CN107115327A - Andrographolide Neulized inhalation pharmaceutical solutions and preparation method thereof - Google Patents
Andrographolide Neulized inhalation pharmaceutical solutions and preparation method thereof Download PDFInfo
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- CN107115327A CN107115327A CN201710249981.7A CN201710249981A CN107115327A CN 107115327 A CN107115327 A CN 107115327A CN 201710249981 A CN201710249981 A CN 201710249981A CN 107115327 A CN107115327 A CN 107115327A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
-
- 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
Abstract
The present invention relates to a kind of andrographolide or the Neulized inhalation pharmaceutical solutions of its pharmaceutical salts, belong to galenic pharmacy field.The Neulized inhalation pharmaceutical solutions of a kind of andrographolide or its pharmaceutical salts, including (1) andrographolide or its pharmaceutical salts;(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 its parenteral solution and being produced.Convenient using process 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, compared with its parenteral solution, method of administration is different, and dosage is reduced, and security is improved.
Description
The application is entitled:Andrographolide Neulized inhalation pharmaceutical solutions and preparation method thereof, is Application No.:
The divisional application of 201510854921.9 patent of invention, parent application day is on December 1st, 2015.
Technical field
The present invention relates to a kind of andrographolide or the Neulized inhalation pharmaceutical solutions of its pharmaceutical salts and preparation method thereof, category
In galenic pharmacy field.
Background technology
LIANBIZHI ZHUSHEYE composition is Andrographolidi Natrii Bisulfis, with clearing heat and detoxicating, effect of anti-inflammation, is faced
It is used for bacillary dysentery, pneumonia, the treatment of acute tonsillitis on bed.Method of administration is intramuscular injection and drip-feed.Happiness is scorching
Flat parenteral solution composition is andrographolide sulfonate, with clearing heat and detoxicating, cough-relieving stop dysentery, clinically for bronchitis, almond
Body is scorching, bacillary dysentery etc..Potasium dehydroandrographolisuccinate succinate injection is used for viral pneumonia, viral infection of upper respiratory tract etc..Andrographolide is injected
Liquid is used for acute upper respiratory infection, viral pneumonia etc..
Relevant Herba Andrographitis in 1988 in March, 2005, national drug adverse reaction monitoring center case report data base
The adverse reaction of lactone or the parenteral solution of its pharmaceutical salts is mainly shown as that acute renal function injury, fash, dizziness, intestines and stomach are anti-
Should, anaphylactoid reaction etc., and recently as the increase of clinical application crowd, its Reporting of harms is also increasing, because
This, it would be highly desirable to a kind of safer formulation is developed, adverse reaction is reduced, clinical application safety is improved.
The content of the invention
The present invention solves the technical problem of provide it is a kind of safely, effectively, the andrographolide of good quality or its
The Neulized inhalation pharmaceutical solutions of pharmaceutical salts;Present invention also offers the preparation method of said preparation.
The present invention is achieved by the following technical solutions:
A kind of Neulized inhalation pharmaceutical solutions of andrographolide or its pharmaceutical salts, including:
(1) andrographolide or its pharmaceutical salts;
(2) isotonic agent and solvent;
Buffer solution can also be added.
Wherein, in terms of andrographolide, the mass ratio of medicinal ingredient and isotonic agent is 1:1-1:5.
Heretofore described Neulized inhalation preparation includes andrographolide, the andrographolide sulphur of 5-50mg pharmaceutical dosages
One kind in compound, Andrographolidi Natrii Bisulfis, potassium dehydroandrographolide succinate, andrographolide.
Isotonic agent is one kind in sodium chloride, potassium chloride, magnesium chloride, calcium chloride, glucose, xylitol, sorbierite.
Buffer solution is citric acid-sodium citrate, citrate-phosphate disodium hydrogen, potassium dihydrogen phosphate-disodium hydrogen phosphate, lemon
One kind in 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 its parenteral solution consumption;Preferable amount is its parenteral solution consumption
0.3-0.6 times.
