CN110314179A - A kind of sucking compound campanulaceae cough-relieving pharmaceutical solutions and preparation method thereof - Google Patents
A kind of sucking compound campanulaceae cough-relieving pharmaceutical solutions and preparation method thereof Download PDFInfo
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- CN110314179A CN110314179A CN201810268091.5A CN201810268091A CN110314179A CN 110314179 A CN110314179 A CN 110314179A CN 201810268091 A CN201810268091 A CN 201810268091A CN 110314179 A CN110314179 A CN 110314179A
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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)
- A61K36/28—Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
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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)
- A61K36/34—Campanulaceae (Bellflower family)
- A61K36/346—Platycodon
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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)
- A61K36/69—Polygalaceae (Milkwort family)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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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
- A61K2236/33—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
-
- 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
-
- 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
Abstract
The present invention relates to a kind of sucking compound campanulaceae cough-relieving pharmaceutical solutions and preparation method thereof, belong to galenic pharmacy field.The pharmaceutical solutions are made of following Chinese medicine material medicine and auxiliary material: (1) campanulaceae, honey polygala root, sweet tussilago, Radix Glycyrrhizae;(2) isotonic agent and solvent.Wherein, sucking campanulaceae, honey polygala root used in compound campanulaceae cough-relieving pharmaceutical solutions, sweet tussilago and Radix Glycyrrhizae amount ratio are as follows: 80-200:20-60:10-30:5-20.Sucking compound campanulaceae cough-relieving pharmaceutical solutions provided by the invention, can quickly form aerosol by atomizer, the aerosol of formation can be by direct snap action at sufferer, and the drug for acting on affected part can quickly be absorbed action;Not only dosage is few, and rapid-action, good effect, without other toxic side effects.
Description
Technical field
The present invention relates to a kind of sucking compound campanulaceae cough-relieving pharmaceutical solutions and preparation method thereof, belong to galenic pharmacy field.
Background technique
Compound campanulaceae cough-relieving prescription is grouped as by campanulaceae, honey polygala root, the sweet groups such as tussilago and Radix Glycyrrhizae.Campanulaceae: promoting the dispersing function of the lung, benefit
Pharynx, eliminating the phlegm, apocenosis;Honey polygala root: tranquilize the mind and promote the intelligence, restoring normal coordination between heart and kidney, eliminating the phlegm, detumescence;Sweet tussilago: moistening lung to lower qi is relieving cough and reducing sputum;It is sweet
Grass: invigorating the spleen and benefiting qi, clearing heat and detoxicating, expelling phlegm and arresting coughing, relieving spasm to stop pain, coordinating the drug actions of a prescription.
There was only tablet currently with the dosage form that compound campanulaceae recipe development goes out, P-Cymene is a kind of classical Chinese patent drug,
For eliminating the phlegm, antibechic.CN1365724A discloses a kind of nano compound antitussive platycodon root medicine and preparation method thereof, but limits
It does not include inhalant in pill, powder, tablet, suppository etc..The tablet listed at present, oral dosage is larger, cannot directly act on
In patient part, the first pass effect by liver is needed, into circulatory system effect in patient part, is worked slower, certain
The medication of patient is limited in degree.
Sucking preparation is that drug dispersion nebulizes by propellant, compressed air or special device, and it is molten to form medicine air
Glue makes drug directly reach site of action.The inhalant dosage form listed at present has dry powder sucking, aerosol and inhalation solution.Dry powder
Sucking needs the device by Special complex, and complicated structure results in the raising of device production cost, is unfavorable for universal trouble
Person affects effective control of disease to the compliance of suction apparatus, frequency of use and dry powder Transfer Technology.Aerosol needs
Pressure vessel and valve system, higher cost need cooling and filling mechanical equipment, and preparation manipulation is cumbersome, aerosol
It with certain internal pressure, heat or easily explodes after being impacted, while borrowing the pressure of the vapour pressure of propellant and working, it can be because
The leakage of propellant and fail.
