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Ophthalmic composition as well as preparation method and application thereof

An ophthalmic composition, the technology of the composition, applied in the directions of drug combination, medical preparation of inactive ingredients, drug delivery, etc., can solve the problems of obstructing the field of vision, unfavorable application, etc., to improve compliance, improve solubility, and reduce ocular irritating effect

Active Publication Date: 2021-11-02
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

[0005] However, there are certain defects in the use and promotion of artificial tears with emulsion as the carrier. For example, lipid nanoemulsion artificial tears, because the emulsion is milky white, maintains a milky white and opaque state when used, which may cause problems that hinder vision. unsuitable for application to the eye

Method used

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  • Ophthalmic composition as well as preparation method and application thereof
  • Ophthalmic composition as well as preparation method and application thereof
  • Ophthalmic composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Compositions were prepared according to the components shown in Table 1, and four compositions of Group 1, Group 2, Group 3 and Group 4 were obtained respectively.

[0033] Table 1

[0034]

[0035] Preparation:

[0036] 1) Dissolve PEG-35 hydrogenated castor oil and / or PEG 400 in the oil phase;

[0037] 2) Dissolve CKC, osmotic pressure regulator glycerol and tromethamine in the water phase;

[0038] 3) Heat the water phase and oil phase to an appropriate temperature of 75-85°C, slowly pour the oil phase into the water phase under rapid mechanical stirring, continue stirring for 20 minutes, add water for injection to the full amount, and mix homogeneously with high shear for at least After 30 minutes, the oil droplets were reduced as much as possible, and the pH value was adjusted to 6.2 with dilute hydrochloric acid.

[0039] PEG-35 hydrogenated castor oil can be replaced by PEG-20 hydrogenated castor oil or PEG-40 hydrogenated castor oil, and PEG400 can be repl...

Embodiment 2

[0043] Compositions were prepared according to the components shown in Table 2, and four compositions of comparison group 1, comparison group 2, comparison group 3 and comparison group 4 were obtained respectively.

[0044] Table 2

[0045]

[0046] The 4 groups of compositions of Example 1, and the 4 groups of comparative compositions of Example 2 were prepared into compositions according to the same method, under the packaging conditions of low-density polyethylene plastic vials, at a temperature of 40 ° C ± 2 ° C, Place it in an environment with a relative humidity of 20±5% for 6 months, and check the appearance regularly. The test results are shown in Table 3:

[0047] table 3

[0048]

[0049] As can be seen from Table 3, the ionic agent CKC of the present invention has excellent compatibility with polyoxyethylene hydrogenated castor oil and / or polyethylene glycol compound emulsion, and the transparent emulsion dosage form of appearance is preserved for a long time...

Embodiment 3

[0051] Compositions were prepared according to the components shown in Table 4, and 4 groups of compositions were obtained respectively.

[0052] Table 4

[0053]

[0054] Preparation:

[0055] 1) Dissolve PEG-20 hydrogenated castor oil or PEG-40 hydrogenated castor oil or PEG 200 in the oil phase;

[0056] 2) Dissolving CKC, osmotic pressure regulator glycerin and tromethamine in the water phase;

[0057] 3) Heat the water phase and oil phase to an appropriate temperature of 75-85°C, slowly pour the oil phase into the water phase under rapid mechanical stirring, continue stirring for 20 minutes, add water for injection to the full amount, and mix homogeneously with high shear for at least After 30 minutes, the oil droplets were reduced as much as possible, and the pH value was adjusted to 6.2 with dilute hydrochloric acid.

[0058] Put the above 4 kinds of compositions under the condition of packaging in low-density polyethylene plastic vials, place them for 3 months in...

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Abstract

The invention discloses an ophthalmic composition as well as a preparation method and the application thereof, and relates to an ophthalmic composition. The ophthalmic composition is in a transparent oil-in-water emulsion dosage form, the average particle size of emulsion droplets is smaller than 100 nm, the particle size of 90% of the emulsion droplets is not larger than 200 nm, and the ophthalmic composition comprises the following components in parts by weight: a first surfactant accounting for 0.1%-4.0% of the total mass of the composition, hexadecyl dimethyl benzyl ammonium chloride (CKC) accounting for 0.001%-0.1% of the total mass of the composition, an oil phase accounting for 0.5%-2% of the total mass of the composition. The pH regulator accounts for 0.001%-0.25% of the total mass of the composition, the osmotic pressure regulator accounts for 1.0%-3% of the total mass of the composition, and the balance is water. According to the invention, the transparency problem of the cationic oil-in-water emulsion ophthalmic composition is solved, the irritation to eyes is low, and the use compliance of patients is improved.

Description

technical field [0001] The invention relates to an ophthalmic composition, in particular to a transparent emulsion type ophthalmic composition and its preparation method and application. Background technique [0002] Dry eye is currently the most common ocular surface disease clinically. It is a type of disease that causes ocular discomfort due to the decrease of tear film stability and the imbalance of ocular surface environment. It may be accompanied by ocular tissue damage and other symptoms. According to the survey, the incidence rate of dry eye syndrome in my country is as high as 21.0%~30.0%. Severe cases can cause a significant decrease in vision and affect their normal work and life. Therefore, dry eye syndrome has been paid more and more attention by people, and it has also attracted the attention of ophthalmology clinicians. [0003] Artificial tears are the most commonly used medicine for the treatment of dry eye, that is, imitation artificial tears are used to f...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K47/44A61K47/10A61K47/14A61K47/18A61P27/02A61P27/04
CPCA61K9/1075A61K9/0048A61K47/44A61K47/10A61K47/14A61K47/186A61P27/02A61P27/04Y02A50/30
Inventor 李勇王静李晴晴王稳定
Owner 山西利普达医药科技有限公司
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