It is an advantage of the present invention to provide a kind of novel form for being better than andrographolide or the parenteral solution of its pharmaceutical salts, the system
Agent is directly sucked by respiratory tract, in localized clusters into higher concentration, and directly acts on the receptor or target acceptor of airway surface
And play a role, and can directly be absorbed from air flue mucous membrane and lung, effective component can be directly delivered to disease by the administering mode
Stove, safely and effectively, bioavilability are high, can realize low dosage and fast and effectively treat, 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 Inhalation in Treating
Special preparation medicine, the safety risks for being substituted for Inhalation in Treating using parenteral solution and producing.And prepared by the present invention
Pharmaceutical solutions is to aim at Neulized inhalation to be designed with patient, is supported the use with atomizer, convenient using process, compared with parenteral solution,
Method of administration is different, and dosage is reduced, and security is improved.
Beneficial effects of the present invention are further illustrated below by way of test example:
Tested as follows by taking LIANBIZHI ZHUSHEYE (Andrographolidi Natrii Bisulfis) as an example
Pneumonia rat model 60 is prepared, Normal group, positive controls, medicine group one, medicine is randomly divided into
Group two, medicine group three, medicine group four, every group 10, wherein, Normal group gives normal saline intravenous injection;It is positive
Control group gives LIANBIZHI ZHUSHEYE intravenous injection;Medicine group one, two, three, four gives Lian Bizhi aerosol inhalation solutions (use respectively
Amount is respectively 0.1 times, 0.3 times, 0.6 times, 0.8 times of LIANBIZHI ZHUSHEYE), successive administration 3 days is observed after treatment, respectively
The cure rate of group, the peak concentration of drug in adverse reaction rate, and lung tissue and blood.Specifically it 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 pneumonia rats, wherein medicine group three, four is controlled
Therapeutic effect is substantially better than positive controls, and medicine group two and positive controls are equivalent, and do not have adverse reaction.
In summary, medicine group dosage is small, and adverse reaction is few, and medicine is mainly gathered into higher concentration in lung,
Effective component is conducive to directly act on focus, bioavilability is high, realizes low dosage and fast and effectively treats, thus tool
Have a clear superiority.
Equally, medicine group is also significantly better than Lian Bizhi injections in the effect for the treatment of bacillary dysentery, acute tonsillitis etc.
Liquid.
The therapeutic effect of Lian Bizhi aerosol inhalation solutions of the present invention is substantially better than LIANBIZHI ZHUSHEYE, has filled up the current country
The blank of the special aerosol inhalation solutions of Lian Bizhi of in the market, compared with LIANBIZHI ZHUSHEYE, dosage greatly reduces, and is lotus
0.1-0.8 times of parenteral solution must be controlled, preferably 0.3-0.6 times, while changing method of administration, the generation of adverse reaction is reduced,
Therefore, the present invention possesses substantive distinguishing features that are creative and protruding and significant progressive.
Similarly, andrographolide, andrographolide sulfonate, potassium dehydroandrographolide succinate, the Neulized inhalation of andrographolide are passed through with pharmaceutical solutions
Above-mentioned experiment is crossed, it is as a result identical with the above results.
Embodiment
The consumption 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, the formulation method of all pharmaceutical compositions provided containing the present invention, belongs to protection scope of the present invention.
Embodiment 1
Preparation method:
Andrographolidi Natrii Bisulfis is weighed by recipe quantity, appropriate water for injection is added, is stirred to dissolve completely, obtains molten
Liquid 1;Recipe quantity sodium chloride and citric acid are weighed, appropriate water for injection is added, is stirred to dissolve, obtains solution 2;By solution 1 with it is molten
Liquid is 2-in-1 simultaneously, stirs, and obtains solution 3;It is another to take disodium hydrogen phosphate appropriate, plus water for injection is configured to the molten of 0.4mol/L in right amount
Liquid, stirring is slowly added into solution 3, regulation pH value to 4.0-6.0, plus water for injection 1000ml, filling, sealing, is produced.
