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A kind of tafluprost eye drop and preparation method thereof

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

Active Publication Date: 2018-07-17
苏州工业园区天龙制药有限公司
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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 a stable tafluprost-containing Eye drops of prostaglandin and preparation method thereof, thereby solving the problem of low solubility of tafluprost in the preparation process, improving the stability of tafluprost in aqueous solution and reducing the formation of related substances, so as to achieve safety , the purpose of effective treatment of glaucoma

Method used

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  • A kind of tafluprost eye drop and preparation method thereof
  • A kind of tafluprost eye drop and preparation method thereof
  • A kind of tafluprost eye drop and preparation method thereof

Examples

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Effect test

Embodiment 1

[0028] prescription:

[0029]

[0030] Preparation Process:

[0031] Weigh polyethylene glycol-15-hydroxystearate and dissolve it in water for injection, add tafluprost, stir to dissolve; take glycerin, EDTA-2Na, benzalkonium chloride, and disodium hydrogen phosphate and dissolve in boiling water In the water for injection, stir to dissolve; after cooling to room temperature, combine the two liquids, filter, dilute with water for injection to prepare the full amount, adjust the pH to 6.0, filter through a 0.22μm microporous filter membrane, and aseptically fill in plastic eye drops Get it in a water bottle.

Embodiment 2

[0033] prescription:

[0034]

[0035]

[0036] Preparation Process:

[0037] Weigh polyethylene glycol-15-hydroxystearate and dissolve it in water for injection, add tafluprost, stir to dissolve; take sodium chloride, EDTA-2Na, benzalkonium chloride, disodium hydrogen phosphate and dissolve in In boiling water for injection, stir to dissolve; after cooling to room temperature, combine the two liquids, filter, dilute with water for injection to prepare the full volume, adjust the pH to 6.0, filter through 0.22μm microporous membrane, sterile filling in plastic Get it in eye drops bottle.

Embodiment 3

[0039] prescription:

[0040]

[0041] Preparation Process:

[0042] Weigh polyethylene glycol-15-hydroxystearate and dissolve it in water for injection, add tafluprost, stir to dissolve; take glycerin, EDTA-2Na, ethyl p-hydroxybenzoate, and disodium hydrogen phosphate and dissolve in In boiling water for injection, stir to dissolve; after cooling to room temperature, combine the two liquids, filter, dilute with water for injection to prepare the full volume, adjust the pH to 6.0, filter through 0.22μm microporous membrane, sterile filling in plastic Get it in eye drops bottle.

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Abstract

The invention relates to a tafluprost eye drop and a preparation method thereof. The eye drop takes tafluprost as an active ingredient and also contains a non-ionic solubilizer and a pharmaceutically acceptable carrier, wherein the non-ionic solubilizer is polyethylene glycol-15-hydroxyl stearate. According to the invention, the problem of low solubility of tafluprost in the preparation process can be solved, the stability of tafluprost in an aqueous solution can be increased, and formation of related substances is reduced.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and relates to a new prostaglandin anti-glaucoma pharmaceutical preparation, specifically a tafluprost eye drop and a preparation method thereof. Background technique [0002] Glaucoma is a type of eye disease that causes optic nerve damage due to excessive intraocular pressure (IOP). It is the world's second most common blindness and the main cause of irreversible blindness. At present, the treatment concept of glaucoma is aimed at reducing IOP, and the advent of high-efficiency and no side effects new drugs prostaglandin derivatives has brought good news to glaucoma patients. Prostaglandin drugs are becoming more and more popular with patients for their good effect of lowering intraocular pressure and excellent safety. Prostaglandin drugs that have been marketed in China include latanoprost, travoprost and tafluprost. [0003] Tafluprost is a selective FP prostaglandin receptor agonist jointly devel...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/216A61K47/14A61P27/06
CPCA61K9/0048A61K9/08A61K31/216A61K47/14
Inventor 侯宇华
Owner 苏州工业园区天龙制药有限公司
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