CN107773593A - A kind of infantile heat-clearing and antitussive Neulized inhalation pharmaceutical solutions and preparation method thereof - Google Patents
A kind of infantile heat-clearing and antitussive Neulized inhalation pharmaceutical solutions and preparation method thereof Download PDFInfo
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- CN107773593A CN107773593A CN201610759641.4A CN201610759641A CN107773593A CN 107773593 A CN107773593 A CN 107773593A CN 201610759641 A CN201610759641 A CN 201610759641A CN 107773593 A CN107773593 A CN 107773593A
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- clearing
- antitussive
- neulized inhalation
- infantile heat
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- 230000000954 anitussive effect Effects 0.000 title claims abstract description 77
- 229940124584 antitussives Drugs 0.000 title claims abstract description 77
- 239000003186 pharmaceutical solution Substances 0.000 title claims abstract description 33
- 238000002360 preparation method Methods 0.000 title claims description 54
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 title abstract 4
- 239000004480 active ingredient Substances 0.000 claims abstract description 44
- 239000007788 liquid Substances 0.000 claims abstract description 21
- 239000007951 isotonicity adjuster Substances 0.000 claims abstract description 19
- 210000002345 respiratory system Anatomy 0.000 claims abstract description 13
- 238000007906 compression Methods 0.000 claims abstract description 6
- 230000006835 compression Effects 0.000 claims abstract description 6
- 239000002904 solvent Substances 0.000 claims abstract description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 144
- PCHPORCSPXIHLZ-UHFFFAOYSA-N diphenhydramine hydrochloride Chemical compound [Cl-].C=1C=CC=CC=1C(OCC[NH+](C)C)C1=CC=CC=C1 PCHPORCSPXIHLZ-UHFFFAOYSA-N 0.000 claims description 73
- 239000006228 supernatant Substances 0.000 claims description 48
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 44
- 239000000243 solution Substances 0.000 claims description 39
- 239000000706 filtrate Substances 0.000 claims description 34
- 229940041682 inhalant solution Drugs 0.000 claims description 25
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 claims description 24
- 241001465251 Ephedra sinica Species 0.000 claims description 24
- 239000003814 drug Substances 0.000 claims description 24
- 229910052602 gypsum Inorganic materials 0.000 claims description 24
- 239000010440 gypsum Substances 0.000 claims description 24
- 210000000582 semen Anatomy 0.000 claims description 24
- 238000003756 stirring Methods 0.000 claims description 24
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 22
- -1 filters Cross Substances 0.000 claims description 22
- 238000011084 recovery Methods 0.000 claims description 22
- 239000000443 aerosol Substances 0.000 claims description 14
- 241001062009 Indigofera Species 0.000 claims description 12
- 239000010231 banlangen Substances 0.000 claims description 12
- 239000000796 flavoring agent Substances 0.000 claims description 12
- 235000019634 flavors Nutrition 0.000 claims description 12
- 239000007924 injection Substances 0.000 claims description 12
- 238000002347 injection Methods 0.000 claims description 12
- 230000001954 sterilising effect Effects 0.000 claims description 12
- 238000000108 ultra-filtration Methods 0.000 claims description 12
- 239000008215 water for injection Substances 0.000 claims description 12
- 239000011780 sodium chloride Substances 0.000 claims description 11
- TWRXJAOTZQYOKJ-UHFFFAOYSA-L Magnesium chloride Chemical compound [Mg+2].[Cl-].[Cl-] TWRXJAOTZQYOKJ-UHFFFAOYSA-L 0.000 claims description 7
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 6
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 6
- 229930195725 Mannitol Natural products 0.000 claims description 6
- 150000001720 carbohydrates Chemical class 0.000 claims description 6
- 239000008103 glucose Substances 0.000 claims description 6
- 239000000594 mannitol Substances 0.000 claims description 6
- 235000010355 mannitol Nutrition 0.000 claims description 6
- 150000003839 salts Chemical class 0.000 claims description 6
- 229930091371 Fructose Natural products 0.000 claims description 4
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 claims description 4
- 239000005715 Fructose Substances 0.000 claims description 4
- 239000003795 chemical substances by application Substances 0.000 claims description 3
- 229910001629 magnesium chloride Inorganic materials 0.000 claims description 3
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims description 2
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims description 2
- 239000001110 calcium chloride Substances 0.000 claims description 2
- 229910001628 calcium chloride Inorganic materials 0.000 claims description 2
- 238000004064 recycling Methods 0.000 claims description 2
- 206010011224 Cough Diseases 0.000 abstract description 16
- 230000000694 effects Effects 0.000 abstract description 12
- 208000006673 asthma Diseases 0.000 abstract description 9
- 206010062717 Increased upper airway secretion Diseases 0.000 abstract description 8
- 208000026435 phlegm Diseases 0.000 abstract description 8
