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 PDF

Info

Publication number
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
Authority
CN
China
Prior art keywords
campanulaceae
water
cough
pharmaceutical solutions
compound
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
CN201810268091.5A
Other languages
Chinese (zh)
Inventor
张保献
胡杰
王志华
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Beijing Kerui Innovative Drug Research Co Ltd
Original Assignee
Beijing Kerui Innovative Drug Research Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Beijing Kerui Innovative Drug Research Co Ltd filed Critical Beijing Kerui Innovative Drug Research Co Ltd
Priority to CN201810268091.5A priority Critical patent/CN110314179A/en
Publication of CN110314179A publication Critical patent/CN110314179A/en
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/34Campanulaceae (Bellflower family)
    • A61K36/346Platycodon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/69Polygalaceae (Milkwort family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/007Pulmonary tract; Aromatherapy
    • A61K9/0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
    • A61K9/0078Sprays 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-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

A kind of sucking compound campanulaceae cough-relieving pharmaceutical solutions and preparation method thereof
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.
CN201810268091.5A 2018-03-29 2018-03-29 A kind of sucking compound campanulaceae cough-relieving pharmaceutical solutions and preparation method thereof Withdrawn CN110314179A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201810268091.5A CN110314179A (en) 2018-03-29 2018-03-29 A kind of sucking compound campanulaceae cough-relieving pharmaceutical solutions and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201810268091.5A CN110314179A (en) 2018-03-29 2018-03-29 A kind of sucking compound campanulaceae cough-relieving pharmaceutical solutions and preparation method thereof

Publications (1)

Publication Number Publication Date
CN110314179A true CN110314179A (en) 2019-10-11

Family

ID=68110503

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201810268091.5A Withdrawn CN110314179A (en) 2018-03-29 2018-03-29 A kind of sucking compound campanulaceae cough-relieving pharmaceutical solutions and preparation method thereof

Country Status (1)

Country Link
CN (1) CN110314179A (en)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1365724A (en) * 2001-01-15 2002-08-28 杨孟君 Nano compound antitussive platycodon root medicine and its preparing process
CN1626149A (en) * 2003-12-11 2005-06-15 天津天士力制药股份有限公司 Medication for treating cough
CN107789556A (en) * 2016-08-30 2018-03-13 北京盈科瑞创新医药股份有限公司 A kind of Juhong Tanke Neulized inhalation pharmaceutical solutions and preparation method thereof
CN107789340A (en) * 2016-08-30 2018-03-13 北京盈科瑞创新医药股份有限公司 A kind of Herba Andrographitis Neulized inhalation pharmaceutical solutions and preparation method thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1365724A (en) * 2001-01-15 2002-08-28 杨孟君 Nano compound antitussive platycodon root medicine and its preparing process
CN1626149A (en) * 2003-12-11 2005-06-15 天津天士力制药股份有限公司 Medication for treating cough
CN107789556A (en) * 2016-08-30 2018-03-13 北京盈科瑞创新医药股份有限公司 A kind of Juhong Tanke Neulized inhalation pharmaceutical solutions and preparation method thereof
CN107789340A (en) * 2016-08-30 2018-03-13 北京盈科瑞创新医药股份有限公司 A kind of Herba Andrographitis Neulized inhalation pharmaceutical solutions and preparation method thereof

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
吴治德,等主编: "《内科学基础与诊疗精要 下》", 30 June 2016, 吉林科学技术出版社 *
王兆东,等: "呼吸道药物递送―雾化吸入剂的研究进展", 《世界临床药物》 *
韦向红: "HPLC法测定复方桔梗止咳片中甘草酸的含量", 《广西中医学院学报》 *

Similar Documents

Publication Publication Date Title
CN107789340B (en) Solution preparation for andrographis paniculata aerosol inhalation and preparation method thereof
CN106974898B (en) Solution preparation for acute bronchitis aerosol inhalation and preparation method thereof
CN106667975A (en) Preparation method of ipratropium bromide solution for inhalation
CN108078975A (en) Application of the pharmaceutical composition containing eucalyptol, limonene and australene in the drug for preparing treatment upper respiratory tract bacterium infection
CN109925300A (en) A kind of Fudosteine Neulized inhalation pharmaceutical solutions and preparation method thereof
CN107789556A (en) A kind of Juhong Tanke Neulized inhalation pharmaceutical solutions and preparation method thereof
CN105287846A (en) Application of Shanhaidan Yujin injection in atomizing inhalation, spray bottle aerosol and rectal administration and method
CN103156930A (en) Respiratory tract dosing preparation containing extract of paeonia lactiflora and licorice
CN103462942B (en) A kind of suction ambroxol hydrochloride solution
CN103169754A (en) Traditional Chinese medicinal composition for treating asthma
CN106667974A (en) Preparation method of terbutaline sulfate solution for inhalation
CN110038066A (en) A kind of Chinese medicine composition and preparation method thereof for treating chronic fatigue syndrome
CN105287854A (en) Preparation method of and application of compound Haqing injection in preparing preparation for atomizing and rectal administration
CN110314179A (en) A kind of sucking compound campanulaceae cough-relieving pharmaceutical solutions and preparation method thereof
CN110314187A (en) A kind of sucking silver-colored a kind of reed mentioned in ancient books pharmaceutical solutions and preparation method thereof
WO2019091082A1 (en) Solution preparation for aerosol inhalation of carbocisteine, and preparation method therefor
CN106266871A (en) A kind of for compound medicine treating cough with asthma and preparation method thereof
CN107137483A (en) One kind, which is breathed heavily, can control Neulized inhalation pharmaceutical solutions and preparation method thereof
CN109106774B (en) Traditional Chinese medicine composition for treating adenoidal hypertrophy and complications thereof, and preparation method and application thereof
CN107773593A (en) A kind of infantile heat-clearing and antitussive Neulized inhalation pharmaceutical solutions and preparation method thereof
CN105311207A (en) Application of compound Haqing injection in preparation of atomization and rectal administration preparation
CN107773581A (en) A kind of silver yellow Neulized inhalation pharmaceutical solutions and preparation method thereof
CN112999204A (en) Shuanghuanglian aerosol inhalation solution preparation and preparation method thereof
CN110522786A (en) A kind of sucking rhododendron mariae pharmaceutical solutions and preparation method thereof
CN109745460A (en) A kind of fresh bamboo sap Neulized inhalation pharmaceutical solutions and preparation method thereof

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
REG Reference to a national code

Ref country code: HK

Ref legal event code: DE

Ref document number: 40009349

Country of ref document: HK

SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
WW01 Invention patent application withdrawn after publication

Application publication date: 20191011

WW01 Invention patent application withdrawn after publication