CN108938905A - The Chinese medical extract and its preparation method and application for treating respiratory disease - Google Patents
The Chinese medical extract and its preparation method and application for treating respiratory disease 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)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/342—Adenophora
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- 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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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- 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)
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- 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)
- A61K36/42—Cucurbitaceae (Cucumber family)
- A61K36/428—Trichosanthes
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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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- 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)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8968—Ophiopogon (Lilyturf)
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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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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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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
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
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Abstract
The present invention provide it is a kind of for treating the Chinese medical extract of respiratory disease, by following parts by weight raw material extraction be made: 1~10 part of adenophora tetraphylla, 1~10 part of affine cudweed, 1~10 part of tussilago, 1~10 part of Radix Ophiopogonis, 1~6 part of campanulaceae, 1~10 part of radices trichosanthis and 1~6 part of Radix Glycyrrhizae.The present invention also provides the preparation method of the Chinese medical extract and purposes, and pharmaceutical preparation containing the Chinese medical extract and preparation method thereof.Chinese medical extract of the invention had both had the function of apparent relieving superficies by cooling, relieving cough and reducing sputum, there is significant anti-inflammatory, antibacterial and antivirus action again, it coughs to respiratory disease or as caused by respiratory disease, especially children chronic cough has effects that treating both manifestation and root cause of disease.Pharmaceutical preparation of the invention, which has, to be carried convenient to take, and bioavilability is high, controllability and the good feature of stability.
Description
Technical field
The invention belongs to the field of Chinese medicines, are related to a kind of Chinese medical extract and preparation method thereof for treating respiratory disease
And purposes, the invention further relates to the pharmaceutical preparations and preparation method thereof for containing the Chinese medical extract.
Background technique
Respiratory disease is the highest disease of paediatrics disease incidence, accounts for 70% or more of pediatric disease sum.Cough is
The most common symptom of paediatrics respiratory disease belongs to the name of disease scope in TCM Pediatrics diseases of pulmonary system.Clinically cause cough
The main reason for reason is complicated, and acute respiratory disease (ARI) is cough accounts for children disease disease incidence first place in global range,
It is simultaneously also the lethal key factor of paediatrics.Either domestic or external, children cough is the common cause that people see a doctor,
Britain, all Pediatric Clinics 30% are to be accounted for all medical treatment due to respiratory disease with cough for symptom and exceeded 8%.Cough is
There is cough from the slight infection of the upper respiratory tract to serious chronic disease in the common sympton of room Children respiratory system disease.
Acute cough in children further can lead to chronic cough (being defined as persistent cough > 4 week).Children chronic cough is controlled long
It is not cured, seriously affects infant physical and mental health and learning life, and bring additional financial burden to parent and society.In recent years,
The disease incidence of childhood chronic cough is in rising trend, and since its course of disease is longer, the decline of children's resistance, pathogen is taken advantage of a weak point can
It is complicated by infection, such as repeated respiratory infections, pneumonia.Therefore, which endangers children's physical and mental health very big, generally acknowledged children
Chronic cough is by polygenes, a multifactor caused quasi-complexity pathologic process.Therefore, multipath, too many levels, multiple target point are complete
Face is adjusted, and the drug for playing comprehensive therapeutic effect can just efficiently control until curing this disease.And traditional Chinese medicine treats children chronic cough
Coughing has the characteristics that comprehensive, globality therapeutic effect and without obvious toxic-side effects.
For above-mentioned disease incidence feature, safe and effective, quality controllable, convenient to take controlled inventor developed a kind of
Treat the Chinese medical extract and preparation of respiratory disease.
Summary of the invention
Therefore, it is an object of the present invention to provide a kind of safe and effective, quality controllable, convenient to take to exhale for treating
Inhale the Chinese medical extract of tract disease.
It is a further object to provide a kind of methods for preparing above-mentioned Chinese medical extract.
A further object of the present invention is to provide a kind of pharmaceutical preparation comprising Chinese medical extract of the present invention.
It is also another object of the present invention to provide the preparation methods of said medicine preparation.
A further object of the present invention is to provide the purposes of Chinese medical extract of the present invention.
The purpose of the present invention is achieved through the following technical solutions.
On the one hand, the present invention provides a kind of for treating the Chinese medical extract of respiratory disease, by following parts by weight
Raw material extraction be made:
1~10 part of adenophora tetraphylla, 1~10 part of affine cudweed, 1~10 part of tussilago, 1~10 part of Radix Ophiopogonis, 1~6 part of campanulaceae, smallpox
1~10 part and 1~6 part of Radix Glycyrrhizae of powder.
Preferably, the Chinese medical extract is made of the raw material extraction of following parts by weight: 1~5 part of adenophora tetraphylla, mouse are bent
1~5 part of grass, 1~5 part of tussilago, 1~5 part of Radix Ophiopogonis, 1~3 part of campanulaceae, 1~5 part of radices trichosanthis and 1~3 part of Radix Glycyrrhizae.