- 206010000269 abscess Diseases 0.000 abstract description 5
- 238000000034 method Methods 0.000 abstract description 5
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical group CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 abstract description 3
- 238000000889 atomisation Methods 0.000 abstract description 3
- 230000008569 process Effects 0.000 abstract description 2
- 238000001914 filtration Methods 0.000 description 10
- 210000003800 pharynx Anatomy 0.000 description 5
- 229940079593 drug Drugs 0.000 description 4
- 230000001225 therapeutic effect Effects 0.000 description 4
- 238000003795 desorption Methods 0.000 description 3
- 210000004185 liver Anatomy 0.000 description 3
- 210000004072 lung Anatomy 0.000 description 3
- 235000011147 magnesium chloride Nutrition 0.000 description 3
- KWGRBVOPPLSCSI-WPRPVWTQSA-N (-)-ephedrine Chemical group CN[C@@H](C)[C@H](O)C1=CC=CC=C1 KWGRBVOPPLSCSI-WPRPVWTQSA-N 0.000 description 2
- 206010068319 Oropharyngeal pain Diseases 0.000 description 2
- 201000007100 Pharyngitis Diseases 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 230000003902 lesion Effects 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 230000029058 respiratory gaseous exchange Effects 0.000 description 2
- 208000024891 symptom Diseases 0.000 description 2
- 208000000059 Dyspnea Diseases 0.000 description 1
- 206010013975 Dyspnoeas Diseases 0.000 description 1
- 244000046052 Phaseolus vulgaris Species 0.000 description 1
- 235000010627 Phaseolus vulgaris Nutrition 0.000 description 1
- 206010036790 Productive cough Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- KWGRBVOPPLSCSI-UHFFFAOYSA-N d-ephedrine Natural products CNC(C)C(O)C1=CC=CC=C1 KWGRBVOPPLSCSI-UHFFFAOYSA-N 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 229960002179 ephedrine Drugs 0.000 description 1
- 238000010579 first pass effect Methods 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000003595 mist Substances 0.000 description 1
- 239000006199 nebulizer Substances 0.000 description 1
- 239000006186 oral dosage form Substances 0.000 description 1
- 229940126701 oral medication Drugs 0.000 description 1
- 229940100688 oral solution Drugs 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000006187 pill Substances 0.000 description 1
- XDQITMCFPPPMBC-TUANDBMESA-N scutelloside Natural products OC[C@H]1O[C@@H](O[C@@H]2O[C@@H]3C[C@H]4[C@H](O)[C@@H](O)[C@@](O)(CO3)[C@@H]24)[C@H](O)[C@@H](O)[C@@H]1O XDQITMCFPPPMBC-TUANDBMESA-N 0.000 description 1
- 238000012163 sequencing technique Methods 0.000 description 1
- 208000013220 shortness of breath Diseases 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/17—Gnetophyta, e.g. Ephedraceae (Mormon-tea family)
-
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/19—Acanthaceae (Acanthus family)
- A61K36/195—Strobilanthes
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- A61K36/18—Magnoliophyta (angiosperms)
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- 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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- 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
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Abstract
The present invention relates to a kind of infantile heat-clearing and antitussive Neulized inhalation pharmaceutical solutions, belong to galenic pharmacy field.A kind of Neulized inhalation pharmaceutical solutions of infantile heat-clearing and antitussive, including（1）Infantile heat-clearing and antitussive active ingredient；（2）Isotonic agent and solvent.Pharmaceutical solutions prepared by the present invention compensate for the blank on domestic market, and pharmaceutical solutions prepared by the present invention is to aim at Neulized inhalation to be designed with patient, by obtained Neulized inhalation pharmaceutical solutions, after ultrasonic atomizer or the atomization of air compression type atomizer, respiratory system is directly sucked in atomised form, it is convenient using process, compared with heat-clearing cough-relieving oral liquid for children, method of administration is different, and dosage is reduced, it is rapid-action, security improves, and can preferably play treatment and catch cold, asthma due to excessive phlegm of coughing, dry sound is mute, the effect of abscess of throat.
Description
Technical field
The present invention relates to a kind of infantile heat-clearing and antitussive Neulized inhalation pharmaceutical solutions and preparation method thereof, belongs to galenic pharmacy neck
Domain.
Background technology
Infantile heat-clearing and antitussive is a kind of classical Chinese patent drug, and main component is ephedrine and scutelloside, has clearing heat and freeing lung,
Relieving asthma, relieving sore-throat the effect of.For catching cold, asthma due to excessive phlegm of coughing, dry sound is mute, the treatment of the disease such as abscess of throat.It is existing small
Youngster's heat clearing away and cough arresting has granule, pill, tablet, oral liquid etc..Because its curative effect is clear and definite, deeply by numerous doctors, suffer from the joyous of both sides
Meet, be the Typical Representative of traditional clearing heat and freeing lung Chinese medicine.
