CN110522810A - A kind of sucking child cough pharmaceutical solutions and preparation method thereof - Google Patents
A kind of sucking child cough pharmaceutical solutions and preparation method thereof Download PDFInfo
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- CN110522810A CN110522810A CN201810503818.3A CN201810503818A CN110522810A CN 110522810 A CN110522810 A CN 110522810A CN 201810503818 A CN201810503818 A CN 201810503818A CN 110522810 A CN110522810 A CN 110522810A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/02—Ammonia; Compounds thereof
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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
-
- 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)
-
- 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)
- A61K36/75—Rutaceae (Rue family)
- A61K36/752—Citrus, e.g. lime, orange or lemon
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/10—Expectorants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/14—Antitussive agents
Abstract
The present invention relates to a kind of sucking child cough pharmaceutical solutions and preparation method thereof, belong to galenic pharmacy field.A kind of sucking child cough pharmaceutical solutions, the pharmaceutical solutions include: (1) effective liquorice, campanulaceae effective component, orange peel tincture, ammonium chloride；(2) isotonic agent and solvent；Wherein, sucking is obtained with the effective liquorice in child cough pharmaceutical solutions by liquid extract of liquorice ultrafiltration；The campanulaceae effective component is obtained by Platycodon glaucus fluidextract ultrafiltration.Sucking child cough pharmaceutical solutions provided by the invention, aerosol is quickly formed by atomizer, it is rapid-action, preservative is free of, can be free of carbohydrate or contents of saccharide significantly reduces, avoid first pass effect stomach function regulating intestinal degradation, and lesions position drug concentration is improved, dosage is reduced, distribution of the drug in its hetero-organization is reduced, drug side-effect is reduced, children's use is safer.
Description
Technical field
The present invention relates to a kind of sucking child cough pharmaceutical solutions and preparation method thereof, belong to galenic pharmacy field.
Background technique
P-Cymene is a kind of classical Chinese patent drug, has the effects that eliminating the phlegm, antibechic, for cough caused by cold in children
It coughs, it is on the books " Chinese Pharmacopoeia " 2015 editions.
Child cough prescription is total to four traditional Chinese medicine and is formed by liquid extract of liquorice, Platycodon glaucus fluidextract, ammonium chloride, orange peel tincture.In prescription
Radix Glycyrrhizae is clearing heat and detoxicating, expelling phlegm and arresting coughing, coordinating the drug actions of a prescription；Campanulaceae promoting the dispersing function of the lung, relieving sore-throat eliminating the phlegm；Orange peel tincture strengthening the spleen and stomach, ventilating, drop are inverse
Resolving sputum；Ammonium chloride resolving sputum, eliminating the phlegm.Radix Glycyrrhizae is sweet in flavor mild-natured, function expelling phlegm and arresting coughing, invigorating middle warmer and replenishing QI, is used for infantile cough, is monarch drug in a prescription；
Campanulaceae is arduous flat, distributed in lung channel, and it is ministerial drug that function, which is ventilatingd the lung and resolving phlegm relieving sore-throat,；It is aided with orange peel tincture, ammonium chloride, Integrated TCM, enhancing is treated
Effect.Children's clinical application nearly 30 years, be OTC Class A kind, and safety and validity have obtained clinical approval already.
There was only syrup currently with the dosage form that child cough prescription lists, patent application document CN101574425A,
CN105497221A also discloses granule and preparation method thereof.However, granule disclosed in the syrup and document of listing is deposited
In following defect:
1, contain preservative sodium benzoate in the syrup listed, there is reported literature sodium benzoate to influence the absorption of drug,
Some adverse reactions can be brought, such as vomiting, hyperglycemia, hypokalemia, convulsions and moral damage, or even have a few peoples to benzene first
Sour sodium allergy, there are also health agencies to find that children's hyperactive may be deepened or be induced to this preservative；
2, listing syrup is large dosage packaging, repeatedly uncaps and causes the secondary pollution of syrup；
3, it listing granule disclosed in syrup and document and adds carbohydrate, syrup sugar content is excessively high, and dry is sweet,
Granula adds the food additives such as sucrose, dextrin, and causing children to take in sugar excess, indigestion etc. influences children growth hair
It educates；
4, syrup and granule are oral, and dosage is larger, need the first pass effect by liver, into the circulatory system
Effect and patient part work slower, limit the medication of patient to a certain extent.