It is highly preferred that the Chinese medical extract is made of the raw material extraction of following parts by weight: 10 parts of adenophora tetraphylla, mouse are bent
10 parts of grass, 10 parts of tussilago, 10 parts of Radix Ophiopogonis, 6 parts of campanulaceae, 10 parts of radices trichosanthis and 6 parts of Radix Glycyrrhizae.
On the other hand, the present invention provides a kind of method for preparing Chinese medical extract of the present invention, the method includes
Following steps:
(1) each raw material is taken in proportion, and extracting in water obtains extracting solution；
(2) extracting solution obtained by step (1) is filtered, it is 1.05~1.30 that filtrate, which is concentrated into relative density, then plus ethanol water
Solution to alcohol content is 30~85%v/v, is placed, filtration, filtrate concentration；Or
It the described method comprises the following steps:
(1 ') takes each raw material in proportion, adds 50%v/v~95%v/v ethanol water to extract, obtains extracting solution；
(2 ') filter extracting solution obtained by step (1 '), filtrate concentration.
Preferably, wherein the step (2 ') further comprises following step: after filtrate is concentrated, adding into concentrate
Ethanol water to alcohol content is 30~85%v/v, is placed, filtration, filtrate concentration.
Preferably, the weight for the water being wherein added in step (1) is 1~40 times of raw material gross weight；The extraction carries out 1
~4 times, 0.5~12h every time；Or
The weight for the ethanol water being wherein added in step (1 ') is 1~40 times of raw material gross weight；It is described extract into
Row 1~4 time, 0.5~12h every time.
Preferably, in which:
Extraction in the step (1) or (1 ') is by the progress such as cold-maceration, circumfluence method or percolation；And/or
Concentration in the step (2) or (2 ') is normal pressure concentration, reduced pressure or film concentration etc..
Preferably, wherein further include doing the concentrate that last filtrate is concentrated to get in the step (2) or (2 ')
It is dry, crush the step of；Preferably, the drying in the step (2) or (2 ') be contact drying, pneumatic conveying drying, tunnel type it is dry,
Vacuum (decompression) drying, fluidized drying, spray drying, freeze-drying, far-infrared ray drying or microwave drying etc..
Preferably, the ethanol water being wherein added in step (2) or (2 ') into concentrate is 95%v/v ethyl alcohol
Aqueous solution.
In another aspect, the present invention provides a kind of for treating the pharmaceutical preparation of respiratory disease, it includes of the present invention
Chinese medical extract and pharmaceutically acceptable auxiliary material.
Preferably, the pharmaceutical preparation is granule, tablet, capsule, syrup or oral solution；Preferably, described
Agent is buccal tablet, oral disintegrating tablet or dispersible tablet.It is highly preferred that the pharmaceutical preparation is granule, oral solution or tablet.Most preferably
Ground, the pharmaceutical preparation are oral solution.
Another aspect, the present invention provide a kind of method for preparing pharmaceutical preparation of the present invention comprising following steps:
Chinese medical extract of the present invention is mixed with pharmaceutically acceptable auxiliary material, is further prepared into the pharmaceutical preparation.
On the other hand, the present invention provide Chinese medical extract of the present invention preparation for treat respiratory disease or
Purposes in the drug of the cough as caused by respiratory disease.
Preferably, the cough as caused by respiratory disease is children chronic cough, respiratory tract infection cough or exhales
Inhale road postinfectious cough.
The raw material of Chinese medical extract provided by the invention by adenophora tetraphylla, affine cudweed, tussilago, Radix Ophiopogonis, campanulaceae, radices trichosanthis and
Radix Glycyrrhizae extracts and is made, and has lung stomach feeding clearly, moisturizes the benefits of promoting the production of body fluid, and cures mainly warm and scorching heresy injures lung stomach-Yin point card, match
5 is rigorous, treating both manifestation and root cause of disease, is the active drug for treating children chronic cough lung yin deficiency.Chinese medical extract of the invention both had
There is apparent relieving superficies by cooling, relieving cough and reducing sputum, and there is significant anti-inflammatory, antibacterial and antivirus action, to respiratory tract disease
Disease is coughed as caused by respiratory disease, and especially children chronic cough has effects that treating both manifestation and root cause of disease.Drug of the invention
Preparation, which has, to be carried convenient to take, and bioavilability is high, controllability and the good feature of stability.
Specific embodiment
The present invention will be further described combined with specific embodiments below, following embodiments be merely to illustrate the present invention and
Not limitation of the present invention, wherein crude drug source: all raw materials are commercially available, and meet standards of pharmacopoeia.
Adenophora tetraphylla: this medicinal material is the dry root of the root of straight ladybell Adenophora stricta Miq..