Conventional oral dosage forms, dose are larger, it is impossible to directly act on patient part, it is necessary to be imitated by first cross of liver
Should, into circulatory system effect in patient part, work slower, limit the medication of patient to a certain extent.Neulized inhalation
Pharmaceutical solutions can directly act on patient part, can improve respiratory tract or pharyngeal as respiratory tract or drug administration at pharynx section preparation
Administration concentration, it is rapid-action, and said preparation avoids the first pass effect of liver, reduces the dosage of medicine, improves medicine biology
Availability, and distribution of the medicine in its hetero-organization is reduced, reduce side effect.The product that Neulized inhalation is listed with pharmaceutical solutions at present
It is relatively fewer, predominantly imported product.And infantile heat-clearing and antitussive is peroral dosage form, the use of Neulized inhalation preparation is clinically had no
Situation.Simultaneously for asthma due to excessive phlegm of coughing, dry sound is mute, abscess of throat etc., and Chinese medicine has the effect of fine, but because unsuitable
Formulation, it is preferably played effect.
It is high it is an object of the invention to provide a kind of bioavilability, lesions position is directly acted on, it is rapid-action, it is safer
Effective infantile heat-clearing and antitussive Neulized inhalation pharmaceutical solutions.
The content of the invention
The present invention solves the technical problem of provide it is a kind of safely, effectively, the infantile heat-clearing and antitussive mist of good quality
Change suction pharmaceutical solutions；Present invention also offers the preparation method of said preparation.
The present invention is achieved by the following technical solutions：
A kind of infantile heat-clearing and antitussive Neulized inhalation pharmaceutical solutions, including：
（1）Infantile heat-clearing and antitussive active ingredient；
（2）Isotonic agent and solvent；
Wherein, isotonic agent refers to inorganic salts isotonic agent or carbohydrate isotonic agent；Infantile heat-clearing and antitussive Neulized inhalation pharmaceutical solutions
Each preparation unit in the amount of the isotonic agent containing inorganic salts be 0.2-0.9%, or infantile heat-clearing and antitussive Neulized inhalation solution system
The amount of the isotonic agent containing carbohydrate is 2-9% in each preparation unit of agent.
90 parts of Chinese ephedra, fry 120 parts of semen armeniacae amarae, 270 parts of gypsum, 90 parts of radix glycyrrhizae, 180 parts of radix scutellariae, 180 parts of Radix Isatidis, northern beans
90 parts of root
Seven flavor medicine is weighed according to above-mentioned parts by weight, Chinese ephedra, gypsum decoct 30min, add and fry semen armeniacae amarae, radix glycyrrhizae, radix scutellariae, plate indigo plant
Root, rhizoma menispermi add 8-12 times to measure decocting to boil 2h, filter；The dregs of a decoction add 8-12 times to measure decocting to boil 1h, filter, merging filtrate, stand, take
Supernatant, it is concentrated into right amount, adding ethanol makes alcohol content be 70-85%, stirs evenly, and stands, and refrigerates 12h, takes supernatant, filters, and filters
For liquid recovery ethanol to without alcohol taste, again plus ethanol makes alcohol content be 75-90%, stirs evenly, and stands, and refrigerates 12h, takes supernatant, filters
Cross, filtrate recycling ethanol adds injection appropriate amount of water, stirred evenly, refrigerate 24~48h, take supernatant, add activated carbon to boil to without alcohol taste
30min, let cool, filter, produce infantile heat-clearing and antitussive active ingredient solution；Appropriate isotonic agent is added, is added to the full amount of water for injection,
PH value is adjusted, ultrafiltration, embedding, sterilizing, produces pharmaceutical solutions of the invention.
Inorganic salts isotonic agent is one kind in sodium chloride, magnesium chloride, calcium chloride；Carbohydrate isotonic agent be glucose, fructose,
One kind in mannitol；It is preferred that sodium chloride.
The pH value of aerosol inhalation solution is 3.0-8.5；Preferable ph is 5.0-7.0.
Neulized inhalation is with 0.2-1.0 times that the consumption per day of solution is heat-clearing cough-relieving oral liquid for children consumption per day；Preferable amount
It is 0.3-0.7 times of heat-clearing cough-relieving oral liquid for children consumption per day.
It is straight with atomised form with ultrasonic atomizer or air compression type atomizer by gained aerosol inhalation solution preparation
Connect suction respiratory system.
Infantile heat-clearing and antitussive Neulized inhalation pharmaceutical solutions of the present invention has clearing heat and freeing lung, relievings asthma, the work(of relieving sore-throat
Effect, can be used for treatment and catches cold, and asthma due to excessive phlegm of coughing, dry sound is mute, abscess of throat etc..
It is an advantage of the present invention to provide a kind of novel form better than heat-clearing cough-relieving oral liquid for children, said preparation refers to medicine
It is dissolved in suitable media, it is through with aerosol form, oral or nasal inhalation delivery to respiratory tract or pharyngeal, administration by means of atomizer
Site of action, reducing distribution of the medicine in other histoorgans, the drug concentration of local lesion is high, for being relatively administered orally,
The treatment total effective rate of nebulizer administration mode greatly improves, and has safely and effectively, and bioavilability is high, toxic side effect is small
Feature, thus have a clear superiority.
