CN1214908A - Process for preparing enoxacin lactate injection - Google Patents
Process for preparing enoxacin lactate injection Download PDFInfo
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- CN1214908A CN1214908A CN 98113230 CN98113230A CN1214908A CN 1214908 A CN1214908 A CN 1214908A CN 98113230 CN98113230 CN 98113230 CN 98113230 A CN98113230 A CN 98113230A CN 1214908 A CN1214908 A CN 1214908A
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- enoxacin
- injection
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- acid
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Abstract
The present invention relates to a preparation method of antibacterial medicine Ennothaxing lactate injection with stable quality and low irritation. It can be extensively used for curing fowl and animal diseases, and can possesses obvious therapeutic effect for curing commonly-encountered bacterial diseases and mould-like bacterial diseases.
Description
The present invention relates to a kind of preparation method of antibacterials for animals, more particularly, relate to a kind of preparation method of antibacterials injection for animals.
Enoxacin is succeeded in developing in nineteen eighty-three by German Bayer company the earliest, is a kind of fluoroquinolone antibacterial agent thing of veterinary's special use, and veterinary's common pathogenic bacteria, Mycoplasma are all had extremely strong killing action.Be that present veterinary clinic is used one of classic antibacterials.Enoxacin is water insoluble, highly basic hydrotropies such as veterinary clinic sodium hydroxide commonly used, preparation oral administration solution or injection.The pH value of obtained solution all exceeds 10, and injection has very strong zest to medicine-feeding part.Recently have yet enoxacin is made hydrochlorate, the dissolubility of enoxacin hydrochlorate in water is not high, and its aqueous solution is placed instability for a long time, to tissue, blood vessel also has stimulation, and can not be as the raw material of the injection of enoxacin.
Task of the present invention provides that a kind of stable in properties, zest are little, pH value is more near the preparation method of the enoxacin injection of animal physiological solution.
In order to achieve the above object, solution of the present invention is: adopting enoxacin lactate is that raw material can prepare the enoxacin injection.Its method is: be dissolved in enoxacin lactate in the water for injection and it is fully dissolved, isoosmotic adjusting agent---the sodium chloride that adds convention amount, adding acid regulator again---it is 3.5～5.5 that lactic acid is regulated pH, with water for injection it is diluted to normal concentration, carries out sterilising filtration, filling bottle, charge into noble gas, air in the displacement bottle outlet, sealing promptly gets the enoxacin injection, also reactant liquor can be filtered the reheat sterilization of sealing back through routine.
The preparation of enoxacin injection also can realize by the following method: with hydrochloric acid enoxacin and sodium lactate is raw material [mole ratio of enoxacin hydrochlorate and sodium lactate is 1: (1～1.05)], at first sodium lactate solution is diluted in the water for injection, stir and add the hydrochloric acid enoxacin down, fully after the dissolving, add conventional isoosmotic adjusting agent---sodium chloride, reuse acid regulator---lactic acid is transferred pH to 3.5～5.5, with water for injection it is diluted to normal concentration.Carry out sterilising filtration, filling bottle, charge into inert nitrogen gas, air in the displacement bottle outlet, sealing promptly gets the enoxacin injection.Also reaction solution can be filtered the reheat sterilization of sealing back through routine.
Isoosmotic adjusting agent commonly used except that sodium chloride, also can adopt anhydrous or water glucose, sorbitol, mannitol are arranged.
Acid regulator commonly used, except that lactic acid, also can use organic acid and mineral acids such as glutamic acid, aspartic acid, citric acid, malic acid, ascorbic acid, succinic acid, tartaric acid, acetic acid, boric acid, hydrochloric acid earlier, its consumption exceeds with control injection pH3.5～5.5.
Also can add light stability agent and antioxidant in the above-mentioned enoxacin injection, to prevent the influence of light and oxygen to injection.Light stability agent is the L-cysteine.Antioxidant is L-cysteine, sodium sulfite, sodium pyrosulfite.
Owing to adopted above-mentioned solution, prepared enoxacin lactate injection good stability, zest is little, and pH value is near animal physiological solution,
Example 1 enoxacin lactate can be mixed with the enoxacin injection by following method:
(1) enoxacin lactate 1.25 grams (being equivalent to enoxacin 1 gram) being diluted in 400 milliliters of injections is used for, the dissolving back adds 4.5 gram sodium chloride fully, regulating pH with lactic acid is 4.5, with water for injection it is diluted to 500 milliliters again, carries out sterilising filtration, filling bottle, charge into nitrogen, air in the displacement bottle outlet, sealing promptly gets per 100 milliliters of injection that contain 200 milligrams of enoxacins.