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 child cough solution eliminating the phlegm, in terms of, it is contemplated that will have good curative effect.It does not deposit in the prior art
In sucking child cough solution special preparation, it will have good market prospects.
Summary of the invention
The technical problem to be solved by the present invention is to provide one kind safely, effectively, the sucking of good quality child cough solution
Preparation；The present invention also provides the preparation methods of said preparation.
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 child cough pharmaceutical solutions, are achieved through the following technical solutions:
A kind of sucking child cough pharmaceutical solutions, the pharmaceutical solutions include:
(1) effective liquorice, campanulaceae effective component, orange peel tincture, ammonium chloride；
(2) isotonic agent and solvent；
Wherein, sucking is obtained with the effective liquorice in child cough pharmaceutical solutions by liquid extract of liquorice ultrafiltration；It is described
Campanulaceae effective component is obtained by Platycodon glaucus fluidextract ultrafiltration.
Of the present invention suck uses child cough pharmaceutical solutions, uses liquid extract of liquorice in every liter of pharmaceutical solutions
37.5-187.5ml, Platycodon glaucus fluidextract 7.5-37.5ml, orange peel tincture 5-25ml, ammonium chloride 2.5-12.5g.
Further, as a preferred embodiment, the dosage of the liquid extract of liquorice is 62-182ml, campanulaceae stream
Medicinal extract dosage is 12.5-36ml, orange peel tincture dosage is 8.5-24ml, and ammonium chloride dosage is 4-12g；Preferably, the Radix Glycyrrhizae stream
The dosage of medicinal extract is 94.5-175ml, Platycodon glaucus fluidextract dosage is 23.5-34.5ml, orange peel tincture dosage is 16.5-22.5ml, chlorine
Change ammonium dosage is 8-11g；It is furthermore preferred that the dosage of the liquid extract of liquorice is 145-165ml, Platycodon glaucus fluidextract dosage is 28-
32ml, orange peel tincture dosage are 18.5-21.5ml, and ammonium chloride dosage is 9.5-10.5g.
Further, in sucking child cough pharmaceutical solutions of the present invention, the solvent is purified water, injection
Water or sterile water for injection.
Further, in sucking child cough pharmaceutical solutions of the present invention, the isotonic agent refers to inorganic salts
Isotonic agent or carbohydrate isotonic agent, preferably inorganic salts isotonic agent.The inorganic salts isotonic agent is sodium chloride, magnesium chloride, chlorine
Change one of calcium or a variety of, preferably sodium chloride；The carbohydrate isotonic agent be one of glucose, fructose, mannitol or
It is a variety of, preferably glucose.
Further, in sucking child cough pharmaceutical solutions of the present invention, inorganic salts are contained in each preparation unit
The amount of class isotonic agent is 0.15%-0.7%, preferably 0.2%-0.5%, more preferable 0.35%-0.5%.Children are used in the sucking
The amount of the isotonic agent containing carbohydrate is 1%-10%, preferably 2%-8%, more preferable 2%- in each preparation unit of cough-relieving pharmaceutical solutions
6.5%.
It further, also include cosolvent in sucking child cough pharmaceutical solutions of the present invention.The cosolvent choosing
From one of ethyl alcohol, propylene glycol, glycerol, polyethylene glycol, Emulsifier EL-60, poloxamer, sapn or polysorbate or
It is a variety of, preferably polysorbate or ethyl alcohol；More preferable polyoxyethylene sorbitan monoleate.