Pharmaceutical solutions prepared by the present invention compensate for the blank on domestic market, and solution system prepared by the present invention
Agent is to aim at Neulized inhalation to be designed with patient, is supported the use with atomizer, convenient using process, with heat-clearing cough-relieving oral liquid for children
Compare, method of administration is different, and dosage is reduced, and security improves.It can avoid simultaneously needed for being administered orally by the first mistake of liver
Effect, to damage caused by patient, increase the compliance of patient, for the children for be inconvenient to be administered orally be one kind well to
Medicine approach.
Beneficial effects of the present invention are further illustrated below by way of test example：
The infant of patient diagnosis infantile cough's asthma due to excessive phlegm 135,1~3 years old age, the course of disease are less than 7 days, and clinical manifestation is different degrees of
Breathing shortness of breath, abundant expectoration, cough.Agematched infant is divided into observation group 1, the and of observation group 2 according to medical sequencing
Control group, every group 45, three groups of infants have comparativity in terms of sex, age and the state of an illness, and therapeutic effect easily compares.
The infantile heat-clearing and antitussive Neulized inhalation that observation group 1 gives embodiment 1 carries out atomization inspiration treatment with pharmaceutical solutions, sees
Examine the infantile heat-clearing and antitussive Neulized inhalation that group 2 gives embodiment 2 and carry out atomization inspiration treatment with pharmaceutical solutions, control group gives small
Youngster's Qingrezhike oral solution（Chongqing Three Gorges sea of clouds medicine company limited company）Carry out oral medication.Three groups of the course for the treatment of is 3 days.
Criterion of therapeutical effect：（1）It is effective：Breathing is steady, the slight cough without cough or only of no phlegm；（2）Effectively：Treatment more than 3 days
Clinical symptoms are clearly better；（3）It is invalid：After treatment 3 days, above clinical symptoms are without improvement or aggravate.Specifically it see the table below：
Three groups for the treatment of infantile cough's asthma due to excessive phlegm curative effects of table compare [n（%）]
| Group | It is effective | Effectively | It is invalid | Total effective rate |
| Observation group 1 | 8（17.8） | 15（33.3） | 22（48.9） | 51.1 |
| Observation group 2 | 17（37.8） | 18（40.0） | 10（22.2） | 77.8 |
| Control group | 10（22.2） | 15（33.3） | 20（44.4） | 55.6 |
Thus table can be seen that observation group 1, observation group 2 and control group has therapeutic action to infantile cough's asthma due to excessive phlegm, wherein observing
The therapeutic effect of group 2 is significantly better than control group（P<0.05）.
Equally, observation group 2 is mute in treatment dry sound, and it is oral that the effect of abscess of throat etc. is also significantly better than infantile heat-clearing and antitussive
Liquid.
Embodiment
The dosage of material is not limited to used in material used in the production process and preparation of following pharmaceutical preparation embodiment or preparation
Character express, all formulation methods containing pharmaceutical composition provided by the invention, belongs to protection scope of the present invention.
Embodiment 1
（1）The preparation of infantile heat-clearing and antitussive active ingredient：
Chinese ephedra 27g, fry semen armeniacae amarae 36g, gypsum 81g, radix glycyrrhizae 27g, radix scutellariae 54g, Radix Isatidis 54g, rhizoma menispermi 27g
Seven flavor medicine is weighed according to above-mentioned parts by weight, Chinese ephedra, gypsum decoct 30min, add and fry semen armeniacae amarae, radix glycyrrhizae, radix scutellariae, plate indigo plant
Root, rhizoma menispermi add 8 times of amount decoctings to boil 2h, filter；The dregs of a decoction add 8 times of amount decoctings to boil 1h, filter, merging filtrate, stand, take supernatant
Liquid, it is concentrated into right amount, adding ethanol makes alcohol content be 70%, stirs evenly, stands, refrigerates 12h, take supernatant, filtration, filtrate recovery
Ethanol is to without alcohol taste, and again plus ethanol makes alcohol content be 75%, stirs evenly, stands, refrigerate 12h, take supernatant, filters, filtrate recovery
Ethanol adds injection appropriate amount of water, stirred evenly, refrigerate 24h, take supernatant, add activated carbon to boil 30min, let cool, filter to without alcohol taste
Cross, inject water to 980ml, produce infantile heat-clearing and antitussive active ingredient solution；
（2）The preparation of infantile heat-clearing and antitussive Neulized inhalation solution：
Infantile heat-clearing and antitussive active ingredient solution 980ml
