CN103690480A - Meloxicam injection for treating rheumatoid arthritis and osteoarthritis and preparation method thereof - Google Patents
Meloxicam injection for treating rheumatoid arthritis and osteoarthritis and preparation method thereof Download PDFInfo
- Publication number
- CN103690480A CN103690480A CN201310699361.5A CN201310699361A CN103690480A CN 103690480 A CN103690480 A CN 103690480A CN 201310699361 A CN201310699361 A CN 201310699361A CN 103690480 A CN103690480 A CN 103690480A
- Authority
- CN
- China
- Prior art keywords
- meloxicam
- sodium hydroxide
- injection
- osteoarthritis
- rheumatoid arthritis
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Abstract
The invention provides a meloxicam injection for treating rheumatoid arthritis and osteoarthritis and a preparation method thereof. Every 1,500ml of injection comprises the following components in: 7.0-20g of meloxicam, 5-9.45g of meglumine, 20-150g of polyethylene glycol-400, 20-75g of poloxamer, 3-9g of glycine, 1.5-5.25g of sodium chloride and 0.225-2.25g of sodium hydroxide. The preparation method comprises the following steps: adding 1,000ml of injection water in a preparation tank, adding meloxicam, meglumine, polyethylene glycol-400, poloxamer, sodium chloride, glycine and sodium chloride; dissolving, and adding meloxicam; heating to 80 DEG C, and stirring for dissolving the meloxicam; adding 0.05g of needle activated carbon; stirring and adsorbing, and performing coarse filtration to remove charcoal; adding injection water to 1,500ml, and filtering with a 0.45mu m filter membrane until the mixture is clear; pouring into an ampoule, and sterilizing. The meloxicam injection has the active effects of quick absorption and high bioavailability, is not affected by pH, enzyme, foods and the like in the digestive tract, and has greatly increased curative effect.
Description
Technical field
The present invention relates to a kind of injection for the treatment of human rheumatoid arthritis, osteoarthritis, belong to Western medicine preparation field
Background technology
Rheumatoid arthritis is a kind of chronic general autoimmunity autoimmune disease that articular synovitis is feature of take.Synovitis is outbreak repeatedly lastingly, the destruction that can cause intraarticular cartilage and bone, and joint function disturbance, even maimed vasculitis pathological changes is involved each organ of whole body, therefore primary disease is called again rheumatoid disease.
The prevalence of China's osteoarthritis is 9.56%, and wherein 60 years old above person reaches 78.5%, and arthralgia and moving obstacle are perplexing a lot of old peoples' life.And old people's gastrointestinal tract toleration is poor, how can not tolerate the treatment of traditional NSAIDs.
The medicine for the treatment of rheumatoid arthritis, osteoarthritis is generally divided into Chinese medicine and the large class of Western medicine two at present, but mostly be solid preparation, and can not substantially change pathological changes, after drug withdrawal easily repeatedly, long-term taking easily produces dependency, therefore, develop the injection of the treatment rheumatoid arthritis that a kind of toxic and side effects is little particularly important.
Meloxicam is a kind of novel tendentiousness epoxidase (COX-2) inhibitor, its stable chemical nature, good light stability, and it is not soluble in water, dissolubility is relevant with pH value, its dissolubility pH value be 4 o'clock minimum, and raise along with the rising of pH value, pH value is greater than at 8 o'clock, can obtain the clinical valid density of 10～20mg/ml.Meloxicam to treatment rheumatoid arthritis and osteoarthritis and multiple pain have good therapeutic effect and untoward reaction slight.Field is existing multiple at home at present for the preparation of meloxicam, and main dosage form has tablet, capsule, granule, but these solid preparations absorptions slowly, and bioavailability is not high, is subject to the impacts such as pH, enzyme, food.
Summary of the invention
The object of this invention is to provide a kind of preparation method for the treatment of Meloxicam and the preparation thereof of human rheumatoid arthritis, osteoarthritis, overcome before this not injection dosage form of this medicine, the deficiency that makes its therapeutical effect fail to give full play to.
