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Levofloxacin single-dose 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 potential safety hazards, secondary pollution of microorganisms, toxic and side effects of preservatives on eyes, etc., meet the requirements of ensuring sterility and avoid toxicity side effects

Active Publication Date: 2015-03-18
ZHUHAI ESSEX BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to provide a new levofloxacin single-dose eye drop without preservatives and a preparation method thereof, which can avoid multi-dose eye drops Microbial secondary pollution during the use of eye drops and the side effects of preservatives on the eyes

Method used

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  • Levofloxacin single-dose eye drops and preparation method thereof
  • Levofloxacin single-dose eye drops and preparation method thereof
  • Levofloxacin single-dose eye drops and preparation method thereof

Examples

Experimental program
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Effect test

reference example 1

[0024]

[0025] Preparation Process

[0026] Weigh the prescribed amount of levofloxacin and dissolve it in an appropriate amount of water for injection, then add disodium hydrogen phosphate and citric acid, stir to dissolve, use water for injection to make the volume to 100mL, and measure the pH; Pore ​​filter membrane filtration; under the 100-level environment, fill 0.4mL of liquid medicine into a 0.8mL packaging container on a three-in-one filling machine of blowing, filling and sealing, and then seal to obtain the finished product.

reference example 2

[0028]

[0029] Weigh the prescribed amount of levofloxacin and dissolve it in an appropriate amount of water for injection, then add disodium hydrogen phosphate and citric acid, stir to dissolve, use water for injection to make the volume to 100mL, and measure the pH; Pore ​​filter membrane filtration; under the 100-level environment, fill 0.4mL of liquid medicine into a 0.8mL packaging container on a three-in-one filling machine of blowing, filling and sealing, and then seal to obtain the finished product.

Embodiment 1

[0031]

[0032] Preparation Process

[0033] Weigh the prescribed amount of levofloxacin and dissolve it in an appropriate amount of water for injection, add sodium chloride, dropwise add 0.1mol / L HCl solution, measure the pH while stirring until the pH is 6.0-7.0, stir and mix, and dilute to 100mL with water for injection ; Under Class 100 environment, filter through a 0.22-0.45 μm microporous membrane; under Class 100 environment, fill 0.4mL of liquid medicine into a 0.8mL packaging container on a three-in-one filling machine of blowing, filling and sealing, and seal , the finished product is obtained.

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PUM

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Abstract

The invention belongs to the field of pharmaceutical preparations and provides levofloxacin single-dose eye drops. The levofloxacin single-dose eye drops comprise an active component, namely levofloxacin, an isotonic regulator selected from sodium chloride, disodium hydrogen phosphate and sodium citrate, a pH regulator selected from hydrochloric acid, sodium dihydrogen phosphate and citric acid, and water for injection. The invention further provides a preparation method of the single-dose eye drops. The levofloxacin single-dose eye drops prepared by the preparation method provided by the invention do not contain preservatives, so that potential danger and toxic and side effects to eyes caused by the preservatives are avoided, and the levofloxacin eye drops which are safer and more reliable are provided for patients.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a levofloxacin single-dose eye drop and a preparation method thereof. Background technique [0002] Levofloxacin is the optically active part of the racemate ofloxacin (L-body). It is a fully synthetic quinolone antibacterial drug. Its antibacterial spectrum is the same as that of ofloxacin, but its antibacterial activity is twice that of ofloxacin. Eye drops with levofloxacin as the active ingredient are widely used clinically to treat blepharitis, hordeolum, dacryocystitis, conjunctivitis, keratitis, and eye postoperative infectious diseases. Levofloxacin eye drops has a definite curative effect and a low incidence of adverse reactions. It is an efficient and safe drug for the treatment of eye infections and has broad clinical application prospects. [0003] Most of the levofloxacin eye drops that have been on the market are packaged in multiple doses for...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/5383A61P31/04A61P27/02
Inventor 胡晶晶钟雪彬霍立茹杨晓兵陈荣震汪礼权李纬
Owner ZHUHAI ESSEX BIO PHARMA
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