Tussilago: this medicinal material is the dry flower of compositae plant coltsfoot Tussilago farfara L..
Radix Ophiopogonis: this medicinal material is the dried pieces of liliaceous plant Radix Ophiopogonis Ophiopogon japonicas (L.f) Ker-Gawl.
Root.
Radices trichosanthis: this medicinal material is the dry root of cucurbitaceous plant snakegourd Trichosanthes kirilowii Maxim..
Campanulaceae: this medicinal material is the drying of Campanulaceae campanulaceae Platycodon grandiflorum (Jacq.) A.DC.
Root.
Radix Glycyrrhizae: this medicinal material is the dry rhizome of glycyrrhizic legume Glycyrrhiza uralensis Fisch..
Affine cudweed: this medicinal material is the herb of compositae plant affine cudweed Gnaphalium affine D.Don.
Unless otherwise stated, terms used herein " radix adenophorea, tuber of dwarf lilyturf drug " refers to of the invention by 1~10 part of adenophora tetraphylla, mouse
1~10 part of Anacamptis pyromaidalis, 1~10 part of tussilago, 1~10 part of Radix Ophiopogonis, 1~6 part of campanulaceae, 1~10 part of radices trichosanthis and 1~6 part of Radix Glycyrrhizae system
Standby extract.
The raw material of Chinese medical extract of the invention is seven flavor medicine, and adenophora tetraphylla, tussilago are monarch drug in a prescription, and Radix Ophiopogonis is ministerial drug, smallpox
Powder, campanulaceae, affine cudweed are to make medicine, with Radix Glycyrrhizae coordinating the drug actions of a prescription.Wherein adenophora tetraphylla is mainly using flavonoids and saponins as active material,
Steroid saponin and polysaccharide component are its main active in Radix Ophiopogonis.Radices trichosanthis mainly contains protein and polysaccharide active matter
Matter, tussilago main active are flavonoids, and campanulaceae main active is saponin component, and Radix Glycyrrhizae is containing enoxolone and sweet
The steroids chemical component such as oxalic acid.Affine cudweed main active is the flavones ingredients such as luteolin, affine cudweed element.
According to nature and flavor, function, ingredient and its physicochemical property and adaption object of medicine each in composition of raw materials, difference is devised
Extraction process route and process conditions, and combine pharmacodynamic test, filter out best process flow.Formula used by it is such as
Under:
10 parts of adenophora tetraphylla, 10 parts of affine cudweed, 10 parts of Radix Ophiopogonis of 10 parts of tussilago
6 portions of campanulaceae, 6 parts of Radix Glycyrrhizae of 10 portions of radices trichosanthis；
Technique 1: the 95%v/v alcohol reflux that weight is 10 times of raw material gross weight is added into medicinal material and extracts twice, every time
1.5 hours, extraction fluid added the water that weight is 4 times of raw material gross weight into the dregs of a decoction and extracts twice, and 1 hour every time, point
It is not concentrated, merges, obtain extract.
Technique 2: the water refluxing extraction that addition weight is 8 times of raw material gross weight into medicinal material twice, 1.5 hours every time, mentions
Liquid is taken to be concentrated, the 95%v/v ethanol precipitation that add weight is 3 times of concentrate weight filters overnight, and decompression filtrate recycling ethanol is dense
Contracting, obtains extract.
Technique 3: the 50%v/v ethyl alcohol that weight is 3 times of raw material gross weight is added into medicinal material and impregnates 12 hours, fills diacolation
Cylinder, then the 50%v/v ethanol percolation for being 10 times of raw material gross weight with weight, percolate concentration, the dregs of a decoction add water refluxing extraction twice,
1 hour every time, extracting solution concentration, the 95%v/v ethyl alcohol alcohol precipitation that add weight is 3 times of concentrate weight, filtration, filtrate concentration, after
Merge with upper liquid, obtains extract.
Technique 4: the 70%v/v alcohol reflux that weight is 8 times of raw material gross weight being added into medicinal material and extracts twice, and every time 1
Hour, filtration, filtrate is centrifuged (4500 turns/min), and concentration obtains extract.
Mouse cough model is caused using ammonium hydroxide, carries out each process activity evaluation, Kunming mouse is taken (to be purchased from Beijing dimension tonneau
China) 75, be randomly divided into 6 groups by weight: (nourishiing yin to clear away the lung-heat cream is purchased from the magnificent doctor in Tianjin Chinese medicine group Tianjin for model group, positive drug
Medicine health care product Co., Ltd product, lot number 940512.) control group, different process administration group (given with 2.4g crude drug/kg dosage
Give through the above-mentioned obtained extract of technique 1-4), every group 15.The administration of animal oral administration gavage, capacity 0.4ml/20g, even
It is three days continuous.It after last dose 1 hour, is placed in 500ml beaker, the cotton balls of 25% ammonium hydroxide containing 0.1ml is put into, upper cover glass
Glass plate.Using the time for generating cough for the first time as incubation period, the cough number in 3 minutes is then recorded.The results showed that each
The obtained extract of process route can significantly reduce the mouse cough number as caused by ammonium hydroxide, but without system between each effective group
Meter learns difference (being shown in Table one).
