CN105726487A - Preparation method and application of high-amoxicillin-content soluble powder - Google Patents
Preparation method and application of high-amoxicillin-content soluble powder Download PDFInfo
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- CN105726487A CN105726487A CN201410755886.0A CN201410755886A CN105726487A CN 105726487 A CN105726487 A CN 105726487A CN 201410755886 A CN201410755886 A CN 201410755886A CN 105726487 A CN105726487 A CN 105726487A
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Abstract
The invention relates to high-amoxicillin-content soluble powder, and a preparation method and application thereof, and belongs to the field of a veterinary drug. The problem that an amoxicillin aqueous solution is low in dissolvability and poor in stability, which affects a therapeutic effect and application of the amoxicillin aqueous solution is solved. The powder comprises amoxicillin, a co-solvent, a stabilizing agent, a corrigent, and a soluble filler, and is used for treating porcine intestinal and respiratory tract infection due to bacteria such as escherichia coli and salmonella.
Description
Technical field:
The invention belongs to field of veterinary, relate to a kind of high-load amoxicillin soluble powder agent and preparation method and application.
Background technology:
Amoxicillin (amoxicillin), have another name called amoxicillin, it is introduced to the market first in nineteen sixty-eight by BEECHAM (Bi Chemu), it it is semisynthetic beta-lactam antibiotic, owing to its intramolecular beta-lactam nucleus is unstable, it is subject to the attack of nucleophilic, electrophilic reagent, under the effect of acid, alkali, some metal ion and oxidant, beta-lactam nucleus can be made to open, the rearrangement of molecule occurs.Amoxicillin is relatively strong to the effect of gram negative bacteria such as gonococcus, hemophilus influenza, bordetella pertussis, escherichia coli, Brucella etc., is mainly used in the infection of urinary system, respiratory system, biliary tract etc. clinically people.
Amoxicillin is currently used primarily in the diseases such as the treatment colibacillosis of fowl, salmonellosis, Bacillus pasteurii disease, infective rhinitis and staphylococcus.Staphylococcus hyicus and haemophilus parasuis infection are also had certain killing action by amoxicillin, and the early infection effect caused by pasteurella multocida and Streptococcus suis for treatment sow or piglet is notable.Modernization scale pig farm, in prevention disease, not only needs the immunity of vaccine, in addition it is also necessary to the health care of medicine and the treatment generation to reduce disease, improves the level of production and the economic benefit on pig farm.Medicinal health-care mainly controls the effective means of the diseases such as bacterial disease, Rickettsial and parasite, is most commonly used that antibiotic in the medicinal health-care of pig, and the raising of the prevention of pig farm disease, control and economic benefit is played an important role by it.Amoxicillin oral absorption is good.Food is little to gastrointestinal drug inhalation effects, test display, and amoxicillin is high at pig vivo biodistribution availability, eliminates rapidly.
But amoxicillin is poorly soluble, mildly bitter flavor, bioavailability is low.Current amoxicillin is mainly 10% content, owing to concentration is low, and poor stability, caking and variable color easily occur, the shelf-life is shorter, has a strong impact on the performance used with drug effect.The preparation method of existing amoxicillin soluble powder agent is merely by being pulverized and mixed and obtains, amoxicillin poor fluidity, easy moisture absorption, is unfavorable for production and the use of product.
Summary of the invention:
For these reasons, the present invention provides a kind of high-load amoxicillin soluble powder agent, it is made up of amoxicillin, cosolvent, stabilizer, correctives and soluble filler, is used for treating the bacterial Intestinum Sus domestica road such as escherichia coli, Salmonella and respiratory tract infection.
Described a kind of high-load amoxicillin soluble powder agent, its each weight percentages of components is: amoxicillin 20%～70%, cosolvent 5%～10%, stabilizer 5%～10%, correctives 1%～5%, soluble filler 5%～69%.
Described cosolvent is one or more compositionss in sodium carbonate, sodium bicarbonate, sodium citrate, citric acid, Macrogol 4000, polyethylene glycol 6000, PEG 8000, polyvinylpyrrolidone K15, K30, it is preferable that sodium citrate.
Described stabilizer is one or more compositionss in sodium dihydrogen phosphate, sodium sulfite, sodium thiosulfate, disodiumedetate, it is preferred to acid dihydride sodium.
Described correctives is one or more compositionss in sucrose, sorbitol, saccharin sodium, aspartame, sodium alginate, arabic gum, gelatin, it is preferable that sodium alginate.
Described soluble filler is one or more combinations in glucose, lactose, dextrin, soluble starch, calcium sulfate, microcrystalline Cellulose, mannitol, it is preferable that lactose.
Its preparation method completes according to the following steps:
Weighing amoxicillin, cosolvent, stabilizer, correctives, soluble filler by percentage composition, pulverize, cross 80 mesh sieves, add 75% ethanol soft material after being sufficiently mixed, cross 50 mesh sieves and granulate, 60 DEG C are drying to obtain high-load amoxicillin soluble powder agent.
The high-load amoxicillin soluble powder agent of any of the above-described combination of the present invention can be used for treating intestinal and the respiratory tract infection of the bacterial pig such as escherichia coli, Salmonella.
