CN104138354A - Ofloxacin injection for animals and preparation method thereof - Google Patents
Ofloxacin injection for animals and preparation method thereof Download PDFInfo
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- CN104138354A CN104138354A CN201310629094.4A CN201310629094A CN104138354A CN 104138354 A CN104138354 A CN 104138354A CN 201310629094 A CN201310629094 A CN 201310629094A CN 104138354 A CN104138354 A CN 104138354A
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- ofloxacin
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- acetic acid
- glacial acetic
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Abstract
The invention discloses an ofloxacin injection for animals and a preparation method thereof and belongs to the technical field of animal medicines. Every 1000mL of the ofloxacin injection for animals contains the following components: 20-80g of ofloxacin, 10-30mL of glacial acetic acid, 50-250mL of glycerolformal, 150-250mL of ethanol, 0.01-0.1g of ethylenediamine tetraacetic acid and the balance of injection water, wherein ofloxacin is used as an active component; ethanol is used as a solvent; glacial acetic acid is used as an acid source, a cosolvent and a stabilizing agent for mainly performing salifying treatment on ofloxacin to improve the solution degree of ofloxacin and improve the stability of ofloxacin; glycerolformal is used as a stabilizing agent and a cosolvent for improving the stability of the injection and increasing the content of effective components. The ofloxacin injection for animals, which is disclosed by the invention, is a faint yellow clear liquid, no crystal is generated after the injection is stored for 6 months at a temperature of 4 DEG C and the room temperature, and the dosage formation is stable and reliable. The ofloxacin injection for animals is simple in preparation method, easy to operate and applicable to large-scale industrial production and application.
Description
Technical field
The present invention is specifically related to a kind of ofloxacin injection for animals, and the preparation method of this injection, belongs to veterinary drug technical field.
Background technology
Ofloxacin is third generation carbostyril family antibacterial drugs, have has a broad antifungal spectrum, antibacterial activity strong, with other antibacterials without advantages such as cross resistances, staphylococcus, streptococcus (comprising enterococcus), streptococcus pneumoniae, gonococcus, escherichia coli, citrobacter, bacillus dysenteriae, bacillus canalis capsulatus, Enterobacter, serratia marcecens genus, Bacillus proteus, hemophilus influenza, acinetobacter calcoaceticus, pylori etc. are had to good antibacterial action, bacillus pyocyaneus and chlamydia trachomatis are also had to certain antibacterial action.
Ofloxacin is antibacterial, by acting on the A subunit of DNA of bacteria helicase, suppresses the synthetic of DNA and copies and cause antibacterial death.Relevant medicine aerobic Flucloxacillin sheet, ofloxacin hydrochloride sheet, lactic acid Ofloxacin, lactic acid ofloxacin capsule, methanesulfonic acid Ofloxacin, methanesulfonic acid ofloxacin capsule, ofloxacin injection, ofloxacin hydrochloride injection etc.
There is the problems such as low, the easy crystallization of dissolubility, poor stability more in current existing ofloxacin injection.As the ofloxacin injection that adopts hydrochloric acid or acetic acid etc. to prepare as cosolvent in conjunction with propylene glycol, in clinical use and the problem such as common crystallization in depositing, visible foreign matters, affect the quality of product, and active constituent content is low, therapeutic effect is undesirable, has caused great inconvenience to clinical treatment.
Summary of the invention
The object of this invention is to provide a kind of ofloxacin injection for animals.
Meanwhile, the present invention also provides a kind of preparation method of ofloxacin injection for animals.
In order to realize above object, the technical solution adopted in the present invention is:
A kind of ofloxacin injection for animals, in every 1000mL injection, contain following component: ofloxacin 20～80g, glacial acetic acid 10～30mL, glycerol formal 50～250mL, ethanol 150～250mL, disodiumedetate 0.01～0.1g, surplus is water for injection.
Preferably, a kind of ofloxacin injection for animals, in every 1000mL injection, contain following component: ofloxacin 40g, glacial acetic acid 16mL, glycerol formal 100～150mL, ethanol 200mL, disodiumedetate 0.03～0.1g, surplus is water for injection.
