AU2011101749A4 - Injection of enrofloxacin and producing method thereof - Google Patents
Injection of enrofloxacin and producing method thereof Download PDFInfo
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- AU2011101749A4 AU2011101749A4 AU2011101749A AU2011101749A AU2011101749A4 AU 2011101749 A4 AU2011101749 A4 AU 2011101749A4 AU 2011101749 A AU2011101749 A AU 2011101749A AU 2011101749 A AU2011101749 A AU 2011101749A AU 2011101749 A4 AU2011101749 A4 AU 2011101749A4
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- enrofloxacin
- injection
- solution
- preparation
- value
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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 81
- 229960000740 enrofloxacin Drugs 0.000 title claims abstract description 81
- 238000002347 injection Methods 0.000 title claims abstract description 64
- 239000007924 injection Substances 0.000 title claims abstract description 64
- 238000000034 method Methods 0.000 title claims description 6
- 230000007935 neutral effect Effects 0.000 claims abstract description 21
- 239000003963 antioxidant agent Substances 0.000 claims abstract description 15
- 230000003078 antioxidant effect Effects 0.000 claims abstract description 15
- 239000002738 chelating agent Substances 0.000 claims abstract description 15
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 48
- 239000007864 aqueous solution Substances 0.000 claims description 19
- 239000002535 acidifier Substances 0.000 claims description 16
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims description 14
- 238000002360 preparation method Methods 0.000 claims description 13
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical group OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 claims description 10
- 238000001914 filtration Methods 0.000 claims description 10
- 230000001954 sterilising effect Effects 0.000 claims description 10
- 238000004659 sterilization and disinfection Methods 0.000 claims description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- AKHNMLFCWUSKQB-UHFFFAOYSA-L sodium thiosulfate Chemical group [Na+].[Na+].[O-]S([O-])(=O)=S AKHNMLFCWUSKQB-UHFFFAOYSA-L 0.000 claims description 8
- 235000019345 sodium thiosulphate Nutrition 0.000 claims description 8
- 235000014655 lactic acid Nutrition 0.000 claims description 7
- 239000004310 lactic acid Substances 0.000 claims description 7
- DWAQJAXMDSEUJJ-UHFFFAOYSA-M Sodium bisulfite Chemical compound [Na+].OS([O-])=O DWAQJAXMDSEUJJ-UHFFFAOYSA-M 0.000 claims description 6
- 238000007865 diluting Methods 0.000 claims description 6
- 239000012528 membrane Substances 0.000 claims description 6
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 claims description 6
- MFBOGIVSZKQAPD-UHFFFAOYSA-M sodium butyrate Chemical compound [Na+].CCCC([O-])=O MFBOGIVSZKQAPD-UHFFFAOYSA-M 0.000 claims description 4
- 239000004475 Arginine Substances 0.000 claims description 3
- ODKSFYDXXFIFQN-BYPYZUCNSA-P L-argininium(2+) Chemical compound NC(=[NH2+])NCCC[C@H]([NH3+])C(O)=O ODKSFYDXXFIFQN-BYPYZUCNSA-P 0.000 claims description 3
- ODKSFYDXXFIFQN-UHFFFAOYSA-N arginine Natural products OC(=O)C(N)CCCNC(N)=N ODKSFYDXXFIFQN-UHFFFAOYSA-N 0.000 claims description 3
- 239000013078 crystal Substances 0.000 abstract description 29
- 238000000926 separation method Methods 0.000 abstract description 28
- 241001465754 Metazoa Species 0.000 abstract description 12
- 230000000694 effects Effects 0.000 abstract description 9
- 230000007794 irritation Effects 0.000 abstract description 9
