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Lomefloxacin hydrochloride eye drops and preparation method and application thereof

A technology of lomefloxacin hydrochloride and eye drops, applied in the field of medicine, can solve the problems of low medication compliance of patients, bitter taste of medicine, loss of medicine liquid, etc., to improve bioavailability, prolong residence time, and ensure full absorption Effect

Active Publication Date: 2013-09-18
KANGYA OF NINGXIA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, since this preparation is an aqueous solution of lomefloxacin hydrochloride, the viscosity is too low, most of the liquid will be lost after eye drops, and the loss will be serious, and the loss will be more serious if the eyes are blinked, and the bioavailability is low. In order to achieve an effective drug concentration, it takes more Dosing at one time leads to low drug compliance of patients and affects the therapeutic effect
[0005] In addition, because lomefloxacin hydrochloride has a slightly bitter taste, after the eye drops are made into the eyes, the liquid will flow into the nose through the tear duct, which will make the drug taste bitter and make the patient feel uncomfortable

Method used

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  • Lomefloxacin hydrochloride eye drops and preparation method and application thereof
  • Lomefloxacin hydrochloride eye drops and preparation method and application thereof
  • Lomefloxacin hydrochloride eye drops and preparation method and application thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0026] prescription:

[0027]

[0028] Its preparation method is:

[0029] (1) Disperse the prescribed amount of sodium hyaluronate in an appropriate amount of water for injection at 40°C to 55°C to swell to make a transparent solution;

[0030] (2) Dissolve the prescribed amount of main drug lomefloxacin hydrochloride in an appropriate amount of water for injection at 60°C to 70°C, add the prescribed amount of sodium dihydrogen phosphate-disodium hydrogen phosphate buffer, sodium chloride, benzalkonium bromide, The mixed solution of glycerin is stirred and mixed, and then transferred to (1), the pH is adjusted to 6.0 with 0.1mol / L sodium hydroxide solution, the full amount of water for injection is added, and filtered with a 0.22μm microporous membrane. After passing the inspection, no Bacteria packaged.

Embodiment 2

[0032] prescription:

[0033]

[0034] Its preparation method is:

[0035] (1) Disperse the prescribed amount of sodium hyaluronate in an appropriate amount of water for injection at 40°C to 55°C to swell to make a transparent solution;

[0036] (2) Dissolve the prescribed amount of the main drug lomefloxacin hydrochloride in an appropriate amount of water for injection at 60°C to 70°C, add the prescribed amount of sodium dihydrogen phosphate-disodium hydrogen phosphate, sodium chloride, benzalkonium bromide, and glycerin Mix the solution, stir and mix, then transfer to (1), adjust the pH to 6.0 with 0.1mol / L sodium hydroxide solution, add the full amount of water for injection, filter with a 0.22μm microporous membrane, and pack aseptically after passing the inspection Instantly.

Embodiment 3

[0038] prescription:

[0039]

[0040] Its preparation method is:

[0041] (1) Disperse the prescribed amount of sodium hyaluronate in an appropriate amount of water for injection at 40°C to 55°C to swell to make a transparent solution;

[0042] (2) Dissolve the prescribed amount of the main drug lomefloxacin hydrochloride in an appropriate amount of water for injection at 60°C to 70°C, add the prescribed amount of sodium dihydrogen phosphate-disodium hydrogen phosphate, sodium chloride, benzalkonium chloride, and glycerin Mix the solution, stir and mix, then transfer to (1), adjust the pH to 6.0 with 0.1mol / L sodium hydroxide solution, add the full amount of water for injection, filter with a 0.22μm microporous membrane, and pack aseptically after passing the inspection Instantly.

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Abstract

The invention discloses lomefloxacin hydrochloride eye drops and a preparation method and application thereof. The lomefloxacin accounts for 0.3% of the active components. The preparation also comprises a tackifier, a buffer salt system, a wetting agent, an isoosmotic adjusting agent, a pH adjusting agent and a bacteriostatic agent, and is suitable for treating the external eye infections such as acute and chronic bacterial conjunctivitis, blepharitis, hordeolum, meibomiantis, dacryocystitis, keratitis, keratohelcosis and the like caused by sensitive pathogenic bacteria. The product is characterized in that: by adding the sodium hyaluronate with a tackifying effect and a moisturizing effect, the viscosity of the lomefloxacin hydrochloride eye drops is improved, the fluidics property thereof is changed, the residence time of the eye drops in the eyes is prolonged, the sufficient absorption of the medicine is ensured, the bioavailability is increased, the administration times are reduced, the compliance of a patient is improved, and an effective treatment effect is realized.

Description

technical field [0001] The invention relates to an ophthalmic pharmaceutical preparation in the field of medicine, in particular to an ophthalmic pharmaceutical preparation that can be used to treat acute and chronic bacterial conjunctivitis, blepharitis, stye, meibomian gland inflammation, dacryocystitis, keratitis and Prescription and preparation method of lomefloxacin hydrochloride eye drops for external ocular infection such as corneal ulcer. Background technique [0002] Lomefloxacin (lomefloxacin) is a third-generation quinolone broad-spectrum antibacterial drug, and its mechanism of action is to inhibit bacterial DNA helicase. It has antibacterial activity against Gram-negative bacteria, positive bacteria and some anaerobic bacteria. Lomefloxacin Hydrochloric acid (lomefloxacin Hydrochloric acid) is the hydrochloride of lomefloxacin, clinically available in capsules, tablets, eye drops, ear drops, injections, etc., for bacterial infections caused by various sensitive...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/496A61K47/36A61K47/38A61K47/32A61P31/04
Inventor 杨亚军马永付
Owner KANGYA OF NINGXIA PHARMA
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