Further, the dosage of the cosolvent in the formulation is 0.005-0.02%, preferably 0.01-0.02%.By
Poor in effective component of chinese medicine dissolubility, the present invention is selected by type to cosolvent and dosage, can effectively eliminate small
Muddiness or opalescence in youngster's cough-relieving pharmaceutical solutions, keep medical fluid clear and bright, the dissolubility of the effective elements of the medicine in a solvent in raising.
Further, the sucking of the present invention preferred 3.0-7.5 of pH value of child cough pharmaceutical solutions, more preferably
For 4-6, most preferably 5-6.The preferably common inorganic acid of pH adjusting agent or inorganic base；The pH adjusting agent be selected from hydrochloric acid, phosphoric acid,
Citric acid, glacial acetic acid, sodium hydroxide, potassium hydroxide, sodium bicarbonate, potassium dihydrogen phosphate, sodium dihydrogen phosphate, disodium hydrogen phosphate or phosphorus
One of sour hydrogen dipotassium is a variety of, preferably hydrochloric acid and sodium hydroxide.
In the present invention, gained aerosol inhalation solution preparation is made to inhale with ultrasonic atomizer or air compression type atomizer
Enter child cough solution and respiratory system is directly sucked in atomised form, directly acts on respiratory tract lesions position, it is rapid-action, it reduces
The toxic side effect of drug, it is safer and more effective.
The second object of the present invention is to provide a kind of preparation method of sucking child cough solution, the method packet
It includes:
(1) raw material liquid extract of liquorice, Platycodon glaucus fluidextract, orange peel tincture, ammonium chloride are weighed according to prescription ratio；
(2) extracting liquorice liquid extract adds 1-4 times of water, is stood more than for 24 hours after stirring evenly, and filtration, ultrafiltration obtains effective liquorice；
(3) Platycodon glaucus fluidextract is taken, adds 1-4 times of water, is stood after stirring evenly more than for 24 hours, is filtered, ultrafiltration obtains campanulaceae effective component；
(4) effective liquorice and campanulaceae effective component are mixed, is stood after stirring evenly more than for 24 hours, filtered, add 0.1-
0.5% active carbon boils 10-60min, filters after letting cool, and ammonium chloride, orange peel tincture, cosolvent is added, filtration, ultrafiltration after stirring evenly,
Adjust pH value 3.0-7.5, add isotonic agent, dissolve, filtration, encapsulating to get.
Further, as a preferred embodiment, in the step (2), add 2-3 times of water every time, stand every time
48h or more.
Further, as a preferred embodiment, in the step (3), add 2-3 times of water every time, stand every time
48h or more.
Further, as a preferred embodiment, in the step (4), 48h or more is stood every time, adds 0.1-
0.5% active carbon boils 10-30min, adjusts the preferred 4-6 of pH value, most preferably 5-6.
Further, as a preferred embodiment, the orange peel tincture can be charged first in the step (4)
After being completely dissolved in aqueous solution containing cosolvent, then mixed again with other ingredients.
Sucking child cough pharmaceutical solutions of the present invention have the effect of eliminating the phlegm, antibechic, can be used for eliminating the phlegm, cough-relieving
Deng.Therefore, the third object of the present invention is to provide a kind of sucking child cough pharmaceutical solutions and treats respiratory tract disease in preparation
Effect in the drug of disease, the respiratory disease includes 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 child cough pharmaceutical solutions provided by the invention, quickly form aerosol by atomizer, formation
Aerosol can directly snap action at sufferer, and the drug for acting on affected part can quickly be absorbed action, local lesion
Drug concentration is high, reduces drug in the distribution of other histoorgans, rapid-action；
2, sucking child cough pharmaceutical solutions provided by the invention, are free of preservative, can be free of carbohydrate or contents of saccharide
It significantly reduces, more former dosage form is compared, had no toxic side effect；First pass effect stomach function regulating intestinal degradation is avoided simultaneously, and improves lesion portion
Position drug concentration, reduces dosage, reduces distribution of the drug in its hetero-organization, reduces drug side-effect, children are using more
Add safety；
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.