And aerosol inhalation solution preparation can directly act on patient part as respiratory tract or pulmonary administration preparation, it can
The administration concentration of respiratory tract or lung is improved, it is rapid-action, and said preparation avoids the first pass effect of liver, reduces the administration of drug
Dosage improves drug bioavailability, and reduces drug in the distribution of its hetero-organization, reduces side effect, has inhalation thorn
Swash small, easy to use, good patient compliance, toxic side effect it is small, be suitable for long-term treatment the advantages that, the World Health Organization it has been recommended that
It is the preferred therapy of the respiratory diseases such as asthma, eliminating the phlegm, tracheitis, bronchitis, pneumonia, chronic obstructive pulmonary disease.Neulized inhalation at present
The product listed with pharmaceutical solutions is relatively fewer, predominantly imported product.Clinically with injection application Neulized inhalation the case where
It is more, but there is no the application method of specification in specification, there is security risk in use.
Sucking with compound campanulaceae cough-relieving solution eliminating the phlegm, in terms of, it is contemplated that will have good curative effect, but the prior art
There is no sucking compound campanulaceae cough-relieving solution special preparations, research and develop the aerosol inhalation solution preparation of compound campanulaceae, are industry
Boundary's technical problem urgently to be resolved, and have good vast market prospect.
Summary of the invention
The invention mainly solves the technical problem of providing one kind safely, effectively, the sucking of good quality compound campanulaceae
Cough-relieving pharmaceutical solutions;The present invention also provides the preparation methods of said preparation, and the preparation method is simple to operation, are conducive to industrial metaplasia
It produces.
An object of the present invention is to provide that a kind of bioavilability is high, directly acts on lesions position, is rapid-action, more pacifying
Complete effective sucking compound campanulaceae cough-relieving pharmaceutical solutions, are achieved through the following technical solutions:
A kind of sucking compound campanulaceae cough-relieving pharmaceutical solutions, the pharmaceutical solutions are by following Chinese medicine material medicine and auxiliary material system
At:
(1) campanulaceae, honey polygala root, sweet tussilago, Radix Glycyrrhizae;
(2) isotonic agent and solvent;
Wherein, sucking campanulaceae, honey polygala root used in compound campanulaceae cough-relieving pharmaceutical solutions, sweet tussilago and Radix Glycyrrhizae use
Measure ratio are as follows: 80-200:20-60:10-30:5-20.
In sucking compound campanulaceae cough-relieving pharmaceutical solutions of the present invention, as a preferred embodiment, campanulaceae, honey
Radix Polygalae, sweet tussilago, Radix Glycyrrhizae amount ratio are as follows: 100-160:30-45:15-25:10-18;As a kind of preferred embodiment party
Formula, campanulaceae, honey polygala root, sweet tussilago, Radix Glycyrrhizae amount ratio are as follows: 120-150:35-40:20-25:12-15.
Sucking of the present invention is used in compound campanulaceae cough-relieving pharmaceutical solutions, as a preferred implementation manner, the solvent
For purified water, water for injection or sterile water for injection.
In sucking compound campanulaceae cough-relieving pharmaceutical solutions of the present invention, isotonic agent refers to inorganic salts isotonic agent or carbohydrate
Isotonic agent.The inorganic salts isotonic agent is one of sodium chloride, magnesium chloride, calcium chloride or a variety of, preferably sodium chloride;Institute
Stating carbohydrate isotonic agent is one of glucose, fructose, mannitol or a variety of, preferably glucose.
In sucking compound campanulaceae cough-relieving pharmaceutical solutions of the present invention, isotonic agent containing inorganic salts in each preparation unit
Amount be 0.1%-0.9%, preferably 0.1%-0.8%, more preferable 0.2%-0.5%.The sucking is molten with the cough-relieving of compound campanulaceae
The amount of the isotonic agent containing carbohydrate is 1%-10%, preferably 1%-8%, more preferable 2%-6% in each preparation unit of liquid formulation.
