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Levofloxacin single-dosage eye drops and preparation method thereof

A technology of levofloxacin and eye drops, which is applied in the field of levofloxacin single-dose eye drops and its preparation, can solve problems such as eye toxicity and side effects, and achieve the effect of avoiding potential damage and good beneficial effects

Inactive Publication Date: 2019-08-09
深圳市瑞霖医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Although antibacterial benzalkonium chloride is less harmful to the eyes under a controlled dose range, after all, benzalkonium chloride is a kind of preservative, and prolonged use will have toxic side effects on the eyes

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Levofloxacin 0.3g;

[0027] Polyvinyl alcohol 0.3g;

[0028] Glycerin 0.5g;

[0029] Sodium citrate 3g;

[0030] Citric acid 0.1g;

[0031] Add water to the above substances to make up to 100mL.

[0032] Its preparation method:

[0033] (1) Weigh levofloxacin, polyvinyl alcohol, glycerin, sodium citrate, add an appropriate amount of water for injection, stir and mix, then add citric acid to make the pH of the mixture 6.0-7.0, and dilute to 100mL with water for injection to obtain liquid medicine;

[0034] (2) In a class 100 environment, filter the medicinal solution obtained in step (1) with a 0.22-0.45 μm microporous membrane; preferably filter 1-5 times;

[0035] Preferably, after step (2), before filling, the medicinal solution obtained in step (2) is sterilized by autoclaving.

[0036] (3) Fill the medicinal liquid obtained in step (2) into a single-dose packaging container under a class 100 environment, and seal it to obtain the finished product.

Embodiment 2

[0038] Levofloxacin 0.45g;

[0039] Polyvinyl alcohol 0.45g;

[0040] Glycerin 2.5g;

[0041] Sodium citrate 8g;

[0042] Citric acid 0.3g;

[0043] Add water to the above substances to make up to 100mL.

[0044] Its preparation method refers to Example 1.

Embodiment 3

[0046] Levofloxacin 0.4g;

[0047] Polyvinyl alcohol 0.4g;

[0048] Glycerin 1.5g;

[0049] Sodium citrate 5g;

[0050] Citric acid 0.2g;

[0051] Add water to the above substances to make up to 100mL.

[0052] Its preparation method refers to Example 1.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to levofloxacin single-dosage eye drops and a preparation method thereof. The eye drops are prepared from, per 100 mL, 0.3-0.45 g of levofloxacin, 0.3-0.45 g of polyvinyl alcohol, 0.5-2.5 g of glycerinum, 3-8 g of an iso-osmia regulating agent, a pH regulating agent with the pH value being 6.0-7.0and the balance water. By adopting the single-dosage eye drops, an antibacterial agent is omitted, potential injuries caused by the antiseptic effect of an antibacterial agent on eyes are avoided, inaddition, due to the combined usage of levofloxacin and polyvinyl alcohol, and the better advantage is achieved compared with only adoption of levofloxacin.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a levofloxacin single-dose eye drop and a preparation method thereof. Background technique [0002] The main component of levofloxacin eye drops is levofloxacin, which belongs to quinolone antibacterial drugs and is the L-isomer of ofloxacin. It has a broad-spectrum antibacterial effect on Gram-positive bacteria and negative bacteria including anaerobic bacteria. According to the antibacterial spectrum of levofloxacin, the antibacterial effect of this product on bacteria is very good, but the antibacterial effect on some fungi is not obvious. [0003] Fu Rong et al. (Journal of Pharmaceutical Analysis [J], 2013, 33 (12)) added 0.004% to 0.006% wt. of the fungicide benzalkonium chloride to levofloxacin to improve the antibacterial effect of this product on fungi. Benzalkonium chloride is a quaternary ammonium compound, and its antibacterial activit...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/5383A61K47/32A61P31/04A61P31/02A61P27/02
CPCA61K9/0048A61K9/08A61K31/5383A61K47/32A61P27/02A61P31/02A61P31/04
Inventor 齐拓荒
Owner 深圳市瑞霖医药有限公司
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