Specific implementation method:
Below by specific embodiment, one high-load amoxicillin soluble powder agent of the present invention and its preparation method and application is further described, but and limit the present invention never in any form.
Embodiment 1:
Preparation method: by the amoxicillin of formula ratio, sodium citrate, sodium dihydrogen phosphate, sodium alginate, lactose powder flour broken mistake 80 mesh sieve,, after mix homogeneously, add soft material processed after 75% ethanol mixes, crossing 50 mesh sieves to granulate, 60 DEG C are drying to obtain high-load amoxicillin soluble powder agent.
Embodiment 2:
Preparation method: the amoxicillin of formula ratio, sodium citrate, sodium dihydrogen phosphate, sodium alginate, lactose were pulverized 80 mesh sieves, after mix homogeneously, adding soft material processed after 75% ethanol mixes, cross 50 mesh sieves and granulate, 60 DEG C are drying to obtain high-load amoxicillin soluble powder agent.
Embodiment 3:
Preparation method: the amoxicillin of formula ratio, sodium citrate, sodium dihydrogen phosphate, sodium alginate, lactose are pulverized and crossed 80 mesh sieves successively, after mix homogeneously, adding soft material processed after 75% ethanol mixes, cross 50 mesh sieves and granulate, 60 DEG C are drying to obtain high-load amoxicillin soluble powder agent.
Embodiment 4:
Prescription content (kg):
Preparation method: the amoxicillin of formula ratio, sodium citrate, sodium dihydrogen phosphate, sodium alginate, lactose are pulverized and crossed 80 mesh sieves successively, after mix homogeneously, adding soft material processed after 75% ethanol mixes, cross 50 mesh sieves and granulate, 60 DEG C are drying to obtain high-load amoxicillin soluble powder agent.
Embodiment 5:
Embodiment 6:
Embodiment 7: a kind of high-load amoxicillin soluble powder agent of the present invention stability in tap water.
High-load amoxicillin soluble powder described in embodiment of the present invention 1-6 and certain commercially available Wymox, amoxicillin raw material being dissolved in respectively in tap water, drug level is containing amoxicillin 60mg in every liter of water.Each group is placed at room temperature, content detection is carried out respectively at 0h, 1h, 2h, 3h, 4h, 5h, 6h, measure according to the content assaying method of " Chinese veterinary pharmacopoeia " version amoxicillin soluble powder in 2010, calculate each time point degradation rate of 1～6 hour, contrasted with 0 hour.Result of the test is in Table 1.
: table 1 amoxicillin stability degradation rate (%) in tap water
Embodiment 8: a kind of high-load amoxicillin soluble powder agent accelerated test result of the present invention.
High-load amoxicillin soluble powder described in embodiment of the present invention 1-6 and amoxicillin raw material are carried out 40 degree of acceleration 6 months and high temperature (60 degree) accelerates 10 days, measure 40 degree to accelerate 0 day, 1 month, 2 months, 3 months, 6 months and the high temperature accelerated test result of 0 day, 5 days, 10 days, calculate the degradation rate of each time point.Result of the test is in Table 2-3.
40 degree, table 2 amoxicillin accelerated test result
Table 3 amoxicillin hot test result
Drawn by aforementioned stable experimental result, high-load amoxicillin soluble powder of the present invention no matter be the stability from tap water or be superior to raw material and commercially available amoxicillin soluble powder agent from the stability of preparation.
Claims (10)
1. a high-load amoxicillin soluble agent, it is characterised in that each weight percentages of components is: amoxicillin 20%～70%, cosolvent 5%～10%, stabilizer 5%～10%, correctives 1%～5%, soluble filler 5%～69%.
2. a kind of high-load amoxicillin soluble powder agent according to claim 1, it is characterised in that described cosolvent is one or more compositionss in sodium carbonate, sodium bicarbonate, sodium citrate, citric acid, Macrogol 4000, polyethylene glycol 6000, PEG 8000, polyvinylpyrrolidone K15, PVP K30.
3. a kind of high-load amoxicillin soluble powder agent according to claim 2, it is characterised in that described cosolvent is sodium citrate.
4. a kind of high-load amoxicillin soluble powder agent according to claim 1, it is characterised in that described stabilizer is one or more compositionss in sodium dihydrogen phosphate, sodium sulfite, sodium thiosulfate, disodiumedetate.
5. a kind of high-load amoxicillin soluble powder agent according to claim 4, it is characterised in that described stabilizer is sodium dihydrogen phosphate.
6. a kind of high-load amoxicillin soluble powder agent according to claim 1, it is characterised in that described correctives is one or more compositionss in sucrose, sorbitol, saccharin sodium, aspartame, sodium alginate, arabic gum, gelatin.
7. a kind of high-load amoxicillin soluble powder agent according to claim 6, it is characterised in that described correctives is sodium alginate.
8. a kind of high-load amoxicillin soluble powder agent according to claim 1, it is characterised in that described soluble filler is one or more combinations in glucose, lactose, dextrin, soluble starch, calcium sulfate, microcrystalline Cellulose, mannitol.