(2) enoxacin lactate 1.25 grams (being equivalent to enoxacin 1 gram), sodium sulfite 0.05 gram are diluted in 40 milliliters of injections and are used for, stir, dissolving, regulating pH with lactic acid is 4.5, with water for injection it is diluted to 50 milliliters again, carry out sterilising filtration, filling bottle charges into nitrogen, air in the displacement bottle outlet, sealing promptly gets per 10 milliliters of injection that contain 200 milligrams of enoxacins.
(3) enoxacin lactate 1.25 grams (being equivalent to enoxacin 1 gram), L-cysteine HCL0.01 gram are added in 8 milliliters of waters for injection, stir, dissolving is regulated pH to 4.5 with lactic acid, with water for injection it is diluted to 10 milliliters again, carry out sterilising filtration, filling bottle charges into nitrogen, air in the displacement bottle outlet, sealing promptly gets per 10 milliliters of injection that contain 1 gram enoxacin.
Example 2: with 1.15 gram concentration is that 70% sodium lactate solution is diluted in 400 milliliters of injections and is used for, stir and add hydrochloric acid enoxacin 2.75 grams down, the dissolving back adds 4.08 gram sodium chloride fully, and regulating pH with lactic acid is 4.5, with water for injection it is diluted to 500 milliliters again, carry out sterilising filtration, filling bottle charges into nitrogen, air in the displacement bottle outlet, sealing promptly gets per 100 milliliters of injection that contain 500 milligrams of enoxacins.
Claims (8)
1, a kind of preparation method of enoxacin lactate injection, it is characterized in that: enoxacin lactate is dissolved in the water for injection, add isoosmotic adjusting agent, acid regulator, antioxidant, light stability agent, the aseptic process through certain promptly gets enoxacin lactate injection.
2, a kind of preparation method of enoxacin lactate injection, it is characterized in that: with hydrochloric acid enoxacin, sodium lactate is raw material, at first sodium lactate solution is diluted in the water for injection, stir and add the hydrochloric acid enoxacin down, after making abundant dissolving, add isoosmotic adjusting agent, acid regulator, antioxidant, light stability agent, the aseptic process through certain promptly gets enoxacin lactate injection.
3, according to the preparation method of claim 1 and the described enoxacin lactate injection of claim 2, it is characterized in that: when isoosmotic adjusting agent selected for use sodium chloride to be isoosmotic adjusting agent, sodium chloride-containing 0.9% in the injection; When selecting for use anhydrous glucose to be isoosmotic adjusting agent, contain anhydrous glucose 5% in the injection; When selecting for use dextrose hydrate to be isoosmotic adjusting agent, contain band water glucose 5.5% in the injection; When selecting for use sorbitol to be isoosmotic adjusting agent, contain sorbitol 5.6% in the injection; When selecting for use mannitol to be isoosmotic adjusting agent, contain mannitol 5% in the injection;
4, according to the preparation method of claim 1 and the described enoxacin lactate injection of claim 2, it is characterized in that: acid regulator is lactic acid, glutamic acid, aspartic acid, citric acid, malic acid, ascorbic acid, succinic acid, tartaric acid, acetic acid, boric acid, and its consumption exceeds with control injection pH3.5～5.5.
5, according to the preparation method of claim 1 and the described enoxacin lactate injection of claim 2, it is characterized in that: light stability agent is the L-cysteine.
6, according to the preparation method of claim 1 and the described enoxacin lactate injection of claim 2, it is characterized in that: antioxidant is L-cysteine, sodium sulfite, sodium pyrosulfite.
7, according to the preparation method of claim 1 and the described enoxacin lactate injection of claim 2, it is characterized in that: the content of enoxacin lactate is 0.01～50% (in enoxacin) in the enoxacin lactate injection.
8, according to the preparation method of claim 1 and the described enoxacin lactate injection of claim 2, it is characterized in that: aseptic process is a sealing reheat sterilization treatment behind sterilising filtration or the conventional filtration.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 98113230 CN1214908A (en) | 1998-06-02 | 1998-06-02 | Process for preparing enoxacin lactate injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 98113230 CN1214908A (en) | 1998-06-02 | 1998-06-02 | Process for preparing enoxacin lactate injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1214908A true CN1214908A (en) | 1999-04-28 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 98113230 Pending CN1214908A (en) | 1998-06-02 | 1998-06-02 | Process for preparing enoxacin lactate injection |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1214908A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
-
1998
- 1998-06-02 CN CN 98113230 patent/CN1214908A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
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| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
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