CN102579332A - Method for preparing ibuprofen injection - Google Patents
Method for preparing ibuprofen injection Download PDFInfo
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- CN102579332A CN102579332A CN2012100818482A CN201210081848A CN102579332A CN 102579332 A CN102579332 A CN 102579332A CN 2012100818482 A CN2012100818482 A CN 2012100818482A CN 201210081848 A CN201210081848 A CN 201210081848A CN 102579332 A CN102579332 A CN 102579332A
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- injection
- ibuprofen
- arginine
- sterilization
- water
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Abstract
The invention aims to provide a method for preparing an ibuprofen injection. A rotary sterilization method is applied to a process for preparing the ibuprofen injection for the first time. By the method, the problem that the production requirement of the injection cannot be reached due to disqualified visible foreign matters caused by the conventional steam sterilization process in the ibuprofen injection can be avoided effectively.
Description
Technical field
The present invention relates to a kind of method for preparing of ibuprofen injection.Ibuprofen injection is mainly used in antipyretic-antalgic, and its curative effect is clear and definite, and effect belongs to the pharmaceutical production technical field rapidly.
Background technology
Ibuprofen injection is the kind by the exploitation of Cumberland company, and trade name: Caldolor obtains the listing permission of FDA in the U.S. in June, 2009.Wherein the mol ratio of arginine and ibuprofen is 0.92: 1.This is the first ejection preparation of ibuprofen.Up to now, most of NSAID have only peroral dosage form, and the listing of ibuprofen injection is pain and heating, inconvenient again oral patient has brought convenience simultaneously.This kind not listing at home as yet at present.
The preparation patent of the ibuprofen injection of Cumberland company is open, but undeclared sterilizing methods in this patent.The injection products that has gone on the market at present adopts steam sterilization also or adopt the method for omnidistance sterile working usually, promptly hundred grades of cleaning shops, produces under all sterilized situation of supplementary material.And omnidistance sterile working has relatively high expectations, and can increase the cost of ibuprofen injection.Adopt 115 ℃ of hot pressing, 30 minutes, or 121 ℃, 15 minutes sterilizing methods, though can reach the state of sterilization fully, the visible foreign matters of ibuprofen injection is defective again.But in the production of injection, must could guarantee the safety of medication, so ibuprofen injection is carried out the terminal sterilization process that is absolutely necessary through the terminal sterilization process.
Therefore be necessary to provide a kind of sterilizing methods of ibuprofen injection, to overcome ibuprofen injection underproof problem of visible foreign matters after sterilization.
Summary of the invention
The purpose of this invention is to provide a kind of sterilizing methods that can guarantee the ibuprofen injection product quality, fundamentally solved ibuprofen injection behind hot steam sterilizer, the underproof problem of visible foreign matters.
The preparation process and the sterilizing methods of ibuprofen injection of the present invention are following:
(1) takes by weighing 92% arginine and be dissolved in the water for injection of 64% recipe quantity, add the ibuprofen stirring and dissolving of recipe quantity.Other gets in the water for injection that 8% arginine is dissolved in 16% recipe quantity, regulates pH value to suitably, with above-mentioned solution mixing.Add 0.2% activated carbon adsorption, decarburization is supplemented to capacity with water for injection, and through 0.22 μ m filtering with microporous membrane, the inspection of semifinished product is qualified, fill, seals.
(2) a kind of sterilizing methods of ibuprofen injection is characterized in that adopting the rotation sterilization, and to the ibuprofen injection sterilization that fill is good, temperature maintenance is about 121 ℃ in the sterilization process, and pressure maintains between the 112-125kPa, and time dimension is held in 12 minutes.
(3) to the ibuprofen injection sterilization that fill is good, temperature maintenance is about 121 ℃ in the sterilization process, and pressure maintains between the 112-125kPa, and time dimension is held in 12 minutes.
The method of verifying above-mentioned sterilization preparation sterilization effect is following: check according to Chinese Pharmacopoeia 2010 editions appendix visible foreign matters inspections item or particulate matter detection.
Advantage of the present invention is following:
(1) medicine of easy crystallize in the intensification sterilization process, the rotation in the sterilization process can address this problem;
(2) carry out the leak detection of the sterilization vacuum of ampoule bottle fast, no matter because defective somewhere, in rotary course, omnibearing motion can reach this effect ideally;
(3) sterilize in a short period of time the medicine of thermal sensitivity, the cold and hot conversion speed of product is fast and balanced.Different rotations can make product move, and makes heat be penetrated in the product more easily veritably;
Each item requirement after the ibuprofen injection of this sterilizing methods preparation can reach the product sterilization.Through detecting, visible foreign matters and particulate matter meet the standard of Chinese Pharmacopoeia.
The specific embodiment
Below specify content of the present invention through embodiment, experimental example, but these embodiment are not construed as limiting the invention.
Embodiment 1:
Prescription:
Technology:
(1) takes by weighing 92% arginine and be dissolved in the water for injection of 64% recipe quantity, add the ibuprofen stirring and dissolving of recipe quantity.Other gets in the water for injection that 8% arginine is dissolved in 16% recipe quantity, regulates pH value to suitably, with above-mentioned solution mixing.Add 0.2% activated carbon adsorption, decarburization is supplemented to capacity with water for injection, and through 0.22 μ m filtering with microporous membrane, the inspection of semifinished product is qualified, fill, seals.
(2) ibuprofen injection that fill is good is rotated sterilization, temperature maintenance is about 121 ℃ in the sterilization process, and pressure maintains between the 112-125kPa, and time dimension is held in 12 minutes.