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
Raw material liquid extract of liquorice, Platycodon glaucus fluidextract, orange peel tincture, ammonium chloride are weighed according to prescription ratio；Extracting liquorice liquid extract,
Add 3 times of water, stood after stirring evenly for 24 hours, filtration, ultrafiltration obtains effective liquorice；Platycodon glaucus fluidextract is taken, adds 3 times of water, is stood after stirring evenly
For 24 hours, it filters, ultrafiltration obtains campanulaceae effective component；Effective liquorice and campanulaceae effective component are mixed, stood after stirring evenly for 24 hours, filter
It crosses, 0.1-0.5% active carbon is added to boil 40min, filtered after letting cool, ammonium chloride, orange peel tincture, appropriate polyoxyethylene sorbitan monoleate is added, stirs
Filtration, ultrafiltration after even, addition sodium hydroxide adjusting pH value to 5.5, add sodium chloride to be adjusted to isotonic solution, dissolve, filtration, encapsulating,
To obtain the final product.
Embodiment 2
Raw material liquid extract of liquorice, Platycodon glaucus fluidextract, orange peel tincture, ammonium chloride are weighed according to prescription ratio；Extracting liquorice liquid extract,
Add 2 times of water, stood after stirring evenly for 24 hours, filtration, ultrafiltration obtains effective liquorice；Platycodon glaucus fluidextract is taken, adds 2 times of water, is stood after stirring evenly
For 24 hours, it filters, ultrafiltration obtains campanulaceae effective component；Effective liquorice and campanulaceae effective component are mixed, stood after stirring evenly for 24 hours, filter
It crosses, 0.1-0.5% active carbon is added to boil 40min, filtered after letting cool, ammonium chloride, orange peel tincture, appropriate polyoxyethylene sorbitan monoleate is added, stirs
Filtration, ultrafiltration after even, addition sodium hydroxide adjusting pH value to 6, add sodium chloride to be adjusted to isotonic solution, dissolve, filtration, encapsulating, i.e.,
.
Embodiment 3
Raw material liquid extract of liquorice, Platycodon glaucus fluidextract, orange peel tincture, ammonium chloride are weighed according to prescription ratio；Extracting liquorice liquid extract,
Add 2 times of water, 48h is stood after stirring evenly, filter, ultrafiltration obtains effective liquorice；Platycodon glaucus fluidextract is taken, adds 2 times of water, is stood after stirring evenly
48h, filtration, ultrafiltration obtain campanulaceae effective component；Effective liquorice and campanulaceae effective component are mixed, 48h is stood after stirring evenly, is filtered
It crosses, 0.1-0.5% active carbon is added to boil 30min, filtered after letting cool, ammonium chloride, orange peel tincture, appropriate polyoxyethylene sorbitan monoleate is added, stirs
Filtration, ultrafiltration after even, addition sodium hydroxide adjusting pH value to 5, add sodium chloride to be adjusted to isotonic solution, dissolve, filtration, encapsulating, i.e.,
.
Embodiment 4
Raw material liquid extract of liquorice, Platycodon glaucus fluidextract, orange peel tincture, ammonium chloride are weighed according to prescription ratio；Extracting liquorice liquid extract,
Add 3 times of water, 48h is stood after stirring evenly, filter, ultrafiltration obtains effective liquorice；Platycodon glaucus fluidextract is taken, adds 3 times of water, is stood after stirring evenly
48h, filtration, ultrafiltration obtain campanulaceae effective component；Effective liquorice and campanulaceae effective component are mixed, 48h is stood after stirring evenly, is filtered
It crosses, 0.1-0.5% active carbon is added to boil 30min, filtered after letting cool, ammonium chloride, orange peel tincture, appropriate polyoxyethylene sorbitan monoleate is added, stirs
Filtration, ultrafiltration after even, addition sodium hydroxide adjusting pH value to 5.5, add sodium chloride to be adjusted to isotonic solution, dissolve, filtration, encapsulating,
To obtain the final product.
