CN102406614A - Amoxicillin potassium clavulanate powder injection and preparation method thereof - Google Patents
Amoxicillin potassium clavulanate powder injection and preparation method thereof Download PDFInfo
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- CN102406614A CN102406614A CN2011103001873A CN201110300187A CN102406614A CN 102406614 A CN102406614 A CN 102406614A CN 2011103001873 A CN2011103001873 A CN 2011103001873A CN 201110300187 A CN201110300187 A CN 201110300187A CN 102406614 A CN102406614 A CN 102406614A
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- amoxicillin
- clavulanate potassium
- potassium clavulanate
- injectable powder
- powder injection
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Abstract
The invention discloses an amoxicillin potassium clavulanate powder injection which is prepared from the following raw materials in percentage by weight: 10% of amoxicillin, 2.5% of potassium clavulanate, 4% of cosolvent and the balance of soluble filler. The invention also discloses a preparation method of the amoxicillin potassium clavulanate powder injection. The test proves that the amoxicillin potassium clavulanate powder injection disclosed by the invention has the characteristics of stability in storage, convenience in transportation, good water solubility and the like and greatly improves the curative effect of the amoxicillin and potassium clavulanate, thereby being a novel broad-spectrum and efficient special powder injection for animals.
Description
Technical field
The present invention relates to amoxicillin and clavulanate potassium injectable powder and preparation method thereof.
Background technology
Amoxicillin (Amoxicillin) is semi-synthetic penbritin class medicine, and slightly soluble in water is almost insoluble in ethanol.Bactericidal action is strong, is applicable to the infection due to the sensitive bacterial (not beta-lactamase-producing strain).But owing to produce the appearance more and more widely of beta-lactamase pathogenic strain, pathogenic bacterium can make the beta-lactam nucleus in the molecule of amoxicillin be prone to be hydrolyzed to lose activity and produce drug resistance.
Clavulanate potassium (Clavulanate Potassium) is the oxapenam chemical compound, contains a beta-lactam nucleus, very easily dissolving in water; Meet heat, light, moist lability, be prone to decompose, faint antibacterial activity is only arranged; But can with the beta-lactamase strong bonded of majority; Generate irreversible conjugate, have brute force and the effect of broad-spectrum inhibition beta-lactamase, not only staphylococcic enzyme is had effect; And the enzyme that multiple gram-negative bacteria produced also had effect, be an effective β-Nei Xiananmeiyizhiyao therefore.But it is invalid that it is used separately.The drug resistance normal and the penicillin medicine Combined application causes to overcome the production by biological beta-lactamase improves curative effect.And general effect duration is 18 months, causes commercial production and storing and clinical use inconvenient like this.
The amoxicillin is a penbritin class antibiotic, and clavulanate potassium itself has only faint antibacterial activity, but has the enzyme inhibition of powerful wide spectrum beta-lactam, and both share, and can protect the amoxicillin to exempt from the beta-lactam enzyme hydrolysis.Can enlarge antimicrobial spectrum, improve antibacterial activity.Based on above consideration, before dosage form applications such as existing Amoxicillin Sodium and clavulanate potassium tablets, capsule, dispersible tablet patent.Existing technology all is to adopt Amoxicillin Sodium directly to mix with clavulanate potassium, but owing to drawing of having of Amoxicillin Sodium itself is moist, in production, controls badly will cause Moisture high UCL, has brought hidden danger to production.And tablet, capsule preparation technology's complexity, poorly water-soluble etc. have all produced obstruction to its extensive use.
Summary of the invention
One object of the present invention is to provide the amoxicillin and clavulanate potassium injectable powder, draws defectives such as wet and clavulanate potassium monomer instability to overcome existing amoxicillin and clavulanate potassium compound preparation dosage form complicated process of preparation, Amoxicillin Sodium.
The technical problem that will solve required for the present invention, can realize through following technical scheme:
Amoxicillin and clavulanate potassium injectable powder of the present invention, form by following raw materials by weight percent:
Said cosolvent is sucrose, lactose or saccharin sodium.
Said solubility filler is a glucose.
Another object of the present invention is to provide the method for preparing of said amoxicillin and clavulanate potassium injectable powder, and its preparation technology is: with glucose for injection dilution clavulanate potassium monomer, make the clavulanate potassium content of monomer be reduced to 40% earlier.And then with Amoxicillin Sodium be mixed and made into the amoxicillin sodium for injection clavulanate potassium.
