CN106806418A - A kind of swap buffers Neulized inhalation pharmaceutical solutions and preparation method thereof - Google Patents
A kind of swap buffers Neulized inhalation pharmaceutical solutions and preparation method thereof Download PDFInfo
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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)
- A61K36/35—Caprifoliaceae (Honeysuckle family)
- A61K36/355—Lonicera (honeysuckle)
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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)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
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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)
- A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
- A61K36/634—Forsythia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/53—Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
Abstract
The present invention relates to a kind of Neulized inhalation pharmaceutical solutions of swap buffers, belong to galenic pharmacy field.A kind of Neulized inhalation pharmaceutical solutions of swap buffers, including (1) swap buffers active ingredient；(2) isotonic agent and solvent, can also include buffer solution.Pharmaceutical solutions prepared by the present invention compensate for the blank on domestic market, can prevent due to a lack of the special preparation medicine of Inhalation in Treating, the safety risks for being substituted for Inhalation in Treating using Shuanhuanglian injection and producing.And pharmaceutical solutions prepared by the present invention is to aim at Neulized inhalation to be designed with patient, is supported the use with atomizer, convenient using process, compared with Shuanhuanglian injection, method of administration is different, and dosage is reduced, and security is improved.
Description
Technical field
The present invention relates to a kind of swap buffers Neulized inhalation pharmaceutical solutions and preparation method thereof, belong to galenic pharmacy neck
Domain.
Background technology
《Chinese Pharmacopoeia clinical application notice》(2010 editions) include Shuanhuanglian injection, point out 'Shuang Hualian ' injection
Liquid be clinically used for treatment flu, cough, larynx numbness, acute tonsillitis, rheumatism lung heat, in addition with treat skin disease,
The document reports such as Japanese Type-B encephalitis, chronic prostatitis and acute Traumatic Intracranial Hematoma.
Shuanhuanglian injection is made up of medicines such as honeysuckle, the root of large-flowered skullcap, the capsules of weeping forsythia, with antibacterial, anti-inflammatory, resists
The pharmacological actions such as virus, enhancing body immune function, while infected by influenza, Respiratory Syncytial Virus(RSV) etc. are felt
Antagonism is infected with, for heating, cough, pharyngalgia, the infection of the upper respiratory tract, acute branch caused by affection of exogenous wind-heat
Tracheitis, light-duty pneumonia, acute tonsilla palatina inflammation etc., Shuanhuanglian injection is controlled as the hospital of traditional Chinese hospital in recent years
Treat one of choice drug of infection of the upper respiratory tract disease.
Recently as the increase of clinical application crowd, its Reporting of harms is also increasing, is mainly manifested in
Allergic reaction (including dermoreaction, anaphylactic shock, angioneurotic edema etc.), digestive system reaction and
Phlebitis etc., country was once disabling the Shuanhuanglian injection of indivedual factory's productions, it would therefore be highly desirable to develop one kind more
It is the formulation of safety, reduces adverse reaction, improves clinical application safety.
The content of the invention
The present invention solves the technical problem of provide it is a kind of safely, effectively, the swap buffers 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 swap buffers Neulized inhalation pharmaceutical solutions, including：
(1) swap buffers active ingredient；
(2) isotonic agent and solvent；
Buffer solution can also be added.
Wherein, in terms of scutelloside, active ingredient is 1: 1-1: 5 with the mass ratio of isotonic agent.
Heretofore described Neulized inhalation preparation include the pharmaceutical dosages of the 5-20mg in terms of scutelloside it is effective into
Point.
