CN104188914B - Amoxicillin powder and its production technology - Google Patents
Amoxicillin powder and its production technology Download PDFInfo
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- CN104188914B CN104188914B CN201410389607.3A CN201410389607A CN104188914B CN 104188914 B CN104188914 B CN 104188914B CN 201410389607 A CN201410389607 A CN 201410389607A CN 104188914 B CN104188914 B CN 104188914B
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- powder
- amoxicillin
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- mannitol
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- 229960003022 amoxicillin Drugs 0.000 title claims abstract description 24
- LSQZJLSUYDQPKJ-UHFFFAOYSA-N p-Hydroxyampicillin Natural products O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)C(N)C1=CC=C(O)C=C1 LSQZJLSUYDQPKJ-UHFFFAOYSA-N 0.000 title claims abstract description 24
- LSQZJLSUYDQPKJ-NJBDSQKTSA-N amoxicillin Chemical compound C1([C@@H](N)C(=O)N[C@H]2[C@H]3SC([C@@H](N3C2=O)C(O)=O)(C)C)=CC=C(O)C=C1 LSQZJLSUYDQPKJ-NJBDSQKTSA-N 0.000 title claims abstract description 23
- 239000000843 powder Substances 0.000 title claims abstract description 22
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 18
- 238000005516 engineering process Methods 0.000 title claims abstract description 10
- ABVRVIZBZKUTMK-JSYANWSFSA-M potassium clavulanate Chemical compound [K+].[O-]C(=O)[C@H]1C(=C/CO)/O[C@@H]2CC(=O)N21 ABVRVIZBZKUTMK-JSYANWSFSA-M 0.000 claims abstract description 10
- 229940038649 clavulanate potassium Drugs 0.000 claims abstract description 8
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 7
- 229930195725 Mannitol Natural products 0.000 claims abstract description 7
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 7
- 239000000594 mannitol Substances 0.000 claims abstract description 7
- 235000010355 mannitol Nutrition 0.000 claims abstract description 7
- 239000011812 mixed powder Substances 0.000 claims abstract description 7
- 239000000741 silica gel Substances 0.000 claims abstract description 7
- 229910002027 silica gel Inorganic materials 0.000 claims abstract description 7
- 239000004411 aluminium Substances 0.000 claims abstract description 4
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims abstract description 4
- 229910052782 aluminium Inorganic materials 0.000 claims abstract description 4
- 239000005030 aluminium foil Substances 0.000 claims abstract description 4
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Chemical compound OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract 4
- 239000000203 mixture Substances 0.000 claims 1
- 239000000273 veterinary drug Substances 0.000 abstract description 7
- 239000000463 material Substances 0.000 abstract description 5
- 238000001514 detection method Methods 0.000 abstract description 4
- 238000010521 absorption reaction Methods 0.000 abstract description 2
- 239000000047 product Substances 0.000 description 9
- 241000894006 Bacteria Species 0.000 description 4
- 239000003814 drug Substances 0.000 description 4
- GZCGUPFRVQAUEE-SLPGGIOYSA-N aldehydo-D-glucose Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O GZCGUPFRVQAUEE-SLPGGIOYSA-N 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000003860 storage Methods 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- QJVHTELASVOWBE-AGNWQMPPSA-N (2s,5r,6r)-6-[[(2r)-2-amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid;(2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Chemical compound OC(=O)[C@H]1C(=C/CO)/O[C@@H]2CC(=O)N21.C1([C@@H](N)C(=O)N[C@H]2[C@H]3SC([C@@H](N3C2=O)C(O)=O)(C)C)=CC=C(O)C=C1 QJVHTELASVOWBE-AGNWQMPPSA-N 0.000 description 2
- 108090000204 Dipeptidase 1 Proteins 0.000 description 2
- 102000004190 Enzymes Human genes 0.000 description 2
- 108090000790 Enzymes Proteins 0.000 description 2
- 102000006635 beta-lactamase Human genes 0.000 description 2
- 230000003115 biocidal effect Effects 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 238000001228 spectrum Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000012795 verification Methods 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 150000003952 β-lactams Chemical class 0.000 description 2
- -1 Amoxicillin compound Chemical class 0.000 description 1
- 206010059866 Drug resistance Diseases 0.000 description 1
- 208000010201 Exanthema Diseases 0.000 description 1
- 101100346764 Mus musculus Mtln gene Proteins 0.000 description 1
