CN102885770A - Novel gatifloxacin eye drop and preparation method thereof - Google Patents
Novel gatifloxacin eye drop and preparation method thereof Download PDFInfo
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- CN102885770A CN102885770A CN2012104395078A CN201210439507A CN102885770A CN 102885770 A CN102885770 A CN 102885770A CN 2012104395078 A CN2012104395078 A CN 2012104395078A CN 201210439507 A CN201210439507 A CN 201210439507A CN 102885770 A CN102885770 A CN 102885770A
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- gatifloxacin
- eye drop
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- carbomer
- water
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Abstract
The invention discloses a novel gatifloxacin eye drop and a preparation method thereof. The preparation method of the eye drop disclosed by the invention comprises the steps of: dissolving gatifloxacin and relevant accessories in water; adding a swelling carbomer aqueous solution to the liquid medicine and then uniformly stirring; adding a sufficient amount of water; and finally, filtering and dispensing to obtain the eye drop. According to the novel gatifloxacin eye drop and the preparation method thereof, the defects of the current gatifloxacin eye drop are overcome; the residence time of the medicine on ocular surface is prolonged by the physical thickening and moisturizing lubrication effects of carbomer; and furthermore, the medicine seldom flows into mouth and nasal cavity so as to reduce medicine loss and avoid bitterness from the gatifloxacin eye drop, and therefore, compliance of patients is increased and clinical curative effect is ensured.
Description
Technical field:
The present invention relates to medical technical field, disclose a kind of new Gatifloxacin eyedrops and its preparation method.
Background technology:
Gatifloxacin, chemical name: 1-cyclopropyl-6-fluoro-Isosorbide-5-Nitrae-dihydro-8-methoxyl group-7-(3-methyl isophthalic acid-piperazinyl)-4-oxo-3-quinoline carboxylic acid, chemical structural formula:
Molecular formula: C
19H
22FN
3O
4, molecular weight: 375.40.
The eye part diseases such as the eye conjunctivitis that eye antibacterial infection etc. causes, keratitis, iridocyclitis, infection eye drop commonly used, eye drops such as gentamycin, ofloxacin, ciprofloxacin, lomefloxacin, kanamycin, neomycin, polymyxin β.Along with the prolongation of clinical service time and the increase of frequency of utilization, above-mentioned medicine has produced drug resistance and crossing drug resistant to some antibacterial such as staphylococcus aureus, bacillus pyocyaneus, escherichia coli etc., and clinical efficacy is a greater impact.
The fluoroquinolones eye drop of domestic and international clinical use or ophthalmic ointment such as lomefloxacin, ciprofloxacin, ofloxacin belong to second filial generation fluoroquinolones, wherein lomefloxacin originally to the antibacterial activity of bacillus pyocyaneus just extremely a little less than, and ciprofloxacin, ofloxacin are also not bery strong to the antibacterial activity of gram positive bacteria, and the infectious effects such as chlamydia, mycoplasma are poorer.In addition, these three medicines have more serious photosensitive side effect, and restriction has been made to the use of lomefloxacin preparation by the countries such as Germany, and add glazing poison caveat in operation instruction and in the label.
Gatifloxacin belong to the 4th generation fluoroquinolone antibacterial agent.Its raw material, oral formulations, intravenous formulations, eye drop etc. are in succession in country's listings such as the U.S..This medicine is compared with the first generation to third generation fluoroquinolones, and 4 major advantages are arranged: (1) activity is stronger, and antimicrobial spectrum is wider, and particularly the antibacterial activity to gram positive bacteria is strong 2～16 times even 32 times to third generation kind than the first generation; (2) this product has very strong inhibitory action to the pathogen that other antibiosis such as aminoglycoside, Macrolide have drug resistance, and does not have cross resistance between Gatifloxacin and these antibiotic.But ciprofloxacin, lomefloxacin, ofloxacin etc. have cross resistance with aminoglycoside, Macrolide etc.(3) Gatifloxacin chlamydia, mycoplasma, legionella pneumophilia etc. have very strong activity, and (4) Gatifloxacin is because at C
8Upper introducing methoxy group waits side effect thereby overcome the light poison, and not only chemical constitution is very stable, and safety and effectiveness improves greatly.
In view of characteristics such as Gatifloxacin high-efficiency broad spectrum low toxicities, U.S. Allergan drugmaker has applied for gatifloxacin eye drop to FDA, has got permission listing in March, 2003.
Present domestic gatifloxacin eye drop goes on the market, but has no the report of the gatifloxacin eye drop that adds carbomer.
Goal of the invention
The present invention is for overcoming the defective of existing gatifloxacin eye drop, and provide a kind of new Gatifloxacin eyedrops and its preparation method, physics thickening and moisturizing lubrication by carbomer, prolonged the time of staying of medicine at the eye table, and medicine is difficult for having reduced the loss of medicine in inflow entrance and the nasal cavity, and avoided the bitterness of gatifloxacin eye drop, improve patient's compliance, guaranteed clinical efficacy.
Summary of the invention:
The invention provides a kind of new Gatifloxacin eyedrops and its preparation method.
