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Eye drops for treating glaucoma and preparation method thereof

A technology for eye drops and glaucoma, which is applied in the field of medicine, can solve the problems of low solubility of tafluprost, poor water solubility and poor stability of tafluprost, and achieve the effects of reducing impurities, improving curative effect and improving stability

Active Publication Date: 2020-10-30
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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  • Eye drops for treating glaucoma and preparation method thereof
  • Eye drops for treating glaucoma and preparation method thereof
  • Eye drops for treating glaucoma and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] An eye drop for treating glaucoma, its formula is:

[0028] Tafluprost 0.0375g

[0029] Modified polylysine 1.05g

[0030] Citric acid 1.25g

[0031] Water for injection 1000mL, adjust the pH to 6.7.

[0032] Preparation:

[0033] Step 1: at 10°C, weigh the amount of tafluprost in the formula, add water for injection, stir to form an emulsion, add modified polylysine, and form nano micelles after stirring;

[0034] Step 2: Dissolving the stabilizer citric acid with water for injection at 10°C to obtain an aqueous solution of the stabilizer citric acid;

[0035] Step 3: At 10°C, mix the aqueous solution of stabilizer citric acid with the micelles obtained in Step 1, then add water for injection, and stir to dissolve;

[0036] Step 4: Adjust the pH to 6.7, add sterilized water for injection to 1000mL, filter and fill, and sterilize at 125°C to obtain the finished preparation.

Embodiment 2

[0038] An eye drop for treating glaucoma, its formula is:

[0039] Tafluprost 0.040g

[0040] Modified polylysine 2.5g

[0041] Ascorbic acid 1.25g

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

[0043] Preparation:

[0044] Step 1: at 10°C, weigh the amount of tafluprost in the formula, add water for injection, stir to form an emulsion, add modified polylysine, and form nano micelles after stirring;

[0045] Step 2: Dissolving the stabilizer ascorbic acid with water for injection at 10°C to obtain an aqueous solution of the stabilizer;

[0046] Step 3: At 10°C, mix the aqueous solution of the stabilizer with the micelles obtained in Step 1, then add water for injection, and stir to dissolve;

[0047] Step 4: Adjust the pH to 6.7, add sterilized water for injection to 1000mL, filter and fill, and sterilize at 125°C to obtain the finished preparation.

Embodiment 3

[0049] An eye drop for treating glaucoma, its formula is:

[0050] Tafluprost 0.0425g

[0051] Modified polylysine 2.75g

[0052] Erythorbic acid 1.25g

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

[0054] Preparation:

[0055]Step 1: at 10°C, weigh the amount of tafluprost in the formula, add water for injection, stir to form an emulsion, add modified polylysine, and form nano micelles after stirring;

[0056] Step 2: Dissolving the stabilizer erythorbic acid in water for injection at 10°C to obtain an aqueous solution of the stabilizer erythorbic acid;

[0057] Step 3: At 10°C, mix the aqueous solution of the stabilizer erythorbic acid with the micelles obtained in Step 1, then add water for injection, and stir to dissolve;

[0058] Step 4: Adjust the pH to 6.7, add sterilized water for injection to 1000mL, filter and fill, and sterilize at 125°C to obtain the finished preparation.

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Abstract

The invention belongs to the technical field of medicines and discloses eye drops for treating glaucoma and a preparation method thereof. The eye drops comprise tafluprost, modified polylysine and a stabilizing agent, wherein the tafluprost is an active component, ethyl stearate in the modified polylysine has hydrophobicity and can coat the tafluprost to protect the tafluprost, the stability of the medicine is improved, and the problems that the tafluprost is unstable in an aqueous solution, poor in solubility and easy to absorb by a packaging container are solved; extra preservatives do not need to be added; and the modified polylysine can be biodegraded and is relatively safe to a human body.

Description

[0001] technical background [0002] The invention belongs to the technical field of medicine, and relates to an eye drop for treating glaucoma and a preparation method thereof. Background technique [0003] Glaucoma is a type of eye disease in which high intraocular pressure (IOP) causes damage to the optic nerve. It is the second most common cause of blindness and the leading cause of irreversible blindness in the world. At present, the treatment concept of glaucoma is aimed at reducing IOP, and the advent of new drug prostaglandin derivatives with high efficiency and no side effects has brought good news to glaucoma patients. Prostaglandin drugs are becoming more and more popular among patients due to their good effect of lowering intraocular pressure and excellent safety. Domestically marketed prostaglandin drugs include latanoprost, travoprost, bimatoprost and other Fluprostin. [0004] Tafluprost eye drops, common name of eye drops: Tafluprost EyeDrops, molecular for...

Claims

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Application Information

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IPC IPC(8): A61K9/107A61K47/34A61K47/14A61K47/12A61K47/22A61K31/216A61P27/06
CPCA61K9/0048A61K9/1075A61K31/216A61K47/12A61K47/14A61K47/22A61K47/34A61P27/06
Inventor 王信
Owner 陈丽娜
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