CN102949334A - Levofloxacin hydrochloride gel-type eye-drops - Google Patents
Levofloxacin hydrochloride gel-type eye-drops Download PDFInfo
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- CN102949334A CN102949334A CN2011102395967A CN201110239596A CN102949334A CN 102949334 A CN102949334 A CN 102949334A CN 2011102395967 A CN2011102395967 A CN 2011102395967A CN 201110239596 A CN201110239596 A CN 201110239596A CN 102949334 A CN102949334 A CN 102949334A
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- levofloxacin hydrochloride
- hydrochloride gel
- drops
- eye drop
- water
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Abstract
The invention discloses levofloxacin hydrochloride gel-type eye-drops comprising levofloxacin hydrochloride, poloxamer, another auxiliary material, and water. The water is injection water. The other auxiliary material is a pH regulating agent which is one or a complex of the components selected from sodium dihydrogen phosphate, potassium dihydrogen phosphate, borax, acetic acid, sodium acetate, and sodium hydroxide. The levofloxacin hydrochloride gel-type eye-drops have high medicine concentration in cornea and aqueous humor. Therefore, the levofloxacin hydrochloride gel-type eye-drops are beneficial for controlling bacteria reproduction and growth, shortening disease course, and improving curative rate.
Description
Technical field
The present invention relates to a kind of eye drop of Levofloxacin Hydrochloride Gel type, belong to technical field of pharmaceuticals.
Background technology
0.3% its Main Ingredients and Appearance of Levofloxacin Hydrochloride Gel type eye drop is levofloxacin (Levofloxacin).Levofloxacin is a kind of broad-spectrum long-acting fluoroquinolone antibacterial agent, it is the S type laevoisomer of ofloxacin, being 8~128 times of ofloxacin R type dextroisomer to the inhibition ability of Gram-positive and negative bacteria breeding, is 2 times of racemic modification ofloxacin.Levofloxacin is brought into play bactericidal action by suppressing DNA gyrase activity.Levofloxacin eye drops clinical practice has a broad antifungal spectrum has stronger antibacterial action to Gram-positive, negative bacteria.Clinical ophthalmology is mainly used in bacillary eye surface diseases.At present, bacterial keratitis and conjunctivitis are ophthalmology common disease, frequently-occurring disease, and therefore researching and developing antibiotics collyrium safe, long-acting, comfortable dosage form has important clinical meaning.
Summary of the invention
In view of the defective that above-mentioned prior art exists, the objective of the invention is to propose a kind of eye drop of Levofloxacin Hydrochloride Gel type.
Purpose of the present invention will be achieved by the following technical programs:
A kind of eye drop of Levofloxacin Hydrochloride Gel type comprises levofloxacin hydrochloride, poloxamer and other adjuvants and water in the described eye drop, described water is water for injection;
Described other adjuvants are the PH regulator, and described PH regulator is that in sodium dihydrogen phosphate, potassium dihydrogen phosphate, Borax, acetic acid, sodium acetate, the sodium hydroxide one or more are composite.
The eye drop of a kind of Levofloxacin Hydrochloride Gel type as previously discussed, wherein said eye drop also comprise one or more assembly in stabilizing agent, the thickening agent.
Outstanding effect of the present invention is: the temperature of this dosage form before undergoing phase transition is the lower mobile liquid condition of a kind of viscosity below 30 ℃ the time, can evenly distribute and the rapid gel that forms under the effect of temperature after splashing into ophthalmic, adhere to eyeball surface, thereby medicine is slowly discharged in conjunctival sac, keep the long duration, can be as most of loss the behind the eye drop eye drip.
Below in conjunction with embodiment, the specific embodiment of the present invention is described in further detail, so that technical solution of the present invention is easier to understand, grasp.
The specific embodiment
A kind of eye drop of Levofloxacin Hydrochloride Gel type comprises levofloxacin hydrochloride, poloxamer and other adjuvants and water in the described eye drop, also comprise one or more assembly in stabilizing agent, the thickening agent.Described water is water for injection; Described other adjuvants are the PH regulator, and described PH regulator is that in sodium dihydrogen phosphate, potassium dihydrogen phosphate, Borax, acetic acid, sodium acetate, the sodium hydroxide one or more are composite.