Eye drop of the present invention is: Gatifloxacin and the relevant auxiliary materials of getting recipe quantity are dissolved in the water for injection, and the carbomer aqueous solution of swelling is joined in the medicinal liquid, stir, and add water to capacity, filter, and packing, and get final product.
Gatifloxacin eye drop provided by the invention is mainly filled a prescription as follows:
The percent weight in volume of Gatifloxacin and carbomer is that the concentration of Gatifloxacin is 0.02-2%, and carbomer is 0.01-2.0%.
This eye drop steady quality, after lucifuge stored 24 months under the room temperature, the observation index such as outward appearance, pH value, particulate matter, content, minute catabolite had no significant change, and illustrate that it is reliable and stable that product is stored at ambient temperature.
Specific implementation method:
Further set forth the present invention below by example, but do not place restrictions on the present invention.
Embodiment 1:
Method for making:
Getting Gatifloxacin and relevant auxiliary materials is dissolved in respectively in an amount of water for injection.
Get the carbomer of recipe quantity in water for injection, under 80-90 ℃ of condition, constantly stir, make its abundant swelling, boil, and use the microporous filter membrane filtered while hot.
Slowly add in the Gatifloxacin solution filtering good carbomer solution, the limit edged stirs, and adds water for injection to capacity, filters, and gets settled solution, packing, quality testing, qualified getting final product.
Embodiment 2:
Prescription:
Method for making:
Getting Gatifloxacin, sodium chloride and relevant auxiliary materials is dissolved in respectively in an amount of water for injection.
Get the carbomer of recipe quantity in water for injection, under 80-90 ℃ of condition, constantly stir, make its abundant swelling, boil, and use the microporous filter membrane filtered while hot.
Slowly add in the Gatifloxacin solution filtering good carbomer solution, the limit edged stirs, and adds water for injection to capacity, filters, and gets settled solution, packing, quality testing, qualified getting final product.
Embodiment 3:
Prescription:
Method for making:
Getting Gatifloxacin, sodium chloride and relevant auxiliary materials is dissolved in respectively in an amount of water for injection.
Get the carbomer of recipe quantity in water for injection, under 80-90 ℃ of condition, constantly stir, make its abundant swelling, boil, and use the microporous filter membrane filtered while hot.
Slowly add in the Gatifloxacin solution filtering good carbomer solution, the limit edged stirs, and adds water for injection to capacity, filters, and gets settled solution, packing, quality testing, qualified getting final product.
Claims (5)
1. the feature of a new gatifloxacin eye drop is: contain Gatifloxacin, carbomer and other adjuvants and water for injection.
2. eye drop according to claim 1, wherein the concentration of Gatifloxacin is 0.02-2% (W/V), and the concentration of carbomer is 0.01-2.0% (W/V), and pH value is 5.5-6.5.
3. gatifloxacin eye drop according to claim 1 contains isotonic agent.
4. the contained isotonic agent of described gatifloxacin eye drop according to claim 3 is further defined to sodium chloride.
5. the preparation method of each described gatifloxacin eye drop according to claim 1-4: after Gatifloxacin and relevant auxiliary materials are dissolved in the water, the carbomer aqueous solution of swelling is added into the liquid, stir, add water to capacity, filter, packing, and get final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012104395078A CN102885770A (en) | 2012-11-02 | 2012-11-02 | Novel gatifloxacin eye drop and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012104395078A CN102885770A (en) | 2012-11-02 | 2012-11-02 | Novel gatifloxacin eye drop and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102885770A true CN102885770A (en) | 2013-01-23 |
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| CN2012104395078A Pending CN102885770A (en) | 2012-11-02 | 2012-11-02 | Novel gatifloxacin eye drop and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106310285A (en) * | 2015-06-15 | 2017-01-11 | 江苏吉贝尔药业股份有限公司 | New ripasudil hydrochloride hydrate eye drop and preparation method thereof |
| CN107753424A (en) * | 2017-12-01 | 2018-03-06 | 北京诺康达医药科技有限公司 | A kind of multiple-unit container anti-inflammatory eye drops without preservative and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102078284A (en) * | 2009-11-27 | 2011-06-01 | 沈阳兴齐制药有限公司 | Gatifloxacin-containing gel for eyes and preparation method thereof |
-
2012
- 2012-11-02 CN CN2012104395078A patent/CN102885770A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102078284A (en) * | 2009-11-27 | 2011-06-01 | 沈阳兴齐制药有限公司 | Gatifloxacin-containing gel for eyes and preparation method thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106310285A (en) * | 2015-06-15 | 2017-01-11 | 江苏吉贝尔药业股份有限公司 | New ripasudil hydrochloride hydrate eye drop and preparation method thereof |
| CN107753424A (en) * | 2017-12-01 | 2018-03-06 | 北京诺康达医药科技有限公司 | A kind of multiple-unit container anti-inflammatory eye drops without preservative and preparation method thereof |
| CN107753424B (en) * | 2017-12-01 | 2020-05-05 | 北京诺康达医药科技股份有限公司 | Preservative-free multi-dose packaged anti-inflammatory eye drops and preparation method thereof |
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Application publication date: 20130123 |