CN103142588B - Amoxicillin sodium sulbactam sodium for injection and preparation method of amoxicillin sodium sulbactam sodium - Google Patents
Amoxicillin sodium sulbactam sodium for injection and preparation method of amoxicillin sodium sulbactam sodium Download PDFInfo
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- CN103142588B CN103142588B CN201310120583.7A CN201310120583A CN103142588B CN 103142588 B CN103142588 B CN 103142588B CN 201310120583 A CN201310120583 A CN 201310120583A CN 103142588 B CN103142588 B CN 103142588B
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Abstract
The invention relates to amoxicillin sodium sulbactam sodium for injection for livestock and a preparation method of the amoxicillin sodium sulbactam sodium. The invention aims at providing an amoxicillin sodium sulbactam sodium freeze-dried powder injection. The amoxicillin sodium sulbactam sodium freeze-dried powder injection comprises effective components of amoxicillin sodium and sulbactam sodium, and also contains an antioxygen, a pH(Potential Of Hydrogen) regulating agent and a dispersing agent, and thus the solubility of the amoxicillin sodium is greatly increased, and the pH of medicine liquid after being re-dissolved is within a range of 8.5-9.5. According to the amoxicillin sodium sulbactam sodium and the preparation method of the amoxicillin sodium sulbactam sodium, through research of the preparation of an amoxicillin sodium sulbactam sodium stock solution and determination of a freeze-drying process, the amoxicillin sodium sulbactam sodium freeze-dried powder injection which is stable in quality, better in appearance characteristics and safe and effective in use is obtained.
Description
Technical field
The invention belongs to field of veterinary, especially a kind of preparation technology of amoxicillin sodium for injection sulbactam sodium.
Background technology:
Amoxicillin is penicillins broad ectrum antibiotic, to Streptococcus such as streptococcus pneumoniae, Hemolytic streptococcuss, do not produce the aerobic gram positive coccus such as penicillinase staphylococcus, enterococcus faecalis, the aerobic gram-negative bacterias such as escherichia coli, proteus mirabilis, Salmonella, hemophilus influenza, Diplococcus gonorrhoeae do not produce beta lactamase bacterial strain and helicobacter pylori has good antibacterial activity.Bactericidal action is brought into play by anti-bacteria Cell wall synthesis in amoxicillin, can make antibacterial become spheroid rapidly and dissolve, breaks.Therefore the application in veterinary clinic is more extensive, is mainly used in treating animal bacteria sexuality and dyes.
The dosage form of at present conventional amoxicillin is mainly powder, injection; Often there is refusing to eat, anorexia phenomenon in powder, be not easy to animal oral in animal; Injection is oil solution, and peak time is long, and onset is slow.
Summary of the invention
The present invention is in order to overcome the deficiency in existing dosage form, the amoxicillin sodium for injection sulbactam sodium of research and development.This invention makes amoxicillin sodium and sulbactam sodium under a kind of anaerobic, anhydrous sealing condition, has reduced medicine and the chance contacting outward, thereby has improved bioavailability and the stability of medicine.The amoxicillin sodium for injection sulbactam sodium outward appearance making becomes white blocks of solid, loose porous.The present invention overcomes the deficiencies in the prior art, and a kind of good effect, safe and reliable amoxicillin sodium for injection sulbactam sodium are provided.
through optimal design of the present invention the amoxicillin sodium for injection sulbactam sodium prepared of method not only improve bioavailability and the stability of medicine, the similar drugs preparing with respect to commercially available and additive method also has better biocidal property and curative effect (as blood medicine concentration).
The concrete technical scheme of the present invention is: a kind of amoxicillin sodium for injection sulbactam sodium for animals, and the raw material that comprises following parts by weight:
Amoxicillin Sodium 2 weight portions; Sulbactam sodium 0.5-1 weight portion; Antioxidant 0.1 weight portion; Solid dispersion carrier 0.4～6 weight portion; Water for injection 90～100 weight portions.
Advantage of the present invention and beneficial effect are:
_ _ 1, the present invention is dissolved rear lyophilizing amoxicillin sodium and sulbactam sodium, and the amoxicillin sodium and sulbactam sodium after lyophilizing, in anaerobic, anhydrous cillin bottle, has changed the condition of storage of product, has increased the stability of amoxicillin sodium and sulbactam sodium; By optimizing dosage form and preparation process, improved the drug metabolism feature of amoxicillin sodium for injection.
