CN107095848A - A kind of enrofloxacin injection and preparation method thereof - Google Patents
A kind of enrofloxacin injection and preparation method thereof Download PDFInfo
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- CN107095848A CN107095848A CN201710528459.2A CN201710528459A CN107095848A CN 107095848 A CN107095848 A CN 107095848A CN 201710528459 A CN201710528459 A CN 201710528459A CN 107095848 A CN107095848 A CN 107095848A
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- SPFYMRJSYKOXGV-UHFFFAOYSA-N Baytril Chemical compound C1CN(CC)CCN1C(C(=C1)F)=CC2=C1C(=O)C(C(O)=O)=CN2C1CC1 SPFYMRJSYKOXGV-UHFFFAOYSA-N 0.000 title claims abstract description 76
- 229960000740 enrofloxacin Drugs 0.000 title claims abstract description 76
- 238000002347 injection Methods 0.000 title claims abstract description 54
- 239000007924 injection Substances 0.000 title claims abstract description 54
- 238000002360 preparation method Methods 0.000 title claims description 10
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims abstract description 48
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 25
- 239000008215 water for injection Substances 0.000 claims abstract description 23
- ULWHHBHJGPPBCO-UHFFFAOYSA-N propane-1,1-diol Chemical class CCC(O)O ULWHHBHJGPPBCO-UHFFFAOYSA-N 0.000 claims abstract description 13
- MBBZMMPHUWSWHV-BDVNFPICSA-N N-methylglucamine Chemical compound CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO MBBZMMPHUWSWHV-BDVNFPICSA-N 0.000 claims abstract description 12
- 229960003194 meglumine Drugs 0.000 claims abstract description 12
- 239000002994 raw material Substances 0.000 claims abstract description 8
- 239000000243 solution Substances 0.000 claims description 22
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 5
- 239000003708 ampul Substances 0.000 claims description 5
- 238000001914 filtration Methods 0.000 claims description 5
- 239000012982 microporous membrane Substances 0.000 claims description 5
- 238000003756 stirring Methods 0.000 claims description 5
- 108010010998 polyactin A Proteins 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 5
- 238000004519 manufacturing process Methods 0.000 abstract description 4
- 239000000203 mixture Substances 0.000 abstract description 4
- 230000004888 barrier function Effects 0.000 abstract description 3
- 238000009472 formulation Methods 0.000 abstract description 3
- 238000011031 large-scale manufacturing process Methods 0.000 abstract description 2
- 238000012360 testing method Methods 0.000 description 10
- 239000003814 drug Substances 0.000 description 9
- 229940079593 drug Drugs 0.000 description 6
- 239000003182 parenteral nutrition solution Substances 0.000 description 6
- 206010012735 Diarrhoea Diseases 0.000 description 5
- 239000007788 liquid Substances 0.000 description 5
- 238000005057 refrigeration Methods 0.000 description 4
- 241001465754 Metazoa Species 0.000 description 3
- 230000000844 anti-bacterial effect Effects 0.000 description 3
- 230000007012 clinical effect Effects 0.000 description 3
- 238000002425 crystallisation Methods 0.000 description 3
- 230000008025 crystallization Effects 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 241000588724 Escherichia coli Species 0.000 description 2
- NIPNSKYNPDTRPC-UHFFFAOYSA-N N-[2-oxo-2-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)ethyl]-2-[[3-(trifluoromethoxy)phenyl]methylamino]pyrimidine-5-carboxamide Chemical compound O=C(CNC(=O)C=1C=NC(=NC=1)NCC1=CC(=CC=C1)OC(F)(F)F)N1CC2=C(CC1)NN=N2 NIPNSKYNPDTRPC-UHFFFAOYSA-N 0.000 description 2
- 229940029202 anti-idiotypic vaccine Drugs 0.000 description 2
- 229940088710 antibiotic agent Drugs 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- MYSWGUAQZAJSOK-UHFFFAOYSA-N ciprofloxacin Chemical compound C12=CC(N3CCNCC3)=C(F)C=C2C(=O)C(C(=O)O)=CN1C1CC1 MYSWGUAQZAJSOK-UHFFFAOYSA-N 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000008014 freezing Effects 0.000 description 2
- 238000007710 freezing Methods 0.000 description 2
- 230000035876 healing Effects 0.000 description 2
- 244000144972 livestock Species 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 244000144977 poultry Species 0.000 description 2
- 238000013112 stability test Methods 0.000 description 2
- 238000010257 thawing Methods 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 206010022086 Injection site pain Diseases 0.000 description 1
- 241000204031 Mycoplasma Species 0.000 description 1
- 206010034133 Pathogen resistance Diseases 0.000 description 1
- 241000282887 Suidae Species 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 150000001412 amines Chemical class 0.000 description 1