Embodiment 2:
Prescription:
Technology:
(1) takes by weighing 92% arginine and be dissolved in the water for injection of 64% recipe quantity, add the ibuprofen stirring and dissolving of recipe quantity.Other gets in the water for injection that 8% arginine is dissolved in 16% recipe quantity, regulates pH value to suitably, with above-mentioned solution mixing.Add 0.2% activated carbon adsorption, decarburization is supplemented to capacity with water for injection, and through 0.22 μ m filtering with microporous membrane, the inspection of semifinished product is qualified, fill, seals.
(2) ibuprofen injection that fill is good is carried out the hot pressing steam sterilization, sterilising temp maintains about 121 ℃, and time dimension is held in 12 minutes.
It is following that each item of embodiment 1-2 detects index:
Above data declaration; The prepared ibuprofen injection of sterilizing methods through embodiment 1 and embodiment 2; In equal significant difference and meet the relevant regulations of Chinese Pharmacopoeia such as content, sterility test, pH value, endotoxin, and the ibuprofen injection after the rotation sterilization is obviously than the injection clear of hot steam sterilizer.
Explain that the rotation sterilization process is more suitable for the preparation of ibuprofen injection, product quality is more stable, is produced on a large scale.
Claims (6)
1. ibuprofen injection, its characteristics are to adopt arginine as cosolvent, and solvent is a water for injection.
Wherein the mol ratio of arginine and ibuprofen was more than or equal to 1: 1.
2. ibuprofen injection as claimed in claim 1, wherein the concentration of ibuprofen is 80mg/ml.
3. ibuprofen injection as claimed in claim 1, its pH value scope is 7.2-8.0.
4. ibuprofen injection as claimed in claim 1, wherein the mol ratio of arginine and ibuprofen is 1: 1-1.3: 1.
5. the method for preparing of ibuprofen injection in, its method is: take by weighing 92% arginine and be dissolved in the proper amount of water for injection, add the ibuprofen stirring and dissolving of recipe quantity.Other gets 8% arginine and is dissolved in the proper amount of water for injection, regulates pH value to suitably, with above-mentioned solution mixing.Add activated carbon adsorption, decarburization is supplemented to capacity with water for injection, and through 0.22 μ m filtering with microporous membrane, the inspection of semifinished product is qualified, fill, seals.
6. the sterilizing methods of an ibuprofen injection is characterized in that adopting the rotation sterilization, and to the ibuprofen injection sterilization that fill is good, temperature maintenance is about 121 ℃ in the sterilization process, and time dimension is held in 12 minutes.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100818482A CN102579332A (en) | 2012-03-26 | 2012-03-26 | Method for preparing ibuprofen injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012100818482A CN102579332A (en) | 2012-03-26 | 2012-03-26 | Method for preparing ibuprofen injection |
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| CN102579332A true CN102579332A (en) | 2012-07-18 |
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| CN2012100818482A Pending CN102579332A (en) | 2012-03-26 | 2012-03-26 | Method for preparing ibuprofen injection |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102854263A (en) * | 2012-08-31 | 2013-01-02 | 石家庄中硕药业集团有限公司 | Method for simultaneous determination of content of ibuprofen and arginine in ibuprofen injection |
| CN103720647A (en) * | 2013-12-16 | 2014-04-16 | 扬子江药业集团广州海瑞药业有限公司 | Dexibuprofen injection composition |
| CN107198676A (en) * | 2017-06-23 | 2017-09-26 | 江苏神龙药业股份有限公司 | A kind of ibuprofen injection for intravenously administrable |
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| JP2004339231A (en) * | 2004-07-12 | 2004-12-02 | Mitsubishi Pharma Corp | Production method for fat emulsion containing medicine |
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| CN102100686A (en) * | 2009-12-21 | 2011-06-22 | 北京润德康医药技术有限公司 | Medicinal composition containing ibuprofen and arginine and preparation method and application thereof |
| CN102160852A (en) * | 2010-02-23 | 2011-08-24 | 付正香 | Ibuprofen injection and preparation method thereof |
| CN102160851A (en) * | 2010-02-21 | 2011-08-24 | 付正香 | Ibuprofen injection and preparation method thereof |
| CN102266285A (en) * | 2010-06-03 | 2011-12-07 | 沈阳双鼎科技有限公司 | Low excitant ibuprofen injection |
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Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
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| JP2004339231A (en) * | 2004-07-12 | 2004-12-02 | Mitsubishi Pharma Corp | Production method for fat emulsion containing medicine |
| CN101926763A (en) * | 2009-06-22 | 2010-12-29 | 哈药集团生物工程有限公司 | Method for preparing lipoalprostadil sterile preparation |
| CN102100686A (en) * | 2009-12-21 | 2011-06-22 | 北京润德康医药技术有限公司 | Medicinal composition containing ibuprofen and arginine and preparation method and application thereof |
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| CN102160852A (en) * | 2010-02-23 | 2011-08-24 | 付正香 | Ibuprofen injection and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102854263A (en) * | 2012-08-31 | 2013-01-02 | 石家庄中硕药业集团有限公司 | Method for simultaneous determination of content of ibuprofen and arginine in ibuprofen injection |
| CN102854263B (en) * | 2012-08-31 | 2014-04-16 | 石家庄中硕药业集团有限公司 | Method for simultaneous determination of content of ibuprofen and arginine in ibuprofen injection |
| CN103720647A (en) * | 2013-12-16 | 2014-04-16 | 扬子江药业集团广州海瑞药业有限公司 | Dexibuprofen injection composition |
| CN107198676A (en) * | 2017-06-23 | 2017-09-26 | 江苏神龙药业股份有限公司 | A kind of ibuprofen injection for intravenously administrable |
| CN107198676B (en) * | 2017-06-23 | 2022-04-01 | 燃点(南京)生物医药科技有限公司 | Ibuprofen injection for intravenous administration |
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Application publication date: 20120718 |
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