- 239000000243 solution Substances 0.000 description 34
- 230000002411 adverse Effects 0.000 description 15
- 238000006243 chemical reaction Methods 0.000 description 15
- 229960001484 edetic acid Drugs 0.000 description 8
- 239000004615 ingredient Substances 0.000 description 5
- 239000008213 purified water Substances 0.000 description 5
- 238000004806 packaging method and process Methods 0.000 description 4
- 239000000047 product Substances 0.000 description 4
- 238000003756 stirring Methods 0.000 description 4
- 229940072132 quinolone antibacterials Drugs 0.000 description 3
- 241000287828 Gallus gallus Species 0.000 description 2
- 206010067482 No adverse event Diseases 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 235000013330 chicken meat Nutrition 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 244000144972 livestock Species 0.000 description 2
- 244000144977 poultry Species 0.000 description 2
- 235000013594 poultry meat Nutrition 0.000 description 2
- 239000002244 precipitate Substances 0.000 description 2
- 230000002265 prevention Effects 0.000 description 2
- 206010067484 Adverse reaction Diseases 0.000 description 1
- 241000272525 Anas platyrhynchos Species 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 241000588724 Escherichia coli Species 0.000 description 1
- 241001430197 Mollicutes Species 0.000 description 1
- 229930194936 Tylosin Natural products 0.000 description 1
- 239000004182 Tylosin Substances 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 235000019658 bitter taste Nutrition 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 231100000053 low toxicity Toxicity 0.000 description 1
- 239000002547 new drug Substances 0.000 description 1
- 230000008092 positive effect Effects 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- UURAUHCOJAIIRQ-QGLSALSOSA-N tiamulin Chemical compound CCN(CC)CCSCC(=O)O[C@@H]1C[C@@](C)(C=C)[C@@H](O)[C@H](C)[C@@]23CC[C@@H](C)[C@]1(C)[C@@H]2C(=O)CC3 UURAUHCOJAIIRQ-QGLSALSOSA-N 0.000 description 1
- 229960004885 tiamulin Drugs 0.000 description 1
- 229960004059 tylosin Drugs 0.000 description 1
- WBPYTXDJUQJLPQ-VMXQISHHSA-N tylosin Chemical compound O([C@@H]1[C@@H](C)O[C@H]([C@@H]([C@H]1N(C)C)O)O[C@@H]1[C@@H](C)[C@H](O)CC(=O)O[C@@H]([C@H](/C=C(\C)/C=C/C(=O)[C@H](C)C[C@@H]1CC=O)CO[C@H]1[C@@H]([C@H](OC)[C@H](O)[C@@H](C)O1)OC)CC)[C@H]1C[C@@](C)(O)[C@@H](O)[C@H](C)O1 WBPYTXDJUQJLPQ-VMXQISHHSA-N 0.000 description 1
- 235000019375 tylosin Nutrition 0.000 description 1
Classifications
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Inorganic Chemistry (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oncology (AREA)
- Communicable Diseases (AREA)
- Dermatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Abstract of description The invention relates to an enrofloxacin injection, which is neutral in pH value. The enrofloxacin injection comprises 10 to 20 parts of enrofloxacin, 0.1 to 0.5 parts of antioxidant and 0.1 to 0.5 parts of chelating agent. The pH value of the enrofloxacin injection prepared by the invention is neutral, so the enrofloxacin injection has no irritation when used for animal injection, in addition, the content of the enrofloxacin in the injection is improved to 20% so that the curative effect of single administration is greatly improved, and simultaneously, the prepared enrofloxacin injection has stable properties, has no crystal separation after long-time storage, and is an injection with good curative effect and no irritation.