- 230000000843 anti-fungal effect Effects 0.000 description 1
- 229940121375 antifungal agent Drugs 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 235000019658 bitter taste Nutrition 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 229960003405 ciprofloxacin Drugs 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000000369 enteropathogenic effect Effects 0.000 description 1
- -1 ethyl compound Chemical class 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000011049 filling Methods 0.000 description 1
- 229940124307 fluoroquinolone Drugs 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 238000005286 illumination Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 238000010255 intramuscular injection Methods 0.000 description 1
- 239000007927 intramuscular injection Substances 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 230000003340 mental effect Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000000284 resting effect Effects 0.000 description 1
- 239000004576 sand Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 239000000273 veterinary drug Substances 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Biochemistry (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
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Abstract
It is as made from the raw material of following parts by weight the invention discloses a kind of enrofloxacin injection：2.5 10 parts of Enrofloxacin, 28 parts of meglumine, 0.2 0.5 parts of α mannatides, 10 30 parts of propane diols, 0.05 part of EDTA0.01,0.5 0.9 parts of sodium hydroxide, 70 80 parts of water for injection.Enrofloxacin injection prepared by the present invention, absorbed after injection fast, long half time is eliminated, bioavilability is higher, and stability is preferable, pain can be reduced during injection, its poor technical barrier of stability at low temperature is not only solved, is conducive to giving full play to for enrofloxacin injection curative effect, formulation cost is low, manufacturing process is easy to operate, is adapted to enterprise's large-scale production.
Description
Technical field
The present invention relates to veterinary medicine technical field, more particularly to a kind of enrofloxacin injection and preparation method thereof.
Background technology
Enrofloxacin, also known as Enrofloxacin are the special FQNSs of first livestock and poultry, English
Name is Enrofloxacin, is the ethyl compound of Ciprofloxacin, is third generation fluoroquinolones, there is broad-spectrum bactericidal action, right
The bacterium in resting stage and growth period is effective.
Enrofloxacin is succeeded in developing first the eighties by Bayer A.G, and most of country of the world is had been enter at present
And market.China succeeded in developing in 1993, had been widely used in veterinary clinic.Enrofloxacin has has a broad antifungal spectrum, sterilization
The features such as active strong, internal widely distributed and other antibacterials are without cross resistance.Clinical tests prove that, better than current
Other conventional antibacterials.After administration, Enrofloxacin can reach at a relatively high concentration in the tissue such as liver, lung, kidney, be that blood medicine is dense
Several times of degree, good effect is obtained in terms of prevention and treatment fowl bacterial and Mycoplasma disease.Enrofloxacin is strong
The research of health livestock and poultry interior medicine dynamics is much reported.
Because Enrofloxacin has strong bitter taste in itself, as peroral dosage form in use, the tolerance dose of animal compares
It is low, so general in Clinical practice be administered in the form of parenteral solution.But enrofloxacin injection stability is poor, especially exists
Crystallization is easily separated out under low temperature environment, efficacy and saferry is had a strong impact on, this is especially prominent in northern China cold district
Problem, because Enrofloxacin solubility in water is smaller.It is therefore, existing but Enrofloxacin is soluble in sodium hydroxide solution
Have in technology mainly increases Enrofloxacin in water when preparing enrofloxacin injection using the method for adding sodium hydroxide
Solubility, but in order to reach expected therapeutic effect as early as possible, the concentration of Enrofloxacin can be increased, cause the addition of sodium hydroxide
Amount also increases therewith, and because the biotic environment in animal body is faintly acid, if the too high parenteral solution of injection pH value, to animal
Excitant is larger, is unfavorable for giving full play to for enrofloxacin injection curative effect on the contrary.
