CN103301060A - Veterinary amoxicillin-sulbactam suspension injection and preparation method thereof - Google Patents
Veterinary amoxicillin-sulbactam suspension injection and preparation method thereof Download PDFInfo
- Publication number
- CN103301060A CN103301060A CN 201210070930 CN201210070930A CN103301060A CN 103301060 A CN103301060 A CN 103301060A CN 201210070930 CN201210070930 CN 201210070930 CN 201210070930 A CN201210070930 A CN 201210070930A CN 103301060 A CN103301060 A CN 103301060A
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- CN
- China
- Prior art keywords
- sulbactam
- amoxicillin
- injection
- oil
- suspension injection
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000002347 injection Methods 0.000 title claims abstract description 31
- 239000007924 injection Substances 0.000 title claims abstract description 31
- 229960005256 sulbactam Drugs 0.000 title claims abstract description 27
- 238000002360 preparation method Methods 0.000 title claims abstract description 14
- 239000000725 suspension Substances 0.000 title claims abstract description 13
- FKENQMMABCRJMK-RITPCOANSA-N sulbactam Chemical compound O=S1(=O)C(C)(C)[C@H](C(O)=O)N2C(=O)C[C@H]21 FKENQMMABCRJMK-RITPCOANSA-N 0.000 claims abstract description 23
- WVDDGKGOMKODPV-UHFFFAOYSA-N Benzyl alcohol Chemical group OCC1=CC=CC=C1 WVDDGKGOMKODPV-UHFFFAOYSA-N 0.000 claims abstract description 21
- 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 claims abstract description 14
- 229960003022 amoxicillin Drugs 0.000 claims abstract description 14
- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 claims abstract description 14
- 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 claims abstract description 14
- CEGOLXSVJUTHNZ-UHFFFAOYSA-K aluminium tristearate Chemical group [Al+3].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O CEGOLXSVJUTHNZ-UHFFFAOYSA-K 0.000 claims abstract description 10
- 239000000375 suspending agent Substances 0.000 claims abstract description 8
- 235000019445 benzyl alcohol Nutrition 0.000 claims abstract description 7
- 229960004926 chlorobutanol Drugs 0.000 claims abstract description 7
- 230000000844 anti-bacterial effect Effects 0.000 claims description 11
- AVKUERGKIZMTKX-NJBDSQKTSA-N ampicillin 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=CC=C1 AVKUERGKIZMTKX-NJBDSQKTSA-N 0.000 claims description 9
- 229960000723 ampicillin Drugs 0.000 claims description 9
- 230000002421 anti-septic effect Effects 0.000 claims description 7
- 238000003756 stirring Methods 0.000 claims description 6
- 239000003814 drug Substances 0.000 claims description 4
- 238000002156 mixing Methods 0.000 claims description 4
- 239000000203 mixture Substances 0.000 claims description 4
- 229940060184 oil ingredients Drugs 0.000 claims description 4
- 239000002994 raw material Substances 0.000 abstract description 5
- 239000000273 veterinary drug Substances 0.000 abstract description 3
- 238000004519 manufacturing process Methods 0.000 abstract description 2
- 238000000034 method Methods 0.000 abstract description 2
- 239000008194 pharmaceutical composition Substances 0.000 abstract description 2
- 230000000845 anti-microbial effect Effects 0.000 abstract 2
- 239000003755 preservative agent Substances 0.000 abstract 2
- 230000002335 preservative effect Effects 0.000 abstract 2
- 229940063655 aluminum stearate Drugs 0.000 abstract 1
- 239000004615 ingredient Substances 0.000 abstract 1
- 238000005516 engineering process Methods 0.000 description 6
- 108090000204 Dipeptidase 1 Proteins 0.000 description 3
- 102000006635 beta-lactamase Human genes 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
- 238000001228 spectrum Methods 0.000 description 2
- 239000003782 beta lactam antibiotic agent Substances 0.000 description 1
- 239000003781 beta lactamase inhibitor Substances 0.000 description 1
- 229940126813 beta-lactamase inhibitor Drugs 0.000 description 1
- 230000003115 biocidal effect Effects 0.000 description 1
- 210000000481 breast Anatomy 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 239000007927 intramuscular injection Substances 0.000 description 1
- 230000010412 perfusion Effects 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000002132 β-lactam antibiotic Substances 0.000 description 1
- 229940124586 β-lactam antibiotics Drugs 0.000 description 1
- 229940126085 β‑Lactamase Inhibitor Drugs 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to a veterinary drug, in particular to a stable, efficient and broad-spectrum veterinary amoxicillin-sulbactam suspension injection and a preparation method thereof. The pharmaceutical composition of the veterinary amoxicillin-sulbactam suspension injection comprises the following ingredients by volume weight: 5%-30% (w/v) of amoxicillin, 0.15%-5% (w/v) of sulbactam, 5%-20% (w/v) of suspending agent, 0.3%-8% (w/v) of antimicrobial preservative, and the balance of injection oil, wherein the suspending agent is aluminum stearate, and the antimicrobial preservative is benzyl alcohol or acetone chloroform. Specific raw materials and proportions are selected to greatly prolong the stability of the amoxicillin-sulbactam suspension injection, and meanwhile, the raw materials are simple and available, the processing technique is simple, the operation is convenient and the production cost is low.