Active ingredient is prepared obtaining：
1 part of honeysuckle, 1 part of the root of large-flowered skullcap, 2 parts of the capsule of weeping forsythia
The root of large-flowered skullcap is given as one thinks fit it is cataclasm, add water to cook it is secondary, 1 hour every time, by several times filter, merging filtrate, filter
Liquid adjusts pH to 1.0~2.0 with hydrochloric acid solution, and 30 minutes are incubated at 80 DEG C, stands 24 hours, filtration,
Precipitation plus 8 times of amount water, stirring, pH is adjusted to 7.0 with 40% sodium hydroxide solution, and adds equivalent ethanol, is stirred
Mixing makes molten, filtration, and filtrate adjusts pH to 2.0 with hydrochloric acid solution, and 60 DEG C are incubated 30 minutes, stand 12 hours,
Filtration, precipitation ethanol is washed till pH to 4.0, plus 10 times of amount water, and 40% sodium hydroxide solution is used in stirring
PH to 6.0 is adjusted, 0.5% activated carbon is added, is sufficiently stirred for, 50 DEG C are incubated 30 minutes, add 1 times of amount second
Alcohol stirs, and filters immediately, and filtrate adjusts pH to 2.0 with hydrochloric acid solution, and 60 DEG C are incubated 30 minutes, stand
12 hours, filtration after precipitation is washed with a small amount of ethanol, was dried in less than 60 DEG C, obtains Baical Skullcap root P.E；
Honeysuckle, the capsule of weeping forsythia add water and impregnate 30 minutes, decoct secondary, 1 hour every time, filtration by several times, merging
Filtrate, it is 1.20~1.25 to be concentrated into 70~80 DEG C of relative densities, is let cool to 40 DEG C, slowly adds ethanol to make to contain
Alcohol amount is sufficiently stirred for up to 75%, stands 12 hours, leaching supernatant, reclaims ethanol to without alcohol taste, adds
3~4 times of amount water, adjust pH to 7.0, are sufficiently stirred for and are heated to boiling, stand 48 hours, leaching supernatant,
It is 1.10~1.15 to be concentrated into 70~80 DEG C of relative densities, is let cool to 40 DEG C, adds ethanol to reach alcohol content
85%, 12 hours are stood, leaching supernatant reclaims ethanol to without alcohol taste, obtains honeysuckle and capsule of weeping forsythia extract solution；
Take Baical Skullcap root P.E to add water in right amount, heat and make dissolving with 40% sodium hydroxide solution tune pH to 7.0,
Honeysuckle, capsule of weeping forsythia extract solution are added, active ingredient of the invention is obtained.
Isotonic agent is in sodium chloride, potassium chloride, magnesium chloride, calcium chloride, glucose, xylitol, sorbierite
One kind.
Buffer solution be citric acid-sodium citrate, citrate-phosphate disodium hydrogen, potassium dihydrogen phosphate-disodium hydrogen phosphate,
One kind in citric acid-sodium hydroxide, citric acid-disodium hydrogen phosphate.
The pH value of aerosol inhalation solution is 3.0-8.5；Preferable ph is 4.0-7.0.
The consumption of aerosol inhalation solution is 0.1-0.8 times of Shuanhuanglian injection consumption；Preferable amount is double yellow
Connect 0.3-0.6 times of parenteral solution consumption.
Swap buffers Neulized inhalation pharmaceutical solutions of the present invention can be used for treatment affection of exogenous wind-heat caused by heating,
Cough, pharyngalgia, the infection of the upper respiratory tract, acute bronchitis, light-duty pneumonia, acute tonsilla palatina inflammation etc..
It is an advantage of the present invention to provide a kind of novel form better than Shuanhuanglian injection, said preparation is directly by exhaling
Road suction is inhaled, in localized clusters into higher concentration, and the receptor or target acceptor of airway surface is directly acted on
And play a role, and can directly be absorbed from air flue mucous membrane and lung, the administering mode can be straight by effective component
Connect and be delivered to focus, safely and effectively, bioavilability is high, low dosage can be realized and fast and effectively treated,
Thus have a clear superiority.
Pharmaceutical solutions prepared by the present invention compensate for the blank on domestic market, can prevent due to a lack of suction
Enter to treat special preparation medicine, the security for being substituted for Inhalation in Treating using Shuanhuanglian injection and producing
Hidden danger.It is supporting with atomizer and pharmaceutical solutions prepared by the present invention is to aim at Neulized inhalation to be designed with patient
Use, convenient using process, compared with Shuanhuanglian injection, method of administration is different, and dosage is reduced,
Security is improved.
Beneficial effects of the present invention are further illustrated below by way of test example：
Infection of the upper respiratory tract rat model 60 is prepared, Normal group, positive controls, medicine is randomly divided into
Thing group one, medicine group two, medicine group three, medicine group four, every group 10, wherein, Normal group gives
Normal saline is injected intravenously；Positive controls give Shuanhuanglian injection intravenous injection；Medicine group one,
2nd, three, four give respectively swap buffers aerosol inhalation solution (consumption be respectively 0.1 times of Shuanhuanglian injection,
0.3 times, 0.6 times, 0.8 times), successive administration 3 days, observation by after treatment, the cure rate of each group, no
Good reaction incidence, and the drug concentration in lung tissue and blood.Specifically see the table below：
Situation after the treatment of table each group
It can thus be seen that each medicine group has preferable therapeutic action to respiratory tract infection rat, its Chinese medicine
The therapeutic effect of thing group two, three, four is substantially better than positive controls, and medicine group one is equivalent with positive controls,
And there is no adverse reaction.
