Brimonidine d-tartrate ophthalmic gel preparation as well as preparation method and application thereof

A technology of brimonil for eye fixation and ophthalmic gel, which is applied in the direction of non-active ingredient medical preparations, active ingredient-containing medical preparations, pharmaceutical formulas, etc., can solve problems such as limited effects, and achieve reduction of toxic and side effects, Prolong the residence time and solve the effect of rapid metabolism

Inactive Publication Date: 2014-07-16
TIANJIN UNIV OF TRADITIONAL CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, although 0.1% and 0.15% brimonidine tartrate eye drops can reduce the adverse reactions of brimonidine

Method used

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  • Brimonidine d-tartrate ophthalmic gel preparation as well as preparation method and application thereof
  • Brimonidine d-tartrate ophthalmic gel preparation as well as preparation method and application thereof
  • Brimonidine d-tartrate ophthalmic gel preparation as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

Example 1

A brimonidine tartrate ophthalmic gel preparation was prepared, with a total mass of 100 g, of which, brimonidine tartrate was 0.01 g, 974P NF was 0.1 g, and the rest was water for injection.

The preparation method is as follows: (1) Prepare the gel matrix, add 0.1g 974P NF to 15g phosphate buffer under constant stirring, and stir evenly to obtain the gel matrix;

(2) Prepare a drug solution, gradually add 0.01 g of brimonidine tartrate to 5 g of water for injection, mix well, and prepare a drug solution;

(3) Mixing: The drug solution prepared in step (2) is added to the gel matrix prepared in step (1) under constant stirring, and the solution is filtered through a microporous membrane, and then injected from the membrane Use water to 100g.

Example Embodiment

Example 2-10

According to the method described in Example 1, the ophthalmic gel preparations in Examples 2 to 10 were prepared using the components and their weight parts as shown in Table 1, respectively; wherein, when a thickener is used, it is prepared The gel matrix is ​​added to the buffer together with the gel material in the step of gel matrix, and when isotonic regulators and preservatives are used, it is added to the water for injection together with brimonidine tartrate in the step of preparing the drug solution.

Table 1 Components and weight parts of ophthalmic gel preparations

Note: The thickeners HPMC E4M, HPMC F4M, HPMCK4M used in this example are products produced by Dow Chemical, and their trade names are Metoprolum. TM E4M, Madoxiu TM F4M, Midasiu TM K4M.

Testing and evaluation

Corneal retention time test

The inventors selected sodium fluorescein as the color-developing material, and took Example 1, Example 2, Example 3, Example 5, Example 7, and Example 10...

Example Embodiment

Example 1 170**±12 151**±8

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PUM

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Abstract

The invention discloses a brimonidine d-tartrate ophthalmic gel preparation, which is prepared from 0.01-7 parts by weight of brimonidine d-tartrate, 0.1-12 parts by weight of gel material and the balance of water for injection. The ophthalmic gel preparation can prolong the detection time of drugs in eyes, reduce medication times, improve bioavailablity and reduce toxic and side effects. The invention also discloses a preparation method and an application of the brimonidine d-tartrate ophthalmic gel preparation.

Description

technical field The invention relates to a medicine for reducing intraocular pressure, in particular to brimonidine tartrate ophthalmic gel preparation and its preparation method and application. Background technique Glaucoma is a disease characterized by sustained or indirect increase in intraocular pressure, visual field defect, optic disc depression and atrophy, and vision loss. Brimonidine tartrate is an α2-adrenergic agonist mainly used in the treatment of primary open-angle glaucoma and ocular hypertension. It has been reported in the literature that brimonidine tartrate is highly selective for α2-adrenergic receptors, has an obvious and long-lasting effect of lowering intraocular pressure, and has potential neuroprotective effects. It has a dual mechanism of action, that is, reduces intraocular pressure by reducing aqueous humor production and increasing scleral uveal outflow, and the effect of reducing intraocular pressure reaches its peak after 2 hours of medicati...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/498A61K47/38A61K47/36A61K47/32
Inventor 刘志东庞晓晨李楠高秀梅胡利民李佳玮祁东利
Owner TIANJIN UNIV OF TRADITIONAL CHINESE MEDICINE
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