Table one, the Chinese medical extract prepared using different process are to mouse antitussive effect
It is above-mentioned the experimental results showed that the Chinese medical extract of four different extraction processes preparations all has good cough-relieving and makees
With four extraction process routes according to the selection of the property and taste of medicine each in composition of raw materials are scientific and reasonable.
Embodiment 1
Bulk pharmaceutical chemicals are weighed by following proportion: (note: every part is 100g)
10 parts of adenophora tetraphylla, 10 parts of affine cudweed, 10 parts of Radix Ophiopogonis of 1 part of tussilago
6 portions of campanulaceae, 1 part of Radix Glycyrrhizae of 10 portions of radices trichosanthis
(1) seven taste bulk pharmaceutical chemicals more than, the water that add weight is 12 times of medicinal material total weight, heating and refluxing extraction 3 times, 1 is small every time
When, combined extract, filtration, it is 1.05 that filtrate, which is concentrated into relative density, and adding 95%v/v ethyl alcohol to alcohol content is 70%v/
V is placed, filtration, filtrate decompression recycling design, and concentration dry, pulverize, and obtains Chinese medical extract 850g of the invention, spare；
(2) above-mentioned Chinese medical extract 232g is taken, 80 meshes is crossed, adds 220g dextrin, 48g Icing Sugar, is pelletized, packaging is to get this
Invention medicinal granule.
Embodiment 2
Bulk pharmaceutical chemicals are weighed by following proportion: (note: every part is 100g)
5 parts of adenophora tetraphylla, 5 parts of affine cudweed, 5 parts of Radix Ophiopogonis of 10 parts of tussilago
1 portion of campanulaceae, 3 parts of Radix Glycyrrhizae of 1 portion of radices trichosanthis
Chinese medical extract obtained in (1) is added 180g starch, 110g dextrin with embodiment 1, step (2) by step (1), is mixed
It is even, particle is made, it is dry, capsule is then produced in conventional fashion.
Embodiment 3
Bulk pharmaceutical chemicals are weighed by following proportion: (note: every part is 100g)
1 part of adenophora tetraphylla, 2 parts of affine cudweed, 1 part of Radix Ophiopogonis of 5 parts of tussilago
3 portions of campanulaceae, 6 parts of Radix Glycyrrhizae of 5 portions of radices trichosanthis
(1) seven taste bulk pharmaceutical chemicals more than, the 50%v/v ethyl alcohol that add weight is 10 times of medicinal material total weight, refluxing extraction 3 times, often
Secondary 1 hour, combined extract filtered, filtrate decompression recycling design, and concentration dry, pulverize, obtain Chinese medical extract of the invention
450g, it is spare；
(2) above-mentioned Chinese medical extract 235g is taken, 80 meshes is crossed, adds 265g starch, is pelletized, dry, tabletting obtains medicine of the present invention
Object tablet.
Embodiment 4
Bulk pharmaceutical chemicals are weighed by following proportion: (note: every part is 100g)
10 parts of adenophora tetraphylla, 1 part of affine cudweed, 10 parts of Radix Ophiopogonis of 5 parts of tussilago
3 portions of campanulaceae, 6 parts of Radix Glycyrrhizae of 10 portions of radices trichosanthis
(1) seven taste bulk pharmaceutical chemicals more than, the 70%v/v ethyl alcohol that add weight is 10 times of medicinal material total weight, refluxing extraction 3 times, often
Secondary 1 hour, combined extract filtered, filtrate decompression recycling design, and concentration dry, pulverize, obtain Chinese medical extract of the invention
700g, it is spare；
(2) above-mentioned Chinese medical extract 200g is taken, is sieved with 100 mesh sieve, the poly- low-substituted hydroxypropyl cellulose of 110g, 25g polyethylene are added
Pyrrolidones, 105g mannitol, mix, and tabletting obtains drug oral disintegrating tablet of the present invention.
Embodiment 5
Bulk pharmaceutical chemicals are weighed by following proportion: (note: every part is 100g)
10 parts of adenophora tetraphylla, 10 parts of affine cudweed, 10 parts of Radix Ophiopogonis of 10 parts of tussilago
6 portions of campanulaceae, 6 parts of Radix Glycyrrhizae of 10 portions of radices trichosanthis
(1) seven taste bulk pharmaceutical chemicals more than, the water that add weight is 8 times of medicinal material total weight, heating and refluxing extraction 2 times, 1.5 is small every time
When, combined extract, filtration, it is 1.15 that filtrate, which is concentrated into relative density, and adding 95%v/v ethyl alcohol to alcohol content is 80%v/
V is placed, filtration, and filtrate recycling ethanol is concentrated, and is refrigerated, filtration, and sodium benzoate 1g, stevioside 20g is added in filtrate, filling, i.e.,
Obtain medicine oral liquid of the present invention.