In summary, medicine group dosage is small, and adverse reaction is few, and medicine it is main lung be gathered into compared with
High concentration, is conducive to effective component to directly act on focus, and bioavilability is high, realizes low dosage and fast
Fast effective treatment, thus have a clear superiority.
Equally, medicine group is also significantly better than 'Shuang Hualian ' injection in the effect for the treatment of pneumonia, acute bronchitis etc.
Liquid.
The therapeutic effect of swap buffers aerosol inhalation solution of the present invention is substantially better than Shuanhuanglian injection, has filled up mesh
The blank of the special aerosol inhalation solution of swap buffers on preceding domestic market, compared with Shuanhuanglian injection, uses
Dosage greatly reduces, and is 0.1-0.8 times of Shuanhuanglian injection, preferably 0.3-0.6 times, while changing
Method of administration, reduces the generation of adverse reaction, therefore, the present invention possesses creative and prominent substance
Feature and significant progress.
Specific embodiment
The consumption of the production process of following pharmaceutical preparation embodiment and material used by preparation or material used by preparation is not
It is limited to character express, the formulation method of all pharmaceutical compositions provided containing the present invention is belonged to of the invention
Protection domain.
Embodiment 1
(1) preparation of active ingredient：
Honeysuckle 250g, root of large-flowered skullcap 250g, capsule of weeping forsythia 500g
The root of large-flowered skullcap is given as one thinks fit it is cataclasm, add water to cook it is secondary, 1 hour every time, by several times filter, merging filtrate, filter
Liquid adjusts pH to 1.0~2.0 with hydrochloric acid solution, and 30 minutes are incubated at 80 DEG C, stands 24 hours, filtration,
Precipitation plus 8 times of amount water, stirring, pH is adjusted to 7.0 with 40% sodium hydroxide solution, and adds equivalent ethanol, is stirred
Mixing makes molten, filtration, and filtrate adjusts pH to 2.0 with hydrochloric acid solution, and 60 DEG C are incubated 30 minutes, stand 12 hours,
Filtration, precipitation ethanol is washed till pH to 4.0, plus 10 times of amount water, and 40% sodium hydroxide solution is used in stirring
PH to 6.0 is adjusted, 0.5% activated carbon is added, is sufficiently stirred for, 50 DEG C are incubated 30 minutes, add 1 times of amount second
Alcohol stirs, and filters immediately, and filtrate adjusts pH to 2.0 with hydrochloric acid solution, and 60 DEG C are incubated 30 minutes, stand
12 hours, filtration after precipitation is washed with a small amount of ethanol, was dried in less than 60 DEG C, obtains Baical Skullcap root P.E；
Honeysuckle, the capsule of weeping forsythia add water and impregnate 30 minutes, decoct secondary, 1 hour every time, filtration by several times, merging
Filtrate, it is 1.20~1.25 to be concentrated into 70~80 DEG C of relative densities, is let cool to 40 DEG C, slowly adds ethanol to make to contain
Alcohol amount is sufficiently stirred for up to 75%, stands 12 hours, leaching supernatant, reclaims ethanol to without alcohol taste, adds
3~4 times of amount water, adjust pH to 7.0, are sufficiently stirred for and are heated to boiling, stand 48 hours, leaching supernatant,
It is 1.10~1.15 to be concentrated into 70~80 DEG C of relative densities, is let cool to 40 DEG C, adds ethanol to reach alcohol content
85%, 12 hours are stood, leaching supernatant reclaims ethanol to without alcohol taste, obtains honeysuckle and capsule of weeping forsythia extract solution；
Take Baical Skullcap root P.E to add water in right amount, heat and make dissolving with 40% sodium hydroxide solution tune pH to 7.0,
Honeysuckle, capsule of weeping forsythia extract solution are added, active ingredient of the invention is obtained.
(2) preparation of swap buffers Neulized inhalation solution：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Sodium and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to 0.4mol/L
Solution, stirring be slowly added into solution 3, regulation pH value to 5.0-7.0, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 2
(1) preparation of active ingredient：With embodiment 1.
(2) preparation of swap buffers Neulized inhalation solution：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Sodium, adds appropriate water for injection, is stirred to dissolve, and obtains solution 2；Solution 1 and solution is 2-in-1 simultaneously, stirring
Uniformly, solution 3 is obtained；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to the molten of 0.4mol/L
Liquid, stirring is slowly added into solution 3, regulation pH value to 4.0-7.0, plus water for injection 1000ml, is filled
Dress, sealing, obtain final product.
Embodiment 3
(1) preparation of active ingredient：With embodiment 1.