A preparation method for ofloxacin injection for animals, comprises the following steps: by ofloxacin add in ethanol, dissolve for subsequent use; Add successively again glacial acetic acid, glycerol formal and disodiumedetate, after mixing, add to the full amount of water for injection, adsorb, filter and get final product.
Preferably, add again glycerol formal after adding glacial acetic acid to stir evenly, stir evenly, then add the disodium ethylene diamine tetra-acetic acid solution of dissolving.
Beneficial effect of the present invention:
In ofloxacin injection of the present invention, ofloxacin is active component, ethanol is solvent, glacial acetic acid is not only acid source but also be cosolvent and stabilizing agent, mainly ofloxacin is carried out to salify processing, improve the dissolubility of ofloxacin, improve its stability, glycerol formal is stabilizing agent and cosolvent, can strengthen the stability of injection, improve the content of effective ingredient, disodium ethylene diamine tetra-acetic acid solution on the one hand can complexation of metal ions, prevents that metal ion from reacting with ofloxacin, contributes to the dissolving of ofloxacin on the other hand.Ofloxacin injection in the present invention is faint yellow supernatant liquid, deposits 6 and monthlyly occur without crystallization under 4 DEG C and room temperature, and dosage form is reliable and stable.
The present invention first uses organic solvent dissolve with ethanol ofloxacin raw material in preparation process, add again a small amount of glacial acetic acid as cosolvent, make ofloxacin salify under acid condition, improve the dissolubility of ofloxacin, improve its dissolubility in low temperature environment simultaneously, strengthen the stability of ofloxacin in low temperature environment, prevent crystalline polamer, add again organic solvent glycerin formal as cosolvent and stabilizing agent, strengthen the stability of injection.Its preparation method is simple, easy to operate, is suitable for large-scale industrial production and application.
Detailed description of the invention
Following embodiment is only described in further detail the present invention, but does not form any limitation of the invention.
Embodiment 1
Ofloxacin injection for animals in the present embodiment, contains following component: ofloxacin 20g, glacial acetic acid 10mL, glycerol formal 50mL, dehydrated alcohol 150mL, disodiumedetate 0.01g, surplus is water for injection in every 1000mL injection.
In the present embodiment, the preparation method of ofloxacin injection for animals comprises the following steps:
(1) ofloxacin is added in dehydrated alcohol, limit edged stirs, and stirs evenly to obtain white emulsion liquid;
(2) in white emulsion liquid, add glacial acetic acid, limit edged stirs, and stirs evenly to obtain weak yellow liquid;
(3) in weak yellow liquid, add glycerol formal, limit edged stirs, and stirs evenly to obtain faint yellow supernatant liquid;
(4) get disodiumedetate and be dissolved in part water for injection, after dissolving completely, added in faint yellow supernatant liquid, limit edged stirs;
(5) add water for injection to full dose, then add active carbon, de-charcoal after leaving standstill, fine straining, fill and get final product.
Embodiment 2
Ofloxacin injection for animals in the present embodiment, contains following component: ofloxacin 40g, glacial acetic acid 16mL, glycerol formal 100mL, dehydrated alcohol 200mL, disodiumedetate 0.03g, surplus is water for injection in every 1000mL injection.
In the present embodiment, the preparation method of ofloxacin injection for animals is with embodiment 1.
Embodiment 3
Ofloxacin injection for animals in the present embodiment, contains following component: ofloxacin 40g, glacial acetic acid 16mL, glycerol formal 150mL, dehydrated alcohol 200mL, disodiumedetate 0.1g, surplus is water for injection in every 1000mL injection.
In the present embodiment, the preparation method of ofloxacin injection for animals is with embodiment 1.
Embodiment 4
Ofloxacin injection for animals in the present embodiment, contains following component: ofloxacin 60g, glacial acetic acid 30mL, glycerol formal 250mL, dehydrated alcohol 200mL, disodiumedetate 0.05g, surplus is water for injection in every 1000mL injection.
In the present embodiment, the preparation method of ofloxacin injection for animals is with embodiment 1.
