CN107296803A - A kind of suction salbutamol sulfate solution and preparation method thereof - Google Patents
A kind of suction salbutamol sulfate solution and preparation method thereof Download PDFInfo
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- CN107296803A CN107296803A CN201710621366.4A CN201710621366A CN107296803A CN 107296803 A CN107296803 A CN 107296803A CN 201710621366 A CN201710621366 A CN 201710621366A CN 107296803 A CN107296803 A CN 107296803A
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- salbutamol sulfate
- sulfate solution
- suction
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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
- 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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- 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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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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
- A61K9/08—Solutions
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Abstract
The invention discloses a kind of suction salbutamol sulfate solution and preparation method thereof, the suction is made up of with salbutamol sulfate solution active component salbutamol sulfate, auxiliary material and water for injection.The advantage of the invention is that solving the problem of pH value is unstable, prescription is simple, and stability is good, and production cost is low, it is ensured that drug quality and drug safety, and normal temperature storage was up to 2 years.
Description
Technical field
The present invention relates to a kind of suction salbutamol sulfate solution and preparation method thereof, belong to the technology neck of pharmaceutical preparation
Domain.
Background technology
Bronchial astehma is (referred to as：Asthma) it is a kind of common disease, frequently-occurring disease.At present, the people of global asthmatic patient about 300,000,000, in
State's asthmatic patient about 30,000,000.Asthma is the important diseases for influenceing people physically and mentally healthy.Salbutamol sulfate be a kind of application compared with
Long, extensive β is acted on2Receptor stimulating agent, there is stronger bronchiectatic activity, is antiasthmatic safer, the most frequently used at present,
Suitable for prevention bronchial astehma, the bronchial spasm of asthmatic bronchitis and emphysematic patients, alleviate because bronchial astehma,
The symptom such as expiratory dyspnea caused by the airway obstructive disease such as chronic bronchitis and pulmonary emphysema.Especially its inhalant dosage form is wide
The general treatment for bronchial asthma in acute attack, can effectively alleviate the acute symptom of asthma.
The existing formulation of its country's listing has the formulations such as tablet, capsule, small-volume injection, aerosol, powder spray, and it is inhaled
Enter at present with aerosol and powder spray clinically for main application, but both formulations are heterogencity system in preparation,
Solution is separated in storing process, and dosage is not easy accurate control, and is non-sterile preparation, and clinical practice has disadvantage
End.The suction of the present invention, with the sterile water solution that salbutamol sulfate solution is salbutamol sulfate, is homogeneous system, stability
Good, dosage is accurate, it is ensured that sterile level.The present invention considers that inhalation solution, by pulmonary absorption, can directly reach lesion
Position, effect is direct, rapid-action, can be prevented effectively from oral administration first pass effect as caused by liver, greatly improve biological utilisation
Degree, and drug dose used is fewer than Formulations for systemic administration consumption, it is to avoid or there is provided one kind for the issuable side effect of reduction Formulations for systemic administration
Solution for inhalation.
There is numerous studies work to be directed to the development of salbutamol sulfate, Chinese patent application in the prior art
201610310723.0 a kind of suction salbutamol sulfate solution composition and preparation method thereof is disclosed, in the patent simply
Relevant material is controlled, other key indexs, such as pH value, content etc. is not accounted for, and study on the stability is long-term
Test data was only supported by 12 months, it is difficult to ensure that its stability, and promoted the use of in clinical and circulation.
Its less stable of salbutamol sulfate, has the structure and pharmacological properties of many catabolites unclear, not only
Drug safety is influenceed, and is made troubles to storage, transport.Due to its above-mentioned characteristic, in salbutamol sulfate solution preparation,
It has surprisingly been found that by adding a small amount of pH value regulator in salbutamol sulfate solution, not only can be to greatest extent
The addition of auxiliary material is reduced, and can guarantee that drug quality, its stability is greatly improved.
The present invention salbutamol sulfate compared with prior art, with it is following significantly beneficial effect：
1st, inhalation solution of the present invention can directly reach diseased region by pulmonary absorption, and effect is direct, rapid-action, can have
Effect avoids that the first pass effect as caused by liver is administered orally, and greatly improves bioavilability, and drug dose used is given than whole body
Survival dose is few, it is to avoid or reduce the issuable side effect of Formulations for systemic administration.
2nd, the auxiliary material in determination prescription of the invention is only a small amount of pH value regulator, and prescription is simple, reduces supplementary product kind
And consumption, it is ensured that the security of clinical application.
3rd, former, auxiliary material is pharmaceutical injection level as defined in State Food and Drug Administration used in prescription, is disappeared
Unless the unpredictable adverse reaction risk that pharmaceutic adjuvant is brought.
