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Medicinal composition for treating bacterial conjunctivitis and keratitis and preparation and preparation method

A technology for conjunctivitis and keratitis, which is applied in the field of sustained-release ophthalmic preparations containing levofloxacin hydrochloride and its preparation, can solve the problems of poor controllability of preparation quality standards, difficulty in achieving uniform administration, and unstable gel state and other problems, to achieve the effect of high controllability of quality standards, maintaining effective drug concentration, and reducing the frequency of dosing

Inactive Publication Date: 2005-02-16
成都三明药物研究所
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It is a gel in vitro, the gel state is unstable, and the quality standard of the preparation is poorly controllable. The method of use is to apply a small amount to the lower conjunctival sac each time. It is not a one-off but multi-dose. Causes external pollution, easy to be contaminated during use, and because it is applied in the lower conjunctival sac, it is difficult to achieve uniform drug administration, resulting in inconstant dosage and uneven application, inconvenient use, and easy to cause waste

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Levofloxacin Hydrochloride: 0.05g; Carbomer 940: 0.20g; Hypromellose: 1.50g; Disodium Bicarbonate: 0.25g; Sodium Dihydrogen Carbonate: 0.50g; Sodium Chloride: 0.5g ; Ethylparaben: 0.03g; appropriate amount of sodium hydroxide to adjust the pH value to 6.0. With above-mentioned formula prepared by preparation technology of the present invention:

[0024] a. Dissolve disodium bicarbonate, sodium dihydrogen carbonate and hydroxypropyl methylcellulose in an appropriate amount of water for injection to form a transparent solution.

[0025] b. Take carbomer and add it to an appropriate amount of water for injection to swell. After the swelling is complete, add it to the transparent solution in the above step 1, and keep stirring to form solution 1.

[0026] c. Add levofloxacin hydrochloride and sodium chloride into an appropriate amount of water for injection, stir continuously, and form a light yellow transparent solution after dissolving.

[0027] d. Take ethylparaben, ad...

Embodiment 2

[0030] Levofloxacin Hydrochloride: 0.10g; Carbomer 940: 0.25g; Hypromellose: 1.40g; Disodium Bicarbonate: 0.25g; Sodium Dihydrogen Carbonate: 0.50g; Sodium Chloride: 0.5g ; Ethylparaben: 0.03g; appropriate amount of sodium hydroxide to adjust the pH value to 6.0. Above-mentioned formula is mixed into 100ml solution by the preparation process of embodiment 1, fills after passing the inspection, autoclave sterilization for subsequent use.

Embodiment 3

[0032] Levofloxacin hydrochloride: 0.10g; Carbomer 940: 0.40g; Hypromellose: 1.30g; Disodium bicarbonate: 0.25g; Sodium dihydrogen carbonate: 0.50g; Sodium chloride: 0.5g ; Ethylparaben: 0.03g; appropriate amount of sodium hydroxide to adjust the pH value to 6.0. Above-mentioned formula is mixed into 100ml solution by the preparation process of embodiment 1, fills after passing the inspection, autoclave sterilization for subsequent use.

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PUM

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Abstract

The invention provides a medicine compound and its manufacturing method, concretely, it is slow released eye preparation containing hydrochloric acid levo ofloxacin and its manufacturing method. The invention uses in situ gelling technology to produce the eye drip, the quality is stable, and it can maintain effect medicine density in a long time, upgrades the biological utilization rate, reduces the stimulation to eyes, reduces the medicine feeding frequency, the producing process is high controlled, the cost is low, it provides a new medicine for clinic.

Description

technical field [0001] The invention provides a pharmaceutical composition for treating bacterial conjunctivitis and keratitis and a preparation method thereof, specifically, a slow-release ophthalmic preparation containing levofloxacin hydrochloride and a preparation method thereof. Background technique [0002] At present, the two most commonly used dosage forms of drugs for the treatment of eye infections are: solution and ophthalmic ointment. Solution-type eye drops, the principle of action is: after dripping into the eyes, the drug will be delivered with the secretion of tears, which is characterized by uniform distribution, but due to the continuous secretion of tears in the conjunctival sac and rapid removal from the nasolacrimal duct, it will be in the conjunctiva. The intracapsular residence time is very short, so the intraocular bioavailability is very low. Frequent administration is required to maintain normal drug concentration, which br...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/5383A61P27/02A61P31/02
Inventor 高申储藏阳向波
Owner 成都三明药物研究所
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