Meloxicam of the present invention, every 1500 milliliters of injection contain:
Meloxicam: 7.0～20g, meglumine: 5～9.45g, PEG-4000: 20～150g, poloxamer: 20～75g, glycine: 3～9g, sodium chloride: 1.5～5.25g, sodium hydroxide: 0.225～2.25g, all the other are water for injection.
Preferably, Meloxicam of the present invention, every 1500 milliliters contain following component:
Meloxicam: 15mg, meglumine: 9.45g, PEG-4000: 75g, poloxamer: 75g, glycine: 7.5g, sodium chloride: 4.5g, sodium hydroxide: 0.225g, all the other are water for injection.
The Preparation Method of the Meloxicam for the treatment of rheumatoid arthritis of the present invention, osteoarthritis, is characterized in that comprising the steps:
1, select ampoule, be up to the standards by slightly washing, standby as material-compound tank after fine purifiation, oven dry;
2, take meloxicam: 7.0～20g, meglumine: 5～9.45g, PEG-4000: 20～150g, poloxamer: 20～75g, glycine: 3～9g, sodium chloride: 1.5～5.25g, sodium hydroxide: 0.225～2.25g;
3, in the selected material-compound tank of step 1, add 1000ml water for injection, the meglumine that step 2 is got, PEG-4000, poloxamer, sodium chloride, glycine and sodium hydroxide, put in material-compound tank, be stirred to dissolve, add again meloxicam, under stirring, be warming up to 80 ℃ of left and right and make to dissolve, in this step, sodium hydroxide adds successively, the pH value 8.5～10.0 of the add-subtract control solution by sodium hydroxide concentration;
4, in the material-compound tank through step 3, add 0.05g needle-use activated carbon, stirring and adsorbing 20～30 minutes, coarse filtration is removed charcoal, injects water to 1500ml;
5, step 3 gained solution is extremely clear and bright with 0.45 μ m filtering with microporous membrane, subpackage embedding is in ampoule;
6,, by 100 ℃ of circulation steam sterilizations 30 minutes for the solution through step 5 potting, must treat the Meloxicam of rheumatoid arthritis, osteoarthritis.
Each raw material quantity of more than recording, is intended to provide the usage ratio between each raw material, not technical scheme of the present invention is limited on the numerical value providing.
The present invention is intramuscular injection medication, and adult's consumption is 15 milliliters/day.
Good effect of the present invention is: be used for the treatment of human rheumatoid arthritis, osteoarthritis disease, compare with existing peroral dosage form, have and absorb soon, bioavailability is high, no longer includes the impacts such as pH in digestive tract, enzyme, food.Obvious alleviating pain symptom, curative effect has greatly lifting, has good clinical value.
The specific embodiment:
Embodiment 1
(1) take
(2) ampoule of selecting is up to the standards by slightly washing, standby after fine purifiation, oven dry;
(3) in material-compound tank, add 1000ml water for injection, by got meglumine, PEG-4000, poloxamer, sodium chloride, glycine and sodium hydroxide, put in material-compound tank, be stirred to dissolve, add again meloxicam, under stirring, be warming up to 80 ℃ of left and right and make to dissolve, with the add-subtract control pH value 8.5～10.0 of addition amount of sodium hydroxide;
(4) add the needle-use activated carbon of 0.05g, stirring and adsorbing 20～30 minutes, coarse filtration is removed charcoal, injects water to 1500ml;
(5) clear and bright to solution with 0.45 μ m filtering with microporous membrane, 1000 of embeddings, 100 ℃ of circulation steam sterilizations of rear use 30 minutes.
Embodiment 2
(1) take
(2) ampoule of selecting is up to the standards by slightly washing, standby after fine purifiation, oven dry;
(3) in material-compound tank, add 1000ml water for injection, by meglumine, PEG-4000, poloxamer, sodium chloride, glycine and sodium hydroxide, put in material-compound tank, be stirred to dissolve, add again meloxicam, under stirring, be warming up to 80 ℃ of left and right and make to dissolve, with the add-subtract control pH value 8.5～10.0 of addition amount of sodium hydroxide;
(4) add 0.05%(g/ml) needle-use activated carbon, stirring and adsorbing 20～30 minutes, coarse filtration is removed charcoal, injects water to 1500ml;
(5) clear and bright to solution with 0.45 μ m filtering with microporous membrane, 1000 of embeddings, 100 ℃ of circulation steam sterilizations of rear use 30 minutes.