The content of the invention
It is an object of the invention to provide En Nuosha prepared by a kind of enrofloxacin injection and preparation method thereof, the present invention
Star parenteral solution, not only solves its poor technical barrier of stability at low temperature, is conducive to filling for enrofloxacin injection curative effect
Distribution is waved, and formulation cost is low, and manufacturing process is easy to operate, is adapted to the big production of enterprise.
The purpose of the present invention is achieved by the following technical solution：
A kind of enrofloxacin injection, is as made from the raw material of following parts by weight：2.5-10 parts of Enrofloxacin, meglumine
2-8 parts, α -0.2-0.5 parts of mannatide, 10-30 parts of propane diols, EDTA0.01-0.05 parts, 0.5-0.9 parts of sodium hydroxide,
70-80 parts of water for injection.
It is preferred that, a kind of enrofloxacin injection is as made from the raw material of following parts by weight：6 parts of Enrofloxacin, Portugal's first
6 parts of amine, 0.4 part of α-mannatide, 20 parts of propane diols, EDTA0.03 parts, 0.7 part of sodium hydroxide, 75 parts of water for injection.
Described, the pH value of enrofloxacin injection is 9.5-10.5.
A kind of preparation method of enrofloxacin injection, is as made from following steps：
1) water for injection for accounting for total amount 50% is taken, α-mannatide is added, stirring dissolves it, obtains solution A；
2) remaining 50% water for injection is added into Enrofloxacin, meglumine, propane diols and EDTA, obtains solution B；
3) solution A is added in solution B, stirred, pH is adjusted with sodium hydroxide, with 0.45 μm of filtering with microporous membrane,
Embedding then in being sterilized 40 minutes under 110 DEG C of flowing steams, is cooled to room temperature, packed in ampulla, obtains Enrofloxacin injection
Liquid.
Described, water for injection is heated to 75-85 DEG C in step (1).
Enrofloxacin injection prepared by the present invention, absorbs fast, eliminates long half time, bioavilability is higher after injection,
Stability preferably, can reduce pain during injection, not only solve its poor technical barrier of stability at low temperature, be conducive to grace
Promise sand star parenteral solution curative effect gives full play to, and formulation cost is low, manufacturing process is easy to operate, is adapted to enterprise's large-scale production.
Embodiment
Embodiment 1
A kind of enrofloxacin injection, is as made from the raw material of following parts by weight：10 parts of Enrofloxacin, 2 parts of meglumine,
0.2 part of α-mannatide, 30 parts of propane diols, EDTA0.01 parts, 0.5 part of sodium hydroxide, 80 parts of water for injection.
Described, the pH value of enrofloxacin injection is 9.5.
A kind of preparation method of enrofloxacin injection, is as made from following steps：
1) water for injection for accounting for total amount 50% is taken, α-mannatide is added, stirring dissolves it, obtains solution A；
2) remaining 50% water for injection is added into Enrofloxacin, meglumine, propane diols and EDTA, obtains solution B；
3) solution A is added in solution B, stirred, pH is adjusted with sodium hydroxide, with 0.45 μm of filtering with microporous membrane,
Embedding then in being sterilized 40 minutes under 110 DEG C of flowing steams, is cooled to room temperature, packed in ampulla, obtains Enrofloxacin injection
Liquid.
Described, water for injection is heated to 75 DEG C in step (1).
Embodiment 2
A kind of enrofloxacin injection, is as made from the raw material of following parts by weight：6 parts of Enrofloxacin, 6 parts of meglumine,
0.4 part of α-mannatide, 20 parts of propane diols, EDTA0.03 parts, 0.7 part of sodium hydroxide, 75 parts of water for injection.
Described, the pH value of enrofloxacin injection is 10.
