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Compound theophlline ketotifen sustained released tablet and preparation method thereof

A technology of compound tea ketone and sustained-release tablet, which can be applied to pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problem of electrolyte imbalance, poor asthma effect, and poor curative effect. and other problems, to achieve the effect of reducing the dosage and frequency of medication, high product quality and stability, and low side effects

Active Publication Date: 2017-07-04
DIAO GRP CHENGDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Salbutamol, Bricanyl, etc. have achieved great success in clinical short-term symptom relief, but it has been found that these drugs have poor effects on the delayed response of asthma and chronic asthma, and have rapid desensitization; glucocorticoids such as ground Cemethasone is ineffective in controlling the early symptoms of asthma, and after long-term use, it can cause endocrine disorders, high blood pressure, arteriosclerosis, gastrointestinal bleeding, electrolyte imbalance and other adverse reactions; Triene antagonists, cholinergic antagonists, etc., have a significant effect on the early response of asthma, but are not effective in the treatment of the delayed response of asthma and obstructive pulmonary disease.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Theophylline (as anhydrous theophylline) 200 g

[0034] Ketotifen Fumarate 1.38g

[0035] Ethylcellulose 15g

[0036] Carboxymethyl starch sodium 0.5g

[0037] Polyacrylic No. 2 90g

[0038] Magnesium stearate 2g

[0039] Preparation method: Take 200g of theophylline, 1.38g of ketotifen fumarate, 15g of ethyl cellulose, 0.5g of carboxymethyl starch, and 90g of polyacrylic acid resin No. 2, mix evenly, add an appropriate amount of ethanol to make granules, and store at 70°C Dry, add 2g of magnesium stearate, mix well, compress into tablets, and coat.

Embodiment 2

[0041] Theophylline (as anhydrous theophylline) 200 g

[0042] Ketotifen fumarate (calculated as ketotifen) 1.38g

[0043] Ethyl cellulose 30g

[0044] Carboxymethyl Starch Sodium 1g

[0045] Polyacrylic resin No. 2 60g

[0046] Magnesium stearate 3g

[0047] Preparation method: Take 200g of theophylline, 1.38g of ketotifen fumarate, 30g of ethyl cellulose, 1g of carboxymethyl starch, and 60g of polyacrylic acid resin No. 2, mix evenly, add an appropriate amount of ethanol to make granules, and dry at 70°C , adding 3g of magnesium stearate, mixing evenly, pressing into tablets, and coating.

Embodiment 3

[0049] Theophylline (as anhydrous theophylline) 200 g

[0050] Ketotifen fumarate (calculated as ketotifen) 1.38g

[0051] Ethylcellulose 40g

[0052] Sodium starch glycolate 1.5g

[0053] Polyacrylic No. 2 75g

[0054] Magnesium Stearate 4g

[0055] Preparation method: Take 200g of theophylline, 1.38g of ketotifen fumarate, 40g of ethyl cellulose, 1.5g of carboxymethyl starch, and 75g of polyacrylic acid resin No. 2, mix evenly, add an appropriate amount of ethanol to make granules, and store at 70°C Dry, add 4g of magnesium stearate, mix well, compress into tablets, and coat.

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PUM

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Abstract

The invention discloses a compound theophlline ketotifen sustained released tablet and a preparation method of the compound theophlline ketotifen sustained released tablet. The compound theophlline ketotifen sustained released tablet contains active ingredients and pharmaceutic adjuvants, wherein the active ingredients comprise theophylline and ketotifen fumarate, and the pharmaceutic adjuvants comprise ethyecellulose, carboxymethyl starch sodium, polyacrylic resin II, magnesium stearate and alcohol. The method provided by the invention is simple and feasible, the obtained product can permanently release the active ingredients, the plasma concentration is enabled to be stable, the variation range of the peak concentration and valley concentration is small, the taking dosage and times are reduced, and the side effects are small.

Description

technical field [0001] The invention relates to a slow-release medicine, in particular to a slow-release medicine composed of theophylline and ketotifen fumarate and a preparation method thereof. Background technique [0002] Asthma, chronic bronchitis, and airway obstructive pulmonary disease account for 10% of the total population. In the past thirty years, people have developed a large number of anti-asthma drugs and drugs for the treatment of chronic bronchitis. Salbutamol, Bricanyl, etc. have achieved great success in clinical short-term symptom relief, but it has been found that these drugs have poor effects on the delayed response of asthma and chronic asthma, and have rapid desensitization; glucocorticoids such as ground Cemethasone is ineffective in controlling the early symptoms of asthma, and after long-term use, it can cause endocrine disorders, high blood pressure, arteriosclerosis, gastrointestinal bleeding, electrolyte imbalance and other adverse reactions; T...

Claims

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Application Information

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IPC IPC(8): A61K31/522A61K31/4535A61K9/22A61K9/28A61K47/38A61K47/32A61K47/36A61K47/12A61P11/00A61P11/06
Inventor 颜霞晏梅
Owner DIAO GRP CHENGDU PHARMA
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