Embodiment 6
Bulk pharmaceutical chemicals are weighed by following proportion: (note: every part is 100g)
10 parts of adenophora tetraphylla, 5 parts of affine cudweed, 10 parts of Radix Ophiopogonis of 10 parts of tussilago
6 portions of campanulaceae, 6 parts of Radix Glycyrrhizae of 10 portions of radices trichosanthis
(1) seven taste bulk pharmaceutical chemicals more than, the water that add weight is 5 times of medicinal material total weight, heating and refluxing extraction 2 times, 2 is small every time
When, combined extract, filtration, it is 1.20 that filtrate, which is concentrated into relative density, and adding 95%v/v ethyl alcohol to alcohol content is 60%v/
V is placed, filtration, filtrate recycling ethanol, and concentration dry, pulverize, and obtains Chinese medical extract 845g of the invention, spare；
(2) above-mentioned Chinese medical extract 150g is taken, is sieved with 100 mesh sieve, 120g sucrose and 20g Steviosin are added, mixes, is made
Grain, it is dry, xylitol 10g is added, mixes, tabletting obtains drug buccal tablet of the present invention.
Embodiment 7
Bulk pharmaceutical chemicals are weighed by following proportion: (note: every part is 100g)
10 parts of adenophora tetraphylla, 10 parts of affine cudweed, 10 parts of Radix Ophiopogonis of 10 parts of tussilago
2 portions of campanulaceae, 2 parts of Radix Glycyrrhizae of 1 portion of radices trichosanthis
(1) seven taste bulk pharmaceutical chemicals more than, the 60%v/v ethyl alcohol that add weight is 12 times of medicinal material total weight, seepage pressure effects are collected and are seeped
It filters liquid, filtration, filtrate recycling ethanol, concentration dry, pulverize, and obtain Chinese medical extract 720g of the invention, spare；
(2) above-mentioned Chinese medical extract 270g is taken, is sieved with 100 mesh sieve, microcrystalline cellulose 230g is added, mixes, particle is made, is done
It is dry, obtain medicinal granule of the present invention.
Embodiment 8
Bulk pharmaceutical chemicals are weighed by following proportion: (note: every part is 100g)
5 parts of adenophora tetraphylla, 4 parts of affine cudweed, 1 part of Radix Ophiopogonis of 5 parts of tussilago
2 portions of campanulaceae, 2 parts of Radix Glycyrrhizae of 1 portion of radices trichosanthis
(1) seven taste bulk pharmaceutical chemicals more than, the 70%v/v ethyl alcohol that add weight is 8 times of medicinal material total weight, cold soaking extraction 3 times, every time
8 hours, cooling bath is collected, filtration, filtrate recycling ethanol, being concentrated into relative density is 1.10, and centrifugation, supernatant adds ethyl alcohol to containing
Alcohol amount is 85%v/v, is placed, filtration, filtrate recycling ethanol, and concentration adds sodium benzoate 1g, honey 80g, adds water to stir evenly, boil,
Refrigeration, filtration, filtrate adjust pH value to 6.8, and filling, sterilizing is to get oral solution of the present invention.
Embodiment 9
Bulk pharmaceutical chemicals are weighed by following proportion: (note: every part is 100g)
10 parts of adenophora tetraphylla, 5 parts of affine cudweed, 10 parts of Radix Ophiopogonis of 10 parts of tussilago
6 portions of campanulaceae, 6 parts of Radix Glycyrrhizae of 10 portions of radices trichosanthis
(1) seven taste bulk pharmaceutical chemicals more than, the 95%v/v alcohol reflux that add weight is 8 times of medicinal material total weight twice, every time 1.5
Hour, then the water extraction that add weight is 8 times of medicinal material total weight is twice, 1 hour every time, filtration was concentrated respectively, dry, pulverize, and closed
And Chinese medical extract 1200g of the invention is obtained, it is spare；
(2) above-mentioned Chinese medical extract 200g is taken, 80 meshes are crossed, adds crosslinked polyvinylpyrrolidone microcrystalline cellulose 36g mixed
Even, granulation adds mannitol 110g, microcrystalline cellulose 48g, dispersible tablet of the present invention is made in tabletting.