Magnesium chloride 9g
Water for injection adds to 1000ml
Required infantile heat-clearing and antitussive active ingredient solution is measured by recipe quantity, 9g magnesium chlorides is added, injects water to
1000ml, regulation pH value to 5.0, ultrafiltration, embedding, sterilizing, produce pharmaceutical solutions of the invention.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 2
（1）The preparation of infantile heat-clearing and antitussive active ingredient：
Chinese ephedra 45g, fry semen armeniacae amarae 60g, gypsum 135g, radix glycyrrhizae 45g, radix scutellariae 90g, Radix Isatidis 90g, rhizoma menispermi 45g
Seven flavor medicine is weighed according to above-mentioned parts by weight, Chinese ephedra, gypsum decoct 30min, add and fry semen armeniacae amarae, radix glycyrrhizae, radix scutellariae, plate indigo plant
Root, rhizoma menispermi add 10 times of amount decoctings to boil 2h, filter；The dregs of a decoction add 10 times of amount decoctings to boil 1h, filter, merging filtrate, stand, take supernatant
Liquid, it is concentrated into right amount, adding ethanol makes alcohol content be 75%, stirs evenly, stands, refrigerates 12h, take supernatant, filtration, filtrate recovery
Ethanol is to without alcohol taste, and again plus ethanol makes alcohol content be 80%, stirs evenly, stands, refrigerate 12h, take supernatant, filters, filtrate recovery
Ethanol adds injection appropriate amount of water, stirred evenly, refrigerate 36h, take supernatant, add activated carbon to boil 30min, let cool, filter to without alcohol taste
Cross, inject water to 980ml, produce infantile heat-clearing and antitussive active ingredient solution；
（2）The preparation of infantile heat-clearing and antitussive Neulized inhalation solution：
Infantile heat-clearing and antitussive active ingredient solution 980ml
Sodium chloride 5g
Water for injection adds to 1000ml
Required infantile heat-clearing and antitussive active ingredient solution is measured by recipe quantity, 5g sodium chloride is added, injects water to
1000ml, regulation pH value to 6.0, ultrafiltration, embedding, sterilizing, produce pharmaceutical solutions of the invention.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 3
（1）The preparation of infantile heat-clearing and antitussive active ingredient：
Chinese ephedra 63g, fry semen armeniacae amarae 84g, gypsum 189g, radix glycyrrhizae 63g, radix scutellariae 126g, Radix Isatidis 126g, rhizoma menispermi 63g
Seven flavor medicine is weighed according to above-mentioned parts by weight, Chinese ephedra, gypsum decoct 30min, add and fry semen armeniacae amarae, radix glycyrrhizae, radix scutellariae, plate indigo plant
Root, rhizoma menispermi add 12 times of amount decoctings to boil 2h, filter；The dregs of a decoction add 12 times of amount decoctings to boil 1h, filter, merging filtrate, stand, take supernatant
Liquid, it is concentrated into right amount, adding ethanol makes alcohol content be 80%, stirs evenly, stands, refrigerates 12h, take supernatant, filtration, filtrate recovery
Ethanol is to without alcohol taste, and again plus ethanol makes alcohol content be 85%, stirs evenly, stands, refrigerate 12h, take supernatant, filters, filtrate recovery
Ethanol adds injection appropriate amount of water, stirred evenly, refrigerate 48h, take supernatant, add activated carbon to boil 30min, let cool, filter to without alcohol taste
Cross, inject water to 980ml, produce infantile heat-clearing and antitussive active ingredient solution；
（2）The preparation of infantile heat-clearing and antitussive Neulized inhalation solution：
Infantile heat-clearing and antitussive active ingredient solution 980ml
Sodium chloride 4g
Water for injection adds to 1000ml
Required infantile heat-clearing and antitussive active ingredient solution is measured by recipe quantity, 4g sodium chloride is added, injects water to
1000ml, regulation pH value to 7.0, ultrafiltration, embedding, sterilizing, produce pharmaceutical solutions of the invention.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 4
（1）The preparation of infantile heat-clearing and antitussive active ingredient：
Chinese ephedra 18g, fry semen armeniacae amarae 24g, gypsum 54g, radix glycyrrhizae 18g, radix scutellariae 36g, Radix Isatidis 36g, rhizoma menispermi 18g
Seven flavor medicine is weighed according to above-mentioned parts by weight, Chinese ephedra, gypsum decoct 30min, add and fry semen armeniacae amarae, radix glycyrrhizae, radix scutellariae, plate indigo plant
Root, rhizoma menispermi add 9 times of amount decoctings to boil 2h, filter；The dregs of a decoction add 9 times of amount decoctings to boil 1h, filter, merging filtrate, stand, take supernatant
Liquid, it is concentrated into right amount, adding ethanol makes alcohol content be 85%, stirs evenly, stands, refrigerates 12h, take supernatant, filtration, filtrate recovery
