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Ophthalmic composition as well as preparation method and application thereof

An ophthalmic composition and composition technology, applied in the direction of drug combination, medical preparations of non-active ingredients, drug delivery, etc., can solve the problems of layered demulsification, poor treatment effect, poor patient compliance, etc., and achieve improvement Compliance, reduced eye irritation, improved solubility effects

Active Publication Date: 2021-10-22
山西利普达医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Artificial tears are mainly used to treat mild dry eye. The main product currently on the market is sodium hyaluronate artificial tears, but the tear film retention time of this product is not long enough, it needs to be dripped 5-6 times a day, and the patient's compliance is poor. defect
[0003] At present, there are very few oil-water emulsion artificial tears on the market, part of which is due to the poor stability of the emulsion, which is prone to delamination and demulsification, resulting in poor therapeutic effects.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Compositions were prepared according to the components shown in Table 1, and three compositions of Group 1, Group 2 and Group 3 were obtained respectively.

[0031] Table 1

[0032] components Group 1 Percentage Group 2 Percentage Group 3 Percentage light mineral oil 0.50% 1.0% 0.1% heavy mineral oil 0.50% 1.0% 0 medium chain triglycerides 0 0.50% 0 CKC 0.002% 0.05% 0.08% Division 20 0.30% 0.64% 0.90% Octoxynol 40 0.10% 0 0 Tyloxapol 0 0.36% 0 Poloxamer 188 0 0 0.10% trometamol 0.071% 0.005% 0.25% glycerin 2.50% 1% 1.50% water margin margin margin

[0033] Preparation:

[0034] 1) Dissolve Span 20 and the second emulsion Octoxynol 40, Tyloxapol, or Poloxamer 188 in the oil phase;

[0035] 2) Dissolving CKC, osmotic pressure regulator glycerol and tromethamine in the water phase;

[0036] 3) Heat the water phase and the oil phase to an appropriate temperature o...

Embodiment 2

[0041] Compositions were prepared according to the components shown in Table 2, and three compositions of comparison group 1, comparison group 2 and comparison group 3 were obtained respectively.

[0042] Table 2

[0043] components Comparison group 1 percentage Comparison group 2 percentage Comparison group 3 percentage light mineral oil 0.50% 1.0% 0.1% heavy mineral oil 0.50% 1.0% 0 medium chain triglycerides 0 0.5% 0 CKC 0.002% 0.05% 0.08% Division 20 0 0.10% 0 Octoxynol 40 0 0 0.50% Tyloxapol 0.27% 0 0 Poloxamer 188 0.13% 0 0 trometamol 0.071% 0.005% 0.25% glycerin 2.50% 1.0% 3.0% water margin margin margin

[0044] The above 6 compositions were subjected to a stability test under accelerated conditions for 3 months and a rabbit eye Draize eye irritation test according to the provisions of the Pharmacopoeia. The experimental data obtained are shown in Table 3:

[0...

Embodiment 3

[0049] Compositions were prepared according to the components shown in Table 4, and five compositions of Group 4, Group 5, Group 6, Group 7 and Group 8 were obtained respectively.

[0050] Table 4

[0051] components Group 4 Percentage Group 5 percent Group 6 percent Group 7 percent Group 8 percent light mineral oil 0.50% 2.0% 1.0% 1.0% 0 heavy mineral oil 0.50% 1.0% 1.0% 1.0% 0 medium chain triglycerides 0 0 0 0 0.5% CKC 0.001% 0.1% 0.01% 0.09% 0.05% Span 40 0.85% 0 0 0 0 Span 60 0 1.0% 0 0 0 Pan 65 0 0 0.25% 0 0 Pan 80 0 0 0 0.87% Pan 85 0 0 0 0 0.10% Octoxynol 40 0 0.67% 0 0.63% 0 Tyloxapol 0 0 0.80% 0 0.40% Poloxamer 188 0.15% 0 0 0 0 trometamol 0.001% 0.10% 0.25% 0.25% 0.25% glycerin 3.0% 1.0% 1.50% 0.50% 1.50% water margin margin margin margin margin

[0052] Preparation:

[0053] 1) Dissolve Sp...

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PUM

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Abstract

The invention discloses an ophthalmic composition as well as a preparation method and application thereof, belongs to an ophthalmic solution, and relates to an ophthalmic composition. The ophthalmic composition comprises a cationic agent accounting for 0.001%-0.1% of the total mass of the composition, a first emulsion span accounting for 0.1%-1.0% of the total mass of the composition, a second emulsion accounting for 0.1%-0.5% of the total mass of the composition, an oil phase accounting for 0.1%-5% of the total mass of the composition, a pH regulator accounting for 0.001%-0.25% of the total mass of the composition, and an osmotic pressure regulator accounting for 0.5%-3% of the total mass of the composition, wherein the cationic agent is hexadecyl dimethyl benzyl ammonium chloride, and the second emulsion is octoxynol-40, tyloxapol or poloxamer 188. The compound emulsion of the cationic agent CKC, the first emulsion and the second emulsion has excellent compatibility, better stability and low irritation to eyes.

Description

technical field [0001] The invention belongs to an ophthalmic solution, relates to an ophthalmic composition, in particular to an ophthalmic composition and a preparation method and application thereof. Background technique [0002] Dry eye is mainly divided into two types: one is tear-deficiency dry eye, that is, tear secretion decreases and evaporates normally; the other is evaporative dry eye, that is, tear secretion is normal but evaporates too much, accounting for more than 80% of dry eye. crowd. Improving the quality and quantity of tears and forming a stable tear film is an active way to prevent and relieve dry eye. Artificial tears are mainly used to treat mild dry eye. The main product currently on the market is sodium hyaluronate artificial tears, but the tear film retention time of this product is not long enough, it needs to be dripped 5-6 times a day, and the patient's compliance is poor. defect. [0003] At present, there are very few oil-water emulsion arti...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K47/10A61K47/14A61K47/44A61K47/26A61K47/18A61P27/04A61P27/02
CPCA61K9/107A61K9/0048A61K47/10A61K47/14A61K47/44A61K47/26A61K47/186A61P27/04A61P27/02
Inventor 李勇乔玉峰王静王稳定
Owner 山西利普达医药科技有限公司
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