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Timolol hydrogenmaleate gel and preparation method thereof

A kind of timolol acid gel, gel technology, applied in the field of timolol maleate gel and preparation thereof, can solve the problems of difficult adhesion, poor permeability, inconvenient medication and the like

Active Publication Date: 2017-05-31
BEIJING MERSON PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The invention provides a timolol maleate gel for treating infantile hemangiomas and a preparation method thereof, which overcomes the difficulty in attaching timolol maleate eye drops to the patient site, poor permeability, and inconvenient medication Improve the patient's compliance and be more conducive to the treatment of infantile hemangioma

Method used

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  • Timolol hydrogenmaleate gel and preparation method thereof
  • Timolol hydrogenmaleate gel and preparation method thereof
  • Timolol hydrogenmaleate gel and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] A preparation method of timolol maleate gel (sample 1).

[0035] (1) Preparation of gel matrix: take 10.0g carbomer, add 650g water, stir, add 10% sodium hydroxide solution to adjust the pH value to 7.0-9.0, add 100g glycerin and 2.0g sodium benzoate, continue stirring until uniform, A gel matrix is ​​obtained. (2) Total mixing: Weigh 6.68g of timolol maleate (equivalent to 5.00g of timolol), dissolve it in 200g of water, add it to the gel matrix, and then add 5.0g of caprylic capric acid polyethylene glycol Glyceride and 5.0g of azone, adjust the pH value to 6.5-7.5 with 10% sodium hydroxide solution under stirring, and add water to 1000g. (3) Air bubble removal: Under slow stirring, vacuumize for 30 minutes to remove air bubbles. (4) Filling: Fill the prepared gel in the filling machine, and control the minimum filling amount to 20.0g / piece during filling.

Embodiment 2

[0037] A preparation method of timolol maleate gel (sample 2).

[0038] (1) Preparation of gel matrix: take 10.0g carbomer, add 650g water, stir, add 10% sodium hydroxide solution to adjust the pH value to 7.0-9.0, add 100g glycerin and 2.0g sodium benzoate, continue stirring until uniform, A gel matrix is ​​obtained. (2) Total mixing: Weigh 6.68g of timolol maleate (equivalent to 5.00g of timolol), dissolve it in 200g of water, add it to the gel matrix, and then add 5.0g of caprylic capric acid polyethylene glycol Glyceride and 15.0g of azone, adjust the pH value to 6.5-7.5 with 10% sodium hydroxide solution under stirring, and add water to 1000g. (3) Air bubble removal: Under slow stirring, vacuumize for 30 minutes to remove air bubbles. (4) Filling: Fill the prepared gel in the filling machine, and control the minimum filling amount to 20.0g / piece during filling.

Embodiment 3

[0040] A preparation method of timolol maleate gel (sample 3).

[0041] (1) Preparation of gel matrix: take 10.0g carbomer, add 650g water, stir, add 10% sodium hydroxide solution to adjust the pH value to 7.0-9.0, add 100g glycerin and 2.0g sodium benzoate, continue stirring until uniform, A gel matrix is ​​obtained. (2) Total mixing: Weigh 6.68g of timolol maleate (equivalent to 5.00g of timolol), dissolve it in 200g of water, add it to the gel matrix, and then add 5.0g of caprylic capric acid polyethylene glycol Glyceride and 25.0g of azone, adjust the pH value to 6.5-7.5 with 10% sodium hydroxide solution under stirring, and add water to 1000g. (3) Air bubble removal: Under slow stirring, vacuumize for 30 minutes to remove air bubbles. (4) Filling: Fill the prepared gel in the filling machine, and control the minimum filling amount to 20.0g / piece during filling.

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Abstract

The invention provides timolol hydrogenmaleate gel and a preparation method thereof. The content of the timolol hydrogenmaleate gel is 95.0 to 105.0 percent of the labeled amount, and the timolol hydrogenmaleate gel is transparent or semi-transparent hydrogel and has the pH value between 6.0 and 8.0. The timolol hydrogenmaleate gel disclosed by the invention is high in stability and non-stimulating to the skin and can achieve the medicinal effect through the skin.

Description

technical field [0001] The invention relates to a drug gel which can be used for treating infantile hemangioma and a preparation method thereof. Background technique [0002] Infantile hemangioma (IH) is the most common congenital benign vascular tumor in infants, with an incidence of about 4%. It is more common in newborns in women, and the incidence ratio of male to female is 1:3-1:5, about 60% occur in the head and neck. Although most infantile hemangiomas can gradually subside after a few years, they often leave epileptic scar tissue and cause dysfunction; those that occur on the face can also affect the appearance and bring a heavy psychological burden to the children and their parents. [0003] Infantile hemangiomas can cause deformities in the appearance of children and are difficult to eliminate. A small number of infantile hemangiomas proliferate rapidly and may be accompanied by ulcers, bleeding, infection, or dysfunction (vision, hearing, breathing, swallowing, e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K47/22A61K47/12A61K47/32A61K47/34A61K31/5377A61P35/00
CPCA61K9/06A61K31/5377A61K47/12A61K47/22A61K47/32A61K47/34
Inventor 赵锡龙李银博林秀
Owner BEIJING MERSON PHARMA CO LTD
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