition is prepared by carefully selecting the medicine formula under the guidance of the traditional Chinese medicine theory and clinical tests. The invention can be used for treating wind-heat exogenous infection and also for patients with wind-cold exogenous infection and long-term heat transformation, has strong pertinence, and has the effects of clearing lung heat by using the scutellaria baicalensis and the houttuynia cordata, reducing lung qi by using the almond, nourishing lung yin by using the reed rhizome, tonifying lung qi by using the liquorice, dispersing lung pathogen by using the mulberry leaves and the schizonepeta, and clearing lung heat by using the honeysuckle and the forsythia. In the formula, the cordate houttuynia and the baical skullcap root are used as monarch drugs for clearing lung heat; fructus forsythiae and honeysuckle flower clear away heat and toxic materials, expel pathogenic factors and clear away the lung-heat and soothe the liver, and help monarch drugs and minister drugs; the schizonepeta, herba schizonepetae, pungent and spicy in flavor, the mint, the wind-dispelling and heat-clearing property, the almond, the bitter taste, the lung qi, the reed rhizome, the heat-clearing and the body fluid-generating property, and the medicines assist the monarch and the minister to be the assistant; licorice root, radix Glycyrrhizae coordinates the effects of the other drugs in the recipe.
The medicinal components of the invention are compatible by differentiation of symptoms and signs, are mutually assisted in action, play the efficacies of freeing lung and relieving cough, clearing lung and eliminating phlegm, dispelling wind and heat, and clearing heat and detoxicating, and achieve the aim of treating both principal and secondary aspect of disease for treating wind-heat affecting lung.
(2) The invention has the advantages of simple process, no impurity mixing in the preparation process, simple process, high safety and low cost.
(3) The invention prepares the raw materials of the medicine into granules, and is convenient for patients to take.
Detailed Description
The present invention will be described below with reference to specific examples to make the technical aspects of the present invention easier to understand and grasp, but the present invention is not limited thereto. The experimental methods described in the following examples are all conventional methods unless otherwise specified; the reagents and materials are commercially available, unless otherwise specified.
EXAMPLE 1 pharmaceutical composition and Process for preparing the same
Composition (A): according to the weight parts, 3 parts of heartleaf houttuynia herb, 2 parts of baical skullcap root, 3 parts of weeping forsythia, 2.4 parts of honeysuckle flower, 2 parts of mulberry leaf, 2 parts of fineleaf schizonepeta herb, 1.2 parts of mint, 1.8 parts of bitter apricot seed, 2.4 parts of reed rhizome and 0.6 part of liquorice;
the preparation method comprises the following steps:
(1) respectively weighing herba Houttuyniae, Scutellariae radix, fructus forsythiae, flos Lonicerae, folium Mori, herba Schizonepetae, herba Menthae, semen Armeniacae amarum, rhizoma Phragmitis, and Glycyrrhrizae radix, decocting the medicinal materials with water in an amount 14 times of the raw materials for 1 hr, filtering to obtain filtrate, decocting the residue in water for 1 hr, adding water in an amount 12 times of the raw materials, and decocting for 0.5 hr;
(2) mixing the filtrates obtained by decocting for 2 times, concentrating the mixed filtrates to relative density of 1.05(60 deg.C), adding 5% dextrin, mixing, and spray drying to obtain fine powder A;
(3) and adding 1 part of dextrin into the fine powder A, uniformly mixing, preparing into granules B, and drying to obtain the finished product.
EXAMPLE 2 pharmaceutical composition and Process for preparing the same
Composition (A): according to the weight parts, the traditional Chinese medicine composition comprises 5 parts of heartleaf houttuynia herb, 4 parts of baical skullcap root, 5 parts of weeping forsythia, 4 parts of honeysuckle flower, 4 parts of mulberry leaf, 4 parts of fineleaf schizonepeta herb, 2 parts of mint, 4 parts of bitter apricot seed, 5 parts of reed rhizome and 1.5 parts of liquorice;
the preparation method comprises the following steps:
(1) respectively weighing herba Houttuyniae, Scutellariae radix, fructus forsythiae, flos Lonicerae, folium Mori, herba Schizonepetae, herba Menthae, semen Armeniacae amarum, rhizoma Phragmitis, and Glycyrrhrizae radix, decocting the medicinal materials with water in an amount 14 times of the raw materials for 1 hr, filtering to obtain filtrate, decocting the residue in water for 1 hr, and decocting for 1 hr;
(2) mixing the filtrates obtained by decocting for 2 times, concentrating the mixed filtrates to relative density of 1.08(60 deg.C), adding 10% maltodextrin, and spray drying to obtain fine powder A;
(3) and adding 1 part of maltodextrin into the fine powder A, uniformly mixing, preparing granules B, and drying to obtain the granules.