Embodiment 3
(1) take:
(2) ampoule of selecting is up to the standards by slightly washing, standby after fine purifiation, oven dry;
(3) in material-compound tank, add 1000ml water for injection, take meglumine, PEG-4000, poloxamer, sodium chloride, glycine and the sodium hydroxide of recipe quantity, put in material-compound tank, be stirred to dissolve, the meloxicam that adds recipe quantity, under stirring, be warming up to 80 ℃ of left and right and make to dissolve, with the add-subtract control pH value 8.5～10.0 of addition amount of sodium hydroxide;
(4) add 0.05g needle-use activated carbon, stirring and adsorbing 20～30 minutes, coarse filtration is removed charcoal, injects water to 1500ml;
(5) clear and bright to solution with 0.45 μ m filtering with microporous membrane, 1000 of embeddings, 100 ℃ of circulation steam sterilizations of rear use 30 minutes.
Embodiment 4
(1) take:
(2) ampoule of selecting is up to the standards by slightly washing, standby after fine purifiation, oven dry;
(3) in material-compound tank, add 1000ml water for injection, take meglumine, PEG-4000, poloxamer, sodium chloride, glycine and the sodium hydroxide of recipe quantity, put in material-compound tank, be stirred to dissolve, the meloxicam that adds recipe quantity, under stirring, be warming up to 80 ℃ of left and right and make to dissolve, with the add-subtract control pH value 8.5～10.0 of addition amount of sodium hydroxide;
(4) add 0.05%(g/ml) needle-use activated carbon, stirring and adsorbing 20～30 minutes, coarse filtration is removed charcoal, injects water to 1500ml;
(5) clear and bright to solution with 0.45 μ m filtering with microporous membrane, 1000 of embeddings, 100 ℃ of circulation steam sterilizations of rear use 30 minutes.
Embodiment 5
(1) take:
(2) ampoule be up to the standards by slightly washing, standby after fine purifiation, oven dry;
(3) in material-compound tank, add 1000ml water for injection, take meglumine, PEG-4000, poloxamer, sodium chloride, glycine and the sodium hydroxide of recipe quantity, put in material-compound tank, be stirred to dissolve, the meloxicam that adds recipe quantity, under stirring, be warming up to 80 ℃ of left and right and make to dissolve, with the add-subtract control pH value 8.5～10.0 of addition amount of sodium hydroxide;
(4) add 0.05%(g/ml) needle-use activated carbon, stirring and adsorbing 20～30 minutes, coarse filtration is removed charcoal, injects water to 1500ml;
(5) clear and bright to solution with 0.45 μ m filtering with microporous membrane, 1000 of embeddings, 100 ℃ of circulation steam sterilizations of rear use 30 minutes.
Clinical efficacy comparison
Claims (4)
1. treat the Meloxicam of rheumatoid arthritis, osteoarthritis, it is characterized in that: every 1500 milliliters contain following component:
Meloxicam: 7.0～20g, meglumine: 5～9.45g, PEG-4000: 20～150g, poloxamer: 20～75g, glycine: 3～9g, sodium chloride: 1.5～5.25g, sodium hydroxide: 0.225～2.25g, all the other are water for injection.
2. the Meloxicam for the treatment of rheumatoid arthritis according to claim 1, osteoarthritis, is characterized in that: every 1500 milliliters contain following component:
Meloxicam: 15mg, meglumine: 9.45g, PEG-4000: 75g, poloxamer: 75g, glycine: 7.5g, sodium chloride: 4.5g, sodium hydroxide: 0.225g, all the other are water for injection.
3. the Meloxicam for the treatment of rheumatoid arthritis according to claim 1 and 2, osteoarthritis, is characterized in that, by the increase and decrease of sodium hydroxide concentration, controls pH value scope 8.5～10.0.