Embodiment 2
Preparation method:
Andrographolide is weighed by recipe quantity, appropriate water for injection is added, is stirred to dissolve completely, obtains solution 1;Weigh place
Side's amount magnesium chloride and citric acid, add appropriate water for injection, are stirred to dissolve, obtain solution 2;Solution 1 and solution is 2-in-1 simultaneously, stir
Mix uniform, obtain solution 3;It is another to take disodium hydrogen phosphate appropriate, plus water for injection is configured to 0.4mol/L solution in right amount, stirring is slow
It is added in solution 3, regulation pH value to 4.0-7.0, plus water for injection 1000ml, filling, sealing, produce.
Embodiment 3
Preparation method:
Andrographolide sulfonate is weighed by recipe quantity, appropriate water for injection is added, is stirred to dissolve completely, obtains solution 1;
Recipe quantity calcium chloride and citric acid are weighed, appropriate water for injection is added, is stirred to dissolve, obtains solution 2;Solution 1 and solution is 2-in-1
And, stir, obtain solution 3;It is another to take sodium citrate appropriate, plus water for injection is configured to 0.2mol/L solution, stirring in right amount
It is slowly added into solution 3, regulation pH value to 3.5-4.5, plus water for injection 1000ml, filling, sealing, produce.
Embodiment 4
Preparation method:
Andrographolidi Natrii Bisulfis is weighed by recipe quantity, appropriate water for injection is added, is stirred to dissolve completely, obtains molten
Liquid 1;Recipe quantity glucose and citric acid are weighed, appropriate water for injection is added, is stirred to dissolve, obtains solution 2;By solution 1 with it is molten
Liquid is 2-in-1 simultaneously, stirs, and obtains solution 3;It is another to take disodium hydrogen phosphate appropriate, plus water for injection is configured to the molten of 0.4mol/L in right amount
Liquid, stirring is slowly added into solution 3, regulation pH value to 5.0-5.5, plus water for injection 1000ml, filling, sealing, is produced.
Embodiment 5
Preparation method:
Potassium dehydroandrographolide succinate is weighed by recipe quantity, appropriate water for injection is added, is stirred to dissolve completely, obtains solution 1;Weigh recipe quantity
Xylitol and citric acid, add appropriate water for injection, are stirred to dissolve, obtain solution 2;Solution 1 and solution is 2-in-1 simultaneously, and stirring is equal
It is even, obtain solution 3;It is another to take disodium hydrogen phosphate appropriate, plus water for injection is configured to 0.4mol/L solution in right amount, stirring is slowly added to
Into solution 3, regulation pH value to 3.0-4.0, plus water for injection 1000ml, filling, sealing, produce.
Embodiment 6
Preparation method:
Andrographolide is weighed by recipe quantity, appropriate water for injection is added, is stirred to dissolve completely, obtains solution 1;Weigh recipe quantity
Sorbierite and potassium dihydrogen phosphate, add appropriate water for injection, are stirred to dissolve, obtain solution 2;Solution 1 and solution is 2-in-1 simultaneously, stir
Mix uniform, obtain solution 3;It is another to take disodium hydrogen phosphate appropriate, plus water for injection is configured to 0.4mol/L solution in right amount, stirring is slow
It is added in solution 3, regulation pH value to 6.5-8.5, plus water for injection 1000ml, filling, sealing, produce.
Embodiment 7
Preparation method:
Andrographolidi Natrii Bisulfis is weighed by recipe quantity, appropriate water for injection is added, is stirred to dissolve completely, obtains molten
Liquid 1;Recipe quantity sodium chloride is weighed, appropriate water for injection is added, is stirred to dissolve, obtains solution 2;Solution 1 and solution is 2-in-1 simultaneously,
Stir, obtain solution 3;It is another to take disodium hydrogen phosphate appropriate, plus water for injection is configured to 0.4mol/L solution in right amount, stirring is slow
Slowly it is added in solution 3, regulation pH value to 5.0-6.0, plus water for injection 1000ml, filling, sealing, produce.