EXAMPLE 3 pharmaceutical composition and Process for preparing the same
Composition (A): according to the weight parts, 2 parts of heartleaf houttuynia herb, 1.5 parts of baical skullcap root, 2 parts of weeping forsythia, 2 parts of honeysuckle flower, 1.5 parts of mulberry leaf, 1.5 parts of fineleaf schizonepeta herb, 1 part of mint, 1.5 parts of bitter apricot seed, 2 parts of reed rhizome and 0.3 part of liquorice;
the preparation method comprises the following steps:
(1) respectively weighing herba Houttuyniae, Scutellariae radix, fructus forsythiae, flos Lonicerae, folium Mori, herba Schizonepetae, herba Menthae, semen Armeniacae amarum, rhizoma Phragmitis, and Glycyrrhrizae radix, decocting the medicinal materials with water in an amount 12 times of the raw materials for 0.5 hr, filtering to obtain filtrate, decocting the residue in water for 1 time, and decocting for 0.5 hr;
(2) mixing the filtrates obtained by decocting for 2 times, concentrating the mixed filtrates to relative density of 1.06(60 deg.C), adding 5% soluble starch, and spray drying to obtain fine powder A;
(3) and adding 1 part of soluble starch into the fine powder A, uniformly mixing, preparing into granules B, and drying to obtain the compound feed.
EXAMPLE 4 pharmaceutical composition and method of preparation
Composition (A): according to the weight parts, 1 part of heartleaf houttuynia herb, 1 part of baical skullcap root, 1 part of weeping forsythia, 1 part of honeysuckle flower, 1 part of mulberry leaf, 1 part of fineleaf schizonepeta herb, 0.5 part of mint, 1 part of bitter apricot seed, 1 part of reed rhizome and 0.1 part of liquorice;
the preparation method comprises the following steps:
(1) respectively weighing herba Houttuyniae, Scutellariae radix, fructus forsythiae, flos Lonicerae, folium Mori, herba Schizonepetae, herba Menthae, semen Armeniacae amarum, rhizoma Phragmitis, and Glycyrrhrizae radix, decocting the materials in water with the amount of 14 times of the materials for 1.5 hr, and filtering to obtain filtrate;
(2) concentrating the filtrate to relative density of 1.04(60 deg.C), adding 10% lactose, and spray drying to obtain fine powder A;
(3) and adding 1 part of lactose into the fine powder A, uniformly mixing, preparing into granules B, and drying to obtain the finished product.
Comparative example 1
Replacing Scutellariae radix with Platycodi radix in the composition of example 1;
composition (A): according to the weight parts, 3 parts of heartleaf houttuynia herb, 2 parts of platycodon grandiflorum, 3 parts of weeping forsythia, 2.4 parts of honeysuckle, 2 parts of mulberry leaf, 2 parts of fineleaf schizonepeta herb, 1.2 parts of mint, 1.8 parts of bitter almond, 2.4 parts of reed rhizome and 0.6 part of liquorice;
the preparation method comprises the following steps:
(1) respectively weighing herba Houttuyniae, radix Platycodi, fructus forsythiae, flos Lonicerae, folium Mori, herba Schizonepetae, herba Menthae, semen Armeniacae amarum, rhizoma Phragmitis, and Glycyrrhrizae radix, decocting the medicinal materials with water in an amount 14 times of the raw materials for 1 hr, filtering to obtain filtrate, decocting the residue in water for 1 hr, adding water in an amount 12 times of the raw materials, and decocting for 0.5 hr;
(2) - (3) same as in example 1.
Comparative example 2
Replacing honeysuckle in the composition of the example 1 with chrysanthemum;
composition (A): according to the weight parts, 3 parts of heartleaf houttuynia herb, 2 parts of baical skullcap root, 3 parts of weeping forsythia, 2.4 parts of chrysanthemum, 2 parts of mulberry leaf, 2 parts of fineleaf schizonepeta herb, 1.2 parts of mint, 1.8 parts of bitter apricot seed, 2.4 parts of reed rhizome and 0.6 part of liquorice;
the preparation method comprises the following steps:
(1) respectively weighing herba Houttuyniae, Scutellariae radix, fructus forsythiae, flos Chrysanthemi, folium Mori, herba Schizonepetae, herba Menthae, semen Armeniacae amarum, rhizoma Phragmitis, and Glycyrrhrizae radix, decocting the medicinal materials with water in an amount 14 times of the raw materials for 1 hr, filtering to obtain filtrate, decocting the residue in water for 1 hr, adding water in an amount 12 times of the raw materials, and decocting for 0.5 hr;
(2) - (3) same as in example 1.