(2) preparation of swap buffers Neulized inhalation solution：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Magnesium and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to 0.2mol/L
Solution, stirring be slowly added into solution 3, regulation pH value to 3.5-4.5, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 4
(1) preparation of active ingredient：With embodiment 1.
(2) preparation of swap buffers Neulized inhalation solution：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Calcium and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to 0.4mol/L
Solution, stirring be slowly added into solution 3, regulation pH value to 5.5-6.5, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 5
(1) preparation of active ingredient：With embodiment 1.
(2) preparation of swap buffers Neulized inhalation solution：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Sodium and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；The another sodium citrate that takes is appropriate, plus appropriate water for injection is configured to 0.4mol/L
Solution, stirring be slowly added into solution 3, regulation pH value to 6.0-7.0, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 6
(1) preparation of active ingredient：With embodiment 1.
(2) preparation of swap buffers Neulized inhalation solution：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take grape
Sugar and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to 0.4mol/L
Solution, stirring be slowly added into solution 3, regulation pH value to 6.5-7.5, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 7
(1) preparation of active ingredient：With embodiment 1.
(2) preparation of swap buffers Neulized inhalation solution：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take xylose
Alcohol and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；It is another to take Sodium hydroxide q. s, plus water for injection is configured to 0.1mol/L in right amount
Solution, stirring be slowly added into solution 3, regulation pH value to 3.0-5.0, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 8
(1) preparation of active ingredient：Preparation method is with embodiment 1.
(2) preparation of swap buffers Neulized inhalation solution：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Sodium and potassium dihydrogen phosphate, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；By solution 1 and solution
It is 2-in-1 simultaneously to stir, obtain solution 3；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to
The solution of 0.4mol/L, stirring is slowly added into solution 3, regulation pH value to 4.5-5.5, plus injection
Water 1000ml, filling, sealing is obtained final product.
Embodiment 9
(1) preparation of active ingredient：Preparation method is with embodiment 1.
(2) preparation of swap buffers Neulized inhalation solution：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take sorb
Alcohol and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to 0.2mol/L
Solution, stirring be slowly added into solution 3, regulation pH value to 6.0-8.0, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 10
(1) preparation of active ingredient：Preparation method is with embodiment 1.
(2) preparation of swap buffers Neulized inhalation solution：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Sodium and citric acid, add appropriate water for injection, are stirred to dissolve, and obtain solution 2；Solution 1 and solution is 2-in-1
And, stir, obtain solution 3；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to 0.2mol/L
Solution, stirring be slowly added into solution 3, regulation pH value to 5.5-6.5, plus water for injection 1000ml,
Filling, sealing, obtains final product.
Embodiment 11
(1) preparation of active ingredient：Preparation method is with embodiment 1.
(2) preparation of swap buffers Neulized inhalation solution：
Active ingredient is weighed by recipe quantity, appropriate water for injection is added, stirred, obtain solution 1；Take chlorination
Magnesium, adds appropriate water for injection, is stirred to dissolve, and obtains solution 2；Solution 1 and solution is 2-in-1 simultaneously, stirring
Uniformly, solution 3 is obtained；The another disodium hydrogen phosphate that takes is appropriate, plus appropriate water for injection is configured to the molten of 0.4mol/L
Liquid, stirring is slowly added into solution 3, regulation pH value to 6.5-8.5, plus water for injection 1000ml, is filled
Dress, sealing, obtain final product.
Claims (10)
1. a kind of swap buffers Neulized inhalation pharmaceutical solutions, it is characterised in that effective including (1) swap buffers
Composition；(2) isotonic agent and solvent；
In terms of scutelloside, active ingredient is 1: 1-1: 5 with the mass ratio of isotonic agent.
2. preparation according to claim 1, it is characterised in that described Neulized inhalation preparation include with
The active ingredient of scutelloside meter 5-20mg pharmaceutical dosages.