Embodiment 8
Preparation method:
Andrographolide is weighed by recipe quantity, appropriate water for injection is added, is stirred to dissolve completely, obtains solution 1;Weigh place
Side's amount sodium chloride and citric acid, add appropriate water for injection, are stirred to dissolve, obtain solution 2;Solution 1 and solution is 2-in-1 simultaneously, stir
Mix uniform, obtain solution 3;Another to take Sodium hydroxide q. s, plus appropriate water for injection to be configured to 0.2mol/L solution, stirring is slow to be added
Enter into solution 3, regulation pH value to 4.5-5.5, plus water for injection 1000ml, filling, sealing, produce.
Embodiment 9
Preparation method:
Andrographolide sulfonate is weighed by recipe quantity, appropriate water for injection is added, is stirred to dissolve completely, obtains solution 1;
Recipe quantity sodium chloride is weighed, appropriate water for injection is added, is stirred to dissolve, obtains solution 2;Solution 1 and solution is 2-in-1 simultaneously, stirring
Uniformly, solution 3 is obtained;Separately take disodium hydrogen phosphate appropriate, plus appropriate water for injection is configured to 0.4mol/L solution, stirring is slow to be added
Enter into solution 3, regulation pH value to 4.0-5.0, plus water for injection 1000ml, filling, sealing, produce.
Embodiment 10
Preparation method:
Andrographolidi Natrii Bisulfis is weighed by recipe quantity, appropriate water for injection is added, is stirred to dissolve completely, obtains molten
Liquid 1;Recipe quantity sodium chloride and citric acid are weighed, appropriate water for injection is added, is stirred to dissolve, obtains solution 2;By solution 1 with it is molten
Liquid is 2-in-1 simultaneously, stirs, and obtains solution 3;It is another to take disodium hydrogen phosphate appropriate, plus water for injection is configured to the molten of 0.4mol/L in right amount
Liquid, stirring is slowly added into solution 3, regulation pH value to 5.0-6.0, plus water for injection 1000ml, filling, sealing, is produced.
Embodiment 11
Preparation method:
Potassium dehydroandrographolide succinate is weighed by recipe quantity, appropriate water for injection is added, is stirred to dissolve completely, obtains solution 1;Weigh recipe quantity
Sodium chloride, adds appropriate water for injection, is stirred to dissolve, obtains solution 2;Solution 1 and solution is 2-in-1 simultaneously, stir, obtain solution
3;It is another to take disodium hydrogen phosphate appropriate, plus water for injection is configured to 0.4mol/L solution in right amount, stirring is slowly added into solution 3
In, regulation pH value to 4.5-5.5, plus water for injection 1000ml, filling, sealing, produce.
Claims (9)
1. andrographolide Neulized inhalation pharmaceutical solutions, it is characterised in that including (1) andrographolide or other officinal salts;(2) it is isotonic
Agent and solvent;
In terms of andrographolide, the mass ratio of medicinal ingredient and isotonic agent is 1:1-1:5.
2. preparation according to claim 1, it is characterised in that described Neulized inhalation preparation include 5-50mg andrographolides or
Other officinal salts.
3. preparation according to claim 1, it is characterised in that described isotonic agent be sodium chloride, potassium chloride, magnesium chloride,
One kind in calcium chloride, glucose, xylitol, sorbierite.
4. preparation according to claim 1, it is characterised in that also include buffer solution in said preparation.
5. preparation according to claim 4, it is characterised in that described buffer solution is citric acid-sodium citrate, lemon
One in acid-disodium hydrogen phosphate, potassium dihydrogen phosphate-disodium hydrogen phosphate, citric acid-sodium hydroxide, citric acid-disodium hydrogen phosphate
Kind.
6. preparation according to claim 1, it is characterised in that the pH value of aerosol inhalation solution is 3.0-8.5.
7. preparation according to claim 6, it is characterised in that the pH value of aerosol inhalation solution is 4.0-7.0.
8. preparation according to claim 1, it is characterised in that the consumption of aerosol inhalation solution is its parenteral solution consumption
0.1-0.8 times.
