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Timolol maleate ion exchange resin compound insitu gel preparation and preparation method thereof

A technology of timolol maleate and ion exchange resin, which is applied in the field of ophthalmic ion exchange resin instant gel preparation and preparation, can solve problems such as difficulty in achieving drug sustained-release effect, and can prolong retention time and improve treatment Effect, effect of prolonged retention time

Inactive Publication Date: 2014-12-10
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is difficult to achieve a sustained drug release effect for a long enough time by only using gellan gum as the matrix instant gel

Method used

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  • Timolol maleate ion exchange resin compound insitu gel preparation and preparation method thereof
  • Timolol maleate ion exchange resin compound insitu gel preparation and preparation method thereof
  • Timolol maleate ion exchange resin compound insitu gel preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] prescription:

[0051] Timolol maleate 3.4g; Ion exchange resin 6.8g; Osmotic pressure regulator mannitol 30g; Gel matrix gellan gum 3g; Viscosity regulator xanthan gum 2g; Preservative benzalkonium chloride 0.1g; The pH of the system is tris(hydroxymethyl)aminomethane of 6.13, supplemented with 1000 g of water for injection.

[0052] The ion exchange resin is sodium polystyrene sulfonate cation exchange resin with a particle size of 10 μm;

[0053] Preparation:

[0054] (1) Dissolve timolol maleate in an appropriate amount of water for injection, add ion exchange resin, stir magnetically at 40°C for 1 hour to obtain drug-loaded resin suspension, centrifuge, collect sediment, wash, and dry to obtain drug resin complex;

[0055] (2) Add appropriate amount of water for injection to gellan gum, heat and stir to dissolve. Add drug resin complex after cooling, then add preservative, viscosity regulator, osmotic pressure regulator, stir to dissolve;

[0056](3) Add water...

Embodiment 2

[0058] prescription:

[0059] Timolol maleate 3.4g; Ion exchange resin 3.4g; Mannitol 40g; Gellan gum 4g; .

[0060] The ion exchange resin is a styrene cation exchange resin with a particle size of 15 μm;

[0061] The preparation method is the same as in Example 1. Wherein: in step (3), add water for injection to close to 980g, add tris(hydroxymethyl)aminomethane to adjust pH to be 6.15, make up water for injection to 1000g, promptly make described timolol maleate ion exchange resin Instant gel.

Embodiment 3

[0063] Prescription: Timolol maleate 3.4g; Ion exchange resin 1.7g; Mannitol 40g; Gellan gum 4g; Xanthan gum 1g; Benzalkonium chloride 0.1g; base) aminomethane, supplemented with water for injection 1000g.

[0064] The preparation method is the same as in Example 1. Wherein: in step (3), add water for injection to nearly 980g, add tris(hydroxymethyl)aminomethane to adjust pH to 6.12, replenish water for injection to 1000g, promptly make described maleic acid Timolol ion exchange resin instant gel.

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Abstract

The invention discloses a timolol maleate ion exchange resin compound insitu gel preparation and a preparation method thereof. The timolol maleate ion exchange resin compound insitu gel preparation is characterized in that 2.0g to 7.0g of timolol maleate and 1.0g to 14g of ion exchange resin are contained in 1000g of timolol maleate ion exchange resin compound insitu gel preparation. The timolol maleate ion exchange resin compound insitu gel preparation is prepared by virtue of combination of slow release of the ion exchange resin and a double-controlled release mechinsm of an insitu gel, wherein the insitu gel is formed by combining two mechanisms of positive ion sensitivity and lysozymes (protein) sensitivity, so that the residence time of the insitu gel preparation in eyes is obviously prolonged. Thus, the treatment effect of the insitu gel preparation is improved and the application frequency of the insitu gel preparation is reduced, thereby bringing convenience for a patient when the patient uses the insitu gel preparation. In addition, the whole-body side effects of the insitu gel preparation are obviously decreased.

Description

technical field [0001] The invention relates to an instant ophthalmic ion exchange resin gel preparation and a preparation method, that is, an ophthalmic instant gel preparation containing timolol maleate ion exchange resin complex and a preparation method. Background technique [0002] Glaucoma is a common eye disease characterized by persistent or intermittent elevated intraocular pressure. High intraocular pressure can cause damage to eye tissue and visual function. If it cannot be treated in time, it will cause vision loss or visual function damage, and severe cases can cause blindness. Glaucoma is one of the three major blindness diseases that cause blindness in humans. The incidence rate is about 0.21% to 1.64%, and it is as high as 3.5% for people over 40 years old. The treatment of glaucoma is a major clinical challenge. [0003] Timolol maleate is a potent non-selective β-receptor blocker, without endogenous sympathomimetic activity, without direct cardiac inhibiti...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K31/5377A61K47/36A61K47/38A61K47/32A61P27/06
Inventor 王健郭家旺侯惠民
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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