CN-121971382-A - Use of ophthalmic formulations containing recombinant human beta-nerve growth factor

Abstract

The invention discloses an application of an ophthalmic preparation containing recombinant human beta-nerve growth factor, which can be used for treating dry eye, wherein the ophthalmic preparation containing recombinant human beta-nerve growth factor comprises 5-1000 mug/ml of recombinant human beta-nerve growth factor, 20-70mg/ml of trehalose, 5-30mg/ml of mannitol and 1-13mg/ml of polyvinyl alcohol.

Inventors

• LI SHUGANG
• YU TINGHE
• JIANG DUYUN
• LIU TAO
• YUAN XUE
• XIN YU
• YANG DANDAN

Assignees

• 重庆科润生物医药研发有限公司

Dates

Publication Date

20260505

Application Date

20241030

Claims (5)

1. 1. Use of an ophthalmic formulation comprising a recombinant human β -nerve growth factor comprising 5-1000 μg/ml recombinant human β -nerve growth factor, 20-70mg/ml trehalose, 5-30mg/ml mannitol and 1-13mg/ml polyvinyl alcohol in the manufacture of a medicament for treating dry eye.
2. 2. The use according to claim 1, wherein the ophthalmic preparation further comprises L-methionine and/or cysteine in an amount of 0.01-0.1mg/ml.
3. 3. The ophthalmic formulation of claim 1, further comprising polyethylene glycol having a molecular weight of 4000 to 8000, the polyethylene glycol being present in an amount of 5 to 25mg/ml.
4. 4. The ophthalmic formulation of claim 1, further comprising a buffer selected from at least one of phosphate, citrate, and histidine.
5. 5. The use according to claim 1, wherein the ophthalmic formulation has a pH of 6.5-7.5.

Description

Use of ophthalmic formulations containing recombinant human beta-nerve growth factor Technical Field The invention belongs to the technical field of ophthalmic preparations, and in particular relates to an application of an ophthalmic preparation containing recombinant human beta-nerve growth factor. Background Nerve growth factor (nerve growth factor, NGF) is a cytokine that promotes the growth, development, differentiation, maturation and repair of central and peripheral neurons after nerve damage. Many in vitro and in vivo experimental studies show that NGF has better curative effects on treating some diseases of the visual system, such as optic neuropathy caused by retinitis pigmentosa, optic neuritis, ocular contusion, glaucoma, keratitis, dry eye and the like. Oxervate, recombinant human nerve growth factor (recombinant human NGF, rhNGF) eye drops, approved by the us FDA in 2018, are used for the treatment of neurotrophic keratitis, which can promote corneal epithelial repair and re-neuronize the cornea. In clinical trials, patients receiving Oxervate treatment reached 70% of the total cornea healing after 8 weeks. However, the active ingredient rhNGF of the product has poor stability, and the purity and content of the rhNGF are rapidly reduced under the conditions (such as illumination, refrigeration, high temperature and the like) to be used. According to Oxervate specifications, the product is stored at-20 ℃, can be stored at 2-8 ℃ for 1 week after being provided to a patient, and any unused drug stored at 2-8 ℃ for more than 1 week or left for more than 12 hours can no longer be used. Stringent usage requirements greatly limit patient accessibility and result in costly clinical usage. At present, there is a need to develop a recombinant human β -nerve growth factor ophthalmic formulation with significantly improved stability, so as to reduce the use cost of the recombinant human β -nerve growth factor-containing ophthalmic formulation, and reduce the medical burden of patients, which has an important significance for improving the accessibility of treatment for patients with cornea related lesions. Disclosure of Invention The invention aims to provide the application of an ophthalmic preparation containing recombinant human beta-nerve growth factor in preparing a medicine for treating dry eye, wherein the ophthalmic preparation containing the recombinant human beta-nerve growth factor comprises 5-1000 mug/ml of the recombinant human beta-nerve growth factor, 20-70mg/ml of trehalose, 5-30mg/ml of mannitol and 1-13mg/ml of polyvinyl alcohol. In some embodiments, the ophthalmic formulation further comprises L-methionine and/or cysteine in an amount of 0.01-0.1mg/ml. In some embodiments, the ophthalmic formulation further comprises polyethylene glycol having a molecular weight of 4000 to 8000, the polyethylene glycol being present in an amount of 5 to 25mg/ml. In some embodiments, the ophthalmic formulation further comprises a buffer selected from at least one of phosphate, citrate, and histidine. In some embodiments, the ophthalmic formulation has a pH of 6.5 to 7.5. Drawings Fig. 1 shows a schematic staining of conjunctival PAS, wherein the black arrows represent goblet cells. FIG. 2 shows the HE staining of the cornea, wherein A is normal cornea, B is corneal epithelial thickening, and stromal layer is seen as fibroblast proliferation, corneal stromal edema. Detailed Description Other advantages and effects of the present invention will become apparent to those skilled in the art from the following disclosure, which describes the embodiments of the present invention with reference to specific examples. The invention may be practiced or carried out in other embodiments that depart from the specific details, and the details of the present description may be modified or varied from the spirit and scope of the present invention. Before further describing embodiments of the invention, it is to be understood that the scope of the invention is not limited to the specific embodiments described below, and that the terminology used in the examples of the invention is intended to be in the nature of specific embodiments and is not intended to be limiting of the scope of the invention. Where numerical ranges are provided in the examples, it is understood that unless otherwise stated herein, both endpoints of each numerical range and any number between the two endpoints are significant both in the numerical range. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The invention does not limit the sources of the raw materials, if no special description exists, the adopted raw materials and auxiliary materials are all pharmaceutical grade commercial products, and the solvent is water for injection if no special description exists. Analytical methods in terms of the methods, the f