The sucking of the present invention preferred 3.0-8.5 of pH value of compound campanulaceae cough-relieving pharmaceutical solutions, more preferable pH value are
5.0-8.0 most preferably 6-7.The preferably common inorganic acid of pH adjusting agent or inorganic base;The pH adjusting agent is selected from hydrochloric acid, phosphorus
Acid, citric acid, glacial acetic acid, sodium hydroxide, potassium hydroxide, potassium dihydrogen phosphate, sodium dihydrogen phosphate, disodium hydrogen phosphate or phosphoric acid hydrogen two
One of potassium is a variety of, preferably hydrochloric acid and sodium hydroxide.
It, can also be conventionally according to application or form to the present invention in addition, in the case where not adversely affecting
Atomized inhalation in carrier appropriate and/or one or more additives is added.The carrier can be for conventionally used for preparation
Carrier of semisolid dosage form or liquid dosage form, such as water, aqueous solvent or oil-based solvent etc..Specifically, the carrier can be
Water and/or physiological saline.The additive can be, such as thickener, sugar, sugar alcohol, acid mucopolysaccharide, surfactant, anti-
One of rotten agent, disinfectant, tonicity agents, stabilizer, cosolvent etc. are a variety of.
In the present invention, gained aerosol inhalation solution preparation is made with ultrasonic atomizer or air compression type atomizer
Sucking is directly sucked in respiratory system with compound campanulaceae cough-relieving solution with atomised form, directly acts on lesions position, rapid-action, more
Safely and effectively.
The second object of the present invention is to provide a kind of preparation method of sucking compound campanulaceae cough-relieving solution, the method
Include:
(1) raw material campanulaceae, honey polygala root, sweet tussilago, Radix Glycyrrhizae are weighed according to prescription ratio;
(2) it taking campanulaceae to add water to cook 1-3 times, adds 8-12 times of water, decoct 1-4h, filtering, merging filtrate is concentrated, and it is cooling, add
Ethyl alcohol is to ethanol content 50-95%, standing 8h or more after stirring evenly, and filtration recycles filtrate, water is added to cross macroporous resin column, washes, then
Add ethanol elution, collect eluent, recycles ethyl alcohol, be concentrated to dryness, obtain campanulaceae effective component;
(3) honey polygala root, sweet tussilago, Radix Glycyrrhizae is taken to add water to cook 1-3 times, every time plus 8-12 times of water is measured, and decocts 1-4h, filter
It crosses, merging filtrate, adds ethyl alcohol to alcohol content 50-95%, stir evenly, stand 8h or more, ethyl alcohol is recycled in filtration, adds water, stands 12h
More than, filtration, ultrafiltration is concentrated to dryness, and obtains honey polygala root, sweet tussilago, effective liquorice;
(4) it takes campanulaceae effective component and honey polygala root, sweet tussilago, effective liquorice that water dissolution is added, merges, add water to
Half measures, and stirs evenly, and stands more than for 24 hours, filtration, and ultrafiltration adds water to full dose, adjusts pH value to 3.0-8.5, isotonic agent is added, filters, fills
Envelope, sterilizing to get.
In the above preparation method, it adds water to cook 2 times in the step (2), adds every time as a preferred implementation manner,
8-10 times of water, 2-3h is decocted every time, adds ethyl alcohol to alcohol content 70-85% after merging filtrate, 12h or more is stood after stirring evenly, adds 4 times
Amount water crosses macroporous resin column, and elution uses 20-60% ethyl alcohol.
In the above preparation method, it adds water to cook 2 times in the step (3), adds every time as a preferred implementation manner,
8-10 times of water, decoct 2-3h every time, after decocting filtration merging filtrate, add ethyl alcohol to alcohol content 70-85%, stir evenly standing 12 with
On, recycling ethyl alcohol is stood more than for 24 hours after adding water.
In the above preparation method, as a preferred implementation manner, in the step (4), preferably by the pH value of solution
It is adjusted to 5.0-8.0, the pH value of solution is more preferably adjusted to 6.0-7.0.