Embodiment 5
Raw material liquid extract of liquorice, Platycodon glaucus fluidextract, orange peel tincture, ammonium chloride are weighed according to prescription ratio；Extracting liquorice liquid extract,
Add 3 times of water, 48h is stood after stirring evenly, filter, ultrafiltration obtains effective liquorice；Platycodon glaucus fluidextract is taken, adds 3 times of water, is stood after stirring evenly
48h, filtration, ultrafiltration obtain campanulaceae effective component；Effective liquorice and campanulaceae effective component are mixed, 48h is stood after stirring evenly, is filtered
It crosses, 0.1-0.5% active carbon is added to boil 20min, filtered after letting cool, ammonium chloride, orange peel tincture, appropriate polyoxyethylene sorbitan monoleate is added, stirs
Filtration, ultrafiltration after even, adding sodium hydroxide adjust pH value to 6, sodium chloride are added to be adjusted to isotonic solution, dissolve, filtration, encapsulating to get.
Embodiment 6
Raw material liquid extract of liquorice, Platycodon glaucus fluidextract, orange peel tincture, ammonium chloride are weighed according to prescription ratio；Extracting liquorice liquid extract,
Add 2 times of water, 48h is stood after stirring evenly, filter, ultrafiltration obtains effective liquorice；Platycodon glaucus fluidextract is taken, adds 2 times of water, is stood after stirring evenly
48h, filtration, ultrafiltration obtain campanulaceae effective component；Effective liquorice and campanulaceae effective component are mixed, 48h is stood after stirring evenly, is filtered
It crosses, 0.1-0.5% active carbon is added to boil 20min, filtered after letting cool, ammonium chloride, orange peel tincture, appropriate polyoxyethylene sorbitan monoleate is added, stirs
Filtration, ultrafiltration after even, addition sodium hydroxide adjusting pH value to 6, add sodium chloride to be adjusted to isotonic solution, dissolve, filtration, encapsulating, i.e.,
.
Following tests example illustrates the safeties of sucking child cough pharmaceutical solutions that the embodiment of the present invention is prepared
And drug effect.
The experiment of 1 antibechic of test example
It takes 18-22g kunming mice to carry out drawing cough trial test first, after rejecting unqualified mouse, takes 160 mouse, male and female
It is fifty-fifty, random point 8 groups, every group 20.1-6 group is inhalable aerosol drug group, by Neulized inhalation by the sucking of embodiment 1-6
1-6 group mouse is given respectively with child cough solution, and one group of mouse corresponds to one embodiment sucking pharmaceutical solutions, gives medicament
Amount is 20ml/kg；7th group is model control group, and the physiological saline of 20ml/kg dosage is given by Neulized inhalation；8th group is
Oral group, takes P-Cymene (Guizhou Yibai Pharmaceutical Co., Ltd), taking dose 20ml/kg.After 1h is administered,
Above-mentioned each group mouse is respectively put into 1000ml bell jar and injects 0.2ml ammonium hydroxide and draws cough, record cough latent period is (from injection ammonia
The water time starts the time to needed for occurring cough).It is taken out after 1min, cough number (with contraction of abdominal muscle, magnifies in record 2min
Subject to mouth), as a result see Table 1 for details.