Comparative example 3
Adding the kudzu root, the dwarf lilyturf tuber and the lily into the composition in the embodiment 1, and removing the schizonepeta and the reed rhizome;
composition (A): according to the weight parts, 3 parts of heartleaf houttuynia herb, 2 parts of baical skullcap root, 3 parts of weeping forsythia, 2.4 parts of honeysuckle flower, 2 parts of mulberry leaf, 1.2 parts of mint, 1.8 parts of bitter apricot seed, 0.6 part of liquorice, 2 parts of kudzuvine root, 2 parts of dwarf lilyturf tuber and 2 parts of lily;
the preparation method comprises the following steps:
(1) respectively weighing herba Houttuyniae, Scutellariae radix, fructus forsythiae, flos Lonicerae, folium Mori, herba Menthae, semen Armeniacae amarum, Glycyrrhrizae radix, radix Puerariae, radix Ophiopogonis and Bulbus Lilii, decocting the medicinal materials with water in an amount 14 times of the raw materials for 1 hr, filtering to obtain filtrate, decocting the residue in water for 1 hr, adding water in an amount 12 times of the raw materials, and decocting for 0.5 hr;
(2) - (3) same as in example 1.
Comparative example 4
The difference from example 1 is only the ratio of the raw materials of the medicine is different;
composition (A): 4 parts of heartleaf houttuynia herb, 2 parts of baical skullcap root, 1.8 parts of weeping forsythia, 2.4 parts of honeysuckle, 2 parts of mulberry leaf, 2 parts of fineleaf schizonepeta herb, 4 parts of mint, 3 parts of bitter almond, 2.4 parts of reed rhizome and 3 parts of liquorice;
the preparation method comprises the following steps:
(1) respectively weighing herba Houttuyniae, Scutellariae radix, fructus forsythiae, flos Lonicerae, folium Mori, herba Schizonepetae, herba Menthae, semen Armeniacae amarum, rhizoma Phragmitis, and Glycyrrhrizae radix, decocting the medicinal materials with water in an amount 14 times of the raw materials for 1 hr, filtering to obtain filtrate, decocting the residue in water for 1 hr, adding water in an amount 12 times of the raw materials, and decocting for 0.5 hr;
(2) - (3) same as in example 1.
Test example 1 examples 1-4 and comparative examples 1-4 animal test study
Yeast induced fever in rats: after adaptive feeding for 4 days, carrying out adaptive anal temperature measurement operation on the rats 2 times a day in the morning and at night, and continuously carrying out 3 days to adapt to the environment and measure the temperature and stimulate the temperature. Before the formal experiment, the body temperature is measured for 1 time and 3 times continuously every half an hour, animals with the body temperature change of not more than 0.5 ℃ and the body temperature of not more than 38 ℃ are selected for use, and the average body temperature is taken as the normal body temperature. 120 reserved rats were randomly divided into 10 groups of 12 rats each, namely, a normal group, a model group, examples 1 to 4 groups and comparative examples 1 to 4 groups, wherein the normal group and the model group were administered with water for injection, and the examples and the comparative examples were administered with granules prepared by the respective methods. The administration groups were administered by intragastric administration at 5g/kg for 5 days. The rats were fasted for 6h on the last day without water deprivation. Except the normal group injected with normal saline, the other groups injected with 20% dry yeast suspension 10ml/kg body mass subcutaneously on the back, and the rats with body temperature rising above 0.8 ℃ were selected as experimental animals after 6h of molding. Each administration group is administrated by intragastric administration according to corresponding dose, the normal group and the model group are administrated with distilled water with equal volume, and the anus temperature is measured 0 h, 2h, 4h and 6h after administration. Calculating each time point and calculating the body temperature rise height of each time point.
TABLE 1 Effect of drugs on body temperature of Yeast-induced febrile rats: (
n＝12)
Note: comparison with model group
The research result shows that the medicines in the groups of examples 1 to 4 can obviously reduce the body temperature of the yeast fever rats, and have obvious difference compared with the model group.