Sucking of the present invention has the effect of eliminating the phlegm, antibechic with compound campanulaceae cough-relieving pharmaceutical solutions, can be used for eliminating the phlegm,
Cough-relieving etc..Therefore, the third object of the present invention is to provide a kind of sucking compound campanulaceae cough-relieving pharmaceutical solutions and treats in preparation
Effect in the drug of respiratory disease, the respiratory disease include but is not limited to abundant expectoration, cough and asthma etc..
Compared with prior art, the present invention has the following technical effect that
1, sucking compound campanulaceae cough-relieving pharmaceutical solutions provided by the invention, it is molten can quickly to form gas by atomizer
The aerosol of glue, formation can be by direct snap action at sufferer, and the drug for acting on affected part can quickly be absorbed action;
Not only dosage is few, and rapid-action, good effect, without other toxic side effects.
2, the novel form of compound campanulaceae provided by the invention, is dissolved in drug in suitable media, borrows atomizer molten with gas
Glue form, oral or nasal inhalation delivery to respiratory tract or lung are administered through site of action, reduce drug in other organizers
The drug concentration of the distribution of official, local lesion is high.
And stimulate gastric mucosa for former dosage form tablet, after clothes, dosage is excessive, can cause mild nausea, or even vomiting, stomach and
Duodenal ulcer is used with caution.For oral administration, the treatment of nebulizer administration mode will not generate the secondary of stimulating intestine and stomach and make
With, while total effective rate greatly improves, and has safely and effectively, the feature that bioavilability is high, toxic side effect is small, thus have bright
Aobvious advantage.
3, pharmaceutical solutions prepared by the present invention compensate for the blank on domestic market, and solution prepared by the present invention
Preparation is to aim at Neulized inhalation to be designed with patient, is matched with atomizer, use process is convenient.It can avoid oral administration simultaneously
The required first pass effect by liver, is damaged to caused by patient, increases the compliance of patient, for being inconvenient to the youngster being administered orally
Child is a kind of good administration route.
Specific embodiment
The dosage of substance used in substance used in the production process and preparation of following pharmaceutical preparation embodiment or preparation is not limited to
Character express, all formulation methods containing pharmaceutical composition provided by the invention, all belongs to the scope of protection of the present invention.
Embodiment 1
Sucking compound campanulaceae cough-relieving solution 1000ml:
It weighing campanulaceae to add water to cook 3 times, adds 12 times of water, decoct 4h, filtering, merging filtrate is concentrated, and it is cooling, add ethyl alcohol extremely
Ethanol content 70% stands 8h or more after stirring evenly, filtrate is recycled in filtration, adds 4 times of water, crosses macroporous resin column, washes, then plus
40% ethanol elution collects eluent, recycles ethyl alcohol, is concentrated to dryness, obtains campanulaceae effective component;Weigh honey polygala root, sweet coltsfoot
Flower, Radix Glycyrrhizae add water to cook 3 times, add 12 times of water amounts, decoct 4h, filter, merging filtrate, and ethyl alcohol is added to stir evenly to ethanol content 80%,
12h or more is stood, ethyl alcohol is recycled in filtration, adds water, stands more than for 24 hours, and filtration, ultrafiltration is concentrated to dryness, and obtains honey polygala root, sweet money
Coltsfoot, effective liquorice;It takes campanulaceae effective component and honey polygala root, sweet tussilago, effective liquorice that water dissolution is added, closes
And half amount is added water to, it stirs evenly, stands more than for 24 hours, filtration, ultrafiltration adds water to full dose, adjusts pH value to 3, isotonic agent, filter is added
Cross, encapsulating, sterilizing to get.