Description
EDITORIAL NOTE 2011101749 There are five pages of description only Description Enrofloxacin Injection and Preparation Method thereof Technical Field The invention relates to an antibacterial for the prevention and control of aquatic diseases in poultry and livestock, more particularly to an enrofloxacin injection and a preparation method thereof. Background Enrofloxacin, having the chemical formula as follows: 1,4-dihydro- 1 -cyclopropyl-7-(4-ethyl- I -piperazinyl)-6-fluoro-4-oxo-3-quinoli, not only stands for a new generation of quinolone antibacterials, but is also a new drug special for the prevention and control of aquatic diseases in poultry and livestock. On the premise of keeping the characteristics of quinolone antibacterials such as broad spectrum, high efficiency, low toxicity, excellent absorption and convenient administration, enrofloxacin has significant curative effect against various infections caused by multiple bacteria, and particularly, it is obviously superior, in the aspect of killing a variety of mycoplasmas, to other quinolone antibacterials and various tylosin and tiamulin antibacterials that have been used for many years. However, enrofloxacin has quite low animal tolerance dosage when used in the form of oral liquid because of its extremely strong bitterness, therefore, enrofloxacin is generally administered in the form of injection during clinical application. Enrofloxacin is slightly soluble in water and soluble in basic solvent, so the injection used typically is the basic aqueous solution of enrofloxacin, which specifically is sodium hydroxide aqueous solution, however, the solubility of enrofloxacin in the basic aqueous solution is 10%, so the excess parts are precipitated out in the form of crystal. In addition, due to the subacidity of the biological environment in animal body, intensive irritation to animals would be brought after the basic aqueous solution, i.e. the enrofloxacin-containing sodium hydroxide aqueous solution, is injected into animal body via a syringe, as a result, animals will show distinct discomfort. Summary of the Invention The invention aims to overcome the shortages in the prior art and provide an enrofloxacin injection which is neutral in pH value and has no irritation to animal body. The content of the enrofloxacin in the injection is from 10% to 20% so that the curative effect of single administration is greatly improved, and simultaneously, the prepared enrofloxacin injection has stable properties, has no crystal separation after long-time storage, and is an injection with good curative effect and no irritation. The enrofloxacin injection is neutral in pH value and comprises 10 to 20 parts of enrofloxacin, 0.1 to 0.5 parts of antioxidant and 0.1 to 0.5 parts of chelating agent. The enrofloxacin accounts for 10 to 20% of the total weight of the injection. The antioxidant is sodium thiosulfate or sodium bisulfite. The chelating agent is EDTA. The invention further provides a preparation method of enrofloxacin injection, which comprises the steps of: (1) Adding enrofloxacin to sodium hydroxide aqueous solution; (2) Continuously adding the sodium hydroxide aqueous solution to adjust the pH value to be within a range from 9 to 13; (3) Adding an acidifying agent to adjust the pH value to be neutral; (4) Adding an antioxidant; (5) Adding a chelating agent; (6) Diluting with water to a constant volume to obtain the enrofloxacin injection. After the step (6) is finished, filtering sterilization by a 0.45-micron micropore filter membrane is performed. The concentration of the sodium hydroxide aqueous solution in the step (1) is 0.2 to 0.4 mol/I. The acidifying agent in the step (3) is one or two or three of lactic acid, sodium butyrate and arginine. The antioxidant in the step (4) is sodium thiosulfate or sodium bisulfite. The chelating agent in the step (5) is EDTA. The water in the step (6) is purified water. The invention has the advantages and positive effects as follows: The enrofloxacin injection prepared by the invention is added with one or two or three of lactic acid, sodium butyrate and arginine, finally leading to neutral pH value of the invention, in this way, no irritation is brought when the injection is injected into animals, furthermore, the content of the enrofloxacin is improved to 20% so that the curative effect of single administration is greatly improved, and simultaneously, the prepared enrofloxacin injection has stable properties, has no crystal separation after long-time storage, and is an injection with good curative effect and no irritation. Detailed Description of the Embodiments The invention will be further