CN107569458A - A kind of pharmaceutical composition of amoxicillin sodium and clavulanate potassium compound - Google Patents
A kind of pharmaceutical composition of amoxicillin sodium and clavulanate potassium compound Download PDFInfo
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- CN107569458A CN107569458A CN201710936081.XA CN201710936081A CN107569458A CN 107569458 A CN107569458 A CN 107569458A CN 201710936081 A CN201710936081 A CN 201710936081A CN 107569458 A CN107569458 A CN 107569458A
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- sodium
- clavulanate
- amoxicillin sodium
- potassium
- amoxicillin
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Abstract
The present invention relates to a kind of pharmaceutical composition of amoxicillin sodium and clavulanate potassium compound.The present invention is used as frozen-dried supporting agent using Sodium Caprylate and glycine composition stabilizer, trehalose, be effectively improved Amoxicillin Sodium and potassium clavulanate prepare and storing process in stability, the effect of ensure that Clinical practice and security.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition of amoxicillin sodium and clavulanate potassium compound.
Background technology
Amoxicillin is a kind of the most frequently used semi-synthetic penicillins wide spectrum beta-lactam antibiotic, and bactericidal action is strong,
The ability of penetration cell film is also strong, is one of oral semisynthetic penicillin widely used at present.
Clavulanic acid belongs to irreversibility competitive type β -- and inactivate enzyme after lactamase restrainer, with enzyme strong bonded, because
And act on by force, β -- the lactamase of S. aureus L-forms is acted not only on, and also have work to the beta-lactamase of gram-Negative bacillus
With.Shared with penicillins, cephalosporins and drastically increase antibacterial activity, its minimum inhibitory concentration (MIC) can be made obvious
Decline, medicine can several times to more than ten times of synergy, antibody-resistant bacterium is recovered its sensitiveness.
Amoxicillin sodium and clavulanate potassium
Because potassium clavulanate has hygroscopicity, moisture is easily exceeded, causes its poor storage stability.
The content of the invention
It is stable the invention provides one kind in order to solve the problems, such as existing amoxicillin sodium and clavulanate potassium stability difference
Amoxicillin sodium and clavulanate potassium compound preparation, and provide its preparation method.
The present invention provides a kind of amoxicillin sodium and clavulanate potassium composition, and it includes following component by weight：
4 parts of Amoxicillin Sodium；
1 part of potassium clavulanate；
Sodium Caprylate 0.5-1 parts；
Glycine 0.5-1 parts；
Trehalose 1-5 parts.
The present invention is effectively improved using Sodium Caprylate and glycine composition stabilizer, trehalose as frozen-dried supporting agent
The stability of Amoxicillin Sodium and potassium clavulanate in preparation and storing process, and formulation dissolution is quick, ensure that clinic makes
With the effect of and security.
The preparation method of the present invention is as follows：Step 1, under inert gas shielding, with water for injection by avocin, relax
Batan sodium, trehalose, Sodium Caprylate and glycine dissolving, add activated carbon decolorizing, are then filtered to remove activated carbon, are filtered with micropore
Membrane filtration, freeze-drying, is produced.
Embodiment
Embodiment 1Amoxicillin sodium and clavulanate potassium（4:1）The preparation of suspension injection powder
Prescription (200 bottles)：
Amoxicillin Sodium 100g；
Potassium clavulanate 25g；
Sodium Caprylate 12.5g；
Glycine 12.5g；
Trehalose 30g.
Preparation method
Under inert gas shielding, with water for injection 2000ml by avocin, sulbactam, trehalose, Sodium Caprylate and sweet
Propylhomoserin dissolves, and adds needle-use activated carbon 10g, stirs 30min, crosses and filters out carbon；It is filling with 0.22 μm of miillpore filter aseptic filtration,
Half tamponade, freeze-drying, obtains amoxicillin sodium and clavulanate potassium suspension injection powder.
Embodiment 2Amoxicillin sodium and clavulanate potassium（4:1）The preparation of suspension injection powder
Prescription (400 bottles)：
Amoxicillin Sodium 200g；
Potassium clavulanate 50g；
Sodium Caprylate 25g；
Glycine 25g；
Trehalose 60g.