Embodiment 2
Sucking compound campanulaceae cough-relieving solution 1000ml:
It weighing campanulaceae to add water to cook 3 times, adds 8 times of water, decoct 2h, filtering, merging filtrate is concentrated, and it is cooling, add ethyl alcohol to second
Alcohol content 85% stands 12h or more after stirring evenly, filtrate is recycled in filtration, adds 4 times of water, crosses macroporous resin column, washes, then plus 40%
Ethanol elution collects eluent, recycles ethyl alcohol, is concentrated to dryness, obtains campanulaceae effective component;Weigh honey polygala root, sweet tussilago, sweet
Grass adds water to cook 3 times, adds 10 times of water amounts, decocts 3h, filtration, and merging filtrate adds ethyl alcohol to ethanol content 80%, stirs evenly, stand
Ethyl alcohol is recycled in 12h or more, filtration, adds water, stands more than for 24 hours, and filtration, ultrafiltration is concentrated to dryness, and obtains honey polygala root, sweet coltsfoot
Flower, effective liquorice;It takes campanulaceae effective component and honey polygala root, sweet tussilago, effective liquorice that water dissolution is added, merges,
Half amount is added water to, is stirred evenly, is stood more than for 24 hours, filtration, ultrafiltration, full dose is added water to, isotonic agent is added in tune pH value to 5.5, it filters,
Encapsulating, sterilizing to get.
Embodiment 3
Sucking compound campanulaceae cough-relieving solution 1000ml:
It weighing campanulaceae to add water to cook 3 times, adds 10 times of water, decoct 2h, filtering, merging filtrate is concentrated, and it is cooling, add ethyl alcohol extremely
Ethanol content 80% stands 12h or more after stirring evenly, filtrate is recycled in filtration, adds 4 times of water, crosses macroporous resin column, washes, then plus
40% ethanol elution collects eluent, recycles ethyl alcohol, is concentrated to dryness, obtains campanulaceae effective component;Weigh honey polygala root, sweet coltsfoot
Flower, Radix Glycyrrhizae add water to cook 2 times, add 10 times of water amounts, decoct 2h, filter, merging filtrate, and ethyl alcohol is added to stir evenly to ethanol content 80%,
12h or more is stood, ethyl alcohol is recycled in filtration, adds water, stands more than for 24 hours, and filtration, ultrafiltration is concentrated to dryness, and obtains honey polygala root, sweet money
Coltsfoot, effective liquorice;It takes campanulaceae effective component and honey polygala root, sweet tussilago, effective liquorice that water dissolution is added, closes
And half amount is added water to, it stirs evenly, stands more than for 24 hours, filtration, ultrafiltration adds water to full dose, adjusts pH value to 6.5, isotonic agent, filter is added
Cross, encapsulating, sterilizing to get.
Embodiment 4
Sucking compound campanulaceae cough-relieving solution 1000ml:
It weighing campanulaceae to add water to cook 2 times, adds 8 times of water, decoct 2h, filtering, merging filtrate is concentrated, and it is cooling, add ethyl alcohol to second
Alcohol content 80% stands 12h or more after stirring evenly, filtrate is recycled in filtration, adds 4 times of water, crosses macroporous resin column, washes, then plus 40%
Ethanol elution collects eluent, recycles ethyl alcohol, is concentrated to dryness, obtains campanulaceae effective component;Weigh honey polygala root, sweet tussilago, sweet
Grass adds water to cook 2 times, adds 10 times of water amounts, decocts 2h, filtration, and merging filtrate adds ethyl alcohol to ethanol content 80%, stirs evenly, stand
Ethyl alcohol is recycled in 12h or more, filtration, adds water, stands more than for 24 hours, and filtration, ultrafiltration is concentrated to dryness, and obtains honey polygala root, sweet coltsfoot
Flower, effective liquorice;It takes campanulaceae effective component and honey polygala root, sweet tussilago, effective liquorice that water dissolution is added, merges,
Half amount is added water to, is stirred evenly, is stood more than for 24 hours, filtration, ultrafiltration adds water to full dose, adjusts pH value to 7, isotonic agent is added, filters, fills
Envelope, sterilizing to get.