4th, stability is good, transports and stores and be more convenient.
The content of the invention
It is an object of the invention to provide a kind of prescription is simple, stability and the good suction salbutamol sulfate of security
Solution.
It is a further object of the present invention to provide salbutamol sulfate solution and preparation method thereof, this method technique is simple, has
Beneficial to industrialized production.
The suction that the present invention is provided is by salbutamol sulfate, pH value regulator, injection with salbutamol sulfate solution
Water is constituted.
The species and consumption of pH value regulator are not particularly limited, as long as making sulfuric acid after slant acidity and addition pH value regulator
The pH of albuterol solution reaches 2.0~6.0, preferably 3.0~5.0, particularly preferably 3.5 or so.
The pH value regulator used in the present invention refers to slant acidity species or buffer solution, makes sulfuric acid husky as long as it can be realized
Butylamine alcoholic solution reaches above-mentioned pH scopes.Such as hydrochloric acid, sulfuric acid, preferably citric acid, Acetic acid-sodium acetate buffer solution etc., sulphur
Acid or hydrochloric acid.
The content of active component salbutamol sulfate is it is not also specifically limited, can be with salbutamol sulfate solution of the present invention
It is adapted for medicinal any specification, such as contains 1~5g salbutamol sulfates in every 1000ml salbutamol sulfate solutions, preferably
Contain 1~3g.
In the suction salbutamol sulfate solution of the present invention, in addition to active component salbutamol sulfate and aqueous solvent,
PH value regulator is only selected, and is not added with the auxiliary materials such as antioxidant, stabilizer, complexing of metal ion agent, the matter of medicine is not only can guarantee that
Amount, saves production cost, the need for meeting big production, and reduces the risk for being difficult to expect in clinical application.Meanwhile, this hair
Bright suction salbutamol sulfate solution has extraordinary storage-stable.Suitable for high-volume industrial production.
Another object of the present invention is to provide the preparation technology of described suction salbutamol sulfate solution.
The preparation method of the suction salbutamol sulfate solution of the present invention comprises the following steps：Take the note of recipe quantity 80%
Penetrate and use water, add the main ingredient of recipe quantity, nitrogen charging stirs 30min, adjusts pH value between 3.0-4.0 with pH value regulator, adds water to
Full dose, and successively through 0.45 μm of coarse filtration, 0.22 μm of refined filtration.Refined filtration liquid is taken to carry out the detection such as visible foreign matters, pH value, content, detection
After qualified, nitrogen charging embedding is sterilized 15 minutes, lamp inspection, quality inspection is qualified, produces salbutamol sulfate solution with 121 DEG C.
The prescription of the invention of the present invention is simple, easy to operate, reduces production cost, and product stability is good, can protect
Demonstrate,prove the security of medication.
Embodiment
Below will by embodiment, the invention will be further described, but not therefore limit the present invention to institute
In the scope of embodiments stated.It should be understood by those skilled in the art that the equivalent substitution made to present invention, or change accordingly
Enter, still fall within protection scope of the present invention.
Embodiment 1 1000
The water for injection of recipe quantity 80% is taken, the main ingredient of recipe quantity is added, nitrogen charging stirs 30min, pH is adjusted with sulfuric acid solution
Value is between 3.0-4.0, adding water to full dose, and successively through 0.45 μm of coarse filtration, 0.22 μm of refined filtration.Refined filtration liquid is taken to carry out visible different
Thing, pH value, content etc. are detected, after detection is qualified, and nitrogen charging embedding is sterilized 15 minutes with 121 DEG C, lamp inspection, and packaging produces sulfuric acid husky
Butylamine alcoholic solution finished product.
Embodiment 2 1000
The water for injection of recipe quantity 80% is taken, the main ingredient of recipe quantity is added, nitrogen charging stirs 30min, pH is adjusted with hydrochloric acid solution
Value is between 3.0-4.0, adding water to full dose, and successively through 0.45 μm of coarse filtration, 0.22 μm of refined filtration.Refined filtration liquid is taken to carry out visible different
Thing, pH value, content etc. are detected, after detection is qualified, and nitrogen charging embedding is sterilized 15 minutes with 121 DEG C, lamp inspection, and packaging produces sulfuric acid husky
Butylamine alcoholic solution finished product.