Ethanol is to without alcohol taste, and again plus ethanol makes alcohol content be 90%, stirs evenly, stands, refrigerate 12h, take supernatant, filters, filtrate recovery
Ethanol adds injection appropriate amount of water, stirred evenly, refrigerate 30h, take supernatant, add activated carbon to boil 30min, let cool, filter to without alcohol taste
Cross, inject water to 980ml, produce infantile heat-clearing and antitussive active ingredient solution；
（2）The preparation of infantile heat-clearing and antitussive Neulized inhalation solution：
Infantile heat-clearing and antitussive active ingredient solution 980ml
Sodium chloride 7g
Water for injection adds to 1000ml
Required infantile heat-clearing and antitussive active ingredient solution is measured by recipe quantity, 7g sodium chloride is added, injects water to
1000ml, regulation pH value to 3.0, ultrafiltration, embedding, sterilizing, produce pharmaceutical solutions of the invention.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 5
（1）The preparation of infantile heat-clearing and antitussive active ingredient：
Chinese ephedra 90g, fry semen armeniacae amarae 120g, gypsum 270g, radix glycyrrhizae 90g, radix scutellariae 180g, Radix Isatidis 180g, rhizoma menispermi 90g
Seven flavor medicine is weighed according to above-mentioned parts by weight, Chinese ephedra, gypsum decoct 30min, add and fry semen armeniacae amarae, radix glycyrrhizae, radix scutellariae, plate indigo plant
Root, rhizoma menispermi add 11 times of amount decoctings to boil 2h, filter；The dregs of a decoction add 11 times of amount decoctings to boil 1h, filter, merging filtrate, stand, take supernatant
Liquid, it is concentrated into right amount, adding ethanol makes alcohol content be 70%, stirs evenly, stands, refrigerates 12h, take supernatant, filtration, filtrate recovery
Ethanol is to without alcohol taste, and again plus ethanol makes alcohol content be 80%, stirs evenly, stands, refrigerate 12h, take supernatant, filters, filtrate recovery
Ethanol adds injection appropriate amount of water, stirred evenly, refrigerate 40h, take supernatant, add activated carbon to boil 30min, let cool, filter to without alcohol taste
Cross, inject water to 980ml, produce infantile heat-clearing and antitussive active ingredient solution；
（2）The preparation of infantile heat-clearing and antitussive Neulized inhalation solution：
Infantile heat-clearing and antitussive active ingredient solution 980ml
Sodium chloride 2g
Water for injection adds to 1000ml
Required infantile heat-clearing and antitussive active ingredient solution is measured by recipe quantity, 2g sodium chloride is added, injects water to
1000ml, regulation pH value to 8.5, ultrafiltration, embedding, sterilizing, produce pharmaceutical solutions of the invention.
By gained aerosol inhalation solution preparation, after being atomized with air compression type atomizer, it is directly sucked in and is exhaled with atomised form
Desorption system.
Embodiment 6
（1）The preparation of infantile heat-clearing and antitussive active ingredient：
Chinese ephedra 72g, fry semen armeniacae amarae 96g, gypsum 216g, radix glycyrrhizae 72g, radix scutellariae 144g, Radix Isatidis 144g, rhizoma menispermi 72g
Seven flavor medicine is weighed according to above-mentioned parts by weight, Chinese ephedra, gypsum decoct 30min, add and fry semen armeniacae amarae, radix glycyrrhizae, radix scutellariae, plate indigo plant
Root, rhizoma menispermi add 10 times of amount decoctings to boil 2h, filter；The dregs of a decoction add 8 times of amount decoctings to boil 1h, filter, merging filtrate, stand, take supernatant
Liquid, it is concentrated into right amount, adding ethanol makes alcohol content be 75%, stirs evenly, stands, refrigerates 12h, take supernatant, filtration, filtrate recovery
Ethanol is to without alcohol taste, and again plus ethanol makes alcohol content be 85%, stirs evenly, stands, refrigerate 12h, take supernatant, filters, filtrate recovery
Ethanol adds injection appropriate amount of water, stirred evenly, refrigerate 48h, take supernatant, add activated carbon to boil 30min, let cool, filter to without alcohol taste
Cross, inject water to 980ml, produce infantile heat-clearing and antitussive active ingredient solution；
（2）The preparation of infantile heat-clearing and antitussive Neulized inhalation solution：
Infantile heat-clearing and antitussive active ingredient solution 980ml
Glucose 40g
Water for injection adds to 1000ml
Required infantile heat-clearing and antitussive active ingredient solution is measured by recipe quantity, 40g glucose is added, injects water to
1000ml, regulation pH value to 8.0, ultrafiltration, embedding, sterilizing, produce pharmaceutical solutions of the invention.
By gained aerosol inhalation solution preparation, after being atomized with air compression type atomizer, it is directly sucked in and is exhaled with atomised form
Desorption system.
