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Dripping pills of ketotifen fumarate and its preparation method

A technology of ketotifen fumarate and ketone fumarate, which is applied in the direction of pill delivery, drug combination, allergic diseases, etc., can solve the problem of oral solution storage, transportation, inconvenient carrying, and influence on ketotifen fumarate Therapeutic effects, long disintegration time of tablets or capsules, etc., to achieve the effect of easy carrying and taking, small pill size and good compliance

Inactive Publication Date: 2005-04-06
HONGYI SCI & TECH CO LTD NANCHANG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Ketotifen fumarate has a bitter taste and is slightly soluble in water. Its oral solution is inconvenient to store, transport and carry, its quality is unstable, and it contains preservatives. The disintegration time of its tablets or capsules is long, and its dissolution rate and dissolution Low rate, poor absorption, low bioavailability, large proportion of excipients, inconvenient administration and poor compliance for children, the elderly, bedridden patients and patients with dysphagia, which affect the therapeutic effect of ketotifen fumarate

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0051] prescription:

[0052] Ketotifen Fumarate 1g

[0053] Macrogol 6000 20g

[0054] Makes 1000 capsules

[0055] Preparation method: Take the ketotifen fumarate fine powder that has been superfinely pulverized and passed through a 200 mesh sieve, add it to the molten polyethylene glycol 6000 matrix, stir well, use simethicone oil as a coolant, make pellets by drop method, and dry , that is.

example 2

[0057] prescription:

[0058] Ketotifen Fumarate 1g

[0059] Macrogol 4000 20g

[0060] Makes 1000 capsules

[0061] Preparation method: Take the ketotifen fumarate fine powder that has been ultrafinely pulverized and passed through a 200-mesh sieve, add it to the molten polyethylene glycol 4000 matrix, stir well, use simethicone as a coolant, make pellets by drop method, and dry , that is.

example 3

[0063] prescription:

[0064] Ketotifen Fumarate 1g

[0065] Macrogol 6000 10g

[0066] Macrogol 4000 10g

[0067] Makes 1000 capsules

[0068] Preparation method: Take the ketotifen fumarate fine powder that has been ultrafinely pulverized and passed through a 200-mesh sieve, add it to the molten polyethylene glycol 4000 and polyethylene glycol 6000 mixed matrix, stir well, and use simethicone oil as the coolant , drop into legal pills, dry, and get it.

[0069] 4. Example 4

[0070] prescription:

[0071] Ketotifen Fumarate 1g

[0072] Glyceryl monostearate 20g

[0073] Makes 1000 capsules

[0074] Preparation method: Take the ketotifen fumarate fine powder that has been ultrafinely pulverized and passed through a 200-mesh sieve, add it to the molten glyceryl monostearate matrix, mix well, use ice water as a coolant, make pellets by dropping, dry, Instantly.

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PUM

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Abstract

The invention ketotifen fumarate pill, prepared by superfine crushing and pill producing techniques, can achieve the purposes of increasing disintegration and dispersion speeds, and dissolving-out speed and degree, quickly taking effect, improving drug stability, reducing auxiliary use, reducing production cost, being convenient to carry and take. Its compliance is good and it is especially suitable for children, the aged, patients in bed and patients difficult in swallowing to take.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to ketotifen fumarate dropping pills and a preparation method thereof. Background technique [0002] Ketotifen fumarate is an anti-allergic drug, which is characterized by a strong H 1 Receptor antagonism and inhibition of release of allergic response mediators. Its antihistamine effect is about 10 times stronger than chlorpheniramine maleate (chlorpheniramine) and has a long-lasting effect. On the other hand, it not only inhibits the release of histamine and slow-response allergic substances from submucosal mast cells around the bronchi, but also inhibits the release of histamine and slow-response substances from eosinophils in the blood, resulting in a strong anti-allergic effect. In the human body, it can not only inhibit the release of histamine, slow-response allergic substances and other reaction media by mast cells and basophils in type I alle...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4535A61P37/08
Inventor 钱进许军彭红李平朱丹刘孝乐
Owner HONGYI SCI & TECH CO LTD NANCHANG
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