A kind of preparation method of enrofloxacin injection, is as made from following steps：
1) water for injection for accounting for total amount 50% is taken, α-mannatide is added, stirring dissolves it, obtains solution A；
2) remaining 50% water for injection is added into Enrofloxacin, meglumine, propane diols and EDTA, obtains solution B；
3) solution A is added in solution B, stirred, pH is adjusted with sodium hydroxide, with 0.45 μm of filtering with microporous membrane,
Embedding then in being sterilized 40 minutes under 110 DEG C of flowing steams, is cooled to room temperature, packed in ampulla, obtains Enrofloxacin injection
Liquid.
Described, water for injection is heated to 80 DEG C in step (1).
Embodiment 3
A kind of enrofloxacin injection, is as made from the raw material of following parts by weight：2.5 parts of Enrofloxacin, meglumine 8
Part, 0.5 part of α-mannatide, 10 parts of propane diols, EDTA0.05 parts, 0.9 part of sodium hydroxide, 70 parts of water for injection.
Described, the pH value of enrofloxacin injection is 10.5.
A kind of preparation method of enrofloxacin injection, is as made from following steps：
1) water for injection for accounting for total amount 50% is taken, α-mannatide is added, stirring dissolves it, obtains solution A；
2) remaining 50% water for injection is added into Enrofloxacin, meglumine, propane diols and EDTA, obtains solution B；
3) solution A is added in solution B, stirred, pH is adjusted with sodium hydroxide, with 0.45 μm of filtering with microporous membrane,
Embedding then in being sterilized 40 minutes under 110 DEG C of flowing steams, is cooled to room temperature, packed in ampulla, obtains Enrofloxacin injection
Liquid.
Described, water for injection is heated to 85 DEG C in step (1).
Embodiment 4
Enrofloxacin injection stability test
Enrofloxacin injection prepared by Example 1-3 is steady according to Chinese veterinary pharmacopoeia one annex veterinary drug of version in 2010
Qualitative test guideline carries out accelerated test, is 75 ± 5%, light in 40 ± 2 DEG C of temperature, relative humidity according to commercially available back
Illumination be 4500 ± 500LX under conditions of place 6 months, the 1st during testing, 2,3,6 the end of month it is separately sampled once, to note
Appearance character, pH value and the content (based on sign percentage composition) for penetrating liquid are detected, the results are shown in Table 1.
The enrofloxacin injection stability test result of table 1
As shown in Table 1, after 6 months accelerated tests, the outward appearance and pH value of the enrofloxacin injection that the present invention is provided
Without significant change, illustrate that parenteral solution stability of the present invention is preferable.
Embodiment 5
Enrofloxacin injection Anti-idiotypic vaccine
Enrofloxacin injection prepared by Example 1-3, by commercially available back, respectively in 0~5 DEG C of refrigeration and -20 ± 2 DEG C
Under freezing conditions place 6 months, the 1st during testing, 2,3,6 the end of month it is separately sampled once, to enrofloxacin injection
Thawing condition (in 10 ± 2 DEG C of defrostings) is detected after appearance character and freezing, the results are shown in Table 2.
The Anti-idiotypic vaccine result of the enrofloxacin injection of table 2
Above-mentioned result of the test is shown, after refrigeration experiment in 6 months, the outward appearance for the enrofloxacin injection that the present invention is provided
Character is without significant change.After 6 months refrigeration tests, the enrofloxacin injection that the present invention is provided separates out a small amount of crystallization, should
Crystallization can be good at redissolving in 10 ± 2 DEG C of refrigeration tests, and the use of parenteral solution is not influenceed.Above-mentioned result of the test shows this hair
The frost resistance of the enrofloxacin injection of bright offer is preferable.
Embodiment 6
Enrofloxacin injection clinical effect trial
Colibacillosis of piglet is a class intestine of young pigs communicable disease as caused by enteropathogenic E. Coli, is piglet
A kind of common disease and frequently-occurring disease, large-scale pig farm are very common.Now by taking Escherichia coli as an example, the concentration prepared from embodiment 1-3
Respectively 2.5%, 5%, 10% enrofloxacin injection and control group (commercially available 10% enrofloxacin injection) are to piglet
Colibacillosis carries out clinical effect trial, in terms of Enrofloxacin quality, and dosage is each 5mg/kg, 1 times/day, continuous 3
My god, administering mode is intramuscular injection, the results are shown in Table 3.
