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Preparation method of levofloxacin eye drops

A technology of levofloxacin and eye drops, applied in the field of preparation of levofloxacin eye drops, can solve problems such as inapplicability to sensitive people, damage to epithelial cells, and potential safety hazards, so as to relieve symptoms of eye discomfort, promote healing, and enhance use effects Effect

Inactive Publication Date: 2021-04-02
苏州工业园区天龙制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Most of the existing levofloxacin eye drops are packaged in multiple doses and are used repeatedly. Once the preparation is opened, it is easy to be contaminated by tears and microorganisms in the air during use and storage, thereby causing safety hazards. Therefore, in order to prevent ophthalmic For the secondary pollution of preparations after opening, preservatives are generally required to be added to ophthalmic preparations
However, long-term use of eye drops containing preservatives may cause damage, shedding, and denaturation of epithelial cells in the cornea and conjunctiva, leading to membrane ulcers or erosion, and bring certain safety hazards to patients who take the drug, such as vision loss, eye damage, etc. Symptoms such as hyperemia can cause corneal and conjunctival damage, and can cause inflammation, and are not suitable for sensitive people. Therefore, we propose a preparation method of levofloxacin eye drops to solve the above problems

Method used

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  • Preparation method of levofloxacin eye drops

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Comparison scheme
Effect test

Embodiment 1

[0027] Please refer to figure 1 Shown, the invention discloses a kind of preparation method of levofloxacin eye drops, comprises the following steps:

[0028] S1. Weighing raw materials: 0.46 parts of levofloxacin, 4.46 parts of osmotic pressure regulator, 3 parts of pH regulator, 80 parts of water for injection, 2 parts of compound thickener, 8 parts of metal ion complexing agent and 0.05 part of bacteriostatic agent;

[0029] S2. Preparation of mixed solution A: Weigh levofloxacin into an appropriate amount of water for injection, stir and dissolve at 35-40°C to obtain mixed solution A, and set aside;

[0030] S3. Preparation of mixed solution B: add osmotic pressure regulator, metal ion complexing agent, compound thickener and pH regulator to the mixed solution A prepared in step S2, stir and mix, and dilute to 100mL with water for injection , the metal ion complexing agent is disodium edetate, the weight ratio of the metal ion complexing agent to levofloxacin is 1:0.01, t...

Embodiment 2

[0035] Please refer to figure 1 Shown, the invention discloses a kind of preparation method of levofloxacin eye drops, comprises the following steps:

[0036] S1. Weigh raw materials: 0.48 parts of levofloxacin, 4.46 parts of osmotic pressure regulator, 3-5 parts of pH regulator, 85 parts of water for injection, 2.5 parts of compound thickener, 9 parts of metal ion complexing agent and 0.05 parts of antibacterial agent share;

[0037] S2. Preparation of mixed solution A: Weigh levofloxacin into an appropriate amount of water for injection, stir and dissolve at 35-40°C to obtain mixed solution A, and set aside;

[0038] S3. Preparation of mixed solution B: add osmotic pressure regulator, metal ion complexing agent, compound thickener and pH regulator to the mixed solution A prepared in step S2, stir and mix, and dilute to 100mL with water for injection , the metal ion complexing agent is sodium gluconate, the weight ratio of the metal ion complexing agent to levofloxacin is 1...

Embodiment 3

[0043] Please refer to figure 1 Shown, the invention discloses a kind of preparation method of levofloxacin eye drops, comprises the following steps:

[0044] S1. Weighing raw materials: 0.51 parts of levofloxacin, 8.23 ​​parts of osmotic pressure regulator, 5 parts of pH regulator, 30 parts of water for injection, 3 parts of compound thickener, 10 parts of metal ion complexing agent and 0.1 part of antibacterial agent;

[0045] S2. Preparation of mixed solution A: Weigh levofloxacin, add it to an appropriate amount of water for injection, stir and dissolve at 40°C to obtain mixed solution A, and set aside;

[0046]S3. Preparation of mixed solution B: add osmotic pressure regulator, metal ion complexing agent, compound thickener and pH regulator to the mixed solution A prepared in step S2, stir and mix, and dilute to 100mL with water for injection , the metal ion complexing agent is disodium edetate, the weight ratio of the metal ion complexing agent to levofloxacin is 1:0.50...

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Abstract

The invention discloses a preparation method of levofloxacin eye drops, and relates to the technical field of eye drops. The preparation method comprises the following steps: S1, weighing the following raw materials: 0.46-0.51 part of levofloxacin, 4.46-8.23 parts of an osmotic pressure regulator, 3-5 parts of a pH regulator, 80-90 parts of water for injection, 2-3 parts of a compound thickener, 8-10 parts of a metal ion complexing agent and 0.05-0.1 part of a bacteriostatic agent. According to the preparation method of the levofloxacin eye drops, the levofloxacin, the metal ion complexing agent and the compound thickener are added, and sodium hyaluronate in the compound thickener can prolong the residence time of an active medicine at a treatment level on the ocular surface, so that the intraocular bioavailability is improved, and the administration frequency is remarkably reduced. The compliance and the treatment success rate of a patient can be improved, stimulation of the medicineto eyes can be reduced, the healing of eye wounds can be promoted, eye discomfort symptoms can be relieved, and the use effect of the eye drops can be enhanced. By adding the metal ion complexing agent, the composition of the metal ion complexing agent and the levofloxacin has good stability.

Description

technical field [0001] The invention relates to the technical field of eye drops, in particular to a preparation method of levofloxacin eye drops. Background technique [0002] Levofloxacin is the optically active part of the racemate ofloxacin. 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. The eye drops of the ingredients are widely used clinically to treat blepharitis, hordeolum, dacryocystitis, conjunctivitis, keratitis, and eye postoperative infectious diseases. Levofloxacin eye drops have exact curative effect and low incidence of adverse reactions , is an efficient and safe drug for treating eye infections, and has broad clinical application prospects. [0003] Most of the existing levofloxacin eye drops are packaged in multiple doses and are used repeatedly. Once the preparation is opened, it is easy to be contaminated by tears and microorga...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/36A61K47/38A61K47/26A61K47/18A61K47/12A61K31/5383A61P27/02A61P31/04
CPCA61K9/08A61K9/0048A61K47/36A61K47/38A61K47/26A61K47/183A61K47/12A61K31/5383A61P27/02A61P31/04
Inventor 陈业仓
Owner 苏州工业园区天龙制药有限公司
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