Embodiment 5
Sucking compound campanulaceae cough-relieving solution 1000ml:
It weighing campanulaceae to add water to cook 2 times, adds 8 times of water, decoct 3h, filtering, merging filtrate is concentrated, and it is cooling, add ethyl alcohol to second
Alcohol content 80% stands 12h or more after stirring evenly, filtrate is recycled in filtration, adds 4 times of water, crosses macroporous resin column, washes, then plus 40%
Ethanol elution collects eluent, recycles ethyl alcohol, is concentrated to dryness, obtains campanulaceae effective component;Weigh honey polygala root, sweet tussilago, sweet
Grass adds water to cook 2 times, adds 10 times of water amounts, decocts 2h, filtration, and merging filtrate adds ethyl alcohol to ethanol content 80%, stirs evenly, stand
Ethyl alcohol is recycled in 12h or more, filtration, adds water, stands more than for 24 hours, and filtration, ultrafiltration is concentrated to dryness, and obtains honey polygala root, sweet coltsfoot
Flower, effective liquorice;It takes campanulaceae effective component and honey polygala root, sweet tussilago, effective liquorice that water dissolution is added, merges,
Half amount is added water to, is stirred evenly, is stood more than for 24 hours, filtration, ultrafiltration, full dose is added water to, isotonic agent is added in tune pH value to 5.5, it filters,
Encapsulating, sterilizing to get.
Embodiment 6
Sucking compound campanulaceae cough-relieving solution 1000ml:
It weighing campanulaceae to add water to cook 2 times, adds 10 times of water, decoct 2h, filtering, merging filtrate is concentrated, and it is cooling, add ethyl alcohol extremely
Ethanol content 80% stands 12h or more after stirring evenly, filtrate is recycled in filtration, adds 4 times of water, crosses macroporous resin column, washes, then plus
40% ethanol elution collects eluent, recycles ethyl alcohol, is concentrated to dryness, obtains campanulaceae effective component;Weigh honey polygala root, sweet coltsfoot
Flower, Radix Glycyrrhizae add water to cook 2 times, add 10 times of water amounts, decoct 2h, filter, merging filtrate, and ethyl alcohol is added to stir evenly to ethanol content 80%,
12h or more is stood, ethyl alcohol is recycled in filtration, adds water, stands more than for 24 hours, and filtration, ultrafiltration is concentrated to dryness, and obtains honey polygala root, sweet money
Coltsfoot, effective liquorice;It takes campanulaceae effective component and honey polygala root, sweet tussilago, effective liquorice that water dissolution is added, closes
And half amount is added water to, it stirs evenly, stands more than for 24 hours, filtration, ultrafiltration adds water to full dose, adjusts pH value to 7.0, isotonic agent, filter is added
Cross, encapsulating, sterilizing to get.
Beneficial effects of the present invention are further illustrated below by way of test example:
Patient 75 of patient diagnosis cough phlegm asthma, between 10-47 years old age, clinical manifestation is different degrees of cough phlegm
Asthma.It is divided into observation group 1, observation group 2, observation group 3, observation group 4 and control group according to medical sequencing, every group of case is in year
Age, severity extent, the course of disease etc. substantially close to.