Embodiment 3 1000
First prepare appropriate disodium hydrogen phosphate-phosphate sodium dihydrogen buffer solution standby.The water for injection of recipe quantity 80% is taken, plus
Enter the main ingredient of recipe quantity, nitrogen charging stirs 30min, pH value is adjusted between 3.0-4.0, adding water to full dose with hydrochloric acid solution, and successively
Through 0.45 μm of coarse filtration, 0.22 μm of refined filtration.Refined filtration liquid is taken to carry out the detection such as visible foreign matters, pH value, content, after detection is qualified, nitrogen charging
Embedding, is sterilized 15 minutes with 121 DEG C, lamp inspection, and packaging produces salbutamol sulfate solution finished product.
Embodiment 4 1000
First prepare appropriate Acetic acid-sodium acetate buffer solution standby.The water for injection of recipe quantity 80% is taken, recipe quantity is added
Main ingredient, nitrogen charging stirs 30min, and pH value is adjusted between 3.0-4.0, adding water to full dose with hydrochloric acid solution, and thick through 0.45 μm successively
Filter, 0.22 μm of refined filtration.Refined filtration liquid is taken to carry out the detection such as visible foreign matters, pH value, content, after detection is qualified, nitrogen charging embedding, with 121
DEG C sterilizing 15 minutes, lamp inspection, packaging, produce salbutamol sulfate solution finished product.
Embodiment 5 1000
Appropriate citric acid-disodium hydrogen phosphate buffer solution is first prepared, it is standby.The water for injection of recipe quantity 80% is taken, is added
The main ingredient of recipe quantity, nitrogen charging stirs 30min, adjusts pH value between 3.0-4.0, adding water to full dose with hydrochloric acid solution, and pass through successively
0.45 μm of coarse filtration, 0.22 μm of refined filtration.Refined filtration liquid is taken to carry out the detection such as visible foreign matters, pH value, content, after detection is qualified, nitrogen charging is filled
Envelope, is sterilized 15 minutes with 121 DEG C, lamp inspection, and packaging produces salbutamol sulfate solution finished product.
Not only stability is high for salbutamol sulfate solution of the present invention, and drug safety.By items detection, meet medication
It is required that.
Table 1：The testing result of salbutamol sulfate solution of the present invention
Carry out study on the stability with salbutamol sulfate solution to suction of the present invention, and by its suction with prior art
Contrasted with salbutamol sulfate solution, as a comparison case, according to disclosed in Chinese patent application 201610310723.0
Prescription, through 121 DEG C of pressure sterilizings 15 minutes, prepares corresponding suction salbutamol sulfate solution, the results are shown in Table 2.
Table 2：Present invention suction salbutamol sulfate solution study on the stability result：
Show through stability study, quality assurance of the present invention, mature preparation process is feasible, prescription is simple, can meet big life
The demand of production.
Claims (6)
1. a kind of suction salbutamol sulfate solution, it is characterised in that：Described suction salbutamol sulfate solution is by sulphur
Sour salbutamol, pH value regulator and water for injection composition.
2. the suction salbutamol sulfate solution according to claim 1, it is characterised in that described pH regulated values choosing
From sulfuric acid, hydrochloric acid, acetic acid, Acetic acid-sodium acetate, acetic acid-ammonium acetate, disodium hydrogen phosphate-sodium dihydrogen phosphate, citric acid-citric acid
Sodium or one kind in citric acid-disodium hydrogen phosphate or its mixing.
3. suction salbutamol sulfate solution as claimed in any of claims 1 to 2, it is characterised in that：Often
Contain salbutamol sulfate 1g~10g in 1000ml parenteral solutions.
4. salbutamol sulfate solution according to claim 3, it is characterised in that contain the husky butylamine of sulfuric acid in per 1000ml solution
Alcohol 1g~5g.
5. salbutamol sulfate solution according to claim 4, it is characterised in that contain the husky fourth of sulfuric acid in per 1000ml parenteral solutions
Amine alcohol 1g~3g.