_ _ 2, the amoxicillin sodium for injection sulbactam sodium that the present invention makes, outer formation white blocks shape, loose porous, after redissolving, water dissolves rapidly, and solution clear, has increased the convenience using.
The specific embodiment
Below by specific embodiment, the invention will be further described, and following examples are descriptive, is not determinate, can not limit protection scope of the present invention with this.
Embodiment 1:
An amoxicillin sodium for injection sulbactam sodium for animals, each raw material and parts by weight thereof respectively: Amoxicillin Sodium 2g; Sulbactam sodium 1g; Sodium thiosulfate 0.1g; Macrogol 2000 lg; Sodium hydroxide solution 0.2mol/L (being adjusted to pH to 8.5-9.5); Water for injection is to enough.
(1) preparation: sodium thiosulfate, Macrogol 2000 are joined in the water for injection of 70% recipe quantity, be stirred to completely and dissolve; The Amoxicillin Sodium of recipe quantity, sulbactam sodium are joined in above-mentioned solution, with the sodium hydroxide solution of 0.2mol/L, regulate pH to 8.5-9.5, be stirred to amoxicillin sodium and sulbactam sodium and dissolve completely, solution is as clear as crystal weak yellow liquid; Water for injection standardize solution, crosses 0.22 μ m microporous filter membrane, and sampling is made semi-finished product and detected; The stock solution preparation time is no more than 2 hours;
(2) by needing the liquor capacity of fill in every cillin bottle of cubage in amoxicillin, sulbactam amoxicillin sodium and sulbactam sodium in the solution of measuring, aseptic subpackaged;
(3) lyophilization: case temperature before freezer dryer is chilled to-40 ℃～-50 ℃ in advance, and after subpackage, goods are sent into immediately and carried out lyophilization in front box of freeze dryer; It is as follows that freezing dry process and technology are controlled index:
Pre-freeze: products temperature is down to rapidly to-40 ℃～-50 ℃;
Sublimation drying: initial baffle temperature is-45 ℃, and condenser temperature is-60 ℃, front case vacuum keep is below 30Pa, and constant-speed heating heats up, and to-10～-5 ℃, ice sheet disappears; The sublimation drying time is 5～8 hours;
Redrying: baffle temperature rises to 40 ℃ gradually, heat preservation and dryness, front case vacuum is 3～5Pa; The redrying time is 14～20 hours;
(4) tamponade is offerd for sale, and rolls lid check, packing.
Embodiment 2:
_ _ a kind of amoxicillin sodium for injection sulbactam sodium for animals, each raw material and parts by weight thereof respectively:
_ Amoxicillin Sodium 2g; Sulbactam sodium 0.5g; Sodium sulfite 0.1g; PVP K30 0.4g; Potassium hydroxide solution 0.2mol/L (being adjusted to pH to 8.5-9.5); Water for injection is to enough.
(1) preparation: sodium sulfite, PVP K30 are joined in the water for injection of 70% recipe quantity, be stirred to completely and dissolve; The Amoxicillin Sodium of recipe quantity, sulbactam sodium are joined in above-mentioned solution, with the potassium hydroxide of 0.2mol/L, regulate pH to 8.5-9.5, be stirred to amoxicillin sodium and sulbactam sodium and dissolve completely, solution is as clear as crystal weak yellow liquid; Water for injection standardize solution, crosses 0.22 μ m microporous filter membrane, and sampling is made semi-finished product and detected; The stock solution preparation time is no more than 2 hours;
(2) by needing the liquor capacity of fill in every cillin bottle of cubage in amoxicillin, sulbactam amoxicillin sodium and sulbactam sodium in the solution of measuring, aseptic subpackaged;
(3) lyophilization: case temperature before freezer dryer is chilled to-40 ℃～-50 ℃ in advance, and after subpackage, goods are sent into immediately and carried out lyophilization in front box of freeze dryer; It is as follows that freezing dry process and technology are controlled index:
Pre-freeze: products temperature is down to rapidly to-40 ℃～-50 ℃;
Sublimation drying: initial baffle temperature is-45 ℃, and condenser temperature is-60 ℃, front case vacuum keep is below 30Pa, and constant-speed heating heats up, and to-10～-5 ℃, ice sheet disappears; The sublimation drying time is 5～8 hours;
Redrying: baffle temperature rises to 40 ℃ gradually, heat preservation and dryness, front case vacuum is 3～5Pa; The redrying time is 14～20 hours;
(4) tamponade is offerd for sale, and rolls lid check, packing.
