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Ophthalmic preparation for treating macular edema, optic neuritis and non-infectious entophthalmia through eye drop administration

An ophthalmic preparation and preparation technology, applied in the direction of medical preparations with non-active ingredients, non-central analgesics, medical preparations containing active ingredients, etc., can solve the problems of poor drug delivery, difficulty in effectively treating fundus diseases, and difficult Taking into account safety and effectiveness and other issues, to achieve the effect of small dosage, avoid systemic toxic and side effects, and increase 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

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.
[0008] In summary, the existing main drug delivery methods for the treatment of macular edema and other fundus diseases are difficult to balance safety and effectiveness

Method used

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  • Ophthalmic preparation for treating macular edema, optic neuritis and non-infectious entophthalmia through eye drop administration
  • Ophthalmic preparation for treating macular edema, optic neuritis and non-infectious entophthalmia through eye drop administration
  • Ophthalmic preparation for treating macular edema, optic neuritis and non-infectious entophthalmia through eye drop administration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0088] Embodiment 1, the preparation of ophthalmic preparation of the present invention

[0089] Weigh 0.24g CMC-Na (sodium carboxymethylcellulose, ionic polymer) according to Table 1 and add it to a glass conical flask containing 40mL of pure water, turn on magnetic stirring for 2 hours to obtain solution 1; weigh 1.0g respectively Add polysorbate 80 (surfactant) and 0.24g HPMC (hydroxypropyl methylcellulose, thickener) to a glass conical flask containing 60mL of purified water, turn on magnetic stirring, and heat in a water bath at about 40°C for 1.5 hours. Solution 2 was obtained; 40 mg of dexamethasone and 4 mL of PEG400 (i.e. 4.3 times the amount of surfactant (w / w)) were weighed and put into solution 2, continued heating and stirring for 30 minutes, added solution 1, and stirred for 30 minutes to obtain a mixed solution; Disperse the mixed liquid with a dispersing machine at a speed of 9500 for 5 minutes, stop the machine until the foam disappears, and filter it with a B...

Embodiment 2

[0094] Embodiment 2, the preparation of ophthalmic preparation of the present invention

[0095] The preparation method refers to Example 1, and the raw materials and dosage are shown in Table 1. A colorless and clear solution after removal of impurities was obtained.

[0096] pH adjustment: adjust to pH 6.5 with 0.2N NaOH or / and 0.1N HCl.

[0097] The HPLC detection method is the same as in Example 1, and the HPLC content detection result: 95.1%, particle diameter 12.9nm (92.1%), PdI: 0.509; stability is good, and the appearance and content have no obvious change after being placed at room temperature in the dark for 1 month; 2 A small amount of precipitation appeared after one month.

[0098] The concentration of API in rat vitreous body 1 hour after eye drops was 13.9ng / g, RSD: 17.2%.

Embodiment 3

[0099] Embodiment 3, the preparation of ophthalmic preparation of the present invention

[0100] Refer to Example 1 for the preparation method and pH and osmotic pressure adjustment method. The raw materials and dosage are shown in Table 1, and a light yellow clear solution after impurity removal is obtained.

[0101] HPLC detection: Column: ZORBAX Eclipse Plus C18, 4.6x100mm 3.5μm; mobile phase A: 0.1% phosphoric acid, mobile phase B: methanol (80:20) isocratic elution, Temp.: 35°C, detection wavelength: 280nm, Flowrate : 0.8ml / min; test result: 98.4%. Particle size: 39.7nm (95.5%), PdI: 0.318; stored in the dark at room temperature for 1 month, no change in appearance and content.

[0102] The concentration of API in rat vitreous was 78.3ng / g 0.5 hours after eye drops.

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Abstract

The invention provides an ophthalmic preparation for treating macular edema, optic neuritis and non-infectious entophthalmia. The ophthalmic preparation is composed of an active ingredient for treating eye diseases and an ophthalmic preparation carrier or auxiliary material; the active ingredientfor treating the eye diseases is a glucocorticoid medicine and / or a non-steroidal medicine; the ophthalmic preparation carrier or auxiliary material comprises the following ingredients: a surfactant, an ionic polymer and a solvent, or the ophthalmic preparation carrier or auxiliary material contains the following ingredients: povidone with low polymerization degree, povidone with medium polymerization degree and a solvent. The ophthalmic preparation can carry (wrap) the glucocorticoid and / or the non-steroidal medicines to penetrate through the anterior segment of the eye and be conveyed to the posterior segment of the eye to treat the macular edema, the optic neuritis and the non-infectious entophthalmiain 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 drugs, in particular to an ophthalmic preparation for treating macular edema, optic neuritis and non-infectious endophthalmitis by eye drops. 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, endophthalmitis, etc., may lead to vision loss or even blindness, seriously affecting people's quality of life. For example, about 6.8% of diabetic patients suffer from diabetic macular edema (DME), which is the main cause of blindness in diabetic patients (Urias et al., VisionResearch, V139:221-227, 2017; Mandal et al....

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K45/00A61K47/32A61K47/38A61K31/573A61K47/26A61K47/10A61P27/02A61P9/10A61P29/00
CPCA61K9/08A61K9/0048A61K45/00A61K47/38A61K47/26A61P27/02A61P29/00A61P9/10A61K47/10A61K47/32A61K31/573Y02A50/30
Inventor 董庆张舒成旋薛陆兵
Owner CHENGDU RUIMU BIO PHARM TECH CO LTD
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