Timolol hydrogenmaleate eye drops and preparation method thereof

A technology of timolol acid ophthalmic solution and timolol maleate is applied in pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc. Poor stability and other problems, to achieve the effect of comfortable use, good stability, and no irritation

Inactive Publication Date: 2012-10-24
ANHUI GLOBAL PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Timolol maleate eye drops on the market are generally products without thickeners and stabilizers, and some use sodium chloride as isotonic agent, or hydroxypropyl methylcellulose as stabilizer and thickener. The stability of the above timolol maleate eye drops is relatively poor. During the spot check process, many products have white spots or white precipitates, which affect the clinical effect when used.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0058] A kind of timolol maleate eye drop, its preparation method comprises the following steps:

[0059] (1) Dissolve 3.42g of timolol maleate, 10ml of glycerin, 8.95g of disodium hydrogen phosphate, and 1.30g of sodium dihydrogen phosphate in 100ml of water for injection to obtain a medicinal solution. Heat the medicinal solution to boiling and stir for 15 minutes , cooling the liquid medicine to 40-50°C;

[0060] (2) Add 1ml of benzalkonium bromide to the cooled medicinal solution, stir evenly and filter to obtain the filtrate;

[0061] (3) Add water for injection to the filtrate to 1000ml, adjust the pH value to 6.9-7.2 with the pH regulator disodium hydrogen phosphate and sodium dihydrogen phosphate, and then filter back to the liquid medicine through a microporous filter with a pore size of 0.22 μm Clarity, inspection is qualified, promptly gets described timolol maleate eye drop.

[0062] What has been described above is an embodiment of the present invention. In thi...

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PUM

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Abstract

The invention provides timolol hydrogenmaleate eye drops, comprising timolol hydrogenmaleate, an isotonizing agent, a thickener, and a stabilizing agent, wherein glycerol is used as the isotonizing agent, the thickener and the stabilizing agent and plays a stabilizing role in the timolol hydrogenmaleate eye drops since glycerol has osmosis and thickening functions. According to the invention, glycerol is used as the isotonizing agent, the thickener and the stabilizing agent, and the effect that one raw material has multiple functions is achieved, so that the timolol hydrogenmaleate eye drops can be produced conveniently and can be applied comfortably without irritation; moreover, since glycerol which is used as the isotonizing agent, the thickener and the stabilizing agent in the timolol hydrogenmaleate eye drops, the stability of the medicine is increased and the clinical functions of the timolol hydrogenmaleate eye drops are ensured. In addition, the invention also provides a preparation method of the timolol hydrogenmaleate eye drops.

Description

technical field [0001] The invention relates to a timolol maleate eye drop and a preparation method thereof. Background technique [0002] Timolol maleate eye drops are ophthalmic medicines for preventing and treating glaucoma and reducing intraocular pressure. Timolol maleate eye drops on the market are generally products without thickeners and stabilizers, and some use sodium chloride as isotonic agent, or hydroxypropyl methylcellulose as stabilizer and thickener. The stability of the aforementioned timolol maleate eye drops is relatively poor. During the spot check process, many products have white spots or white precipitates, which affect the clinical effect when used. Contents of the invention [0003] The technical problem to be solved in the present invention is to provide a kind of timolol maleate eye drop, require the good stability of this timolol maleate eye drop; In addition, also need to provide this timolol maleate The preparation method of Lol eye drops. ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/5377A61K47/10A61P27/06
Inventor 朱兆友
Owner ANHUI GLOBAL PHARM CO LTD
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