The mouse test of cough caused by 25% ammonia water spray: 108 healthy Kunming mice were randomly divided into model control groups, examples 1, 2, 3, 4 groups, comparative examples 1, 2, 3, 4 groups of 12 mice each. The model control group was administered 0.02mL/g of 0.9% sodium chloride solution and the examples and comparative groups were administered granules at 5g/kg by gavage 1 time per day for 5 consecutive days. The mice in each group were placed in a 1000mL bell jar after fasting for 12 hours before the start of the test and 1 hour after the last administration, sprayed with 25% ammonia water for 15 seconds, observed for cough action (mouth enlargement, contraction of abdominal muscles, sometimes with cough sounds), and recorded for cough latency (time until cough appears after the mice are placed in the bell jar) and the number of coughs within 3 minutes.
TABLE 2 Effect of drugs on Ammonia induced cough mice: (
n＝12)
Note: comparison with model group
Research results show that the medicines in the groups of examples 1 to 4 can obviously prolong the cough incubation period of the mice with ammonia water induced cough and reduce cough times, and have obvious difference compared with a model group.
Test example 2 clinical trial study
In order to test the treatment effect of the pharmaceutical composition preparation on the syndrome of wind-heat common cold or wind-cold attacking lung and transforming into heat, 80 patients meeting the diagnosis standard of wind-heat cough are randomly divided into 40 patients in a treatment group and a control group. 14 men and 26 women in the control group; the age is 6-51 years. In the treatment group, 17 men and 23 women; the age is 5-50 years. The sex, age and course of disease of the two groups of patients are statistically analyzed, and the difference is not statistically significant (P > 0.05).
The patients in the control group are administered with the oral Baishi Heat clearing granule 3 times a day; the granules of example 1 of the present invention were administered to the treatment group 3 times a day. The treatment period is 5 days.
The traditional Chinese medicine diagnosis standard is as follows: cough is the main symptom, and is usually caused by climate change after cold. Cough, yellow and sticky sputum, difficult expectoration, red and sore throat accompanied by obvious symptoms of wind-heat common cold such as fever, headache, nasal obstruction, turbid nasal discharge, red tongue with thin and yellow coating, and floating and rapid pulse.
Standard of Western diagnosis
Symptoms are: most of the patients have symptoms of upper respiratory tract infection, then cough is taken as a main symptom, dry cough is taken at the beginning, and phlegm is taken at the later stage. Infants have serious symptoms, such as fever, vomiting, diarrhea and the like, and general symptoms are not obvious.
Pulmonary auscultation can smell rough breath sounds or be scattered in dry rales.
Laboratory examination: blood cell analysis: the total number of peripheral blood leucocytes of virus infected persons is normal or low, and the percentage of lymphocytes is increased; the total number of white blood cells and neutrophils in the blood of the bacteria infected person are increased.
X-ray examination shows that the chest radiography is normal, or the lung texture is thickened, the lung portal shadow is deepened, and the disease generally does not need X-ray examination unless the disease is to identify whether the pneumonia or the atelectasis is combined.
Inclusion criteria were: meets the traditional Chinese medicine diagnosis standard and the western medicine diagnosis standard of wind-heat cough.
Criteria for evaluating therapeutic effects
And (3) healing: after treatment, the body temperature returns to normal, and clinical symptoms and physical signs disappear completely or basically.
The effect is shown: after treatment, the body temperature returns to normal, and clinical symptoms and physical signs are obviously improved.
The method has the following advantages: the body temperature is reduced after treatment compared with the body temperature before treatment, and clinical symptoms and physical signs are all better.
And (4) invalidation: after the treatment, the body temperature is not reduced to normal or increased, and cough, pharyngalgia and watery nasal discharge still occur or are aggravated.
The total effective rate of treatment is as follows: [ (clinical recovery case number + significant case number)/total case number ] × 100%
The effective rate of treatment is as follows:
TABLE 3 therapeutic Effect of pharmaceutical composition preparations for treating Cold
Therefore, the preparation of the pharmaceutical composition prepared by the preferred experimental mode has a good treatment effect on wind-heat cough.
The above detailed description is specific to one possible embodiment of the present invention, and the embodiment is not intended to limit the scope of the present invention, and all equivalent implementations or modifications without departing from the scope of the present invention should be included in the technical scope of the present invention.