4. a Preparation Method for the Meloxicam for the treatment of rheumatoid arthritis as claimed in claim 1, osteoarthritis, is characterized in that comprising the steps:
(1) ampoule be up to the standards by slightly washing, standby as material-compound tank after fine purifiation, oven dry;
(2) take meloxicam: 7.0～20g, meglumine: 5～9.45g, PEG-4000: 20～150g, poloxamer: 20～75g, glycine: 3～9g, sodium chloride: 1.5～5.25g, sodium hydroxide: 0.225～2.25g;
(3) in the selected material-compound tank of step (1), add 1000ml water for injection, meglumine, PEG-4000, poloxamer, sodium chloride, glycine and sodium hydroxide that step (2) is got, put in material-compound tank, be stirred to dissolve, sodium hydroxide adds successively, by the pH value 8.5～10.0 of sodium hydroxide concentration add-subtract control solution;
(4), to the meloxicam that adds step (2) to get in the material-compound tank through step (3), under stirring, be warming up to 80 ℃ of left and right and make to dissolve; Add 0.05%(g/ml) needle-use activated carbon, stirring and adsorbing 20～30 minutes, coarse filtration is removed charcoal, injects water to 1500ml;
(5) extremely clear and bright with 0.45 μ m filtering with microporous membrane to step (4) gained solution, subpackage embedding is in ampoule;
(6) will, through 100 ℃ of circulation steam sterilizations 30 minutes for the solution of step (5) subpackage potting, must treat the Meloxicam of rheumatoid arthritis, osteoarthritis.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310699361.5A CN103690480A (en) | 2013-12-18 | 2013-12-18 | Meloxicam injection for treating rheumatoid arthritis and osteoarthritis and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310699361.5A CN103690480A (en) | 2013-12-18 | 2013-12-18 | Meloxicam injection for treating rheumatoid arthritis and osteoarthritis and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN103690480A true CN103690480A (en) | 2014-04-02 |
Family
ID=50352255
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310699361.5A Pending CN103690480A (en) | 2013-12-18 | 2013-12-18 | Meloxicam injection for treating rheumatoid arthritis and osteoarthritis and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103690480A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104922620A (en) * | 2014-11-28 | 2015-09-23 | 山西佳能达华禹制药有限公司 | Application of Sang Jiang Cold Injection (mulberry leaf and ginger cold injection) to preparation of aerosolization and rectal administration preparation and preparation method of Sang Jiang Cold Injection |
| WO2019037757A1 (en) * | 2017-08-24 | 2019-02-28 | 江苏恒瑞医药股份有限公司 | Injectable pharmaceutical composition containing meloxicam, and preparation method therefor |
| WO2019214715A1 (en) * | 2018-05-11 | 2019-11-14 | 南京清普生物科技有限公司 | Meloxicam composition, preparation and preparation method and use thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1972690A (en) * | 2004-06-23 | 2007-05-30 | 贝林格尔·英格海姆维特梅迪卡有限公司 | Use of meloxicam in veterinary medicine for the treatment of inflammatory painful diseases |
| CN102908310A (en) * | 2012-11-02 | 2013-02-06 | 青岛康地恩药业股份有限公司 | Meloxicam injection for treating chronic infectious arthritis of dogs and cats |
-
2013
- 2013-12-18 CN CN201310699361.5A patent/CN103690480A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1972690A (en) * | 2004-06-23 | 2007-05-30 | 贝林格尔·英格海姆维特梅迪卡有限公司 | Use of meloxicam in veterinary medicine for the treatment of inflammatory painful diseases |
| CN102908310A (en) * | 2012-11-02 | 2013-02-06 | 青岛康地恩药业股份有限公司 | Meloxicam injection for treating chronic infectious arthritis of dogs and cats |
Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104922620A (en) * | 2014-11-28 | 2015-09-23 | 山西佳能达华禹制药有限公司 | Application of Sang Jiang Cold Injection (mulberry leaf and ginger cold injection) to preparation of aerosolization and rectal administration preparation and preparation method of Sang Jiang Cold Injection |
| CN104922620B (en) * | 2014-11-28 | 2018-08-03 | 山西佳能达华禹制药有限公司 | Application and preparation method thereof of the mulberry leaf-ginger common cold injection in preparing atomization and rectally preparation |