described below with reference to the embodiments that are regarded in an illustrative sense rather than a restrictive sense and accordingly could not limit the scope of the invention. The enrofloxacin injection in the invention is neutral in pH value, has no irritation to animal body and comprises 10 to 20 parts of enrofloxacin, 0.1 to 0.5 parts of antioxidant and 0.1 to 0.5 parts of chelating agent. The enrofloxacin accounts for 10 to 20% of the total weight of the injection. The antioxidant is sodium thiosulfate or sodium bisulfite. The chelating agent is EDTA (Ethylene Diamine Tetraacetic Acid). Embodiment I A preparation method of enrofloxacin injection comprises the following steps of: (1) Adding 20g enrofloxacin into 60ml sodium hydroxide aqueous solution with the concentration of 0.4mol/l, and stirring until the enrofloxacin is completed dissolved; (2) Continuously adding the sodium hydroxide aqueous solution with the concentration of 0.4mol/l to adjust the pH value to 12; (3) adding 20ml acidifying agent, i.e. lactic acid, wherein in the process of adding the acidifying agent, the enrofloxacin is separated out and crystallized at first, and then completely dissolved when the pH value becomes neutral along with the addition of the acidifying agent; (4) Adding 0.5g antioxidant, i.e. sodium thiosulfate, into the neutral solution; (5) Continuously adding 0.5g chelating agent, i.e. EDTA; (6) diluting with purified water to a constant volume of 100ml after the step (5) is finished, and performing filtering sterilization on the solution with constant volume by a 0.45-micron micropore filter membrane; (7) Separately packaging the injection after filtering sterilization to obtain finished products. In accordance with tests, the prepared enrofloxacin injection is neutral in pH value and the content of the effective ingredient, i.e. the enrofloxacin, in the injection is 20% based on the total weight of the injection. Embodiment 2 A preparation method of enrofloxacin injection comprises the following steps of: (1) Adding 1 5g enrofloxacin into 70ml sodium hydroxide aqueous solution with the concentration of 0.3mol/l, and stirring until a part of the enrofloxacin is dissolved and the remaining enrofloxacin exists in the form of precipitates; (2) Continuously adding the sodium hydroxide aqueous solution with the concentration of 0.3mol/l to adjust the pH value to 11, at this moment, the enrofloxacin is completely dissolved; (3) adding acidifying agents, i.e. 0.15g sodium butyrate and 1 Oml lactic acid, wherein in the process of adding the acidifying agents, the enrofloxacin is continuously separated out from the solution and crystallized, and then completely dissolved when the pH value becomes neutral along with the addition of the acidifying agents; (4) Adding O.4g antioxidant, i.e. sodium bisulfite, into the neutral solution; (5) Continuously adding 0.4g chelating agent, i.e. EDTA; (6) diluting with purified water to a constant volume of 100ml after the step (5) is finished, and performing filtering sterilization on the solution with constant volume by a 0.45-micron micropore filter membrane; (7) Separately packaging the injection after filtering sterilization to obtain finished products. In accordance with tests, the prepared enrofloxacin injection is neutral in pH value and the content of the effective ingredient, i.e. the enrofloxacin, in the injection is 15%. Embodiment 3 A preparation method of enrofloxacin injection comprises the following steps of: (1) Adding lOg enrofloxacin into 60ml sodium hydroxide aqueous solution with the concentration of 0.2mol/l, and stirring until a part of the enrofloxacin is dissolved and the remaining enrofloxacin exists in the form of precipitates; (2) Continuously adding the sodium hydroxide aqueous solution with the concentration of 0.5mol/l to adjust the pH value to 13, until the enrofloxacin is completely dissolved; (3) adding 15ml acidifying agent, i.e. lactic acid, wherein in the process of adding the acidifying agent, the enrofloxacin is continuously separated out from the solution and crystallized, and then completely dissolved when the pH value becomes neutral along with the addition of the acidifying agents; (4) Adding 0.1 g antioxidant, i.e. sodium thiosulfate, into the neutral solution; (5) Continuously adding 0.lg chelating agent, i.e. EDTA; (6) diluting with purified water to a constant volume of 100ml after the step (5) is finished, and performing filtering sterilization on the solution with constant volume by a 0.45-micron micropore filter membrane; (7) Separately packaging the injection after filtering sterilization to obtain finished products.