Embodiment 3:
_ a kind of amoxicillin sodium for injection sulbactam sodium for animals, each raw material and parts by weight thereof respectively:
_ Amoxicillin Sodium 2g; Sulbactam sodium 0.5g; Sodium sulfite 0.1g; PLURONICS F87 6g; Sodium hydroxide solution 0.2mol/L (being adjusted to pH to 8.5-9.5); Water for injection is to enough.
(1) preparation: sodium sulfite, PLURONICS F87 are joined in the water for injection of 70% recipe quantity, be stirred to completely and dissolve; The Amoxicillin Sodium of recipe quantity, sulbactam sodium are joined in above-mentioned solution, with the sodium hydroxide solution of 0.2mol/L, regulate pH to 8.5-9.5, be stirred to amoxicillin sodium and sulbactam sodium and dissolve completely, solution is as clear as crystal weak yellow liquid; Water for injection standardize solution, crosses 0.22 μ m microporous filter membrane, and sampling is made semi-finished product and detected; The stock solution preparation time is no more than 2 hours;
(2) by needing the liquor capacity of fill in every cillin bottle of cubage in amoxicillin, sulbactam amoxicillin sodium and sulbactam sodium in the solution of measuring, aseptic subpackaged;
(3) lyophilization: case temperature before freezer dryer is chilled to-40 ℃～-50 ℃ in advance, and after subpackage, goods enter to carry out lyophilization in front box of freeze dryer immediately; It is as follows that freezing dry process and technology are controlled index:
Pre-freeze: products temperature is down to rapidly to-40 ℃～-50 ℃;
Sublimation drying: initial baffle temperature is-45 ℃, and condenser temperature is-60 ℃, front case vacuum keep is below 30Pa, and constant-speed heating heats up, and to-10～-5 ℃, ice sheet disappears; The sublimation drying time is 5～8 hours;
Redrying: baffle temperature rises to 40 ℃ gradually, heat preservation and dryness, front case vacuum is 3～5Pa; The redrying time is 14～20 hours;
(4) tamponade is offerd for sale, and rolls lid check, packing.
Embodiment 4: the stability comparison of amoxicillin sodium for injection sulbactam sodium
Experiment adopts the amoxicillin sodium for injection sulbactam sodium (lyophilized preparation) and commercially available amoxicillin sodium for injection (lot number 20120302 of the embodiment 1,2,3 in patent description, Sichuan Qian Xing animal pharmaceutical estate company limited, specification 0.5g (in amoxicillin), 0.5g/ props up) in the constant temperature and humidity incubator of 40 ℃ of temperature, humidity 70%, accelerate the effects, respectively at 0 day, January, February, March, 6 months point carry out assay, investigate the stability of amoxicillin in sample.
The changes of contents of 40 ℃ of acceleration of amoxicillin sodium for injection
At 40 ℃, accelerate after 6 months, example 3 is slightly better than example 2, and example 2 is slightly better than example 1, but whole maintaining an equal level, stable content.Commercially available amoxicillin sodium for injection changes of contents under comparing is obvious.
Result demonstration, amoxicillin sodium for injection sulbactam sodium (lyophilized preparation) is under same stored condition, and Determination of amoxicillin stability is obviously better than commercially available amoxicillin sodium for injection, and effect duration obviously extends.
Embodiment 5: the experiment of amoxicillin sodium for injection sulbactam sodium In Vitro Bacteriostasis
Select pig SEPARATION OF GOLD Staphylococcus aureus, isolate is gone down to posterity and cultivates 24h, the aseptic sodium chloride solution with 0.9% dilutes, and joins in preprepared nutrient broth medium, and mix homogeneously, finally makes the Nutrient medium of 100cfu/ml.Be laid in culture dish, treat its culture medium cooled and solidified.Experiment adopts Oxford agar diffusion method by amoxicillin sodium for injection lyophilized preparation and the commercially available amoxicillin sodium for injection (lot number 20120302 of embodiment mono-preparation, Sichuan Qian Xing animal pharmaceutical estate company limited, specification 0.5g (in amoxicillin), 0.5g/ props up) with water for injection, be diluted to respectively the solution of 2 μ g/ml (in amoxicillin), with micropipette rifle, in the cup of Oxford, add 100 μ l respectively, after liquid in the cup of Oxford outwards distributes completely, remove Oxford cup, culture dish is placed in 37 ℃ of constant incubators, cultivate 18～24h, 2 groups of operation repetitives.