| WO2019037757A1 (en) * | 2017-08-24 | 2019-02-28 | 江苏恒瑞医药股份有限公司 | Injectable pharmaceutical composition containing meloxicam, and preparation method therefor |
| CN109963555A (en) * | 2017-08-24 | 2019-07-02 | 江苏恒瑞医药股份有限公司 | A kind of pharmaceutical composition of injectable and preparation method thereof comprising Meloxicam |
| CN109963555B (en) * | 2017-08-24 | 2021-10-08 | 江苏恒瑞医药股份有限公司 | Injectable pharmaceutical composition containing meloxicam and preparation method thereof |
| WO2019214715A1 (en) * | 2018-05-11 | 2019-11-14 | 南京清普生物科技有限公司 | Meloxicam composition, preparation and preparation method and use thereof |
| EP3777862A4 (en) * | 2018-05-11 | 2021-07-07 | Nanjing Delova Biotech Co. Ltd. | Meloxicam composition, preparation and preparation method and use thereof |
| JP2021521212A (en) * | 2018-05-11 | 2021-08-26 | 南京清普生物科技有限公司 | Meloxicam compositions, formulations and methods and applications thereof |
| JP7374501B2 (en) | 2018-05-11 | 2023-11-07 | 南京清普生物科技有限公司 | Meloxicam compositions, preparations and their manufacturing methods and applications |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103690480A (en) | Meloxicam injection for treating rheumatoid arthritis and osteoarthritis and preparation method thereof | |
| CN102266407A (en) | Traditional Chinese medicinal composition for treating hypertension and preparation method thereof | |
| CN1384090A (en) | Extraction process of tanshin general phenolic acid and its prepn and use | |
| CN101717441A (en) | Venin-sourced demulcent CTXn, and purification method and applications thereof | |
| CN104258503B (en) | A kind of multi-functional physical resource cancer therapeutic | |
| CN102824414A (en) | Medicinal tea used for treating constipation | |
| CN1305491C (en) | Chinese medicinal composition for treating irritable bowel syndrome and its preparation method | |
| CN105902687A (en) | Health-care tea for treating gout and preparation method thereof | |
| CN105770357A (en) | Use of alliin in preparation of antidepressants | |
| CN101234123A (en) | Application of certain concentration hydrochloric acid water for treating blood vessel disease | |
| CN104473989A (en) | Traditional Chinese medicine tablet for preventing and treating cardiovascular and cerebrovascular diseases and preparation method thereof | |
| CN102579558A (en) | Application of bauhinia championii total flavonoids in preparation of medicine for treating rheumatoid arthritis | |
| CN103239444A (en) | Dextroindobufen and clopidogrel compound drug composition | |
| CN103520241A (en) | Pathology of Artemisia sacrorum total flavones and new application thereof | |
| RU2010129293A (en) | MEDICINE FOR TREATMENT OF FUNCTIONAL DISORDERS OF THE GASTROINTESTINAL TRACT AND METHOD OF TREATMENT OF FUNCTIONAL DISORDERS OF THE GASTROINTESTINAL TRACT | |
| CN104887790B (en) | Treat herbal mixture water extract of acute pancreatitis and preparation method thereof | |
| CN103059127A (en) | GLP-1 analogs, and preparation method and application thereof | |
| CN101036681A (en) | Analgesic aconitum flavum | |
| CN107951885B (en) | A kind of combination of oral medication for treating capillary leak syndrome | |
| CN109200051A (en) | Purposes of the huperzine and the like as treatment diseases associated with inflammation drug | |
| CN101156911B (en) | A Chinese-medicinal wine for treating rheumatism atrophic arthritis | |
| CN106138669A (en) | A kind of Chinese medicine treating cancer of pancreas and preparation method thereof | |
| CN105147625A (en) | Oral phenobarbital freeze-dried powder preparation and preparation method thereof | |
| CN103705637B (en) | A kind of Chinese medicine composition and preparation method thereof | |
| CN105168154A (en) | Phenobarbital oral freeze-dried powder preparation and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C05 | Deemed withdrawal (patent law before 1993) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20140402 |