Pharmacodynamics test
Pharmacodynamic tests prove that Chinese medical extract of the invention has apparent yin-nourishing, cough-relieving, anti-inflammatory, Immune-enhancing effect
Effect, can be used for respiratory disease and the cough as caused by respiratory disease, especially children chronic cough and Chinese medicine belongs to long
Cough impairment of yin, the card person of consumption of body fluid due to lung-dryness, specific test are as follows:
Experimental animal
Healthy Kunming mouse, half male and half female are purchased from Beijing dimension tonneau China；Healthy adult cavy, half male and half female are purchased from north
Tie up tonneau China in capital.
Experiment reagent
Thyroxin tablet: the second biochemical-pharmaceutical factory of Tianjin, lot number 960603
Reserpine: Nat'l Pharmaceutical & Biological Products Control Institute, lot number 041-8807
Citric acid: Tianjin Chemical Reagents Factory No.1, lot number 960321
Ammonium hydroxide: Tianjin Xinghua chemical reagent factory, lot number 920822
Yi Wensilan: China Drug Co., lot number 871225
Acetic acid: Tianjin Chemical Reagents Factory No.1, lot number 960329
Carbon black ink: Tianjin Ink Factory
Experimental drug
Nourishiing yin to clear away the lung-heat cream: the magnificent Medicines and Health Product Co., Ltd in Tianjin, lot number 940512
1, mouse yin-nourishing is tested
Healthy female Kunming mouse 72, be randomly divided into 6 groups by weight: blank control group, model group, positive drug compare
3 dosage group (2.4,4.8 and 9.6g of group (nourishiing yin to clear away the lung-heat cream) and administration group (Chinese medical extract prepared by the embodiment of the present invention 2)
Crude drug/kg), every group 12.Model and each administration group animal daily every oral administration gavage 3mg thyroxine, 0.02mg reserpine
And drug, continuous 6 days.In 1 hour after the last administration, weight is weighed；The threshold of pain is measured with hot plate method；Liver is taken, with sumptuous reagent
Method measures glycogen content.It the results are shown in Table 1.
1 radix adenophorea, tuber of dwarf lilyturf drug of table causes the influence of mouse yin-deficient model to thyroxine and reserpine
P < 0.01 compared with blank control group ## is infused,
* P < 0.05 compared with model group；
P < 0.01 compared with model group *.
Above-mentioned test result shows that mouse gives thyroxine and after reserpine six days, weight, the threshold of pain and liver occurs in animal
Glycogen content etc. is substantially reduced the deficiency of Yin symptom of (P value is respectively less than 0.01).Three dosage groups of radix adenophorea, tuber of dwarf lilyturf drug of the invention are equal
The weight loss caused by thyroid gland and reserpine can obviously be delayed (P value is respectively smaller than 0.05,0.01 and 0.05)；4.8 and
9.6g crude drug/kg can dose-dependently improve the reduction of liver glycogen (P value is respectively smaller than 0.05 and 0.01)；But the threshold of pain is reduced
Influence it is not statistically significant.Test result shows that radix adenophorea, tuber of dwarf lilyturf drug has obvious nourishing yin effect.
2, cavy antibechic is tested
Cavy 50, divide 5 groups at random by weight: model group, positive drug (nourishiing yin to clear away the lung-heat cream) control group, radix adenophorea, tuber of dwarf lilyturf drug
(Chinese medical extract prepared by the embodiment of the present invention 3) 3 dosage groups (1.2,2.4 and 4.8g crude drug/kg), every group 10, male and female
It is fifty-fifty.Animal oral administration gavage be administered 1ml/200g, continuous three days.After last dose 1 hour, cavy is placed in the close of 2L container
It closes in bell jar, 17.5% citric acid (at air velocity spray head about 15L/ minutes) is sprayed by spray head with the pressure of 600mmHg, spray
Mist 5 minutes, and record guinea pig cough's number and incubation period in 5 minutes.It is shown in Table 2 as the result is shown.
2 radix adenophorea, tuber of dwarf lilyturf drug of table is on guinea pig cough's number caused by citric acid and preclinical influence
* compared with model control group, P < 0.05
* is compared with model control group, P < 0.01
The above result shows that radix adenophorea, tuber of dwarf lilyturf drug has apparent antitussive effect.Wherein, 2.4 He of radix adenophorea, tuber of dwarf lilyturf oral solution
4.8g/kg can significantly reduce guinea pig cough's number caused by citric acid (P value is respectively less than 0.01), and can extend incubation period (P value is equal
Less than 0.05).
3, ammonium hydroxide causes mouse cough test
Kunming mouse 75,5 groups are randomly divided by weight: model group, positive drug (nourishiing yin to clear away the lung-heat cream) control group, the root of straight ladybell
Radix Ophiopogonis drug (Chinese medical extract prepared by the embodiment of the present invention 6) 1.2,2.4 and 4.8g crude drug/kg group, every group 15.Animal mouthful
Take gastric infusion, capacity 0.4ml/20g, continuous three days.It after last dose 1 hour, is placed in 500ml beaker, will contain
The cotton balls of 25% ammonium hydroxide of 0.1ml puts people, upper cover glass plate.Using the time for generating cough for the first time as incubation period, 3 are then recorded
Cough number in minute.It the results are shown in Table 3.