- 230000001133 acceleration Effects 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000000845 anti-microbial effect Effects 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 238000009360 aquaculture Methods 0.000 description 1
- 244000144974 aquaculture Species 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 238000002845 discoloration Methods 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 201000005884 exanthem Diseases 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000000284 extract Substances 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 238000012545 processing Methods 0.000 description 1
- 206010037844 rash Diseases 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 239000011265 semifinished product Substances 0.000 description 1
- 230000001629 suppression Effects 0.000 description 1
Abstract
The invention belongs to veterinary drug technical field, it is related to a kind of amoxicillin powder and its production technology.The percentage by weight of amoxicillin powder is constituted：Amoxicillin and clavulanate potassium 4:1 mixed powder 15 18%, mannitol 30 40%, superfine silica gel powder 0.5 1%, DEXTROSE ANHYDROUS surplus.Its production technology is：Control production environment temperature below 25 DEG C, relative humidity below 20%, proceed as follows：（1）80 mesh sieves are crossed after mannitol, superfine silica gel powder and DEXTROSE ANHYDROUS are crushed respectively, in after 80 ± 5 DEG C of 1 2h of mixing in dry mixed machine, room temperature is naturally cooled to；（2）By amoxicillin and clavulanate potassium 4:1 mixed powder continues to mix 20 30min in adding dry mixed machine；（3）After being vacuum-packed with aluminium foil bag, then packed with modeling aluminium complex pocket.The present invention has carried out meticulous selection to auxiliary material, and relatively stable product is obtained with less and safe auxiliary material, and obtained good product mobility, moisture are low, be difficult the moisture absorption, can fully meet pharmacopeia detection, meets national pharmaceutical control and administration policy.
Description
Technical field
The invention belongs to veterinary drug technical field, and in particular to a kind of amoxicillin point, its production work is also related to
Skill.
Background technology
As fast-developing and the unreasonable of antibiotic of China's aquaculture uses, antibody-resistant bacterium gradually increases.Bacterium is led to
Cross number of ways and drug resistance is produced to antibiotic, wherein to produce beta-lactamase water solution medicine（Such as PCs, cephalo-type
Medicine etc.）In beta-lactam nucleus based on.Potassium clavulanate has strongly and the suppression beta-lactam enzyme effect of wide spectrum, with A Moxi
Woods with the use of beta-lactamase can be suppressed in case Amoxicillin is destroyed, so as to expand the antimicrobial spectrum of Amoxicillin, enhancing
Its antibacterial strength, with good effect, the low advantage of incidence of side effects, it has also become clinical treatment producing enzyme drug-fast bacteria and sensitive bacteria are drawn
Rise in, the preferred antibiotics of severe infection.
But potassium clavulanate have it is very strong draw moist, stability extreme difference, with powder form listing easily discoloration, knot
Block, content decline.At present, although also disclosing that some Amoxicillin compound preparations, mostly tablet or glue in Chinese patent storehouse
Wafer, people is with there is some superiority, but veterinary drug is inconvenient.The patents such as CN103127099A, CN102614174A are provided respectively
The dry suspensoid agent of amoxicillin and clavulanate potassium, the production process of these preparations is cumbersome and auxiliary material is excessive, and water solubility is not ten
Sub-argument thinks that proper scaleization is not promoted.
Additionally, the transport of veterinary drug and storage environment are often relatively more severe, the factor such as rash-and-rough way of loading and unloading, humid environment can not
Avoid.Therefore, veterinary drug is produced with reference to the production method of human medicine, tends not to meet demand.
The content of the invention
The invention aims to provide a kind of amoxicillin powder product that can be deposited steadily in the long term, there is provided
Its corresponding producer rule is another object of the present invention.