Description
Technical field
The present invention relates to a kind of veterinary drug, particularly form suspension injection of compound recipe and preparation method thereof with amoxicillin and sulbactam.
Background technology
The amoxicillin is veterinary clinic a kind of beta-lactam antibiotic commonly used, has wide spectrum but the characteristics of anti-enzyme not, and antibacterial can produce beta-lactamase makes medicine lose antibacterial activity.Sulbactam is beta-lactamase inhibitor, and it suppresses antibacterial and produce beta-lactamase by the active site of competition beta-lactamase, makes antibiotic produce the antibacterial action of using.
The clinical consumption of the compound preparation of ampicillin with sulbactam pharmaceutical composition is big, determined curative effect, and market prospect is also fine.But ubiquity the shortcoming of poor stability, the prescription that can not satisfy the prescriptive period.
Summary of the invention
Main purpose of the present invention provides ampicillin with sulbactam suspension injection for animals of a kind of stable, efficient, wide spectrum and preparation method thereof, but this injection intramuscular injection also can be carried out breast perfusion.
For achieving the above object, the technical solution adopted in the present invention is: a kind of ampicillin with sulbactam suspension injection, and its medicine consists of:
A: amoxicillin: 5%～30% (w/v);
B: sulbactam: 0.15%～5% (w/v);
C: suspending agent: 5%～20% (w/v);
D: antibacterial antiseptic: 0.3%～8% (v/v);
E: oil for injection is to full dose.
Described suspending agent is aluminium stearate; Described antibacterial antiseptic is benzyl alcohol or chlorobutanol.
Preparation technology of the present invention: it is an amount of to get oil for injection, adds suspending agent and makes its dissolving, if can not dissolve fully, can suitably heat.After adding antibacterial antiseptic stirring and evenly mixing, add amoxicillin, sulbactam, oil for injection is crossed homogenizer 2 times to full dose, and pressure is 20～30Mpa, mix homogeneously, and fill is namely.Injection oil consumption in advance is not strict with, and just will reach the purpose of other raw material of dissolving, and amount is not too many simultaneously, is convenient to operations such as dissolving, stirring and gets final product.
The present invention is by selecting specific raw material and proportioning, make the stable significant prolongation of ampicillin with sulbactam suspension injection, and raw material is simple and easy to simultaneously, and processing technique is simple, handled easily, and production cost is low.
The specific embodiment
Embodiment 1
Amoxicillin 5%, sulbactam 0.15%, aluminium stearate 5%, benzyl alcohol 0.5%, oil for injection to 100.
Preparation technology: get oil for injection half amount, add aluminium stearate, water-bath makes its dissolving for 40 ℃.After adding the benzyl alcohol stirring and evenly mixing, add amoxicillin, sulbactam, oil for injection is crossed homogenizer 2 times to full dose, and pressure is 20～30Mpa, mix homogeneously, and fill is namely.
Embodiment 2
Amoxicillin 10%, sulbactam 0.25%, aluminium stearate 8%, chlorobutanol 1.8%, oil for injection to 100.
Preparation technology: get oil for injection half amount, add the aluminium stearate stirring and make its dissolving.After adding the benzyl alcohol stirring and evenly mixing, add amoxicillin, sulbactam, oil for injection is crossed homogenizer 2 times to full dose, and pressure is 20～30Mpa, mix homogeneously, and fill is namely.