Embodiment 7
（1）The preparation of infantile heat-clearing and antitussive active ingredient：
Chinese ephedra 36g, fry semen armeniacae amarae 48g, gypsum 108g, radix glycyrrhizae 36g, radix scutellariae 72g, Radix Isatidis 72g, rhizoma menispermi 36g
Seven flavor medicine is weighed according to above-mentioned parts by weight, Chinese ephedra, gypsum decoct 30min, add and fry semen armeniacae amarae, radix glycyrrhizae, radix scutellariae, plate indigo plant
Root, rhizoma menispermi add 12 times of amount decoctings to boil 2h, filter；The dregs of a decoction add 10 times of amount decoctings to boil 1h, filter, merging filtrate, stand, take supernatant
Liquid, it is concentrated into right amount, adding ethanol makes alcohol content be 75%, stirs evenly, stands, refrigerates 12h, take supernatant, filtration, filtrate recovery
Ethanol is to without alcohol taste, and again plus ethanol makes alcohol content be 75%, stirs evenly, stands, refrigerate 12h, take supernatant, filters, filtrate recovery
Ethanol adds injection appropriate amount of water, stirred evenly, refrigerate 48h, take supernatant, add activated carbon to boil 30min, let cool, filter to without alcohol taste
Cross, inject water to 980ml, produce infantile heat-clearing and antitussive active ingredient solution；
（2）The preparation of infantile heat-clearing and antitussive Neulized inhalation solution：
Infantile heat-clearing and antitussive active ingredient solution 980ml
Fructose 90g
Water for injection adds to 1000ml
Required infantile heat-clearing and antitussive active ingredient solution is measured by recipe quantity, 90g fructose is added, injects water to
1000ml, regulation pH value to 7.5, ultrafiltration, embedding, sterilizing, produce pharmaceutical solutions of the invention.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 8
（1）The preparation of infantile heat-clearing and antitussive active ingredient：
Chinese ephedra 81g, fry semen armeniacae amarae 108g, gypsum 243g, radix glycyrrhizae 81g, radix scutellariae 162g, Radix Isatidis 162g, rhizoma menispermi 81g
Seven flavor medicine is weighed according to above-mentioned parts by weight, Chinese ephedra, gypsum decoct 30min, add and fry semen armeniacae amarae, radix glycyrrhizae, radix scutellariae, plate indigo plant
Root, rhizoma menispermi add 10 times of amount decoctings to boil 2h, filter；The dregs of a decoction add 10 times of amount decoctings to boil 1h, filter, merging filtrate, stand, take supernatant
Liquid, it is concentrated into right amount, adding ethanol makes alcohol content be 85%, stirs evenly, stands, refrigerates 12h, take supernatant, filtration, filtrate recovery
Ethanol is to without alcohol taste, and again plus ethanol makes alcohol content be 85%, stirs evenly, stands, refrigerate 12h, take supernatant, filters, filtrate recovery
Ethanol adds injection appropriate amount of water, stirred evenly, refrigerate 36h, take supernatant, add activated carbon to boil 30min, let cool, filter to without alcohol taste
Cross, inject water to 980ml, produce infantile heat-clearing and antitussive active ingredient solution；
（2）The preparation of infantile heat-clearing and antitussive Neulized inhalation solution：
Infantile heat-clearing and antitussive active ingredient solution 980ml
Mannitol 20g
Water for injection adds to 1000ml
Required infantile heat-clearing and antitussive active ingredient solution is measured by recipe quantity, 20g mannitol is added, injects water to
1000ml, regulation pH value to 6.5, ultrafiltration, embedding, sterilizing, produce pharmaceutical solutions of the invention.
By gained aerosol inhalation solution preparation, after being atomized with air compression type atomizer, it is directly sucked in and is exhaled with atomised form
Desorption system.
Embodiment 9
（1）The preparation of infantile heat-clearing and antitussive active ingredient：
Chinese ephedra 54g, fry semen armeniacae amarae 72g, gypsum 162g, radix glycyrrhizae 54g, radix scutellariae 108g, Radix Isatidis 108g, rhizoma menispermi 54g
Seven flavor medicine is weighed according to above-mentioned parts by weight, Chinese ephedra, gypsum decoct 30min, add and fry semen armeniacae amarae, radix glycyrrhizae, radix scutellariae, plate indigo plant
Root, rhizoma menispermi add 8 times of amount decoctings to boil 2h, filter；The dregs of a decoction add 8 times of amount decoctings to boil 1h, filter, merging filtrate, stand, take supernatant
Liquid, it is concentrated into right amount, adding ethanol makes alcohol content be 80%, stirs evenly, stands, refrigerates 12h, take supernatant, filtration, filtrate recovery
Ethanol is to without alcohol taste, and again plus ethanol makes alcohol content be 90%, stirs evenly, stands, refrigerate 12h, take supernatant, filters, filtrate recovery
Ethanol adds injection appropriate amount of water, stirred evenly, refrigerate 24h, take supernatant, add activated carbon to boil 30min, let cool, filter to without alcohol taste
Cross, inject water to 980ml, produce infantile heat-clearing and antitussive active ingredient solution；
（2）The preparation of infantile heat-clearing and antitussive Neulized inhalation solution：
Infantile heat-clearing and antitussive active ingredient solution 980ml
Glucose 80g
Water for injection adds to 1000ml
Required infantile heat-clearing and antitussive active ingredient solution is measured by recipe quantity, 80g glucose is added, injects water to
1000ml, regulation pH value to 4.0, ultrafiltration, embedding, sterilizing, produce pharmaceutical solutions of the invention.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Embodiment 10
