CN105168145A - Compound amoxycillin soluble powder and preparation method thereof - Google Patents
Compound amoxycillin soluble powder and preparation method thereof Download PDFInfo
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- CN105168145A CN105168145A CN201510715067.8A CN201510715067A CN105168145A CN 105168145 A CN105168145 A CN 105168145A CN 201510715067 A CN201510715067 A CN 201510715067A CN 105168145 A CN105168145 A CN 105168145A
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Abstract
The invention discloses compound amoxycillin soluble powder. The compound amoxycillin soluble powder is prepared from, by mass, 10%-20% of amoxicillin, 2.5%-5% of clavulanate potassium, 10%-40% of polyethylene glycol, 10%-20% of mannitol and the balance anhydrous glucose. A preparation method of the compound amoxycillin soluble powder comprises the steps that 1, the amoxicillin and the polyethylene glycol are weighed; 2, the weighed materials are evenly mixed and put in a stainless steel drying tray, fusing is conducted in a thermal cycling type drying oven at the temperature ranging from 60 DEG C to 80 DEG C, and the materials are stirred and taken out after being fused; 3, fusant is rapidly cooled and collected, the collected coagulum is smashed through an ultra-low temperature pulverizer and screened through a 80-mesh sieve, and a solid dispersion is obtained; 4, the solid dispersion, the clavulanate potassium and the mannitol are mixed through a three-dimensional motion mixer, and then the anhydrous glucose is mixed with the obtained mixture in an equivalent incremental mode for 20-30 min. The product prepared through the preparation method has the advantages of being good in water solubility, good in fluidity, small in water content, not prone to moisture absorption and the like, and the quality standard of the compound amoxycillin soluble powder is much higher than that of pharmacopeia.
Description
Technical field
The present invention relates to a kind of compound amoxicillin soluble powder and preparation method thereof, belong to veterinary drug preparing technical field.
Background technology
Amoxicillin is bacteriogenic natural beta-lactam antibiotic, and containing beta-lactam nucleus in structure, antibacterial action is very weak, but has strong effect wide-spectrum Inhibitory activity.It is combined with beta-lactam antibiotic amoxicillin, makes enzyme level combination formulations, can protect amoxicillin in varying degrees not by beta-lactam enzyme-deactivating, thus improves the effect of the anti-product enzyme fastbacteria of the latter, improves clinical efficacy.Bactericidal action mechanism in amoxicillin is similar with other beta-lactam antibiotic, and namely main penicillin-binding protein (PBPs) combines with antibacterial, affects bacteria cell wall and synthesizes, and bacterial cell swelling is broken and dead.The antibacterial of amoxicillin/clavulanate potassium to resistance to amoxicillin shows and sensitive organism equally valid, all has good antibacterial action to gram positive bacteria and gram-negative bacteria.To alone amoxicillin, the invalid or unconspicuous Kleb of curative effect, resistant Staphylococcus species comprise low-level MRSA, Branhamella, gonococcus etc. and infect and also have certain curative effect this product.
Clavulanate potassium has and very strong draws moist, and stability extreme difference, easy variable color, caking, content decline.From Tablet and Capsula agent, stability is slightly good, and people with there being some superiority, but is not well suited for concerning veterinary drug.After mixing with amoxicillin in addition, water solublity is not fine, can not meet the market demand.So water solublity and the stability of amoxicillin powder will be improved, to break through from prescription and production technology these two aspects.
Summary of the invention
The object of this invention is to provide that a kind of dissolubility is good, the compound amoxicillin soluble powder of good effect, the not easily moisture absorption and preparation method thereof.
Object of the present invention can be achieved through the following technical solutions: a kind of compound amoxicillin soluble powder, it is prepared from by the raw material of following mass percentage: amoxicillin 10-20%, clavulanate potassium 2.5-5%, Polyethylene Glycol 10-40%, mannitol 10-20%, and surplus is anhydrous glucose.
Described Polyethylene Glycol is solid at normal temperatures, is one or more in Macrogol 4000, polyethylene glycol 6000, PEG 8000.