Embodiment 3
Amoxicillin 20%, sulbactam 1%, aluminium stearate 10%, chlorobutanol 3%, oil for injection to 100.
Preparation technology: with embodiment 1.
Embodiment 4
Amoxicillin 25%, sulbactam 5%, aluminium stearate 15%, benzyl alcohol 6%, oil for injection to 100.
Preparation technology: with embodiment 1.
Study on the stability
Sample with embodiment of the invention 1-4 preparation, investigation condition and investigation project according to regulation in " veterinary drug stability test guideline ", sample after respectively illumination, temperature being accelerated to handle and place sample for a long time and investigate, check the situation of change of every indexs such as settling volume ratio, appearance character, content, the result shows: the sample of embodiment of the invention preparation checks that respectively index compares with initial index, no significant change has illustrated the superiority of the present invention aspect the increase product stability.
Claims (4)
1. ampicillin with sulbactam suspension injection, its medicine consists of:
A: amoxicillin: 5%～30% (w/v);
B: sulbactam: 0.15%～5% (w/v);
C: suspending agent: 5%～20% (w/v);
D: antibacterial antiseptic: 0.3%～8% (v/v);
E: oil for injection is to full dose.
Described suspending agent is aluminium stearate; Described antibacterial antiseptic is benzyl alcohol or chlorobutanol.
2. ampicillin with sulbactam suspension injection according to claim 1, it is characterized in that: described antibacterial antiseptic is chlorobutanol.
3. ampicillin with sulbactam suspension injection according to claim 1, it is characterized in that: described medicine consists of:
Amoxicillin 10%～20%, sulbactam 0.25%～1%, aluminium stearate 8%～10%, chlorobutanol 1.8%～3%, oil for injection to 100.
4. the preparation method of ampicillin with sulbactam suspension injection according to claim 1, step comprises: it is an amount of to get oil for injection, adds suspending agent and makes its dissolving, if can not dissolve fully, can suitably heat; After adding antibacterial antiseptic stirring and evenly mixing, add amoxicillin, sulbactam, oil for injection is crossed homogenizer 2 times to full dose, and pressure is 20～30Mpa, mix homogeneously, and fill is namely.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201210070930 CN103301060A (en) | 2012-03-16 | 2012-03-16 | Veterinary amoxicillin-sulbactam suspension injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201210070930 CN103301060A (en) | 2012-03-16 | 2012-03-16 | Veterinary amoxicillin-sulbactam suspension injection and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN103301060A true CN103301060A (en) | 2013-09-18 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 201210070930 Pending CN103301060A (en) | 2012-03-16 | 2012-03-16 | Veterinary amoxicillin-sulbactam suspension injection and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN103301060A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112618486A (en) * | 2020-12-24 | 2021-04-09 | 浙江昂利康制药股份有限公司 | Suspension oil agent for injection and preparation method thereof |
| CN113318106A (en) * | 2021-03-15 | 2021-08-31 | 沈阳伟嘉生物技术有限公司 | Long-acting compound amoxicillin oil suspension injection for livestock and preparation method thereof |
| CN113398069A (en) * | 2021-07-10 | 2021-09-17 | 四川成康动物药业有限公司 | Veterinary amoxicillin and sulfadiazine sodium suspension injection and preparation method and device thereof |
-
2012
- 2012-03-16 CN CN 201210070930 patent/CN103301060A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112618486A (en) * | 2020-12-24 | 2021-04-09 | 浙江昂利康制药股份有限公司 | Suspension oil agent for injection and preparation method thereof |
| CN113318106A (en) * | 2021-03-15 | 2021-08-31 | 沈阳伟嘉生物技术有限公司 | Long-acting compound amoxicillin oil suspension injection for livestock and preparation method thereof |
| CN113318106B (en) * | 2021-03-15 | 2022-05-06 | 沈阳伟嘉生物技术有限公司 | Long-acting compound amoxicillin oil suspension injection for animals and preparation method thereof |
| CN113398069A (en) * | 2021-07-10 | 2021-09-17 | 四川成康动物药业有限公司 | Veterinary amoxicillin and sulfadiazine sodium suspension injection and preparation method and device thereof |
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Application publication date: 20130918 |