It is unstable that said preparation technology has solved the clavulanate potassium monomer, meets the water vigorous reaction shortcoming of blast easily.Can avoid fully producing since Amoxicillin Sodium itself draw moist the Moisture high UCL hidden danger that might cause.
Said preparation technology can be oven dry → weighing → pulverizing → stirring → mixing → check → metering → packing.
These article have characteristics such as using simple, with low cost stable storing, convenient transportation, good water solubility, are mixed with the curative effect that injectable powder can improve amoxicillin and clavulanate potassium greatly, are a kind of novel, wide spectrum, animal specific injectable powder efficiently.
The present invention is a major ingredient with the amoxicillin and clavulanate potassium mainly, is equipped with an amount of solubility filler, is prepared from via conventional methods such as oven dry, weighing, pulverizing, stirring, mixing, check, metering, packings.Adopt in the preparation earlier with glucose for injection dilution clavulanate potassium monomer; Make the clavulanate potassium content of monomer be reduced to 40%; And then be mixed and made into the method for amoxicillin sodium for injection clavulanate potassium with Amoxicillin Sodium, it is unstable to have solved the clavulanate potassium monomer, meets the water vigorous reaction shortcoming of blast easily; Existing technology all is to adopt Amoxicillin Sodium directly to mix with clavulanate potassium; Because Amoxicillin Sodium itself has and draws moistly, control is bad when producing will Moisture high UCL, brings hidden danger to production.The method that the present invention adopts glucose for injection to dilute clavulanate potassium earlier can be avoided fully.These article have characteristics such as using simple, with low cost stable storing, convenient transportation, good water solubility, are mixed with the curative effect that injectable powder can improve amoxicillin and clavulanate potassium greatly, are a kind of novel, wide spectrum, animal specific injectable powder efficiently.
The specific embodiment
In order to make technological means of the present invention, creation characteristic, to reach purpose and effect and be easy to understand and understand,, further set forth the present invention below in conjunction with specific embodiment.
Embodiment 1
The amoxicillin and clavulanate potassium injectable powder by weight percentage, by being major ingredient with the amoxicillin and clavulanate potassium mainly, is equipped with an amount of cosolvent and solubility filler glucose is processed, and said cosolvent is a sodium carbonate.
Prescription and technology:
Production technology
(1) raw material of said components is fully pulverized, and with the processing of sieving of 300 mesh sieves;
(2) adding Amoxicillin Sodium again behind clavulanate potassium and the glucose mix homogeneously, the above-mentioned raw materials after sieving is fully stirred, mix 30 minutes to even;
(3) sample examination, whether the fineness of percentage ratio, the powder of check material content is up to standard, whether water content is qualified etc.;
(4) computation weigh is packaged into bag, and every packed go into 5 grams, 10 grams or the above-mentioned powder of 100 grams promptly get the amoxicillin and clavulanate potassium injectable powder.
Table 1. accelerated test result (40 ± 2 ℃ of temperature, relative humidity 75% ± 5%)
Result of the test
Show according to table 1, amoxicillin and clavulanate potassium injectable powder accelerated test 6 months, each item index does not have significant change.
The result shows through accelerated test, and specification is 10mL:0.6g 10ml:1g; The amoxicillin and clavulanate potassium injectable powder is packaged as simulation listing packing, and the amoxicillin and clavulanate potassium injectable powder is 40 ± 2 ℃ in temperature, relative humidity be 75% ± 5% condition place 6 months stable.
Long term test
Test material
Sample title: amoxicillin and clavulanate potassium injectable powder
Sample specification: 10mL:1g 10ml:0.6g
Sample packaging: simulation listing packing;
Sample lot number: be respectively 20080202,20080204,20080206
Test method
To supply test agent is 25 ± 2 ℃ in temperature; Relative humidity is 60% ± 5% condition held 12 months; In the time of 3,6,9,12 months, take a sample respectively; According to " quality standard " down pertinent regulations measure character, content and pH value, record result's (result sees the following form 2), and with batch 0 month record relatively.
Table 2. long-term test results (25 ± 2 ℃ of temperature, relative humidity 60% ± 5%)
Result of the test
Show according to table 2, amoxicillin and clavulanate potassium injectable powder long term test 36 months, each item index does not have significant change.
Brief summary
Show through long-term test results: specification is 10mL:1g 10ml:0.6g; The amoxicillin and clavulanate potassium injectable powder is packaged as simulation listing packing, and the amoxicillin and clavulanate potassium injectable powder is 25 ± 2 ℃ in temperature, and relative humidity is 60% ± 5% condition held 36 months, and is stable.