The preparation method of the eye drop of the above Levofloxacin Hydrochloride Gel type specifically comprises the steps:
The levofloxacin hydrochloride of step 1, accurate weighing recipe quantity adds in the water for injection of about 70% total amount and stirs, and adopts magnetic agitation, and rotating speed is 65 to turn/min, to fully dissolving, the liquid that obtains clarifying;
Other adjuvants in step 2, the accurate weighing prescription except poloxamer add in the solution of step 1 gained successively, and stirring and dissolving is even, obtains clarifying mixed solution, and gained solution is tentatively filtered with microporous filter membrane;
Step 3, the solution of step 2 gained is cooled to 0 ℃~4 ℃, the poloxamer that adds the recipe quantity of accurate weighing carries out swelling, swelling fully after, add water to recipe quantity, obtain clarifying the solution of thickness;
Step 4 is filtered behind the solution left standstill to the step 3 gained, adopts flowing steam sterilization, namely obtains the eye drop of Levofloxacin Hydrochloride Gel type.
The eye drop preparation method of above-described a kind of Levofloxacin Hydrochloride Gel type, its eye drop that makes are the eye drop of 0.3% Levofloxacin Hydrochloride Gel type.
Levofloxacin Hydrochloride Gel type eye drop rabbit intraocular pharmacokinetic result of study shows, single eye drip cornea and aqueous humor Chinese medicine concentration in 180min are significantly higher than the eye drop group, and bioavailability is better than the eye drop group.Cornea and aqueous humor Chinese medicine concentration are significantly higher than the eye drop group behind the Levofloxacin Hydrochloride Gel type eye drop multiple dosing in 240min.This illustrates the number of times of conventional eye drip, and Levofloxacin Hydrochloride Gel type eye drop has high drug level in cornea and aqueous humor, is beneficial to the Growth and Reproduction of control antibacterial, shortens the course of disease, improves cure rate.
The present invention still has numerous embodiments, and all employing equivalents or equivalent transformation and all technical schemes of forming all drop within protection scope of the present invention.
Claims (2)
1. the eye drop of a Levofloxacin Hydrochloride Gel type, it is characterized in that: comprise levofloxacin hydrochloride, poloxamer and other adjuvants and water in the described eye drop, described water is water for injection;
Described other adjuvants are the PH regulator, and described PH regulator is that in sodium dihydrogen phosphate, potassium dihydrogen phosphate, Borax, acetic acid, sodium acetate, the sodium hydroxide one or more are composite.
2. the eye drop of a kind of Levofloxacin Hydrochloride Gel type as claimed in claim 1, it is characterized in that: described eye drop also comprises one or more assembly in stabilizing agent, the thickening agent.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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CN2011102395967A CN102949334A (en) | 2011-08-19 | 2011-08-19 | Levofloxacin hydrochloride gel-type eye-drops |
Applications Claiming Priority (1)
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CN2011102395967A CN102949334A (en) | 2011-08-19 | 2011-08-19 | Levofloxacin hydrochloride gel-type eye-drops |
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CN102949334A true CN102949334A (en) | 2013-03-06 |
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CN2011102395967A Pending CN102949334A (en) | 2011-08-19 | 2011-08-19 | Levofloxacin hydrochloride gel-type eye-drops |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN107224425A (en) * | 2016-03-24 | 2017-10-03 | 湖北远大天天明制药有限公司 | A kind of preparation method of the sterile gel of lavo-ofloxacin hydrochloride |
CN112190558A (en) * | 2020-10-20 | 2021-01-08 | 迪沙药业集团有限公司 | Levofloxacin composition |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101278895A (en) * | 2007-04-06 | 2008-10-08 | 北京华禧联合科技发展有限公司 | Instant type gel preparation for eye and method of producing the same |
CN101461777A (en) * | 2009-01-06 | 2009-06-24 | 河北科技大学 | Disposable levofloxacin hydrochloride eye drops without bacteriostatic agent and preparation method thereof |
-
2011
- 2011-08-19 CN CN2011102395967A patent/CN102949334A/en active Pending
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101278895A (en) * | 2007-04-06 | 2008-10-08 | 北京华禧联合科技发展有限公司 | Instant type gel preparation for eye and method of producing the same |
CN101461777A (en) * | 2009-01-06 | 2009-06-24 | 河北科技大学 | Disposable levofloxacin hydrochloride eye drops without bacteriostatic agent and preparation method thereof |
Non-Patent Citations (1)
Title |
---|
高斐等: "《左氧氟沙星热敏型眼用凝胶的研制及体外释放研究》", 《中国药房》 * |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN107224425A (en) * | 2016-03-24 | 2017-10-03 | 湖北远大天天明制药有限公司 | A kind of preparation method of the sterile gel of lavo-ofloxacin hydrochloride |
CN107224425B (en) * | 2016-03-24 | 2021-05-25 | 湖北远大天天明制药有限公司 | Preparation method of levofloxacin hydrochloride sterile gel |
CN112190558A (en) * | 2020-10-20 | 2021-01-08 | 迪沙药业集团有限公司 | Levofloxacin composition |
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Application publication date: 20130306 |