Amoxicillin sodium and sulbactam sodium and the In Vitro Bacteriostasis effect comparison of commercially available injection amoxicillin
Result demonstration, amoxicillin sodium for injection sulbactam sodium (lyophilized preparation), significantly better than commercially available amoxicillin sodium for injection, can play good sterilization, fungistatic effect under the same concentrations of amoxicillin.
Embodiment 6: amoxicillin sodium for injection and the commercially available amoxicillin sodium for injection (lot number 20120302 of the embodiment of the present application one preparation, Sichuan Qian Xing animal pharmaceutical estate company limited, specification 0.5g (in amoxicillin), 0.5g/ props up), the blood drug level contrast of amoxicillin+sulbactam sodium (according to both ratios in embodiment 1)
Select healthy Landrace of 5 monthly ages, be divided at random afterwards 5 groups, every group of 5 pigs, the normal feedstuff of feeding, 1 group is blank group; 2,3,4,5,6,7 is test group; 2,4,6 groups is that drug administration by injection is prohibited and to be raised group, and 3,5,7 groups is the drug administration by injection group of feeding,, administration concentration is 10mg/kg body weight (in Amoxicillin Sodium), and experimental period is 6 hours; 2,3 groups of administrations are the amoxicillin sodium and sulbactam sodium for embodiment 1 preparation, and 4,5 groups of administrations are Amoxicillin Sodium+sulbactam sodium (according to both ratios in embodiment 1), and 6,7 groups of administrations are commercially available amoxicillin sodium for injection.
The blood drug level drug metabolism experimental unit of amoxicillin in pig body: μ g/ml
| Group | 0h | 0.5h | 1h | 1.5h | 2h | 3h | 4h | 5h | 6h |
| 1 cell mean | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| 2 cell means | 0 | 8.0 | 16.8 | 12.4 | 9.4 | 5.6 | 1.3 | 0.1 | 0 |
| 3 cell means | 0 | 8.1 | 16.9 | 12.0 | 10.1 | 8.3 | 5.7 | 2.2 | 0.2 |
| 4 cell means | 0 | 6.9 | 16.2 | 11.5 | 7.2 | 2.3 | 0.4 | 0 | 0 |
| 5 cell means | 0 | 7.5 | 16.8 | 12.6 | 7.4 | 3.3 | 0.6 | 0 | 0 |
| 6 cell means | 0 | 7.2 | 16.5 | 12.3 | 7.6 | 2.8 | 0.7 | 0 | 0 |
| 7 cell means | 0 | 7.1 | 16.3 | 12.7 | 7.3 | 3.0 | 0.6 | 0 | 0 |
The jugular vein blood 5ml that extracts respectively experimental group pig at 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h time point, gets upper plasma through centrifugal layering, filters sample detection Determination of amoxicillin and as above shows.
Result shows, effect of drugs is significantly better than other administration groups in two described in the administration embodiment of the present invention 1, and embodiment 1 medicine type administration blood peak concentration of drug is higher than other administrations, and action time is short, absorbs rapidly and search for food blood drug level is had no significant effect.