Preparation method
Under inert gas shielding, with water for injection 4000ml by avocin, sulbactam, trehalose, Sodium Caprylate and sweet
Propylhomoserin dissolves, and adds needle-use activated carbon 10g, stirs 30min, crosses and filters out carbon；It is filling with 0.22 μm of miillpore filter aseptic filtration,
Half tamponade, freeze-drying, obtains amoxicillin sodium and clavulanate potassium suspension injection powder.
The long-term stable experiment of embodiment 3
Lot number 1：459630 batches：1000 bottles of specifications：0.6g/ bottles are packed：Cillin bottle
Investigation condition：25±2℃/60±10%RH
By long-term stable experiment it can be found that the Amoxicillin Sodium and potassium clavulanate composition of the present invention are being prepared and deposited
There is good stability, the effect of ensure that Clinical practice and security during storage.
Claims (2)
1. a kind of amoxicillin sodium and clavulanate potassium composition, it includes following component by weight：
4 parts of Amoxicillin Sodium；
1 part of potassium clavulanate；
Sodium Caprylate 0.5-1 parts；
Glycine 0.5-1 parts；
Trehalose 1-5 parts.
2. amoxicillin sodium and clavulanate potassium composition according to claim 1, it is characterised in that composition is as follows：
Amoxicillin Sodium 100g；
Potassium clavulanate 25g；
Sodium Caprylate 12.5g；
Glycine 12.5g；
Trehalose 30g.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710936081.XA CN107569458B (en) | 2017-10-10 | 2017-10-10 | Pharmaceutical composition of amoxicillin sodium and clavulanate potassium compound |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710936081.XA CN107569458B (en) | 2017-10-10 | 2017-10-10 | Pharmaceutical composition of amoxicillin sodium and clavulanate potassium compound |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN107569458A true CN107569458A (en) | 2018-01-12 |
| CN107569458B CN107569458B (en) | 2020-07-21 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710936081.XA Active CN107569458B (en) | 2017-10-10 | 2017-10-10 | Pharmaceutical composition of amoxicillin sodium and clavulanate potassium compound |
Country Status (1)
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| CN (1) | CN107569458B (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101804051A (en) * | 2010-04-21 | 2010-08-18 | 海南美兰史克制药有限公司 | Liposome injection of pharmaceutical composition of amoxicillin sodium and clavulanate potassium |
| CN101890007A (en) * | 2010-08-04 | 2010-11-24 | 胡建荣 | Amoxicillin sodium potassium clavulanate composition microballoon injection |
| CN103040818A (en) * | 2013-01-11 | 2013-04-17 | 罗诚 | Drug composition containing amoxicillin sodium and clavulanate potassium compound |
| CN104352490A (en) * | 2014-11-13 | 2015-02-18 | 重庆泰通动物药业有限公司 | Compound amoxicillin sodium injection |
-
2017
- 2017-10-10 CN CN201710936081.XA patent/CN107569458B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101804051A (en) * | 2010-04-21 | 2010-08-18 | 海南美兰史克制药有限公司 | Liposome injection of pharmaceutical composition of amoxicillin sodium and clavulanate potassium |
| CN101890007A (en) * | 2010-08-04 | 2010-11-24 | 胡建荣 | Amoxicillin sodium potassium clavulanate composition microballoon injection |
| CN103040818A (en) * | 2013-01-11 | 2013-04-17 | 罗诚 | Drug composition containing amoxicillin sodium and clavulanate potassium compound |
| CN104352490A (en) * | 2014-11-13 | 2015-02-18 | 重庆泰通动物药业有限公司 | Compound amoxicillin sodium injection |
Non-Patent Citations (1)
| Title |
|---|
| 高建青 主编: "《药剂学与工业药剂学实验指导》", 30 June 2012, 浙江大学出版社 * |
Also Published As
| Publication number | Publication date |
|---|---|
| CN107569458B (en) | 2020-07-21 |
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