Ophthalmic preparation for preventing and treating dry maculopathy and retina light damage through eye drop administration

An ophthalmic preparation and preparation technology, applied in the field of ophthalmic drugs, can solve the problems of difficult to achieve effective treatment of ocular fundus diseases, difficult to enter the therapeutic concentration of the posterior segment of the eye, difficult to balance safety and effectiveness, etc., to avoid systemic side effects and properties. The effect of stabilizing and increasing medical compliance

Active Publication Date: 2021-12-17
CHENGDU RUIMU BIO PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

During this process, due to the dilution of tears, the ocular surface barrier of cornea and conjunctiva, and the barrier of lens and vitreous body, eye drops are often concentrated in the tissues of the anterior segment, and it is difficult to enter the posterior segment of the eye and reach an effective therapeutic concentration.
Therefore, although the way of conjunctival sac administration is safe, the drug delivery is poor, and it is difficult to achieve the purpose of effectively treating fundus diseases.
[0010] In summary, the existing main drug administration methods for the treatment of dry macular degeneration and other fundus diseases are difficult to balance safety and effectiveness

Method used

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  • Ophthalmic preparation for preventing and treating dry maculopathy and retina light damage through eye drop administration
  • Ophthalmic preparation for preventing and treating dry maculopathy and retina light damage through eye drop administration
  • Ophthalmic preparation for preventing and treating dry maculopathy and retina light damage through eye drop administration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] Embodiment 1, the preparation of ophthalmic preparation of the present invention

[0088] Preparation method: Weigh 60mg of CMC-Na (sodium carboxymethylcellulose, ionic polymer) according to Table 1 and add it into a glass conical flask containing 10mL of pure water, turn on magnetic stirring for 2 hours to obtain solution 1; Add 0.3g of polysorbate 80 (surfactant) and 0.12g of HPC (low-substituted hydroxypropyl cellulose, thickener) into a glass conical flask containing 20mL of purified water, turn on magnetic stirring, and heat in a water bath at about 40°C for 1.5 hour, to obtain solution 2; weigh 15 mg of metformin hydrochloride and put it into solution 2, continue heating and stirring for 30 minutes, add solution 1, and stir for 30 minutes to obtain a mixed solution; disperse the mixed solution at a speed of 9500 for 5 minutes with a disperser, and stop the machine for 5 minutes. After the foam disappears, use a Buchner funnel to filter under reduced pressure to ob...

Embodiment 2

[0091] Embodiment 2, the preparation of ophthalmic preparation of the present invention

[0092] The preparation method refers to Example 1, and the raw materials and dosage are shown in Table 1, and a colorless and clear solution after removal of impurities is obtained.

[0093] pH and osmotic pressure adjustment: adjust to pH 6.5 with 1N sodium citrate solution, add sodium chloride to adjust osmotic pressure to: 297mOsmol / kg.

[0094] HPLC detection: Column: ZORBAX 300SB-CN, 2.1x150mm, 5μm; mobile phase: 40mM KH 2 PO 4 (pH4.5): Methanol (75:25) isocratic elution, Temp.: 35°C, detection wavelength: 233nm, Flowrate: 0.8ml / min; detection result: 99.1%.

[0095] The particle size is 21.6nm (94.4%), PdI: 0.206; the appearance and content have no obvious change after being stored at room temperature in the dark for 1 month.

[0096] The concentration of API in the vitreous body of rats 1 hour after eye drops was: 39.8±16.6ng / g.

Embodiment 3

[0097] Embodiment 3, the preparation of ophthalmic preparation of the present invention,

[0098] The preparation method refers to Example 1, and the raw materials and dosage are shown in Table 1, and a colorless and clear solution after removal of impurities is obtained. pH test result: 6.9, close to isotonic, no need to adjust.

[0099] The HPLC detection method is the same as in Example 1, and the detection result: 98.6%.

[0100] The particle size is 16.6nm (98.6%), PdI: 0.227, and the appearance and content have no obvious change after being stored in the dark at room temperature for 1 month.

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Abstract

The invention provides an ophthalmic preparation for preventing and treating dry maculopathy and retina light damage. The ophthalmic preparation consists of an active ingredient for treating eye diseases and an ophthalmic preparation carrier or auxiliary material; the active ingredient for treating eye diseases is an adenylate activated protein kinase activator and/or an anti-inflammatory active ingredient; and the ophthalmic preparation carrier or auxiliary material comprises the following ingredients: a surfactant, an ionic polymer and a solvent. The ophthalmic preparation can carry (wrap) the adenylate activated protein kinase activator and/or the anti-inflammatory active ingredient to penetrate through the anterior segment of the eye and be conveyed to the posterior segment of the eye to prevent and treat dry maculopathy and retina light damage in an eye drop administration mode, and the ophthalmic preparation has extremely excellent clinical use value and very positive social significance.

Description

technical field [0001] The invention belongs to the field of ophthalmic medicines, and in particular relates to an ophthalmic preparation for preventing dry macular degeneration and retinal light damage by eyedrop administration. Background technique [0002] There are many patients with fundus diseases, and the number of patients in China alone has exceeded tens of millions. With the aging society and the popularization of electronic products, the incidence rate will increase year by year; common fundus diseases include diabetic macular edema, diabetic retinopathy, age Related macular degeneration, retinal vein occlusion, pathological myopia, geographic atrophy, eye tumors, non-infectious endophthalmitis, etc., may lead to vision loss or even blindness, seriously affecting people's quality of life. [0003] Age-related macular degeneration (AMD) is divided into dry and wet forms. Dry AMD is characterized by geographic atrophy, and wet AMD is characterized by choroidal neova...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K45/00A61K47/32A61K47/38A61K47/26A61K31/155A61P9/10A61P27/02A61P29/00
CPCA61K9/08A61K9/0048A61K45/00A61K47/38A61K47/26A61P27/02A61P29/00A61P9/10A61K47/10A61P31/12A61P31/02A61P31/04A61P31/10A61P27/10A61P27/06A61P37/02A61P35/00Y02A50/30
Inventor 董庆张舒成旋薛陆兵
Owner CHENGDU RUIMU BIO PHARM TECH CO LTD
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