3 radix adenophorea, tuber of dwarf lilyturf drug of table is on ammonium hydroxide induced mice cough number and preclinical influence
* compared with model control group, P < 0.05
* is compared with model control group, P < 0.01
Above-mentioned test result shows radix adenophorea, tuber of dwarf lilyturf drug 2.4,4.8g crude drug/kg and nourishiing yin to clear away the lung-heat cream 4.8g crude drug/Kg energy
Significantly reduce the cough number (P value is respectively smaller than 0.01,0.01 and 0.01) of ammonium hydroxide induced mice, also, radix adenophorea, tuber of dwarf lilyturf drug
4.8g crude drug/kg can be obviously prolonged incubation period (P value is less than 0.05).
4, chmice acute peritonitis is tested
Kunming mouse 50,5 groups are randomly divided by weight, model group, positive drug (nourishiing yin to clear away the lung-heat cream) control group, the root of straight ladybell
Radix Ophiopogonis drug (Chinese medical extract prepared by the embodiment of the present invention 7) 1.2,2.4 and 4.8g crude drug/kg group, every group 10, male and female are each
Half.The administration of animal oral administration gavage, capacity 0.4ml/20g, continuous three days.After last dose 1 hour, tail vein injection 0.5%
Yi Wensilan 0.1ml/20g, after five minutes, in addition to model group intraperitoneal injection of saline 0.2ml/20g, remaining groups of animals abdomen
Chamber injects 0.7% acetic acid 0.2ml/20g, and interval breaked end mouse sacrificed by exsanguination after 30 minutes.Abdomen is rinsed by several times with physiological saline
Chamber merges flushing liquor and is diluted to 6ml, 0.1N NaOH 0.1ml is added, places 1 hour, and 1000xg is centrifuged 10 minutes, is taken
Clear liquid colorimetric at spectrophotometer 590nm records absorbance, and calculates inhibiting rate (inhibiting rate (%)=(model group OD value-
Administration group OD value)/model group OD × 100%), the results are shown in Table 4.
Influence of the 4 radix adenophorea, tuber of dwarf lilyturf drug of table to inflammation mouse peritoneal capillary permeability
* compared with model control group, P < 0.05
* is compared with model control group, P < 0.01
Above-mentioned test result shows radix adenophorea, tuber of dwarf lilyturf drug 2.4,4.8g/kg, can be substantially reduced the mouse abdomen as caused by acetic acid
The increase (P value is respectively smaller than 0.05 and 0.01) of chamber capillary permeability, therefore radix adenophorea, tuber of dwarf lilyturf drug is with apparent anti-inflammatory
Effect.
5, mouse Carbon grain Kuo clear law is tested
Kunming mouse 50, five groups are randomly divided by weight: model group, positive drug (nourishiing yin to clear away the lung-heat cream) control group, sand
Ginseng Radix Ophiopogonis drug (Chinese medical extract prepared by the embodiment of the present invention 8) 1.2,2.4 and 4.8g crude drug/kg group, every group 10, male and female
It is fifty-fifty.The administration of animal oral administration gavage, capacity 0.4ml/20g, continuous 7 days.After last dose 1 hour, tail vein injection carbon
Plain ink 0.2ml/20g after injection at 1 minute and 5 minutes, takes 20 μ l of blood from retroorbital venous clump, is dissolved in 2ml0.1%Na2CO3
Solution shakes up, the colorimetric at ultraviolet specrophotometer wavelength 600nm, with 0.1%Na2CO3Solution makees blank control, measures extinction
It spends (OD), finally puts to death mouse cervical dislocation, weigh liver and spleen weight amount respectively, and calculate and clean up index K (note: K=
(logOD1-logOD2)/(t2-t1)) and correction clean up index α (note: α=weight/(liver weight+spleen weight) × K1/3), it the results are shown in Table
5。
Influence of the 5 radix adenophorea, tuber of dwarf lilyturf drug of table to mouse reticuloendothelial system phagocytic function
* compared with model control group, P < 0.05
* is compared with model control group, P < 0.01
Above-mentioned test result shows radix adenophorea, tuber of dwarf lilyturf drug 2.4,4.8g/kg and can significantly improve to clean up index K and correction is wide
Clear index α (P value is respectively smaller than 0.05 and 0.01).It is bright to show that radix adenophorea, tuber of dwarf lilyturf drug has the phagocytic function of reticuloendothelial system
Aobvious activation and humidification, therefore immune function can be enhanced, intensity is suitable with nourishiing yin to clear away the lung-heat cream.
