A kind of eye drops for treating glaucoma and preparation method thereof

A technology for eye drops and glaucoma, applied in the field of medicine, can solve the problems of poor water solubility and stability of tafluprost and low solubility of tafluprost

Inactive Publication Date: 2021-09-14
陈丽娜
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In view of the poor water solubility and stability of tafluprost, the object of the present invention is to provide an eye drop for the treatment of glaucoma and a preparation method thereof, thereby solving the problem of low solubility of tafluprost in the preparation process At the same time, it can improve the stability of tafluprost in aqueous solution and reduce the formation of related substances, so as to achieve the purpose of safe and effective treatment of glaucoma

Method used

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  • A kind of eye drops for treating glaucoma and preparation method thereof
  • A kind of eye drops for treating glaucoma and preparation method thereof
  • A kind of eye drops for treating glaucoma and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A method for treating glaucoma eye drops, the formula is:

[0028] Tafluprost 0.0375g

[0029] Modified polylysine 1.05g

[0030] Citric acid 1.25g

[0031] Water for injection 1000mL, pH was adjusted to 6.7.

[0032] Preparation:

[0033] Step a: at 10 ℃, weighed formula amounts of tafluprost, water for injection was added, with stirring to form an emulsion, addition of modified polylysine, forming nano-micelles was stirred;

[0034] Step two: at 10 ℃, the citric stabilizer is dissolved with water for injection to obtain an aqueous solution of citric acid stabilizer;

[0035] Step Three: at 10 ℃, the stabilizer is citric acid aqueous solution obtained in step a mixed micelle, and then water for injection was added, stirred and dissolved;

[0036] Step Four: adjusting the pH to 6.7, sterile water for injection was added to 1000mL, filling filtered, dried to give 125 ℃ autoclaving the finished formulation.

Embodiment 2

[0038] A method for treating glaucoma eye drops, the formula is:

[0039] Tafluprost 0.040g

[0040] Modified polylysine 2.5g

[0041] Ascorbic acid 1.25g

[0042] Water for injection 1000mL, adjusted to pH 6.7

[0043] Preparation:

[0044] Step a: at 10 ℃, weighed formula amounts of tafluprost, water for injection was added, with stirring to form an emulsion, addition of modified polylysine, forming nano-micelles was stirred;

[0045] Step two: at 10 ℃, the stabilizers of ascorbic acid were dissolved with water for injection to obtain an aqueous solution of a stabilizer;

[0046] Step Three: at 10 ℃, the aqueous solution of step a stabilizer resulting mixed micelles, and then water for injection was added, stirred and dissolved;

[0047] Step Four: adjusting the pH to 6.7, sterile water for injection was added to 1000mL, filling filtered, dried to give 125 ℃ autoclaving the finished formulation.

Embodiment 3

[0049] A method for treating glaucoma eye drops, the formula is:

[0050] Tafluprost 0.0425g

[0051] Modified polylysine 2.75g

[0052] Erythorbate 1.25g

[0053] Water for injection 1000mL, adjusted to pH 6.7

[0054] Preparation:

[0055]Step 1: At 10 ° C, weigh the equivalent of hefluofluorin, add water for injection, stirring to form an emulsion, add modified polylysine, stir, form a nanocomber;

[0056] Step 2: At 10 ° C, the stabilizer is dissolved with water for injection, and the aqueous solution of the stabilizer is as bad is obtained;

[0057] Step 3: At 10 ° C, the aqueous solution of the stabilizer is abbrevastation is mixed with the micelles obtained by the step, and then the injection water is added, stirred and dissolved.

[0058] Step 4: Adjust pH to 6.7, add water to 1000 ml, filtrate, and give a finished product by high temperature at 125 ° C.

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Abstract

The invention belongs to the technical field of medicine, and discloses an eye drop for treating glaucoma and a preparation method thereof. The eye drop contains tafluprost, modified polylysine and a stabilizer, wherein tafluprost The ethyl stearate in the modified polylysine is hydrophobic, can coat tafluprost, play a protective role to tafluprost, improve the stability of the drug, and solve other problems. Fluprostin is unstable in aqueous solution, has poor solubility and is easily absorbed by packaging containers; no additional preservatives are needed; and the modified polylysine can be biodegraded, which is relatively safe for the human body.

Description

[0001] technical background [0002] The present invention belongs to the technical field of medicine, and relates to a method for preparing an eye drop for the treatment of glaucoma. Background technique [0003] Glaucoma is a type of intraocular pressure (IOP) caused excessive damage to the optic nerve of the eye, is the world's second substantially blindness disease, irreversible blindness main reason. Currently, the treatment of glaucoma concept designed to reduce IOP, and efficient, the advent of new drugs without the side effects of prostaglandin derivative, bringing the gospel to glaucoma patients. Prostaglandin drug with good IOP lowering efficacy and excellent safety profile of patients and more and more popular, the domestic market has been a prostaglandin drug include latanoprost, travoprost, bimatoprost and his tafluprost. [0004] Tafluprost eye drops, eye drops generic name: TafluprostEyeDrops, molecular formula: C 25 Hide 34 Fly 2 O 5 Molecular weight: 452.53, having...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K47/34A61K47/14A61K47/12A61K47/22A61K31/216A61P27/06
CPCA61K9/0048A61K9/1075A61K31/216A61K47/12A61K47/14A61K47/22A61K47/34A61P27/06
Inventor 陈丽娜王信
Owner 陈丽娜
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