6. the preparation method of the suction salbutamol sulfate solution described in Claims 1 to 5 any one, it is characterised in that bag
Include the following steps：
The water for injection of recipe quantity 80% is taken, the main ingredient of recipe quantity is added, nitrogen charging stirs 30min, pH value is adjusted extremely with pH adjusting agent
Between 3.0-4.0, full dose is added water to, and successively through 0.45 μm of coarse filtration, 0.22 μm of refined filtration.Refined filtration liquid is taken to carry out visible foreign matters, pH
Value, content etc. are detected, after detection is qualified, and nitrogen charging embedding is sterilized 15 minutes, lamp inspection, quality inspection is qualified with 121 DEG C, produces sulfuric acid husky
Butylamine alcoholic solution.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710621366.4A CN107296803A (en) | 2017-07-27 | 2017-07-27 | A kind of suction salbutamol sulfate solution and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710621366.4A CN107296803A (en) | 2017-07-27 | 2017-07-27 | A kind of suction salbutamol sulfate solution and preparation method thereof |
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| CN201710621366.4A Pending CN107296803A (en) | 2017-07-27 | 2017-07-27 | A kind of suction salbutamol sulfate solution and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108743569A (en) * | 2018-08-27 | 2018-11-06 | 深圳大佛药业股份有限公司 | Salbutamol sulfate aerosol inhalation solution and preparation method thereof |
| CN110051629A (en) * | 2019-05-17 | 2019-07-26 | 南京望知星医药科技有限公司 | A kind of atomization albuterol solution and preparation method thereof for treating respiratory disorder |
| CN113476428A (en) * | 2021-01-28 | 2021-10-08 | 朗天药业(湖北)有限公司 | Salbutamol sulfate solution for inhalation and preparation method thereof |
| CN114099425A (en) * | 2020-08-28 | 2022-03-01 | 成都倍特药业股份有限公司 | Preparation method of salbutamol sulfate solution |
| CN115463117A (en) * | 2022-09-14 | 2022-12-13 | 四川普锐特药业有限公司 | Budesonide salbutamol compound aerosol inhalation suspension with high delivery efficiency and preparation method thereof |
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| CN1720036A (en) * | 2001-10-26 | 2006-01-11 | 德艾公司 | Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma |
| CN104622855A (en) * | 2014-12-22 | 2015-05-20 | 青岛正大海尔制药有限公司 | Oral solution containing ambroxol hydrochloride and salbutamol sulfate |
| CN105832712A (en) * | 2016-05-12 | 2016-08-10 | 河北仁合益康药业有限公司 | Salbutamol sulfate solution composition for inhaling and preparation method thereof |
| CN106727322A (en) * | 2017-02-14 | 2017-05-31 | 杭州百诚医药科技股份有限公司 | Suction salbutamol sulfate solution and preparation method thereof |
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2017
- 2017-07-27 CN CN201710621366.4A patent/CN107296803A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1720036A (en) * | 2001-10-26 | 2006-01-11 | 德艾公司 | Albuterol inhalation solution, system, kit and method for relieving symptoms of pediatric asthma |
| CN104622855A (en) * | 2014-12-22 | 2015-05-20 | 青岛正大海尔制药有限公司 | Oral solution containing ambroxol hydrochloride and salbutamol sulfate |
| CN105832712A (en) * | 2016-05-12 | 2016-08-10 | 河北仁合益康药业有限公司 | Salbutamol sulfate solution composition for inhaling and preparation method thereof |
| CN106727322A (en) * | 2017-02-14 | 2017-05-31 | 杭州百诚医药科技股份有限公司 | Suction salbutamol sulfate solution and preparation method thereof |
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108743569A (en) * | 2018-08-27 | 2018-11-06 | 深圳大佛药业股份有限公司 | Salbutamol sulfate aerosol inhalation solution and preparation method thereof |
| CN110051629A (en) * | 2019-05-17 | 2019-07-26 | 南京望知星医药科技有限公司 | A kind of atomization albuterol solution and preparation method thereof for treating respiratory disorder |
| CN114099425A (en) * | 2020-08-28 | 2022-03-01 | 成都倍特药业股份有限公司 | Preparation method of salbutamol sulfate solution |
| CN113476428A (en) * | 2021-01-28 | 2021-10-08 | 朗天药业(湖北)有限公司 | Salbutamol sulfate solution for inhalation and preparation method thereof |
| CN113476428B (en) * | 2021-01-28 | 2022-03-29 | 朗天药业(湖北)有限公司 | Salbutamol sulfate solution for inhalation and preparation method thereof |
| CN115463117A (en) * | 2022-09-14 | 2022-12-13 | 四川普锐特药业有限公司 | Budesonide salbutamol compound aerosol inhalation suspension with high delivery efficiency and preparation method thereof |
| CN115463117B (en) * | 2022-09-14 | 2024-06-04 | 四川普锐特药业有限公司 | Budesonide salbutamol compound aerosol inhalation suspension with high delivery efficiency and preparation method thereof |
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| PB01 | Publication | ||
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| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| CB02 | Change of applicant information |
Address after: No. 4 Yaogu Road, Haikou National High-tech Industrial Development Zone, Haikou City, Hainan Province Applicant after: Hainan Beite Pharmaceutical Co. Ltd. Address before: No. 4 Yaogu Road, Haikou National High-tech Industrial Development Zone, Haikou City, Hainan Province Applicant before: Hainan Levtec Pharmaceutical Co., Ltd. |
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| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20171027 |
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| RJ01 | Rejection of invention patent application after publication |