Cough-relieving rate %=(administration group Respiratory frequency time/model control group Respiratory frequency time) × 100%
The sucking of the table 1 antitussive effect test result of child cough pharmaceutical solutions
Compared with model group: * P < 0.05；* P < 0.01 is compared with oral group:▼P < 0.05,▼▼P<0.01；
As shown in Table 1, relative to model control group and oral group, cough latent period obviously increases child cough solution inhalation group
Long, cough-relieving rate obviously rises, and 2min cough number significantly reduces.And atomized medicine introducing group effect is better than oral solution group
Influence of the test example 2 to mouse tracheae section phenols contents
Take kunming mice 80, half male and half female, weight 18-22g；It raises in 20-26 DEG C of SPF grades of animal feeding room, from
By diet, drinking-water.8 groups are randomly divided into, every group 10, respectively atomization medicine inhalation group (administration embodiment 1-6), model comparison
Group, P-Cymene take orally group (Guizhou Yibai Pharmaceutical Co., Ltd).Oral solution and inhalation solution carry out appropriate work as
Amount conversion.The isometric physiological saline of model control group nebulizer administration, oral solution group are 0.2ml/10g, and atomized medicine introducing is implemented
Example 1-6 group dosage is 0.2ml/10g.It is administered daily 1 time, continuous 2 days, is deprived of food but not water before administration in the 3rd day, last dose
After 30min, 5% phenol red solution (0.1ml/10g) is injected intraperitoneally, mouse is euthanized after injecting phenol red 30min, dorsal position is solid
Fixed, exposure tracheae removes tracheae surrounding tissue, cuts one section from thyroid cartilage to tracheae bifurcation and waits long air pipes, 5ml is added
5% sodium bicarbonate solution, is put into centrifuge tube, after being centrifuged 5min, takes supernatant, surveys OD in wavelength 546nm with spectrophotometer
Value, the results are shown in Table 2.
The influence of 2 oral administration group of table and atomized medicine introducing group to mouse tracheae section phenols contents
Note: compared with model control group*P < 0.05,**P<0.01；Compared with oral group:▼P < 0.05,▼▼P<0.01；
As a result: experimental data shows that compared with oral solution administration group, children of the invention suck can with cough-relieving pharmaceutical solutions
To dramatically increase mouse tracheae section phenols contents, show that atomized soln preparation expectorant effect of the invention becomes apparent from, effect is more
Group is taken orally better than P-Cymene.
Claims (18)
1. a kind of sucking child cough pharmaceutical solutions, which is characterized in that including effective liquorice, campanulaceae effective component, orange
Pi Ding, ammonium chloride, isotonic agent and solvent.
2. pharmaceutical solutions according to claim 1, which is characterized in that wherein the effective liquorice is by liquid extract of liquorice
Ultrafiltration obtains, and the campanulaceae effective component is obtained by Platycodon glaucus fluidextract ultrafiltration.
3. pharmaceutical solutions according to claim 2, which is characterized in that wherein flowed in every liter of pharmaceutical solutions using Radix Glycyrrhizae
Medicinal extract 37.5-187.5ml, Platycodon glaucus fluidextract 7.5-37.5ml, orange peel tincture 5-25ml, ammonium chloride 2.5-12.5g.
4. pharmaceutical solutions according to claim 2 or 3, it is characterised in that the dosage of the liquid extract of liquorice is 62-
182ml, Platycodon glaucus fluidextract dosage are 12.5-36ml, orange peel tincture dosage is 8.5-24ml, and ammonium chloride dosage is 4-12g.
5. according to the described in any item pharmaceutical solutions of claim 2-4, which is characterized in that the dosage of the liquid extract of liquorice is
94.5-175ml, Platycodon glaucus fluidextract dosage are 23.5-34.5ml, orange peel tincture dosage is 16.5-22.5ml, and ammonium chloride dosage is 8-
11g；It is furthermore preferred that the dosage of the liquid extract of liquorice is 145-165ml, Platycodon glaucus fluidextract dosage is 28-32ml, orange peel tincture is used
Amount is 18.5-21.5ml, and ammonium chloride dosage is 9.5-10.5g.
6. pharmaceutical solutions according to claim 1-5, which is characterized in that the isotonic agent refers to inorganic salts etc.
Penetration enhancer or carbohydrate isotonic agent, preferably inorganic salts isotonic agent.
7. according to the described in any item pharmaceutical solutions of claim 6, which is characterized in that the inorganic salts isotonic agent is chlorination
One of sodium, magnesium chloride, calcium chloride are a variety of, preferably sodium chloride；The carbohydrate isotonic agent is glucose, fructose, sweet dew
One of alcohol is a variety of, preferably glucose.