Through test; The amoxicillin and clavulanate potassium injectable powder of embodiment 1 has characteristics such as use is simple, with low cost, stable storing, good water solubility; Having improved the curative effect of amoxicillin and clavulanate potassium greatly, is a kind of novel, wide spectrum, animal specific injectable powder efficiently.
More than show and described ultimate principle of the present invention, principal character and advantage of the present invention.The technical staff of the industry should understand; The present invention is not restricted to the described embodiments; That describes in the foregoing description and the description just explains principle of the present invention; The present invention also has various changes and modifications under the prerequisite that does not break away from spirit and scope of the invention, and these variations and improvement all fall in the scope of the invention that requires protection.The present invention requires protection domain to be defined by appending claims and equivalent thereof.
Claims (5)
1. the amoxicillin sodium and clavulanate potassium injectable powder is characterized in that, is made up of following raw materials by weight percent:
2. amoxicillin and clavulanate potassium injectable powder according to claim 1 is characterized in that, said cosolvent is sucrose, lactose or saccharin sodium.
3. amoxicillin and clavulanate potassium injectable powder according to claim 1 is characterized in that, said solubility filler is a glucose.
4. preparation is according to the method for the described amoxicillin and clavulanate potassium injectable powder of claim 1-3; It is characterized in that; Its preparation technology is: earlier with glucose for injection dilution clavulanate potassium monomer; Make the clavulanate potassium content of monomer be reduced to 40%, and then be mixed and made into the amoxicillin sodium for injection clavulanate potassium with Amoxicillin Sodium.
5. method according to claim 4 is characterized in that, diluted clavulanate potassium monomer and Amoxicillin Sodium mix 30 minutes to even.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011103001873A CN102406614A (en) | 2011-09-30 | 2011-09-30 | Amoxicillin potassium clavulanate powder injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2011103001873A CN102406614A (en) | 2011-09-30 | 2011-09-30 | Amoxicillin potassium clavulanate powder injection and preparation method thereof |
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| CN102406614A true CN102406614A (en) | 2012-04-11 |
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| CN2011103001873A Pending CN102406614A (en) | 2011-09-30 | 2011-09-30 | Amoxicillin potassium clavulanate powder injection and preparation method thereof |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104188916A (en) * | 2014-08-28 | 2014-12-10 | 四川制药制剂有限公司 | Amoxicillin sodium and clavulanate potassium pharmaceutical composition |
| CN104188914A (en) * | 2014-08-08 | 2014-12-10 | 河南牧翔动物药业有限公司 | Compound amoxicillin powder and production process thereof |
| CN104910194A (en) * | 2015-05-28 | 2015-09-16 | 高希章 | Preparation method and compound preparation of clavulanate potassium |
| CN114869884A (en) * | 2021-07-30 | 2022-08-09 | 江苏恒丰强生物技术有限公司 | Compound amoxicillin powder for porcine respiratory diseases and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101647779A (en) * | 2008-08-11 | 2010-02-17 | 广州威尔曼新药开发中心有限公司 | Novel almoxicillin sodium and clavulanate potassium compound powder preparation for injection and technology for preparing same |
-
2011
- 2011-09-30 CN CN2011103001873A patent/CN102406614A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101647779A (en) * | 2008-08-11 | 2010-02-17 | 广州威尔曼新药开发中心有限公司 | Novel almoxicillin sodium and clavulanate potassium compound powder preparation for injection and technology for preparing same |
Non-Patent Citations (1)
| Title |
|---|
| 邹斌: "《新编禽兽医药实用手册》", 30 April 2009, 内蒙古人民出版社 * |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104188914A (en) * | 2014-08-08 | 2014-12-10 | 河南牧翔动物药业有限公司 | Compound amoxicillin powder and production process thereof |
| CN104188916A (en) * | 2014-08-28 | 2014-12-10 | 四川制药制剂有限公司 | Amoxicillin sodium and clavulanate potassium pharmaceutical composition |
| CN104188916B (en) * | 2014-08-28 | 2015-11-11 | 四川制药制剂有限公司 | Amoxicillin sodium potassium clavulanate composition |
| CN104910194A (en) * | 2015-05-28 | 2015-09-16 | 高希章 | Preparation method and compound preparation of clavulanate potassium |
| CN114869884A (en) * | 2021-07-30 | 2022-08-09 | 江苏恒丰强生物技术有限公司 | Compound amoxicillin powder for porcine respiratory diseases and preparation method thereof |
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Application publication date: 20120411 |
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