A preparation method for compound amoxicillin soluble powder, comprises the following steps:
1. according to amoxicillin: Polyethylene Glycol=1:1-1:4 takes amoxicillin and Polyethylene Glycol; 2. load weighted mixing of materials is even, put into rustless steel drip pan, carry out melting with heat-circulation type baking oven, temperature controls at 60-80 DEG C, stirs during material melting, takes out; 3. fused mass is cooled rapidly, collect, adopt super-low temperature pulverizator to pulverize the coagulum of collection, cross 80 mesh sieves, obtain solid dispersion; 4. adopt three-dimensional motion mixer solid dispersion, clavulanate potassium and mannitol to be mixed, then taked by anhydrous glucose the mode of equal increments to mix with said mixture, incorporation time is 20-30min.
Step 3. middle fused mass is collected in rustless steel container.
Step 4. middle anhydrous glucose, mannitol pulverized 80 mesh sieves.
Contained by this product, raw material clavulanate potassium is responsive especially to humiture, strictly should control the humidity of whole production process, and ambient temperature should control below 22 DEG C, and relative humidity should control at about 25%RH.
Preparation method disclosed by the invention obtains product good water solubility, good fluidity, and water content is little, not easily the advantage such as moisture absorption, and its quality standard is far above pharmacopoeial quality standard.
Detailed description of the invention
Embodiment 1
A preparation method for compound amoxicillin soluble powder, comprises the following steps:
1. amoxicillin 10g and polyethylene glycol 6000 40g is taken; 2. load weighted mixing of materials is even, put into rustless steel drip pan, carry out melting with heat-circulation type baking oven, temperature controls, at 60 DEG C, to stir during material melting, takes out; 3. fused mass is cooled rapidly, collect in rustless steel container, adopt super-low temperature pulverizator to pulverize the coagulum of collection, cross 80 mesh sieves, obtain solid dispersion; 4. 80 mesh sieves pulverized by anhydrous glucose, mannitol, take clavulanate potassium 5g, mannitol 10g, 100g is supplied with anhydrous glucose, three-dimensional motion mixer is adopted solid dispersion, clavulanate potassium and mannitol to be mixed, then taked by anhydrous glucose the mode of equal increments to mix with said mixture, incorporation time is 20-30min.
Embodiment 2
A preparation method for compound amoxicillin soluble powder, comprises the following steps:
1. amoxicillin 20g and PEG 8000 20g is taken; 2. load weighted mixing of materials is even, put into rustless steel drip pan, carry out melting with heat-circulation type baking oven, temperature controls, at 80 DEG C, to stir during material melting, takes out; 3. fused mass is cooled rapidly, collect in rustless steel container, adopt super-low temperature pulverizator to pulverize the coagulum of collection, cross 80 mesh sieves, obtain solid dispersion; 4. 80 mesh sieves pulverized by anhydrous glucose, mannitol, take clavulanate potassium 4g, mannitol 15g, 100g is supplied with anhydrous glucose, three-dimensional motion mixer is adopted solid dispersion, clavulanate potassium and mannitol to be mixed, then taked by anhydrous glucose the mode of equal increments to mix with said mixture, incorporation time is 20-30min.
Embodiment 3
A preparation method for compound amoxicillin soluble powder, comprises the following steps:
1. amoxicillin 15g and Macrogol 4000 30g is taken; 2. load weighted mixing of materials is even, put into rustless steel drip pan, carry out melting with heat-circulation type baking oven, temperature controls, at 70 DEG C, to stir during material melting, takes out; 3. fused mass is cooled rapidly, collect in rustless steel container, adopt super-low temperature pulverizator to pulverize the coagulum of collection, cross 80 mesh sieves, obtain solid dispersion; 4. 80 mesh sieves pulverized by anhydrous glucose, mannitol, take clavulanate potassium 2.5g, mannitol 20g, 100g is supplied with anhydrous glucose, three-dimensional motion mixer is adopted solid dispersion, clavulanate potassium and mannitol to be mixed, then taked by anhydrous glucose the mode of equal increments to mix with said mixture, incorporation time is 20-30min.
Embodiment 4-embodiment 14
In embodiment 4 to embodiment 14, variable is as following table, and all the other preparation processes are with embodiment 1.
Claims (5)
1. a compound amoxicillin soluble powder, is characterized in that: it is prepared from by the raw material of following mass percentage: amoxicillin 10-20%, clavulanate potassium 2.5-5%, Polyethylene Glycol 10-40%, mannitol 10-20%, and surplus is anhydrous glucose.
2. a kind of compound amoxicillin soluble powder according to claim 1, is characterized in that: described Polyethylene Glycol is solid at normal temperatures, is one or more in Macrogol 4000, polyethylene glycol 6000, PEG 8000.