Embodiment 5
Ofloxacin injection for animals in the present embodiment, contains following component: ofloxacin 80g, glacial acetic acid 30mL, glycerol formal 200mL, dehydrated alcohol 250mL, disodiumedetate 0.1g, surplus is water for injection in every 1000mL injection.
In the present embodiment, the preparation method of ofloxacin injection for animals is with embodiment 1.
Test example
(1) choose respectively hydrochloric acid, glacial acetic acid, vitamin C as acid source, ofloxacin is carried out to salify processing.First use anhydrous alcohol solution ofloxacin, then add respectively acid source, investigate dissolving situation and character, the results detailed in following table 1.
The impact of the different acid sources of table 1 on ofloxacin solubility property
(2) choose organic solvent alpha-pyrrolidone, glycerol formal as stabilizing agent and cosolvent, add in previous step salify Ofloxacin solution after treatment, further investigate dissolving situation and character, the results detailed in following table 2.
Table 2 different solvents on salify after the impact of ofloxacin solubility property
Can find out from table 1, table 2, select glacial acetic acid as acid source and cosolvent, then add organic solvent alpha-pyrrolidone and glycerol formal as stabilizing agent and cosolvent, all can obtain faint yellow settled solution.But the ofloxacin injection of preparing based on alpha-pyrrolidone is easily crystallization, poor stability under low temperature environment, selects glycerol formal as stabilizing agent and cosolvent.
(3) get ofloxacin injection for animals prepared by embodiment 1～5, carry out respectively content detection and study on the stability (with reference to " veterinary drug quality standard " version in 2003), the results detailed in following table 3.
Table 3 embodiment 1～5 prepares content and the Stability Determination result of injection
Claims (4)
1. an ofloxacin injection for animals, it is characterized in that: in every 1000mL injection, contain following component: ofloxacin 20～80g, glacial acetic acid 10～30mL, glycerol formal 50～250mL, ethanol 150～250mL, disodiumedetate 0.01～0.1g, surplus is water for injection.
2. ofloxacin injection for animals according to claim 1, it is characterized in that: in every 1000mL injection, contain following component: ofloxacin 40g, glacial acetic acid 16mL, glycerol formal 100～150mL, ethanol 200mL, disodiumedetate 0.03～0.1g, surplus is water for injection.
3. a preparation method for ofloxacin injection for animals as claimed in claim 1 or 2, is characterized in that: comprise the following steps: by ofloxacin add in ethanol, dissolve for subsequent use; Add successively again glacial acetic acid, glycerol formal and disodiumedetate, after mixing, add to the full amount of water for injection, adsorb, filter and get final product.
4. the preparation method of ofloxacin injection for animals according to claim 3, is characterized in that: after adding glacial acetic acid to stir evenly, add glycerol formal again, stir evenly, then add the disodium ethylene diamine tetra-acetic acid solution of dissolving.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310629094.4A CN104138354A (en) | 2013-11-30 | 2013-11-30 | Ofloxacin injection for animals and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201310629094.4A CN104138354A (en) | 2013-11-30 | 2013-11-30 | Ofloxacin injection for animals and preparation method thereof |
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| CN104138354A true CN104138354A (en) | 2014-11-12 |
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| CN201310629094.4A Pending CN104138354A (en) | 2013-11-30 | 2013-11-30 | Ofloxacin injection for animals and preparation method thereof |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101690713A (en) * | 2009-09-28 | 2010-04-07 | 洛阳普莱柯生物工程有限公司 | Preparation method for carbostyril injection |
| CN101693008A (en) * | 2009-10-16 | 2010-04-14 | 蚌埠丰原涂山制药有限公司 | Ofloxacin injection and preparation process thereof |
-
2013
- 2013-11-30 CN CN201310629094.4A patent/CN104138354A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101690713A (en) * | 2009-09-28 | 2010-04-07 | 洛阳普莱柯生物工程有限公司 | Preparation method for carbostyril injection |
| CN101693008A (en) * | 2009-10-16 | 2010-04-14 | 蚌埠丰原涂山制药有限公司 | Ofloxacin injection and preparation process thereof |
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Application publication date: 20141112 |