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Ophthalmic composition containing non-drug-resistant antimicrobial agent

An ophthalmic composition and drug resistance technology, applied in the direction of fungicides, drug combinations, local antibacterial agents, etc., can solve problems such as drug resistance, achieve health and safety, broad-spectrum and high-efficiency antibacterial and antiseptic effects, and overcome drug resistance Effect

Active Publication Date: 2019-08-16
SOUTHEAST UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Technical problem to be solved: the present invention provides an ophthalmic composition containing non-resistant bactericides, which is used to solve the problem of drug resistance of more and more types of bacterial strains to traditional bactericidal preservatives

Method used

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Experimental program
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Effect test

Embodiment 1

[0023] The application of the composition of the present invention in the contact lens care solution is carried out in strict accordance with the suspension quantitative sterilization method in GB19192-2003 "Hygienic Requirements for Contact Lens Care Solution" Appendix A Disinfection Effect Test, and the measurement bacteria used in the test is gold Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, Escherichia coli.

[0024] Table 1 Multifunctional Contact Lens Care Solution Formula

[0025]

[0026]

[0027] The measurement result of table 2 suspension quantitative bactericidal experiment 6 hours

[0028]

[0029] The composition of the invention is a colorless clear liquid, and the physiological parameters meet the industry standard. Among them, the pH value is 7.21-7.24, the osmotic pressure is 302mOsm / Kg, and the surface tension is 38-42dyne / cm -2 , the viscosity is 11±2mPa.s.

[0030] Suspension quantitative bactericidal test results show that ...

Embodiment 2

[0032] Table 3 Artificial tear formula

[0033]

[0034]

[0035] The composition of the present invention is a colorless clear liquid, the pH value is 7.20, the osmotic pressure is 300mOsm / Kg, and the surface tension is 45dyne / cm -2 , the viscosity is 14±2mPa.s.

[0036] Suspension quantitative bactericidal experiment measured that the bactericidal rate to Pseudomonas aeruginosa was 99.9%, the bactericidal rate to Escherichia coli was 99.9%, the bactericidal rate to Staphylococcus aureus was 99.9%, and the bactericidal rate to Candida albicans was 99.3%.

Embodiment 3

[0038] Table 4 eye drop formula

[0039] components Content (%, g / mL) Rupatadine Fumarate 0.10 HPMC 0.030 PHMG 0.00015 PAPB 0.00005 Na 2 HPO 4

1.50 NaH 2 PO 4

0.16 NaCl 0.57 Tween 80 0.26 Water for Injection Add to 100mL

[0040] The composition of the present invention is a colorless clear liquid, the pH value is 7.17, the osmotic pressure is 288mOsm / Kg, and the surface tension is 38.5dyne / cm -2 , the viscosity is 10±2mPa.s.

[0041] Suspension quantitative bactericidal experiments showed that the bactericidal rate to Pseudomonas aeruginosa was 99.9%, the bactericidal rate to Escherichia coli was 99.9%, the bactericidal rate to Staphylococcus aureus was 99.9%, and the bactericidal rate to Candida albicans was 99.6%.

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Abstract

The invention provides an ophthalmic composition containing a non-drug resistant antimicrobial agent. An aqueous solution of the ophthalmic composition comprises at least 1 ppm to 10 ppm of polyhexamethylene monoguanidine, and the relative molecular weight of the polyhexamethylene monoguanidine has a relative molecular weight of 1000 kDa to 5000 kDa. The ophthalmic composition may also comprises effective amounts of a germicidal disinfectant, a surfactant, a buffer, a tackifier, an osmotic pressure adjusting agent, a chelating agent and other active ingredients. According to the composition disclosed by the invention, the polyhexamethylene monoguanidine with high polymerization degree is adopted as an antimicrobial active ingredient, so that the drug resistance of a traditional antimicrobial ingredient known to a person skilled in the art to bacteria can be overcome, the broad-spectrum high-efficiency antibacterial and antiseptic effects can be exerted, the aseptic state of the 'multi-dose' composition can be continuously maintained for a long time, and thus, the health and safety of a user are guaranteed.

Description

technical field [0001] The present invention relates to a multipurpose composition, in particular to an ophthalmic composition containing polyhexamethylene monoguanidine, a non-drug-resistant fungicide. Background technique [0002] Ophthalmic preparations produced under aseptic conditions will inevitably be contaminated by microorganisms exposed to the air and other sources (such as the hands of human patients) when the package is opened for use. Therefore, effective bactericidal preservatives need to be added to the preparations to prevent The sterility of the product is compromised. Such products are usually used by patients multiple times, usually referred to as "multi-dose" forms, which require the bactericide in the composition to have continuous and effective bactericidal and antiseptic capabilities, especially for ophthalmic compositions such as contact lens care solutions and artificial tears. Eye drops and eye lotion should prevent the reproduction of bacteria, fu...

Claims

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Application Information

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IPC IPC(8): A61K31/785A61K9/08A61P27/02A61P27/04A61P31/02A01N25/02A01N47/44A01P1/00A01P3/00
CPCA61K31/785A61K9/08A61K9/0048A61P31/02A61P27/02A61P27/04A01N47/44A01N25/02A61K2300/00Y02A50/30
Inventor 邹志红王岩陈思秦敏
Owner SOUTHEAST UNIV
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