CN1839840A - Gatifloxacin eye drop and its preparing process - Google Patents
Gatifloxacin eye drop and its preparing process Download PDFInfo
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- CN1839840A CN1839840A CN 200610037724 CN200610037724A CN1839840A CN 1839840 A CN1839840 A CN 1839840A CN 200610037724 CN200610037724 CN 200610037724 CN 200610037724 A CN200610037724 A CN 200610037724A CN 1839840 A CN1839840 A CN 1839840A
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- Prior art keywords
- gatifloxacin
- eye drop
- water
- hyaluronic acid
- acid sodium
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Abstract
The invention discloses a novel Gatifloxacin eye drop and preparing process which comprises, dissolving Gatifloxacin and related auxiliary materials into water, charging aqueous solution of swelling hyaluronic sodium into medicinal liquid, stirring homogeneously, watering to full amount, filtering and split charging.
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, structural formula is as follows:
C
19H
22FN
3O
4：375.40
Eye part diseases such as the eye conjunctivitis that eye bacterial infection etc. causes, keratitis, iridocyclitis, infection eye drop, for example eye drops such as gentamycin, ofloxacin, ciprofloxacin, lomefloxacin, kanamycin, neomycin, polymyxin β commonly used.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 really strong to the antibacterial activity of gram positive bacteria, and 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 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 have drug-fast pathogen to other antibiosis such as aminoglycoside, Macrolidees very strong inhibitory action, 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
8Last introducing methoxy group, thus overcome side effect such as 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, Japanese Anzurin Pharmaceutical Co., Ltd has developed gatifloxacin eye drop, permits to Japanese Senju Pharma Co., Ltd (Sunju pharmaceutical co) in Japan and permits the company to Allergan in the U.S..0.3% gatifloxacin eye drop obtains the drugs approved by FDA listing on March 31st, 2003, and commodity are called Zymar (breath agate).The star eye drop has been got permission listing in March, 2003.Domestic gatifloxacin eye drop also goes on the market, but does not see the report of the gatifloxacin eye drop that adds hyaluronic acid sodium.
The invention provides a kind of new Gatifloxacin eyedrops and its preparation method, substantially overcome the defective of existing gatifloxacin eye drop, hyaluronic acid sodium is by the physics thickening and the lubrication of preserving moisture, prolonged the time of staying of medicine at the eye table, medicine is difficult in inflow entrance and the nasal cavity, and the one, reduced the loss of medicine, the 2nd, overcome the bitterness of gatifloxacin eye drop, improve patient's compliance, guaranteed its clinical efficacy.
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, by the physics thickening of hyaluronic acid sodium and the lubrication of preserving moisture, 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 its clinical efficacy.
Summary of the invention
The invention provides a kind of new Gatifloxacin eyedrops and its preparation method.
The preparation method of new gatifloxacin eye drop of the present invention is: the Gatifloxacin and the relevant auxiliary materials of getting ormal weight are dissolved in the water, with swelling the aqueous solution of hyaluronic acid sodium join in the medicinal liquid, stir, backwater is to capacity, filters, packing, the sons and daughters gets.
The main prescription of new gatifloxacin eye drop provided by the invention is as follows:
The percent weight in volume of Gatifloxacin and hyaluronic acid sodium is: Gatifloxacin 0.04-10.0%, hyaluronic acid sodium are 0.01-10.0%.
New gatifloxacin eye drop steady quality, after lucifuge stored 24 months under the room temperature condition, observation index such as outward appearance, pH value, particulate matter, content, branch catabolite had no significant change, and illustrate that it is reliable and stable that product stores at ambient temperature.
The specific embodiment
Further set forth the present invention below by example, but do not place restrictions on the present invention.
Embodiment one:
Prescription:
Gatifloxacin 3g
Hyaluronic acid sodium 1g
Relevant auxiliary materials is an amount of
Water for injection adds to 1000ml
Method for making:
Get Gatifloxacin and relevant auxiliary materials is dissolved in the proper amount of water for injection respectively.