9. a kind of high-load amoxicillin soluble powder agent according to claim 8, it is characterised in that described soluble powder filler is lactose.
10. according to the arbitrary described a kind of high-load amoxicillin soluble powder agent of claim 1-9, it is characterised in that the preparation method of this soluble powder completes according to the following steps:
Weighing amoxicillin, cosolvent, stabilizer, correctives, soluble filler by percentage composition, pulverize, cross 80 mesh sieves, add 75% ethanol soft material after being sufficiently mixed, cross 50 mesh sieves and granulate, 60 DEG C are drying to obtain high-load amoxicillin soluble powder agent.
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| CN201410755886.0A CN105726487B (en) | 2014-12-10 | 2014-12-10 | Preparation method and application of high-content amoxicillin soluble powder |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106176617A (en) * | 2016-08-31 | 2016-12-07 | 中牧南京动物药业有限公司 | Amoxicillin soluble powder and preparation method thereof |
| CN107308116A (en) * | 2017-07-06 | 2017-11-03 | 山东中牧兽药有限公司 | A kind of amoxicillin soluble powder for animals and preparation method thereof |
| CN107308115A (en) * | 2017-07-05 | 2017-11-03 | 山东中牧兽药有限公司 | A kind of fumaric acid tiamulin soluble powder |
| CN107412169A (en) * | 2017-04-21 | 2017-12-01 | 河北利华药业有限公司 | Amoxicillin dry suspension for animals and preparation method thereof |
| CN108272756A (en) * | 2018-04-09 | 2018-07-13 | 四川恒通动保生物科技有限公司 | A kind of amoxicillin soluble powder 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 |
| CN111529493A (en) * | 2020-05-30 | 2020-08-14 | 潍坊中科力邦生物工程研究院 | Amoxicillin soluble powder easy to dissolve in water and high in stability and preparation method thereof |
| CN114569560A (en) * | 2022-03-25 | 2022-06-03 | 江西利德菲生物药业有限公司 | Amoxicillin soluble powder with high dissolubility and preparation method thereof |
| CN117379378A (en) * | 2023-12-07 | 2024-01-12 | 山东金瑞生物科技有限公司 | Compound amoxicillin soluble powder for livestock and preparation process thereof |
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| EP1602361A2 (en) * | 2004-06-01 | 2005-12-07 | Vaccifar BV | Antibiotic in the form of a water-soluble powder for veterinary and human use |
| CN103285374A (en) * | 2013-05-20 | 2013-09-11 | 广东大华农动物保健品股份有限公司 | Amoxicillin colistin sulphate granule and preparation method thereof |
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2014
- 2014-12-10 CN CN201410755886.0A patent/CN105726487B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1602361A2 (en) * | 2004-06-01 | 2005-12-07 | Vaccifar BV | Antibiotic in the form of a water-soluble powder for veterinary and human use |
| CN103285374A (en) * | 2013-05-20 | 2013-09-11 | 广东大华农动物保健品股份有限公司 | Amoxicillin colistin sulphate granule and preparation method thereof |
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106176617A (en) * | 2016-08-31 | 2016-12-07 | 中牧南京动物药业有限公司 | Amoxicillin soluble powder and preparation method thereof |
| CN106176617B (en) * | 2016-08-31 | 2018-02-13 | 中牧南京动物药业有限公司 | Amoxicillin soluble powder and preparation method thereof |
| CN107412169A (en) * | 2017-04-21 | 2017-12-01 | 河北利华药业有限公司 | Amoxicillin dry suspension for animals and preparation method thereof |
| CN107412169B (en) * | 2017-04-21 | 2020-06-02 | 河北利华药业有限公司 | Veterinary amoxicillin dry suspension and preparation method thereof |
| CN107308115A (en) * | 2017-07-05 | 2017-11-03 | 山东中牧兽药有限公司 | A kind of fumaric acid tiamulin soluble powder |
| CN107308116A (en) * | 2017-07-06 | 2017-11-03 | 山东中牧兽药有限公司 | A kind of amoxicillin soluble powder for animals and preparation method thereof |
| CN108272756A (en) * | 2018-04-09 | 2018-07-13 | 四川恒通动保生物科技有限公司 | A kind of amoxicillin soluble powder and preparation method thereof |
| CN108272756B (en) * | 2018-04-09 | 2022-10-28 | 四川恒通动保生物科技有限公司 | Amoxicillin soluble powder 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 |
| CN111529493A (en) * | 2020-05-30 | 2020-08-14 | 潍坊中科力邦生物工程研究院 | Amoxicillin soluble powder easy to dissolve in water and high in stability and preparation method thereof |
| CN114569560A (en) * | 2022-03-25 | 2022-06-03 | 江西利德菲生物药业有限公司 | Amoxicillin soluble powder with high dissolubility and preparation method thereof |
| CN117379378A (en) * | 2023-12-07 | 2024-01-12 | 山东金瑞生物科技有限公司 | Compound amoxicillin soluble powder for livestock and preparation process thereof |
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| CN105726487B (en) | 2020-01-07 |
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