Based on above-mentioned purpose, this invention takes following technical scheme：Amoxicillin powder, its percentage by weight constitutes and is：
Amoxicillin and clavulanate potassium 4:1 mixed powder 15-18%；
Mannitol 30-40%；
Superfine silica gel powder 0.5-1%；
DEXTROSE ANHYDROUS surplus.
The production technology of the amoxicillin powder, step is：Control production environment temperature below 25 DEG C, it is relatively wet
Degree is proceeded as follows below 20%：
（1）After mannitol, superfine silica gel powder and DEXTROSE ANHYDROUS are crushed respectively cross 80 mesh sieves, in 80 in dry mixed machine ±
After 5 DEG C of mixing 1-2h, room temperature is naturally cooled to；
（2）By amoxicillin and clavulanate potassium 4:1 mixed powder continues to mix 20-30min in adding dry mixed machine；
（3）After being vacuum-packed with aluminium foil bag, then packed with modeling aluminium complex pocket.
In order to lift the stability and security of product, the present invention has carried out meticulous selection to auxiliary material, with less and safe
Property auxiliary material high obtains relatively stable product, and obtained good product mobility, moisture are low, be difficult the moisture absorption, can expire completely
Sufficient pharmacopeia detection, meets national pharmaceutical control and administration policy.
Additionally, the present invention employs dry mixed machine in production technology, production efficiency is high, and by controlling production ring
The moisture content of product effectively to solve the problems, such as in border, mode of changing package, and packaging first half finished product moisture content can be controlled in ＜ 2%.Additionally,
In workshop condition, the pulvis can expose storage 4 more than hour, be fully able to meet related detection requirement and subsequent packages work
Make；Detected through workshop, Amoxicillin and clavulanic acid content are respectively the 90%-110% of labelled amount.
Specific embodiment
With reference to specific embodiment, the present invention will be further described.
Embodiment 1
The present embodiment is prepared for six samples of batch according to the proportioning of table 1.
Each batch weight of table 1 is matched
Wherein, the production technology of 14010101 batches is：Control production environment temperature is below 25 DEG C, relative humidity is 20%
Hereinafter, proceed as follows：
（1）After mannitol, superfine silica gel powder and DEXTROSE ANHYDROUS are crushed respectively cross 80 mesh sieves, in 80 in dry mixed machine ±
After 5 DEG C of mixing 1h, room temperature is naturally cooled to；
（2）By amoxicillin and clavulanate potassium 4:1 mixed powder continues to mix 20min in adding dry mixed machine；
（3）After being vacuum-packed with aluminium foil bag, then packed with modeling aluminium complex pocket.
Step is identical therewith for the production technology of remaining batch, and difference is shown in Table 2.
Each batch processing parameter of table 2
Embodiment 2
It is to investigate feasibility of the invention, the present embodiment extracts 6 samples of batch in embodiment 1 to have carried out stability and examine
Examine, method is：Take respectively different batches sample be placed on 42 DEG C of temperature, the acceleration environment of humidity 75% under carry out 6 months by a definite date
Study on the stability, in the 0th, 1,3, sampling in 6 months according to《Veterinary drug national standard》（Chemicals, middle powder stick）First compound
Amoxicillin powder quality standard detects that result of the test is shown in Table 3.
The different batches amoxicillin powder accelerated test result of table 3
Experiment confirm, amoxicillin powder of the invention under new process regulation, accelerated verification experimental verification, property
The changes of contents of shape, Amoxicillin and clavulanic acid is not obvious, and all detection projects meet《Veterinary drug national standard》（Chemical drugs
Product, middle powder stick）Standard, product quality is controllable, can fully meet the product market demand.
Meanwhile, gained semi-finished product can stablize storage four under the conditions of unpackaged and related inspection is completed more than hour, enough
Test is tested and subsequent packages work.