At 10-45 years old 1 age of observation group, 15 people, average age 33.5 years old, the course of disease 3-4 days, the sucking for giving embodiment 1 was used
Compound campanulaceae cough-relieving pharmaceutical solutions carry out atomization inspiration treatment, and three times, each 2ml, the course for the treatment of is 3 days for daily administration;
At 11-47 years old 2 age of observation group, 15 people, average age 30.4 years old, the course of disease 3-4 days, the sucking for giving embodiment 3 was used
Compound campanulaceae cough-relieving pharmaceutical solutions carry out atomization inspiration treatment, and three times, each 2ml, the course for the treatment of is 3 days for daily administration;
At 10-46 years old 3 age of observation group, 15 people, average age 32.8 years old, the course of disease 3-4 days, the sucking for giving embodiment 5 was used
Compound campanulaceae cough-relieving pharmaceutical solutions carry out atomization inspiration treatment, and three times, each 2ml, the course for the treatment of is 3 days for daily administration;
At 11-45 years old 4 age of observation group, 15 people, average age 31.5 years old, the course of disease 3-4 days, the sucking for giving embodiment 6 was used
Compound campanulaceae cough-relieving pharmaceutical solutions carry out atomization inspiration treatment, and three times, each 2ml, the course for the treatment of is 3 days for daily administration;
At 9-45 years old control group age, 15 people, average age 31.8 years old, the course of disease 3-4 days, control group gave compound campanulaceae cough-relieving
Piece (Tonghua Zhong Chen medicine company Co., Ltd) carries out oral medication three times per day, and 4 tablets once, and the course for the treatment of 3 days.
Criterion of therapeutical effect: (1) clinic control: without cough after treatment 3 days, no phlegm, no asthma, (2) are effective: without cough or only slight cough
It coughs, no phlegm or phlegm are few, and asthma is subsided;(3) effectively: treatment 3 days or more clinical symptoms and pharyngeal sign are clearly better;(4) invalid:
After treatment 3 days, clinical symptoms and pharyngeal sign are panted without improving or aggravating without alleviation.Specifically it see the table below:
Three groups of patient's curative effects of table compare [n (%)]
Thus table can be seen that observation group 1, observation group 2, observation group 3 and observation group 4 compared with the control group, in eliminating the phlegm town
The therapeutic effect that cough has had, and four groups of therapeutic effect is significantly better than control group (P < 0.05).
Claims (13)
1. a kind of sucking compound campanulaceae cough-relieving pharmaceutical solutions, the pharmaceutical solutions are made of following Chinese medicine material medicine and auxiliary material:
(1) campanulaceae, honey polygala root, sweet tussilago, Radix Glycyrrhizae;
(2) isotonic agent and solvent.
2. sucking compound campanulaceae cough-relieving pharmaceutical solutions according to claim 1, wherein campanulaceae, honey polygala root, sweet tussilago
With the amount ratio of Radix Glycyrrhizae are as follows: 80-200:20-60:10-30:5-20.
3. sucking compound campanulaceae cough-relieving pharmaceutical solutions according to claim 1 or 2, which is characterized in that the campanulaceae,
The amount ratio of honey polygala root, sweet tussilago and Radix Glycyrrhizae is 100-160:30-45:15-25:10-18;Preferred campanulaceae, honey polygala root, honey
The amount ratio of tussilago and Radix Glycyrrhizae is 120-150:35-40:20-25:12-15.
4. compound campanulaceae cough-relieving pharmaceutical solutions according to claim 1-3, which is characterized in that the solvent is pure
Change water, water for injection or sterile water for injection.
5. compound campanulaceae cough-relieving pharmaceutical solutions according to claim 1-4, which is characterized in that the isotonic agent
Refer to inorganic salts isotonic agent or carbohydrate isotonic agent;The inorganic salts isotonic agent is sodium chloride, magnesium chloride, one in calcium chloride
Kind is a variety of, preferably sodium chloride;The carbohydrate isotonic agent be one of glucose, fructose, mannitol or a variety of, preferably
Glucose.
6. compound campanulaceae cough-relieving pharmaceutical solutions according to claim 5, which is characterized in that contain in each preparation unit
The amount of inorganic salts isotonic agent is 0.1%-0.9%, preferably 0.1%-0.8%, more preferable 0.2%-0.5%;Each system
The amount of the isotonic agent containing carbohydrate is 1%-10%, preferably 1%-8%, more preferable 2%-6% in agent unit.