8. according to the described in any item pharmaceutical solutions of claim 6-7, which is characterized in that contain inorganic salts in each preparation unit
The amount of isotonic agent is 0.15%-0.7%, preferably 0.2%-0.5%, more preferable 0.35%-0.5%；Contain in each preparation unit
The amount of carbohydrate isotonic agent is 1%-10%, preferably 2%-8%, more preferable 2%-6.5%.
9. pharmaceutical solutions according to claim 1-8, which is characterized in that the preparation also includes cosolvent, institute
It states cosolvent and is selected from ethyl alcohol, propylene glycol, glycerol, polyethylene glycol, Emulsifier EL-60, poloxamer, sapn or polysorbate
One of or a variety of, preferably polysorbate or ethyl alcohol；More preferable polyoxyethylene sorbitan monoleate.
10. pharmaceutical solutions according to claim 9, which is characterized in that the dosage of the cosolvent in the formulation is
0.005-0.02%, preferably 0.01-0.02%.
11. -10 described in any item pharmaceutical solutions according to claim 1, which is characterized in that the solvent is purified water, injection
With water or sterile water for injection.
12. -11 described in any item pharmaceutical solutions according to claim 1, which is characterized in that it further include pH adjusting agent, the pH
Regulator is selected from hydrochloric acid, phosphoric acid, citric acid, glacial acetic acid, sodium hydroxide, potassium hydroxide, sodium bicarbonate, potassium dihydrogen phosphate, phosphoric acid
One of sodium dihydrogen, disodium hydrogen phosphate or dipotassium hydrogen phosphate are a variety of, preferably hydrochloric acid and sodium hydroxide.
13. -12 described in any item pharmaceutical solutions according to claim 1, which is characterized in that the pH value of the pharmaceutical solutions is preferred
3.0-7.5, more preferably 4-6, most preferably 5-6.
14. -13 described in any item pharmaceutical solutions according to claim 1, which is characterized in that preparation method the following steps are included:
(1) raw material liquid extract of liquorice, Platycodon glaucus fluidextract, orange peel tincture, ammonium chloride are weighed according to prescription ratio；
(2) extracting liquorice liquid extract adds 1-4 times of water, is stood more than for 24 hours after stirring evenly, and filtration, ultrafiltration obtains effective liquorice；
(3) Platycodon glaucus fluidextract is taken, adds 1-4 times of water, is stood after stirring evenly more than for 24 hours, is filtered, ultrafiltration obtains campanulaceae effective component；
(4) effective liquorice and campanulaceae effective component are mixed, is stood after stirring evenly more than for 24 hours, filtered, add 0.1-0.5% living
Property charcoal boil 10-60min, filtered after letting cool, be added ammonium chloride, orange peel tincture, cosolvent, after stirring evenly filtration, ultrafiltration, adjust pH value
3.0-7.5 adds isotonic agent, dissolve, filtration, encapsulating to get.
15. pharmaceutical solutions according to claim 14, which is characterized in that in the step (2), add 2-3 times of water every time, often
Secondary standing 48h or more；In the step (3), adds 2-3 times of water every time, stand 48h or more every time.
16. pharmaceutical solutions according to claim 14 or 15, which is characterized in that in the step (4), stand 48h every time
More than, add 0.1-0.5% active carbon to boil 10-30min, adjusts the preferred 4-6 of pH value, most preferably 5-6.
17. the described in any item pharmaceutical solutions of 4-16 according to claim 1, which is characterized in that in the step (4), the orange
Skin tincture is charged first to be completely dissolved in the aqueous solution containing cosolvent after, then mixed again with other ingredients.
18. effect of the described in any item pharmaceutical solutions of claim 1-17 in the drug of preparation treatment respiratory disease, institute
Stating respiratory disease includes bronchitis, cough, more phlegm.
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