Claims (5)
1. an amoxicillin sodium for injection sulbactam sodium lyophilized preparation for animals, it is characterized in that forming and weight proportion as follows:
Wherein, Amoxicillin Sodium weight is in amoxicillin, and sulbactam sodium weight is in sulbactam;
The preparation method of described lyophilized preparation comprises the following steps:
(1) preparation: antioxidant, dispersion carrier are joined in the water for injection of 70% recipe quantity, be stirred to completely and dissolve; The Amoxicillin Sodium of recipe quantity, sulbactam sodium are joined in above-mentioned solution, with sodium hydroxide solution or the potassium hydroxide solution of 0.2mol/L, regulate pH to 8.5-9.5, be stirred to amoxicillin sodium and sulbactam sodium and dissolve completely, solution is as clear as crystal weak yellow liquid; Water for injection standardize solution, crosses 0.22 μ m microporous filter membrane, and sampling is made semi-finished product and detected;
(2) by needing the liquor capacity of fill in every cillin bottle of cubage in amoxicillin, sulbactam amoxicillin sodium and sulbactam sodium in the solution of measuring, aseptic subpackaged;
(3) lyophilization: case temperature before freezer dryer is chilled to-40 ℃～-50 ℃ in advance, and after subpackage, goods are sent into immediately and carried out lyophilization in front box of freeze dryer; It is as follows that freezing dry process and technology are controlled index:
Pre-freeze: products temperature is down to rapidly to-40 ℃～-50 ℃
Sublimation drying: initial baffle temperature is-45 ℃, and condenser temperature is-60 ℃, front case vacuum keep is below 30Pa, and constant-speed heating heats up, and to-10～-5 ℃, ice sheet disappears;
Redrying: baffle temperature rises to 40 ℃ gradually, heat preservation and dryness, front case vacuum is 3～5Pa;
(4) tamponade is offerd for sale, and rolls lid check, packing;
Wherein said antioxidant is any one in sodium sulfite, sodium thiosulfate.
2. amoxicillin sodium for injection sulbactam sodium lyophilized preparation as claimed in claim 1, is characterized in that aqueous dispersion carrier is one or both in Macrogol 2000, PVP K30, PLURONICS F87.
3. amoxicillin sodium for injection sulbactam sodium lyophilized preparation as claimed in claim 1 or 2, is characterized in that in (3) step, and the sublimation drying time is 5～8 hours, and the redrying time is 14～20 hours.
4. amoxicillin sodium for injection sulbactam sodium lyophilized preparation as claimed in claim 1 or 2, is characterized in that, in (1) step, the stock solution preparation time is no more than 2 hours, and immediately-50 ℃ of reach in freezers suddenly freeze processing.
5. the preparation method of the amoxicillin sodium for injection sulbactam sodium lyophilized preparation described in claim 1-4 any one, is characterized in that, it comprises the steps:
(1) preparation: antioxidant, dispersion carrier are joined in the water for injection of 70% recipe quantity, be stirred to completely and dissolve; The Amoxicillin Sodium of recipe quantity, sulbactam sodium are joined in above-mentioned solution, with sodium hydroxide solution or the potassium hydroxide of 0.2mol/L, regulate pH to 8.5-9.5, be stirred to amoxicillin sodium and sulbactam sodium and dissolve completely, solution is as clear as crystal weak yellow liquid; Water for injection standardize solution, crosses 0.22 μ m microporous filter membrane, and sampling is made semi-finished product and detected; The stock solution preparation time is no more than 2 hours;
(2) by needing the liquor capacity of fill in every cillin bottle of cubage in amoxicillin, sulbactam amoxicillin sodium and sulbactam sodium in the solution of measuring, aseptic subpackaged;
(3) lyophilization: case temperature before freezer dryer is chilled to-40 ℃～-50 ℃ in advance, and after subpackage, goods are sent into immediately and carried out lyophilization in front box of freeze dryer; It is as follows that freezing dry process and technology are controlled index:
Pre-freeze: products temperature is down to rapidly to-40 ℃～-50 ℃;
Sublimation drying: initial baffle temperature is-45 ℃, and condenser temperature is-60 ℃, front case vacuum keep is below 30Pa, and constant-speed heating heats up, and to-10～-5 ℃, ice sheet disappears; The sublimation drying time is 5～8 hours;
Redrying: baffle temperature rises to 40 ℃ gradually, heat preservation and dryness, front case vacuum is 3～5Pa; The redrying time is 14～20 hours;
(4) tamponade is offerd for sale, and rolls lid check, packing.
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| CN101632660B (en) * | 2009-08-18 | 2010-09-08 | 海南永田药物研究院有限公司 | Suspensoid powder injection of amoxicillin sodium sulbactam sodium medicine composition and novel application thereof |
| CN102895228B (en) * | 2012-11-01 | 2014-07-23 | 哈药集团制药总厂 | Amoxicillin and sulbactam sodium medicinal composition injection and preparation method thereof |
| CN103012429B (en) * | 2012-12-28 | 2014-12-31 | 吴秋萍 | Novel amoxicillin sodium compound and composition of amoxicillin sodium compound and sulbactam sodium compound |
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