7. compound campanulaceae cough-relieving pharmaceutical solutions according to claim 1-6, which is characterized in that the pharmaceutical solutions
Further include pH adjusting agent, the pH adjusting agent be selected from hydrochloric acid, phosphoric acid, citric acid, glacial acetic acid, sodium hydroxide, potassium hydroxide,
One of potassium dihydrogen phosphate, sodium dihydrogen phosphate, disodium hydrogen phosphate or dipotassium hydrogen phosphate are a variety of, preferably hydrochloric acid and hydroxide
Sodium;The dosage of the pH adjusting agent makes the compound campanulaceae cough-relieving pharmaceutical solutions pH value 3.0-8.5, and more preferable pH value is
5.0-8.0 most preferably 6-7.
8. compound campanulaceae cough-relieving pharmaceutical solutions according to claim 1-7, which is characterized in that the pharmaceutical solutions
Further include carrier appropriate and/or one or more additives, the carrier can for conventionally used for prepare semisolid dosage form or
The carrier of liquid dosage form, selected from water, aqueous solvent or oil-based solvent etc., it is preferred that the carrier can be water and/or physiology salt
Water;The additive can for thickener, sugar, sugar alcohol, acid mucopolysaccharide, surfactant, preservative, disinfectant, tonicity agents,
One of stabilizer, cosolvent etc. are a variety of.
9. the preparation method that compound campanulaceae cough-relieving pharmaceutical solutions are used in the described in any item suckings of claim 1-8, which is characterized in that
It in turn includes the following steps:
(1) raw material campanulaceae, honey polygala root, sweet tussilago, Radix Glycyrrhizae are weighed according to prescription ratio;
(2) it taking campanulaceae to add water to cook 1-3 times, adds 8-12 times of water, decoct 1-4h, filtering, merging filtrate is concentrated, and it is cooling, add ethyl alcohol
To ethanol content 50-95%, 8h or more is stood after stirring evenly, filtration recycles filtrate, water is added to cross macroporous resin column, washes, then plus second
Alcohol elution, collects eluent, recycles ethyl alcohol, is concentrated to dryness, obtains campanulaceae effective component;
(3) honey polygala root, sweet tussilago, Radix Glycyrrhizae is taken to add water to cook 1-3 times, every time plus 8-12 times of water is measured, and decocts 1-4h, is filtered, and is closed
And filtrate, add ethyl alcohol to stir evenly to ethanol content 50-95%, stand 8h or more, ethyl alcohol is recycled in filtration, adds water, stand 12h with
On, filtration, ultrafiltration is concentrated to dryness, and obtains honey polygala root, sweet tussilago, effective liquorice;
(4) it takes campanulaceae effective component and honey polygala root, sweet tussilago, effective liquorice that water dissolution is added, merges, add water to half
Amount, stirs evenly, and stands more than for 24 hours, filtration, and ultrafiltration adds water to full dose, adjusts pH value to 3.0-8.5, isotonic agent is added, filters, fills
Envelope, sterilizing to get.
10. preparation method according to claim 9, which is characterized in that preferably add water to cook 2 times in the step (2), often
It is secondary to add 8-10 times of water, 2-3h is decocted every time, adds ethyl alcohol to alcohol content 70-85% after merging filtrate, standing 12h or more after stirring evenly,
4 times of amount water are added to cross macroporous resin column, elution uses 20-60% ethyl alcohol.
11. any preparation method according to claim 9-10, which is characterized in that preferably add water in the step (3)
It decocts 2 times, every time plus 8-10 times of water, decocts 2-3h every time, decoct after filtering merging filtrate, add ethyl alcohol to alcohol content 70-85%,
It stirs evenly and stands 12h or more, recycling ethyl alcohol is stood more than for 24 hours after adding water.
12. any preparation method according to claim 9-11, which is characterized in that, preferably will be molten in the step (4)
The pH value of liquid is adjusted to 5.0-8.0, and the pH value of solution is more preferably adjusted to 6.0-7.0.
13. the described in any item suckings of claim 1-8 treat respiratory disease in preparation with compound campanulaceae cough-relieving pharmaceutical solutions
Drug in effect, more specifically preparation eliminating the phlegm, antibechic drug in effect.
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