Claims (13)
1. it is a kind of for treating the Chinese medical extract of respiratory disease, it is made of the raw material extraction of following parts by weight:
1~10 part of adenophora tetraphylla, 1~10 part of affine cudweed, 1~10 part of tussilago, 1~10 part of Radix Ophiopogonis, 1~6 part of campanulaceae, radices trichosanthis 1
~10 parts and 1~6 part of Radix Glycyrrhizae.
2. Chinese medical extract according to claim 1, wherein raw material of the Chinese medical extract by following parts by weight
Extraction is made: 1~5 part of adenophora tetraphylla, 1~5 part of affine cudweed, 1~5 part of tussilago, 1~5 part of Radix Ophiopogonis, 1~3 part of campanulaceae, radices trichosanthis 1
~5 parts and 1~3 part of Radix Glycyrrhizae；
Preferably, the Chinese medical extract is made of the raw material extraction of following parts by weight: 10 parts of adenophora tetraphylla, affine cudweed 10
Part, 10 parts of tussilago, 10 parts of Radix Ophiopogonis, 6 parts of campanulaceae, 10 parts of radices trichosanthis and 6 parts of Radix Glycyrrhizae.
3. a kind of method for preparing Chinese medical extract of any of claims 1 or 2, the described method comprises the following steps:
(1) each raw material is taken in proportion, and extracting in water obtains extracting solution；
(2) extracting solution obtained by step (1) is filtered, it is 1.05~1.30 that filtrate, which is concentrated into relative density, then plus ethanol water
It is 30~85%v/v to alcohol content, places, filtration, filtrate concentration；Or
It the described method comprises the following steps:
(1 ') takes each raw material in proportion, adds 50%v/v~95%v/v ethanol water to extract, obtains extracting solution；
(2 ') filter extracting solution obtained by step (1 '), filtrate concentration.
4. according to the method described in claim 3, wherein the step (2 ') further comprises following step: being concentrated by filtrate
Afterwards, it is 30~85%v/v that ethanol water to alcohol content is added into concentrate, is placed, filtration, filtrate concentration.
5. according to the method described in claim 3, the weight for the water being wherein added in step (1) is the 1~40 of raw material gross weight
Times；The extraction carries out 1~4 time, every time 0.5~12h；Or
The weight for the ethanol water being wherein added in step (1 ') is 1~40 times of raw material gross weight；The extraction carries out 1~
4 times, 0.5~12h every time.
6. according to the method described in claim 3, wherein:
Extraction in the step (1) or (1 ') is carried out by cold-maceration, circumfluence method or percolation；And/or
Concentration in the step (2) or (2 ') is normal pressure concentration, reduced pressure or film concentration.
7. method according to any one of claim 3 to 6, wherein further including in the step (2) or (2 ') will be last
The concentrate that is concentrated to get of filtrate is dry, the step of crushing；Preferably, the drying in the step (2) or (2 ') is contact
Drying, pneumatic conveying drying, tunnel type is dry, be dried under reduced pressure, fluidized drying, spray drying, freeze-drying, far-infrared ray drying or microwave
It is dry.
8. method according to any one of claim 3 to 6, wherein it is added in step (2) or (2 ') into concentrate
The ethanol water is 95%v/v ethanol water.
9. a kind of for treating the pharmaceutical preparation of respiratory disease, it includes Chinese medical extract of any of claims 1 or 2 and medicines
Acceptable auxiliary material on.
10. pharmaceutical preparation according to claim 9, wherein the pharmaceutical preparation is granule, tablet, capsule, syrup
Agent or oral solution；Preferably, the tablet is buccal tablet, oral disintegrating tablet or dispersible tablet.
11. a kind of method for preparing pharmaceutical preparation described in claim 9 or 10 comprising following steps: by claim 1 or
Chinese medical extract described in 2 is mixed with pharmaceutically acceptable auxiliary material, is further prepared into the pharmaceutical preparation.
12. Chinese medical extract of any of claims 1 or 2 is in preparation for treating respiratory disease or being drawn by respiratory disease
Purposes in the drug of the cough risen.
13. purposes described in claim 12, wherein the cough as caused by respiratory disease is children chronic cough, breathing
It coughs after road infection cough or respiratory tract infection.
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| CN101134092A (en) * | 2006-08-31 | 2008-03-05 | 天津药物研究院 | Traditional Chinese medicine compound preparations for treating respiratory disease and method for preparing the same |
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| CN102813715A (en) * | 2012-09-06 | 2012-12-12 | 江苏省中医院 | Compound medicine for treating post-infectious cough and preparation method and application thereof |
| CN103432386A (en) * | 2013-08-19 | 2013-12-11 | 湖北丽益医药科技有限公司 | Chinese traditional medicine preparation for treating coughs and preparation method of same |
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Application publication date: 20181207 |