The hyaluronic acid sodium of getting prescription constantly stirs under 60-70 ℃ of condition in water for injection, makes its abundant swelling, boils, and uses the microporous filter membrane filtered while hot.
Slowly add in the Gatifloxacin solution filtering good hyaluronic acid sodium solution, the limit edged stirs, and adds water for injection to capacity, filters, and gets settled solution, packing, and quality testing.
Embodiment two:
Prescription:
Gatifloxacin 3g
Hyaluronic acid sodium 1g
Sodium chloride 2g
Relevant auxiliary materials is an amount of
Water for injection adds to 1000ml
Method for making:
Getting Gatifloxacin, sodium chloride and relevant auxiliary materials is dissolved in the proper amount of water for injection respectively.
The hyaluronic acid sodium of getting prescription constantly stirs under 60-70 ℃ of condition in water for injection, makes its abundant swelling, boils, and uses the microporous filter membrane filtered while hot.
Slowly add in the Gatifloxacin solution filtering good hyaluronic acid sodium solution, the limit edged stirs, and adds water for injection to capacity, filters, and gets settled solution, packing, and quality testing.
Embodiment three:
Prescription:
Gatifloxacin 3g
Hyaluronic acid sodium 2g
Sodium chloride 2g
Relevant auxiliary materials is an amount of
Water for injection adds to 1000ml
Method for making:
Getting Gatifloxacin, sodium chloride and relevant auxiliary materials is dissolved in the proper amount of water for injection respectively.
The hyaluronic acid sodium of getting prescription constantly stirs under 60-70 ℃ of condition in water for injection, makes its abundant swelling, boils, and uses the microporous filter membrane filtered while hot.
Slowly add in the Gatifloxacin solution filtering good hyaluronic acid sodium solution, the limit edged stirs, and adds water for injection to capacity, filters, and gets settled solution, packing, and quality testing.
Claims (6)
1, the feature of new gatifloxacin eye drop is: mainly contain Gatifloxacin, hyaluronic acid sodium and other adjuvants and water.
2, be water for injection according to the water described in the claim 1.
3, according to claim 1,2 described eye drop water, wherein the concentration of Gatifloxacin is 0.04-10.0% (W/V), and the concentration of hyaluronic acid sodium is 0.01-10.0% (W/V), and pH value is 5.5-6.5.
4, gatifloxacin eye drop according to claim 1 contains isotonic agent.
5, according to the contained isotonic agent of the described gatifloxacin eye drop of claim 4, further limit sodium chloride.
6, according to the preparation method of each described gatifloxacin eye drop among the claim 1-5: after Gatifloxacin and relevant auxiliary materials are dissolved in the water, with swelling the aqueous solution of hyaluronic acid sodium join in the medicinal liquid, stir, add water to capacity, filtration, packing, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610037724 CN1839840A (en) | 2006-01-12 | 2006-01-12 | Gatifloxacin eye drop and its preparing process |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610037724 CN1839840A (en) | 2006-01-12 | 2006-01-12 | Gatifloxacin eye drop and its preparing process |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1839840A true CN1839840A (en) | 2006-10-04 |
Family
ID=37029144
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200610037724 Pending CN1839840A (en) | 2006-01-12 | 2006-01-12 | Gatifloxacin eye drop and its preparing process |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1839840A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008044734A1 (en) * | 2006-10-12 | 2008-04-17 | Kyorin Pharmaceutical Co., Ltd. | Aqueous liquid preparation comprising gatifloxacin |
| 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 |
-
2006
- 2006-01-12 CN CN 200610037724 patent/CN1839840A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2008044734A1 (en) * | 2006-10-12 | 2008-04-17 | Kyorin Pharmaceutical Co., Ltd. | Aqueous liquid preparation comprising gatifloxacin |
| CN101573118B (en) * | 2006-10-12 | 2011-09-07 | 杏林制药株式会社 | Aqueous liquid preparation comprising gatifloxacin |
| EP2078527A4 (en) * | 2006-10-12 | 2011-12-21 | Kyorin Seiyaku Kk | Aqueous liquid preparation comprising gatifloxacin |
| 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 |
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| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |