CN107569458B - Pharmaceutical composition of amoxicillin sodium and clavulanate potassium compound - Google Patents
Pharmaceutical composition of amoxicillin sodium and clavulanate potassium compound Download PDFInfo
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- CN107569458B CN107569458B CN201710936081.XA CN201710936081A CN107569458B CN 107569458 B CN107569458 B CN 107569458B CN 201710936081 A CN201710936081 A CN 201710936081A CN 107569458 B CN107569458 B CN 107569458B
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- amoxicillin sodium
- clavulanate
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- amoxicillin
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Abstract
The invention relates to a pharmaceutical composition of an amoxicillin sodium and clavulanate potassium compound. The sodium caprylate and the glycine are adopted to form the stabilizer, and the trehalose is used as the freeze-drying supporting agent, so that the stability of the amoxicillin sodium and the clavulanate potassium in the preparation and storage processes is effectively improved, and the curative effect and the safety of clinical use are ensured.
Description
Technical Field
The invention relates to a pharmaceutical composition of an amoxicillin sodium and clavulanate potassium compound.
Background
Amoxicillin is one of the most commonly used semisynthetic penicillins, namely broad-spectrum β -lactam antibiotics, has strong bactericidal effect and strong capability of penetrating cell membranes, and is one of the oral semisynthetic penicillins widely applied at present.
The clavulanic acid belongs to an irreversible competitive β -lactamase inhibitor, which is firmly combined with enzyme to inactivate the enzyme, so the clavulanic acid has strong action, not only acts on β -lactamase of staphylococcus aureus, but also acts on β -lactamase of gram-negative bacillus.
The potassium clavulanate has hygroscopicity, and the moisture content is easy to exceed the standard, so that the storage stability of the potassium clavulanate is poor.
Disclosure of Invention
In order to solve the problem of poor stability of the existing amoxicillin sodium and potassium clavulanate, the invention provides a stable amoxicillin sodium and potassium clavulanate compound preparation and a preparation method thereof.
The invention provides an amoxicillin sodium and clavulanate potassium composition which comprises the following components in parts by weight:
4 parts of amoxicillin sodium;
1 part of potassium clavulanate;
0.5-1 part of sodium caprylate;
0.5-1 part of glycine;
1-5 parts of trehalose.
The sodium caprylate and the glycine are adopted to form the stabilizer, the trehalose is used as the freeze-drying supporting agent, the stability of the amoxicillin sodium and the clavulanate potassium in the preparation and storage processes is effectively improved, the preparation is dissolved quickly, and the curative effect and the safety of clinical use are ensured.
The preparation method of the invention comprises the following steps: step 1, under the protection of inert gas, dissolving amoxicillin sodium, potassium clavulanate, trehalose, sodium caprylate and glycine with water for injection, adding activated carbon for decolorization, then filtering to remove the activated carbon, filtering with a microporous filter membrane, and freeze-drying to obtain the amoxicillin sodium/potassium clavulanate/sodium caprylate/glycine injection.
Detailed Description
Example 1Preparation of amoxicillin sodium and clavulanate potassium (4:1) suspension powder injection
Prescription (200 bottles):
100g of amoxicillin sodium;
25g of clavulanate potassium;
12.5g of sodium caprylate;
12.5g of glycine;
trehalose 30 g.
Preparation method
Under the protection of inert gas, 2000ml of water for injection is used for dissolving amoxicillin sodium, potassium clavulanate, trehalose, sodium caprylate and glycine, 10g of active carbon for injection is added, stirring is carried out for 30min, and carbon is removed by filtration; sterilizing and filtering with a 0.22 mu m microporous filter membrane, filling, semi-tamponade, and freeze-drying to obtain the amoxicillin sodium and clavulanate potassium suspension powder injection.
Example 2Preparation of amoxicillin sodium and clavulanate potassium (4:1) suspension powder injection
Prescription (400 bottles):
200g of amoxicillin sodium;
50g of potassium clavulanate;
25g of sodium caprylate;
25g of glycine;
trehalose 60 g.
Preparation method
Under the protection of inert gas, 4000ml of water for injection is used for dissolving amoxicillin sodium, potassium clavulanate, trehalose, sodium caprylate and glycine, 10g of active carbon for injection is added, stirring is carried out for 30min, and carbon is removed by filtration; sterilizing and filtering with a 0.22 mu m microporous filter membrane, filling, semi-tamponade, and freeze-drying to obtain the amoxicillin sodium and clavulanate potassium suspension powder injection.
Example 3 Long term stability test
Batch number 1: 459630 batch size: 1000 bottles of specification: 0.6 g/bottle package: penicillin bottle
Examination conditions were as follows: 25 plus or minus 2 ℃/60 plus or minus 10% RH
Long-term stability tests show that the amoxicillin sodium and potassium clavulanate composition has good stability in the preparation and storage processes, and ensures the curative effect and safety of clinical use.
Claims (1)
1. An amoxicillin sodium and clavulanate potassium composition is characterized by comprising the following components:
100g of amoxicillin sodium;
25g of clavulanate potassium;
12.5g of sodium caprylate;
12.5g of glycine;
30g of trehalose, namely 30g of trehalose,
the preparation method comprises the following steps: under the protection of inert gas, 2000ml of water for injection is used for dissolving amoxicillin sodium, potassium clavulanate, trehalose, sodium caprylate and glycine, 10g of active carbon for injection is added, stirring is carried out for 30min, and the active carbon is removed by filtration; sterilizing with 0.22 μm microporous membrane, filtering, bottling, semi-pressing, and freeze drying.
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 CN107569458A (en) | 2018-01-12 |
| CN107569458B true CN107569458B (en) | 2020-07-21 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
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| CN201710936081.XA Active CN107569458B (en) | 2017-10-10 | 2017-10-10 | Pharmaceutical composition of amoxicillin sodium and clavulanate potassium compound |
Country Status (1)
| Country | Link |
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| CN (1) | CN107569458B (en) |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103040818A (en) * | 2013-01-11 | 2013-04-17 | 罗诚 | Drug composition containing amoxicillin sodium and clavulanate potassium compound |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101804051B (en) * | 2010-04-21 | 2012-02-15 | 海南美兰史克制药有限公司 | Liposome injection of pharmaceutical composition of amoxicillin sodium and clavulanate potassium |
| CN101890007B (en) * | 2010-08-04 | 2012-05-23 | 胡建荣 | Amoxicillin sodium potassium clavulanate composition microballoon injection |
| CN104352490A (en) * | 2014-11-13 | 2015-02-18 | 重庆泰通动物药业有限公司 | Compound amoxicillin sodium injection |
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2017
- 2017-10-10 CN CN201710936081.XA patent/CN107569458B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103040818A (en) * | 2013-01-11 | 2013-04-17 | 罗诚 | Drug composition containing amoxicillin sodium and clavulanate potassium compound |
Also Published As
| Publication number | Publication date |
|---|---|
| CN107569458A (en) | 2018-01-12 |
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