In accordance with tests, the prepared enrofloxacin injection is neutral in pH value and the content of the effective ingredient, i.e. the enrofloxacin, in the injection is 10%. Embodiment 4 A preparation method of enrofloxacin injection comprises the following steps of: (1) Adding 18g enrofloxacin into 60ml sodium hydroxide aqueous solution with the concentration of 0.4mol/l, and stirring until the enrofloxacin is completed dissolved; (2) Continuously adding the sodium hydroxide aqueous solution with the concentration of 0.4mol/1 to adjust the pH value to 12; (3) adding 16ml acidifying agent, i.e. lactic acid, wherein in the process of adding the acidifying agent, the enrofloxacin is separated out and crystallized at first, and then completely dissolved when the pH value becomes neutral along with the addition of the acidifying agent; (4) Adding 0.5g antioxidant, i.e. sodium thiosulfate, into the neutral solution; (5) Continuously adding 0.3g chelating agent, i.e. EDTA; (6) diluting with purified water to a constant volume of 100ml after the step (5) is finished, and performing filtering sterilization on the solution with constant volume by a 0.45-micron micropore filter membrane; (7) Separately packaging the injection after filtering sterilization to obtain finished products. In accordance with tests, the prepared enrofloxacin injection is neutral in pH value and the content of the effective ingredient, i.e. the enrofloxacin, in the injection is 20% based on the total weight of the injection. The results of analysis for the enrofloxacin injection prepared in Embodiments 1 to 4 are shown in Table 1, Table 2 or Table 3: Time I Month 3 Months 6 Months 12Months 18Months 24Months Type Embodiment Yellowish Yellowish Yellowish Yellowish Yellowish Yellowish solution without solution solution solution solution without solution crystal without crystal without crystal without crystal crystal without crystal separation separation separation separation separation separation Embodiment Yellowish Yellowish Yellowish Yellowish Yellowish Yellowish solution without solution solution solution solution without solution crystal without crystal without crystal without crystal crystal without crystal separation separation separation separation separation separation Embodiment Yellowish Yellowish Yellowish Yellowish Yellowish Yellowish solution without solution solution solution solution without solution 3 crystal without crystal without crystal without crystal crystal without crystal separation separation separation separation separation separation Embodiment Yellowish Yellowish Yellowish Yellowish Yellowish Yellowish solution without solution solution solution solution without solution 4 crystal without crystal without crystal without crystal crystal without crystal separation separation separation separation separation separation Table 1 Test on Enrofloxacin Injection's Stability It is apparent from Table I that, the enrofloxacin injection prepared by the invention has stable ingredients and no crystal separation after long-time storage. Embodiment I Embodiment 2 Embodiment 3 Embodiment 4 Chicken No adverse No adverse No adverse No adverse (2.5mg/kg) reaction reaction reaction reaction Duck No adverse No adverse No adverse No adverse reaction reaction reaction (2.5mg/kg) reaction Cow No adverse No adverse No adverse No adverse (2.5mg/kg) reaction reaction reaction reaction Pig No adverse No adverse No adverse No adverse (2.5mg/kg) reaction reaction reaction reaction Table 2 Adverse Reaction of Enrofloxacin Injection to Animals It is apparent from Table 2 that, the enrofloxacin injection prepared by the invention has no irritation to animals and causes no adverse reaction to animals after being injected. Control Group Embodiment Embodiment Embodiment Embodiment (No 1 2 3 4 Administration) Infection 100% 100% 100% 100% 100% Rate Mortality 94% 2% 6% 11% 3% Rate Cure Rate 98% 93% 89% 97% Table 3 Test on Curative Effect of Artificial Infected Chickens with Escherichia coli It is apparent from Table 3 that, the enrofloxacin injection prepared by the invention has good curative effect and high cure rate.
Claims (10)
1. An enrofloxacin injection, characterized in that: the injection, which is neutral in pH value, comprises 10 to 20 parts of enrofloxacin, 0.1 to 0.5 parts of antioxidant and 0.1 to 0.5 parts of chelating agent.
2. The enrofloxacin injection according to claim 1, characterized in that: the enrofloxacin accounts for 10 to 20% of the total weight of the injection.
3. The enrofloxacin injection according to claim 1, characterized in that: the antioxidant is sodium thiosulfate or sodium bisulfite.
4. The enrofloxacin injection according to claim 1, characterized in that: the chelating agent is EDTA.
5. A preparation method of enrofloxacin injection, characterized in that: the method comprises the steps of: (1) Adding enrofloxacin to sodium hydroxide aqueous solution; (2) Continuously adding the sodium hydroxide aqueous solution to adjust the pH value to be within a range from 9 to 13; (3) Adding an acidifying agent to adjust the pH value to be neutral; (4) Adding an antioxidant; (5) Adding a chelating agent; (6) Diluting with water to a constant volume to obtain the enrofloxacin injection.
6. The preparation method of enrofloxacin injection according to claim 5, characterized in that: after the step (6) is finished, filtering sterilization by a 0.45-micron micropore filter membrane is performed.
7. The preparation method of enrofloxacin injection according to claim 5, characterized in that: the concentration of the sodium hydroxide aqueous solution in the step (1) is 0.2 to 0.4 mol/l.
8. The preparation method of enrofloxacin injection according to claim 5, characterized in that: the acidifying agent in the step (3) is one or two or three of lactic acid, sodium butyrate and arginine.