（1）The preparation of infantile heat-clearing and antitussive active ingredient：
Chinese ephedra 63g, fry semen armeniacae amarae 84g, gypsum 189g, radix glycyrrhizae 63g, radix scutellariae 126g, Radix Isatidis 126g, rhizoma menispermi 63g
Seven flavor medicine is weighed according to above-mentioned parts by weight, Chinese ephedra, gypsum decoct 30min, add and fry semen armeniacae amarae, radix glycyrrhizae, radix scutellariae, plate indigo plant
Root, rhizoma menispermi add 10 times of amount decoctings to boil 2h, filter；The dregs of a decoction add 8 times of amount decoctings to boil 1h, filter, merging filtrate, stand, take supernatant
Liquid, it is concentrated into right amount, adding ethanol makes alcohol content be 80%, stirs evenly, stands, refrigerates 12h, take supernatant, filtration, filtrate recovery
Ethanol is to without alcohol taste, and again plus ethanol makes alcohol content be 85%, stirs evenly, stands, refrigerate 12h, take supernatant, filters, filtrate recovery
Ethanol adds injection appropriate amount of water, stirred evenly, refrigerate 40h, take supernatant, add activated carbon to boil 30min, let cool, filter to without alcohol taste
Cross, inject water to 980ml, produce infantile heat-clearing and antitussive active ingredient solution；
（2）The preparation of infantile heat-clearing and antitussive Neulized inhalation solution：
Infantile heat-clearing and antitussive active ingredient solution 980ml
Mannitol 60g
Water for injection adds to 1000ml
Required infantile heat-clearing and antitussive active ingredient solution is measured by recipe quantity, 60g mannitol is added, injects water to
1000ml, regulation pH value to 3.5, ultrafiltration, embedding, sterilizing, produce pharmaceutical solutions of the invention.
By gained aerosol inhalation solution preparation, after being atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Claims (8)
- A kind of 1. infantile heat-clearing and antitussive Neulized inhalation pharmaceutical solutions, it is characterised in that including（1）Infantile heat-clearing and antitussive effectively into Point；（2）Isotonic agent and solvent；Wherein, isotonic agent refers to inorganic salts isotonic agent or carbohydrate isotonic agent；Infantile heat-clearing and antitussive Neulized inhalation pharmaceutical solutions Each preparation unit in the amount of the isotonic agent containing inorganic salts be 0.2-0.9%, or infantile heat-clearing and antitussive Neulized inhalation solution system The amount of the isotonic agent containing carbohydrate is 2-9% in each preparation unit of agent.
- 2. preparation according to claim 1, it is characterised in that infantile heat-clearing and antitussive Neulized inhalation is so with pharmaceutical solutions It is prepared：90 parts of Chinese ephedra, fry 120 parts of semen armeniacae amarae, 270 parts of gypsum, 90 parts of radix glycyrrhizae, 180 parts of radix scutellariae, 180 parts of Radix Isatidis, rhizoma menispermi 90 PartSeven flavor medicine is weighed according to above-mentioned parts by weight, Chinese ephedra, gypsum decoct 30min, add and fry semen armeniacae amarae, radix glycyrrhizae, radix scutellariae, plate indigo plant Root, rhizoma menispermi add 8-12 times to measure decocting to boil 2h, filter；The dregs of a decoction add 8-12 times to measure decocting to boil 1h, filter, merging filtrate, stand, take Supernatant, it is concentrated into right amount, adding ethanol makes alcohol content be 70-85%, stirs evenly, and stands, and refrigerates 12h, takes supernatant, filters, and filters For liquid recovery ethanol to without alcohol taste, again plus ethanol makes alcohol content be 75-90%, stirs evenly, and stands, and refrigerates 12h, takes supernatant, filters Cross, filtrate recycling ethanol adds injection appropriate amount of water, stirred evenly, refrigerate 24~48h, take supernatant, add activated carbon to boil to without alcohol taste 30min, let cool, filter, produce infantile heat-clearing and antitussive active ingredient solution；Appropriate isotonic agent is added, is added to the full amount of water for injection, PH value is adjusted, ultrafiltration, embedding, sterilizing, produces pharmaceutical solutions of the invention.
- 3. preparation according to claim 1, it is characterised in that described inorganic salts isotonic agent be sodium chloride, magnesium chloride, One kind in calcium chloride；Described carbohydrate isotonic agent is one kind in glucose, fructose, mannitol.
- 4. preparation according to claim 2, it is characterised in that Neulized inhalation is 3.0-8.5 with the pH value of solution.
- 5. preparation according to claim 4, it is characterised in that Neulized inhalation is 5.0-7.0 with the pH value of solution.
- 6. preparation according to claim 1, it is characterised in that Neulized inhalation is infantile heat-clearing and antitussive with the consumption per day of solution 0.2-1.0 times of oral liquid consumption per day.
- 7. preparation according to claim 6, it is characterised in that Neulized inhalation is infantile heat-clearing and antitussive with the consumption per day of solution 0.3-0.7 times of oral liquid consumption per day.
- 8. the preparation described in claim 1, it is characterised in that：By gained aerosol inhalation solution preparation, with ultrasonic atomizer or Air compression type atomizer, respiratory system is directly sucked in atomised form.
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