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A kind of lomefloxacin hydrochloride eye drops and preparation process thereof

A technology of lomefloxacin hydrochloride and eye drops, which can be applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, antibacterial drugs, etc. Insufficient absorption, poor penetration, etc., to achieve excellent physical and chemical properties, ensure sterile environment and safety, and reduce irritation

Active Publication Date: 2020-06-09
JIANGSU YUANHENG PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the prior art, the lomefloxacin eye drops have the following problems: 1, stability, uniformity, and absorbability are not good enough; 2, the penetration is poor during use, and the intraocular pressure cannot be significantly reduced, which is harmful to the treatment of sensitive pathogenic bacteria. The curative effect of acute and chronic bacterial conjunctivitis, blepharitis, stye, meibomian gland inflammation, dacryocystitis, keratitis and corneal ulcer needs to be further strengthened

Method used

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  • A kind of lomefloxacin hydrochloride eye drops and preparation process thereof
  • A kind of lomefloxacin hydrochloride eye drops and preparation process thereof

Examples

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Effect test

Embodiment 1

[0032] A kind of lomefloxacin hydrochloride eye drops of the present embodiment is prepared from the following substances in mass percentage: 0.36% of lomefloxacin hydrochloride, 4.2% of solubilizing additives, 0.07% of propyl p-hydroxybenzoate, 0.05% of sodium alginate %, glycerin 0.16%, buffer 0.016%, mannitol 0.046%, biodegradation aid 0.25%, and the balance is water for injection.

[0033] The preparation method of this eye drop comprises the following steps:

[0034] S1. Disperse sodium alginate and solubilizing additives in an appropriate amount of water for injection preheated to 52°C to make the system swell into a transparent solution;

[0035] S2. Disperse lomefloxacin hydrochloride in an appropriate amount of water for injection, mix it with the transparent solution preheated to 38°C and stir evenly, then add glycerin, mannitol, biodegradation additives and appropriate amount of water for injection, stir and mix, add Buffer to adjust pH and add remaining water for ...

Embodiment 2

[0043] A kind of lomefloxacin hydrochloride eye drops of the present embodiment is prepared from the following substances in mass percentage: 0.42% of lomefloxacin hydrochloride, 4.5% of solubilizing additives, 0.09% of propyl p-hydroxybenzoate, 0.06% of sodium alginate %, glycerin 0.17%, buffer 0.017%, mannitol 0.058%, biodegradation aid 0.28%, and the balance is water for injection.

[0044] The preparation method of this eye drop comprises the following steps:

[0045] S1. Disperse sodium alginate and solubilizing additives in an appropriate amount of water for injection preheated to 53°C to make the system swell into a transparent solution;

[0046] S2. Disperse lomefloxacin hydrochloride in an appropriate amount of water for injection, mix it with the transparent solution preheated to 43°C and stir evenly, then add glycerin, mannitol, biodegradation aids and appropriate amount of water for injection, stir and mix, add Buffer to adjust pH and add remaining water for injec...

Embodiment 3

[0054] A kind of lomefloxacin hydrochloride eye drops of the present embodiment is prepared from the following substances in mass percentage: 0.45% of lomefloxacin hydrochloride, 5.3% of solubilizing additives, 0.10% of propyl p-hydroxybenzoate, and 0.07% of sodium alginate %, glycerin 0.18%, buffer 0.023%, mannitol 0.055%, biodegradation aid 0.28%, and the balance is water for injection.

[0055] The preparation method of this eye drop comprises the following steps:

[0056] S1. Disperse sodium alginate and solubilizing additives in an appropriate amount of water for injection preheated to 49°C to make the system swell into a transparent solution;

[0057] S2. Disperse lomefloxacin hydrochloride in an appropriate amount of water for injection, mix it with the transparent solution preheated to 42°C and stir evenly, then add glycerin, mannitol, biodegradation additives and appropriate amount of water for injection, stir and mix, add Buffer to adjust pH and add remaining water ...

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Abstract

The invention discloses lomefloxacin hydrochloride eye drops and a preparation technology thereof, and relates to the field of pharmaceutical preparations for department of ophthalmology. The preparation technology comprises the following steps of screening sodium alginate as a thickening excipient, enabling the sodium alginate, a dissolving assisting additive and injection water to swell to forma transparent solution, then mixing the transparent solution with an isoosmotic adjustment agent namely glycerine, an intraocular pressure adjusting agent namely mannitol and a biodegradation adjunctto obtain a mixture, then adjusting the pH of the mixture with a buffered solution, performing filtration, and performing bacteria-free encapsulation so as to obtain the lomefloxacin hydrochloride eyedrops. The preparation method of the lomefloxacin hydrochloride eye drops disclosed by the invention is simple and controllable, severe condition is not needed, the lomefloxacin hydrochloride eye drops are good in stability, uniformity and absorptivity, and high in permeation effects while in use, intraocular pressure is notably reduced, and the lomefloxacin hydrochloride eye drops have notable treatment effects on treating external eye infection of acute bacterial conjunctivitis, chronic bacterial conjunctivitis, blepharitis marginalis, hordeolum, blepharoadenitis, dacryadeitis, keratitis, keratohelcosis and the like.

Description

technical field [0001] The invention relates to the field of ophthalmic pharmaceutical preparations, in particular to a lomefloxacin hydrochloride eye drop and a preparation process thereof, which are used for treating acute and chronic bacterial conjunctivitis, blepharitis, stye and meibomian glands caused by sensitive pathogenic bacteria External ocular infections such as keratitis, dacryocystitis, keratitis and corneal ulcers. Background technique [0002] The chemical name of lomefloxacin is 1-ethyl-6,8-difluoro-7-(3-methyl-1-piperazine)-4-oxo-3-quinolinecarboxylic acid. The pH value of lomefloxacin hydrochloride is 3.5-4.5, slightly soluble in water, almost insoluble in ethanol or chloroform; easily soluble in sodium hydroxide test solution, dissolved in ammonia test solution; with malonic acid and acetic anhydride at 30 Heating in a water bath at ~90°C for 5 to 10 minutes, it turns reddish brown, and its chemical structure is as follows: [0003] [0004] Lomeflox...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/36A61K47/26A61K47/42A61K47/38A61K47/69A61K31/496A61K31/722A61P31/04A61P27/02
Inventor 不公告发明人
Owner JIANGSU YUANHENG PHARMA
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