9. preparation according to claim 8, it is characterised in that the consumption of aerosol inhalation solution is its parenteral solution consumption
0.3-0.6 times.
Priority Applications (1)
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CN201710249981.7A CN107115327A (en) | 2015-12-01 | 2015-12-01 | Andrographolide Neulized inhalation pharmaceutical solutions and preparation method thereof |
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CN201510854921.9A CN106806359A (en) | 2015-12-01 | 2015-12-01 | A kind of Neulized inhalation pharmaceutical solutions of andrographolide or its pharmaceutical salts and preparation method thereof |
CN201710249981.7A CN107115327A (en) | 2015-12-01 | 2015-12-01 | Andrographolide Neulized inhalation pharmaceutical solutions and preparation method thereof |
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CN201510854921.9A Division CN106806359A (en) | 2015-12-01 | 2015-12-01 | A kind of Neulized inhalation pharmaceutical solutions of andrographolide or its pharmaceutical salts and preparation method thereof |
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CN201710249982.1A Pending CN107088187A (en) | 2015-12-01 | 2015-12-01 | Potassium dehydroandrographolide succinate Neulized inhalation pharmaceutical solutions and preparation method thereof |
CN201710249981.7A Pending CN107115327A (en) | 2015-12-01 | 2015-12-01 | Andrographolide Neulized inhalation pharmaceutical solutions and preparation method thereof |
CN201510854921.9A Pending CN106806359A (en) | 2015-12-01 | 2015-12-01 | A kind of Neulized inhalation pharmaceutical solutions of andrographolide or its pharmaceutical salts and preparation method thereof |
CN201710249184.9A Pending CN107126431A (en) | 2015-12-01 | 2015-12-01 | Xiyanping Neulized inhalation pharmaceutical solutions and preparation method thereof |
CN201710249185.3A Pending CN107126432A (en) | 2015-12-01 | 2015-12-01 | Lian Bizhi Neulized inhalation pharmaceutical solutionses and preparation method thereof |
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CN201510854921.9A Pending CN106806359A (en) | 2015-12-01 | 2015-12-01 | A kind of Neulized inhalation pharmaceutical solutions of andrographolide or its pharmaceutical salts and preparation method thereof |
CN201710249184.9A Pending CN107126431A (en) | 2015-12-01 | 2015-12-01 | Xiyanping Neulized inhalation pharmaceutical solutions and preparation method thereof |
CN201710249185.3A Pending CN107126432A (en) | 2015-12-01 | 2015-12-01 | Lian Bizhi Neulized inhalation pharmaceutical solutionses and preparation method thereof |
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CN109771398B (en) * | 2019-02-25 | 2019-09-20 | 广州南鑫药业有限公司 | A kind of Peramivir solution-type inhalant and preparation method thereof |
CN113577044A (en) * | 2020-04-30 | 2021-11-02 | 江西青峰药业有限公司 | An inhalant solution containing andrographolide sulfonate or its salt for treating new type coronavirus pneumonia, and its preparation method |
CN113616589A (en) * | 2020-05-06 | 2021-11-09 | 江西青峰药业有限公司 | A nasal drop containing andrographolide sulfonate or its salt for treating novel coronavirus pneumonia, and its preparation method |
CN113633615A (en) * | 2020-05-11 | 2021-11-12 | 江西青峰药业有限公司 | Andrographolide sulfonate spray and application thereof in preparation of novel coronavirus pneumonia treatment drug |
CN112535662A (en) * | 2020-12-23 | 2021-03-23 | 无锡济煜山禾药业股份有限公司 | Antibacterial and anti-inflammatory nasal spray |
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CN102382082A (en) * | 2011-09-07 | 2012-03-21 | 周晓东 | Novel potassium sodium dehydroandroan drographolide succinate compound and drug combination thereof |
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CN1732924A (en) * | 2005-07-21 | 2006-02-15 | 王召 | Andrograpolide sodium bisulphite injection and preparation process thereof |
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CN107126431A (en) | 2017-09-05 |
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