Observation index：Observe the mental status of piglet and diarrhoea situation after medication.
Clinical efficacy criterion：Divide and rule more, it is effective and invalid 3 grades.
Cure：After medication 1-2 days, excrement retrogradation continued medication to the 3rd day, and stopping of having loose bowels, excrement recovers normal.
It is effective：After medication 1-2 days, excrement retrogradation, number of times of having loose bowels is reduced, and is continued medication to the 3rd day, is had loose bowels and do not stop.
It is invalid：After medication 3 days, diarrhoea is still without being clearly better.
Cure rate=healing head number/treatment head number × 100%
Efficient=effective head number/treatment head number × 100%
Clinical effect trial result of the different enrofloxacin injections of table 3 to colibacillosis of piglet
| Packet | Treatment/head | Healing/head | Effective/head | Invalid/head | Cure rate/% | Effective percentage/% |
| Embodiment 1 | 50 | 39 | 11 | 0 | 78 | 100 |
| Embodiment 2 | 50 | 41 | 9 | 0 | 82 | 100 |
| Embodiment 3 | 50 | 38 | 12 | 0 | 76 | 100 |
| Control group | 50 | 22 | 9 | 19 | 44 | 62 |
Described above is only the preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art
For member, under the premise without departing from the principles of the invention, some improvements and modifications can also be made, these improvements and modifications also should
It is considered as protection scope of the present invention.
Claims (5)
1. a kind of enrofloxacin injection, it is characterised in that be as made from the raw material of following parts by weight：Enrofloxacin 2.5-10
Part, 2-8 parts of meglumine, α -0.2-0.5 parts of mannatide, 10-30 parts of propane diols, EDTA0.01-0.05 parts, sodium hydroxide
0.5-0.9 parts, 70-80 parts of water for injection.
2. enrofloxacin injection according to claim 1, it is characterised in that be made by the raw material of following parts by weight
's：6 parts of Enrofloxacin, 6 parts of meglumine, 0.4 part of α-mannatide, 20 parts of propane diols, EDTA0.03 parts, sodium hydroxide 0.7
Part, 75 parts of water for injection.
3. enrofloxacin injection according to claim 1, it is characterised in that the pH value of the enrofloxacin injection is
9.5-10.5。
4. the preparation method of enrofloxacin injection any one of a kind of claim 1-3, it is characterised in that be by following
Made from step：
1) water for injection for accounting for total amount 50% is taken, α-mannatide is added, stirring dissolves it, obtains solution A；
2) remaining 50% water for injection is added into Enrofloxacin, meglumine, propane diols and EDTA, obtains solution B；
3) solution A is added in solution B, stirred, pH is adjusted with sodium hydroxide, with 0.45 μm of filtering with microporous membrane, embedding
In ampulla, then in being sterilized 40 minutes under 110 DEG C of flowing steams, room temperature is cooled to, packs, obtains enrofloxacin injection.
5. preparation method according to claim 4, it is characterised in that water for injection is heated to 75-85 in the step (1)
℃。
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| CN103126982A (en) * | 2013-03-07 | 2013-06-05 | 庞永中 | Novel veterinary medicament meglumine enrofloxacin injection and preparation method thereof |
| CN104586757A (en) * | 2015-01-08 | 2015-05-06 | 邳州正康生物技术有限公司 | Veterinary enrofloxacin injection and preparation method thereof |
| CN105193709A (en) * | 2015-07-06 | 2015-12-30 | 河南牧业经济学院 | Enrofloxacin injection and preparation method thereof |
-
2017
- 2017-07-01 CN CN201710528459.2A patent/CN107095848A/en active Pending
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|---|---|---|---|---|
| US5998418A (en) * | 1995-01-13 | 1999-12-07 | Bayer Aktiengesellschaft | Enrofloxacine injection or infusion solutions |
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Application publication date: 20170829 |