3. preparation according to claim 1 and 2, it is characterised in that active ingredient is to be prepared
Arrive：
1 part of honeysuckle, 1 part of the root of large-flowered skullcap, 2 parts of the capsule of weeping forsythia
The root of large-flowered skullcap is given as one thinks fit it is cataclasm, add water to cook it is secondary, 1 hour every time, by several times filter, merging filtrate, filter
Liquid adjusts pH to 1.0~2.0 with hydrochloric acid solution, and 30 minutes are incubated at 80 DEG C, stands 24 hours, filtration,
Precipitation plus 8 times of amount water, stirring, pH is adjusted to 7.0 with 40% sodium hydroxide solution, and adds equivalent ethanol, is stirred
Mixing makes molten, filtration, and filtrate adjusts pH to 2.0 with hydrochloric acid solution, and 60 DEG C are incubated 30 minutes, stand 12 hours,
Filtration, precipitation ethanol is washed till pH to 4.0, plus 10 times of amount water, and 40% sodium hydroxide solution is used in stirring
PH to 6.0 is adjusted, 0.5% activated carbon is added, is sufficiently stirred for, 50 DEG C are incubated 30 minutes, add 1 times of amount second
Alcohol stirs, and filters immediately, and filtrate adjusts pH to 2.0 with hydrochloric acid solution, and 60 DEG C are incubated 30 minutes, stand
12 hours, filtration after precipitation is washed with a small amount of ethanol, was dried in less than 60 DEG C, obtains Baical Skullcap root P.E；
Honeysuckle, the capsule of weeping forsythia add water and impregnate 30 minutes, decoct secondary, 1 hour every time, filtration by several times, merging
Filtrate, it is 1.20~1.25 to be concentrated into 70~80 DEG C of relative densities, is let cool to 40 DEG C, slowly adds ethanol to make to contain
Alcohol amount is sufficiently stirred for up to 75%, stands 12 hours, leaching supernatant, reclaims ethanol to without alcohol taste, adds
3~4 times of amount water, adjust pH to 7.0, are sufficiently stirred for and are heated to boiling, stand 48 hours, leaching supernatant,
It is 1.10~1.15 to be concentrated into 70~80 DEG C of relative densities, is let cool to 40 DEG C, adds ethanol to reach alcohol content
85%, 12 hours are stood, leaching supernatant reclaims ethanol to without alcohol taste, obtains honeysuckle and capsule of weeping forsythia extract solution；
Take Baical Skullcap root P.E to add water in right amount, heat and make dissolving with 40% sodium hydroxide solution tune pH to 7.0,
Honeysuckle, capsule of weeping forsythia extract solution are added, active ingredient of the invention is obtained.
4. preparation according to claim 1, it is characterised in that described isotonic agent is sodium chloride, chlorine
Change the one kind in potassium, magnesium chloride, calcium chloride, glucose, xylitol, sorbierite.
5. preparation according to claim 1, it is characterised in that also include buffer solution in said preparation.
6. preparation according to claim 5, it is characterised in that described buffer solution is citric acid-lemon
Lemon acid sodium, citrate-phosphate disodium hydrogen, potassium dihydrogen phosphate-disodium hydrogen phosphate, citric acid-sodium hydroxide, Chinese holly
One kind in rafter acid-disodium hydrogen phosphate.
7. preparation according to claim 1, it is characterised in that the pH value of aerosol inhalation solution is
3.0-8.5。
8. preparation according to claim 7, it is characterised in that the pH value of aerosol inhalation solution is
4.0-7.0。
9. preparation according to claim 1, it is characterised in that the consumption of aerosol inhalation solution is double yellow
Connect 0.1-0.8 times of parenteral solution consumption.
10. preparation according to claim 9, it is characterised in that the consumption of aerosol inhalation solution is double
0.3-0.6 times of coptis injection consumption.
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| CN202110223963.8A CN112999204A (en) | 2015-12-01 | 2015-12-01 | Shuanghuanglian aerosol inhalation solution preparation and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110090244A (en) * | 2018-01-30 | 2019-08-06 | 北京盈科瑞创新药物研究有限公司 | A kind of sucking cruelly red pharmaceutical solutions of a kind of reed mentioned in ancient books and preparation method thereof |
| CN110090245A (en) * | 2018-01-30 | 2019-08-06 | 盈科瑞（横琴）药物研究院有限公司 | A kind of sucking a kind of reed mentioned in ancient books orchid pharmaceutical solutions and preparation method thereof |
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| CN100493493C (en) * | 2004-06-11 | 2009-06-03 | 吴文耀 | Shuanghuanglian gel for eyes |
| CN101653480B (en) * | 2009-09-15 | 2012-01-11 | 哈药集团三精制药股份有限公司 | Preparation method of Shuanghuanglian aerosol |
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| CN101843667A (en) * | 2010-06-07 | 2010-09-29 | 哈尔滨珍宝制药有限公司 | Shuanghuanglian medicinal composition and preparation method thereof |
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Cited By (2)
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| CN110090244A (en) * | 2018-01-30 | 2019-08-06 | 北京盈科瑞创新药物研究有限公司 | A kind of sucking cruelly red pharmaceutical solutions of a kind of reed mentioned in ancient books and preparation method thereof |
| CN110090245A (en) * | 2018-01-30 | 2019-08-06 | 盈科瑞（横琴）药物研究院有限公司 | A kind of sucking a kind of reed mentioned in ancient books orchid pharmaceutical solutions and preparation method thereof |
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