Claims (11)
1. The pharmaceutical composition for treating wind-heat affecting lung is characterized by being prepared from the following raw materials in parts by weight: 1-5 parts of heartleaf houttuynia herb, 1-4 parts of baical skullcap root, 1-5 parts of weeping forsythia, 1-4 parts of honeysuckle, 1-4 parts of mulberry leaf, 1-4 parts of fineleaf schizonepeta herb, 0.5-2 parts of mint, 1-4 parts of bitter almond, 1-5 parts of reed rhizome and 0.1-1.5 parts of liquorice.
2. The pharmaceutical composition for treating wind-heat affecting lung according to claim 1, wherein the composition is prepared from the following raw materials in parts by weight: 2-5 parts of heartleaf houttuynia herb, 1.5-4 parts of baical skullcap root, 2-5 parts of weeping forsythia, 2-4 parts of honeysuckle, 1.5-4 parts of mulberry leaf, 1.5-4 parts of fineleaf schizonepeta herb, 1-2 parts of mint, 1.5-4 parts of bitter apricot seed, 2-5 parts of reed rhizome and 0.3-1.5 parts of liquorice.
3. The pharmaceutical composition for treating wind-heat affecting lung according to claim 1, wherein the composition is prepared from the following raw materials in parts by weight: 3-5 parts of heartleaf houttuynia herb, 2-4 parts of baical skullcap root, 3-5 parts of weeping forsythia, 2.4-4 parts of honeysuckle, 2-4 parts of mulberry leaf, 2-4 parts of fineleaf schizonepeta herb, 1.2-2 parts of mint, 1.8-4 parts of bitter almond, 2.4-5 parts of reed rhizome and 0.6-1.5 parts of liquorice.
4. The pharmaceutical composition for treating wind-heat affecting lung of any one of claims 1-3, wherein the composition further comprises a pharmaceutically acceptable excipient.
5. The pharmaceutical composition for treating wind-heat affecting lung of claim 4, wherein the adjuvant is selected from any one or more of dextrin, maltodextrin, soluble starch and lactose.
6. The process for the preparation of a pharmaceutical composition for the treatment of wind-heat affecting the lung as claimed in any one of claims 1 to 5, comprising the steps of:
(1) weighing the traditional Chinese medicine raw materials, decocting the raw materials together with water, filtering to obtain filtrate, repeatedly decocting the filtered traditional Chinese medicine dregs with water, and mixing the obtained filtrates;
(2) and concentrating the combined filtrate, adding auxiliary materials, and drying to obtain fine powder A, namely the pharmaceutical composition for treating wind-heat affecting lung.
7. The method for preparing the pharmaceutical composition for treating wind-heat affecting lung according to claim 6, wherein in the step (1), the water adding amount of the decoction is 10-14 times of the amount of the medicinal materials, the repeated water adding decoction is performed for 1-2 times, and the decoction time is 0.5-1.5 h; in the step (2), the combined filtrate is concentrated to a relative density of 1.04-1.08 at 60 ℃.
8. The pharmaceutical composition for treating wind-heat affecting lung according to any one of claims 1-5 or the pharmaceutical composition prepared by the preparation method according to any one of claims 6-7, wherein the dosage form of the preparation is granules.
9. A method of preparing a formulation of the pharmaceutical composition of claim 8, comprising the steps of: (1) weighing the traditional Chinese medicine raw materials, decocting the raw materials together with water, filtering to obtain filtrate, repeatedly decocting the filtered traditional Chinese medicine dregs with water, and mixing the obtained filtrates;
(2) concentrating the combined filtrate, adding adjuvants, drying to obtain fine powder A, adding adjuvants into the obtained fine powder A, mixing, granulating B, and drying.
10. A method of preparing a formulation of the pharmaceutical composition of claim 8, comprising the steps of: (1) weighing the traditional Chinese medicine raw materials, decocting the raw materials together with water, filtering to obtain filtrate, repeatedly decocting the filtered traditional Chinese medicine dregs with water, and mixing the obtained filtrates;
(2) concentrating the combined filtrate, adding adjuvants, drying to obtain fine powder A, adding adjuvants into the obtained fine powder A, mixing, granulating B, and drying;
in the step (1), the amount of water added for decoction is 10-14 times of the amount of the medicinal materials, the number of times of repeated water adding for decoction is 1-2 times, and the decoction time is 0.5-1.5 hours; in the step (2), the combined filtrate is concentrated to a relative density of 1.04-1.08 at 60 ℃.
11. Use of a pharmaceutical composition according to any one of claims 1 to 5 or a formulation of a pharmaceutical composition according to claim 8 for the manufacture of a medicament for the treatment of wind-heat affecting the lung.
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