Claims (1)
1. amoxicillin powder, it is characterised in that percentage by weight composition is：
Amoxicillin and clavulanate potassium 4:1 mixed powder 15-18%,
Mannitol 30-40%,
Superfine silica gel powder 0.5-1%,
DEXTROSE ANHYDROUS surplus；
The production technology of the amoxicillin powder, control production environment temperature below 25 DEG C, relative humidity 20% with
Under, proceed as follows：
（1）80 mesh sieves are crossed after mannitol, superfine silica gel powder and DEXTROSE ANHYDROUS are crushed respectively, in 80 ± 5 DEG C in dry mixed machine
After mixing 1-2h, room temperature is naturally cooled to；
（2）By amoxicillin and clavulanate potassium 4:1 mixed powder continues to mix 20-30min in adding dry mixed machine；
（3）After being vacuum-packed with aluminium foil bag, then packed with modeling aluminium complex pocket.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410389607.3A CN104188914B (en) | 2014-08-08 | 2014-08-08 | Amoxicillin powder and its production technology |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201410389607.3A CN104188914B (en) | 2014-08-08 | 2014-08-08 | Amoxicillin powder and its production technology |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN104188914A CN104188914A (en) | 2014-12-10 |
| CN104188914B true CN104188914B (en) | 2017-07-11 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201410389607.3A Active CN104188914B (en) | 2014-08-08 | 2014-08-08 | Amoxicillin powder and its production technology |
Country Status (1)
| Country | Link |
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| CN (1) | CN104188914B (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105168145A (en) * | 2015-10-29 | 2015-12-23 | 林州中农生物肽科技有限公司 | Compound amoxycillin soluble powder and preparation method thereof |
| 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 |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102846603A (en) * | 2011-06-29 | 2013-01-02 | 王洪涛 | Preparation method for a compound antibiotic veterinary medicine |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102406614A (en) * | 2011-09-30 | 2012-04-11 | 上海恒丰强动物药业有限公司 | Amoxicillin potassium clavulanate powder injection and preparation method thereof |
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2014
- 2014-08-08 CN CN201410389607.3A patent/CN104188914B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102846603A (en) * | 2011-06-29 | 2013-01-02 | 王洪涛 | Preparation method for a compound antibiotic veterinary medicine |
Non-Patent Citations (2)
| Title |
|---|
| 甘露醇的药用研究进展;詹天荣等;《中国海洋药物》;20031231(第3期);参见第57页左栏第11行,第58页第2栏 * |
| 阿莫西林克拉维酸钾（7:1）干混悬剂工艺及稳定性研究;吴小玉等;《中国药师》;20061231;第9卷(第5期);参见第395页第2.2栏 * |
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| Publication number | Publication date |
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| CN104188914A (en) | 2014-12-10 |
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| GR01 | Patent grant | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Compound amoxicillin powder and its production technology Effective date of registration: 20211224 Granted publication date: 20170711 Pledgee: China Construction Bank Corporation Zhengzhou Railway Sub Branch Pledgor: HENAN SOAR VETERINARY PHARMACEUTICAL Co.,Ltd. Registration number: Y2021980016170 |
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| PC01 | Cancellation of the registration of the contract for pledge of patent right |
Granted publication date: 20170711 Pledgee: China Construction Bank Corporation Zhengzhou Railway Sub Branch Pledgor: HENAN SOAR VETERINARY PHARMACEUTICAL Co.,Ltd.|HENAN MUXIANG BIOTECHNOLOGY Co.,Ltd. Registration number: Y2021980016170 |
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| PC01 | Cancellation of the registration of the contract for pledge of patent right | ||
| PE01 | Entry into force of the registration of the contract for pledge of patent right |
Denomination of invention: Compound amoxicillin powder and its production process Granted publication date: 20170711 Pledgee: China Construction Bank Corporation Zhengzhou Railway Sub Branch Pledgor: HENAN SOAR VETERINARY PHARMACEUTICAL Co.,Ltd.|HENAN MUXIANG BIOTECHNOLOGY Co.,Ltd. Registration number: Y2024980004821 |
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| PE01 | Entry into force of the registration of the contract for pledge of patent right |