9. The preparation method of enrofloxacin injection according to claim 5, characterized in that: the antioxidant in the step (4) is sodium thiosulfate or sodium bisulfite.
10. The preparation method of enrofloxacin injection according to claim 5, characterized in that: the chelating agent in the step (5) is EDTA.
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CN201010179923XA CN101810569B (en) | 2010-05-22 | 2010-05-22 | Enrofloxacin injection liquid and preparation method thereof |
CN201010179923.X | 2010-05-22 |
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AU2011101749A Ceased AU2011101749A4 (en) | 2010-05-22 | 2011-05-20 | Injection of enrofloxacin and producing method thereof |
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KR (1) | KR20130080422A (en) |
CN (1) | CN101810569B (en) |
AU (2) | AU2011257785A1 (en) |
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CN101810569B (en) * | 2010-05-22 | 2011-09-21 | 鼎正动物药业(天津)有限公司 | Enrofloxacin injection liquid and preparation method thereof |
CN102772359A (en) * | 2012-08-02 | 2012-11-14 | 挑战(天津)动物药业有限公司 | Enrofloxacin injection and preparation method thereof |
CN104606671B (en) * | 2014-12-30 | 2017-01-18 | 天津市中升挑战生物科技有限公司 | Compound lysozyme enrofloxacin injection preparation |
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 |
CN107095848A (en) * | 2017-07-01 | 2017-08-29 | 山东中牧兽药有限公司 | A kind of enrofloxacin injection and preparation method thereof |
CN112174888B (en) * | 2019-07-04 | 2022-10-14 | 天津市中升挑战生物科技有限公司 | Enrofloxacin single crystal form and preparation method thereof |
CN111973553A (en) * | 2020-09-03 | 2020-11-24 | 江西省科达动物药业有限公司 | High-stability enrofloxacin injection and preparation method thereof |
CN117530922B (en) * | 2024-01-09 | 2024-04-26 | 中国农业大学 | High-stability compound injection for livestock and preparation method and application thereof |
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DE19500784A1 (en) * | 1995-01-13 | 1996-07-18 | Bayer Ag | Enrofloxacin solutions for injection or infusion |
CN1288725A (en) * | 2000-06-30 | 2001-03-28 | 程广亚 | Preparation of serial veterinary injecta products |
DE102006010642A1 (en) * | 2006-03-08 | 2007-09-27 | Bayer Healthcare Aktiengesellschaft | Drug formulations containing fluoroquinolones |
ES2315123B1 (en) * | 2006-09-25 | 2009-12-30 | Divasa-Farmavic, S.A. | STABLE PHARMACEUTICAL COMPOSITIONS OF TETRACICLINES IN SOLUTION, PROCEDURE FOR OBTAINING AND USES. |
CN101301291B (en) * | 2008-04-11 | 2010-09-01 | 天津生机集团股份有限公司 | Compound enrofloxacin injection for animals and preparation thereof |
CN101347432B (en) * | 2008-09-05 | 2011-06-22 | 郑州后羿制药有限公司 | Long-acting enrofloxacin injection for livestock and poultry and method of preparing the same |
CN101810569B (en) * | 2010-05-22 | 2011-09-21 | 鼎正动物药业(天津)有限公司 | Enrofloxacin injection liquid and preparation method thereof |
-
2010
- 2010-05-22 CN CN201010179923XA patent/CN101810569B/en not_active Expired - Fee Related
-
2011
- 2011-05-20 AU AU2011257785A patent/AU2011257785A1/en active Pending
- 2011-05-20 WO PCT/CN2011/074426 patent/WO2011147280A1/en active Application Filing
- 2011-05-20 KR KR1020127021886A patent/KR20130080422A/en not_active Application Discontinuation
- 2011-05-20 AU AU2011101749A patent/AU2011101749A4/en not_active Ceased
Also Published As
Publication number | Publication date |
---|---|
WO2011147280A1 (en) | 2011-12-01 |
AU2011257785A1 (en) | 2012-08-30 |
CN101810569A (en) | 2010-08-25 |
CN101810569B (en) | 2011-09-21 |
KR20130080422A (en) | 2013-07-12 |
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