3. a kind of preparation method of compound amoxicillin soluble powder according to claim 1 or 2, is characterized in that comprising the following steps:
1. according to amoxicillin: Polyethylene Glycol=1:1-1:4 takes amoxicillin and Polyethylene Glycol; 2. load weighted mixing of materials is even, put into rustless steel drip pan, carry out melting with heat-circulation type baking oven, temperature controls at 60-80 DEG C, stirs during material melting, takes out; 3. fused mass is cooled rapidly, collect, adopt super-low temperature pulverizator to pulverize the coagulum of collection, cross 80 mesh sieves, obtain solid dispersion; 4. adopt three-dimensional motion mixer solid dispersion, clavulanate potassium and mannitol to be mixed, then taked by anhydrous glucose the mode of equal increments to mix with said mixture, incorporation time is 20-30min.
4. the preparation method of a kind of compound amoxicillin soluble powder according to claim 3, is characterized in that: step 3. in fused mass collect in rustless steel container.
5. the preparation method of a kind of compound amoxicillin soluble powder according to claim 3, is characterized in that: step 4. in anhydrous glucose, mannitol pulverized 80 mesh sieves.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201510715067.8A CN105168145A (en) | 2015-10-29 | 2015-10-29 | Compound amoxycillin soluble powder and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510715067.8A CN105168145A (en) | 2015-10-29 | 2015-10-29 | Compound amoxycillin soluble powder and preparation method thereof |
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| CN105168145A true CN105168145A (en) | 2015-12-23 |
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| CN201510715067.8A Pending CN105168145A (en) | 2015-10-29 | 2015-10-29 | Compound amoxycillin soluble powder and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105919941A (en) * | 2016-05-17 | 2016-09-07 | 湖南泰谷生物兽药有限公司 | Composition containing amoxicillin and potassium clavulanate, and preparation method thereof |
| CN108670956A (en) * | 2018-07-04 | 2018-10-19 | 河南牧翔动物药业有限公司 | A kind of amoxicillin soluble powder and preparation method thereof |
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| WO2001045667A2 (en) * | 1999-12-22 | 2001-06-28 | LEK, tovarna farmacevtskih in kemičnih izdelkov, d.d. | Water-soluble powders for oral solution and use thereof |
| CN101023917A (en) * | 2006-02-22 | 2007-08-29 | 刘凤鸣 | Technology for preparing medicine and relative oral preparations |
| CN102008445A (en) * | 2010-12-10 | 2011-04-13 | 青岛康地恩药业有限公司 | Amoxicillin soluble powder as well as preparation method and application thereof |
| 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 |
| CN104983685A (en) * | 2015-06-25 | 2015-10-21 | 四川恒通动物制药有限公司 | Amoxicillin soluble powder and preparation method |
-
2015
- 2015-10-29 CN CN201510715067.8A patent/CN105168145A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2001045667A2 (en) * | 1999-12-22 | 2001-06-28 | LEK, tovarna farmacevtskih in kemičnih izdelkov, d.d. | Water-soluble powders for oral solution and use thereof |
| CN101023917A (en) * | 2006-02-22 | 2007-08-29 | 刘凤鸣 | Technology for preparing medicine and relative oral preparations |
| CN102008445A (en) * | 2010-12-10 | 2011-04-13 | 青岛康地恩药业有限公司 | Amoxicillin soluble powder as well as preparation method and application thereof |
| 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 |
| CN104983685A (en) * | 2015-06-25 | 2015-10-21 | 四川恒通动物制药有限公司 | Amoxicillin soluble powder and preparation method |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105919941A (en) * | 2016-05-17 | 2016-09-07 | 湖南泰谷生物兽药有限公司 | Composition containing amoxicillin and potassium clavulanate, and preparation method thereof |
| CN108670956A (en) * | 2018-07-04 | 2018-10-19 | 河南牧翔动物药业有限公司 | A kind of amoxicillin soluble powder and preparation method thereof |
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Address after: 456550 Luban Avenue, Linzhou industrial cluster, Henan, Anyang, China, No. 8 Applicant after: Linzhou Zhongnong Ying Tai biological peptide Co. Ltd. Address before: 456550 Luban Avenue, Linzhou industrial cluster, Henan, Anyang, China, No. 8 Applicant before: LINZHOU SINAGRI BIOLOGICAL PEPTIDES TECHNOLOGY CO., LTD. |
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| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20151223 |
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| RJ01 | Rejection of invention patent application after publication |