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Compound tranilast orally disintegrating tablet formulation and preparation method thereof

The technology of oral disintegrating tablet and preparation is applied in the field of compound tranister oral disintegrating tablet and its preparation field, which can solve the problems of β-receptor agonist insensitivity, drug resistance to asthma treatment, non-lasting effect, etc. Less residue, high bioavailability, fast onset effect

Inactive Publication Date: 2009-03-04
SHANGHAI NORMAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Disadvantages: the effect is not long-lasting, and it only plays a role in relieving the patient's asthma symptoms; long-term application can lead to down-regulation of β-receptors, making patients desensitized to β-receptor agonists, and even resistant to asthma treatment. Phenomenon
[0007] Ordinary tablets and capsules need to drink water and swallow to complete the medication process. This dosage form has poor compliance for some elderly, children, and patients with difficulty swallowing. In some Restricted use under special conditions (e.g. lack of drinking water)

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0030] Tranister 80g

[0031] Salbutamol Sulfate 2.4g

[0032] Low-substituted hydroxypropyl cellulose 10g

[0033] Microcrystalline Cellulose 20g

[0034] Lactose 60g

[0035] Magnesium stearate 0.3g

[0036] Micronized silica gel 3.2g

[0037] Sodium carbonate 20g

[0038] Stevia 10g

[0039] The preparation uses a direct compression process, and the specific preparation process is as follows: respectively crush stevioside and the main drug through an 80-mesh sieve, and mix the stevioside and the main drug evenly; microcrystalline cellulose, lactose, sodium carbonate, and low-substituted hypromellose The base cellulose was passed through 80 mesh sieves respectively, weighed according to the prescription amount and added to the main drug mixed with stevioside and mixed in turn, then added the prescription amount of magnesium stearate and micropowder silica gel respectively, sieved and mixed, and carried out intermediate rest. Content detection. After the weight of the...

example 2

[0041] Tranister 80g

[0042] Salbutamol Sulfate 2.4g

[0043] Sodium carboxymethyl starch 10g

[0044] Microcrystalline Cellulose 10g

[0045] Mannitol 60g

[0046] Micronized silica gel 0.3g

[0047] Talc powder 3.2g

[0048] Citric acid 25g

[0049] Aspartame 10g

[0050] The preparation adopts the wet granulation and tabletting process. The main drug and various auxiliary materials are passed through an 80-mesh sieve, and the prescribed amount of the main drug, aspartame, citric acid, carboxymethyl starch sodium, microcrystalline cellulose, and mannitol Mix, add appropriate amount of ethanol as a wetting agent, and fully mix the main ingredient and auxiliary materials in a wet state. Fully dry the above wet material in a blast drying oven, and sieve after drying. The obtained granules are fully mixed with lubricants and glidants to obtain intermediates. After measuring the content of the intermediates, calculate the tablet weight according to the content of the inter...

example 3

[0052] Tranister 80g

[0053] Salbutamol Sulfate 2.4g

[0054] Croscarmellose Sodium 15g

[0055] Microcrystalline Cellulose 25g

[0056] Sucrose 35g

[0057] Magnesium stearate 0.3g

[0058] Talc powder 3.2g

[0059] Citric acid 15g

[0060] Stevia 10g

[0061] The preparation adopts the wet granulation and tabletting process. The main drug and various auxiliary materials are passed through an 80-mesh sieve. Lactose is mixed, and an appropriate amount of ethanol is added as a wetting agent, and the main ingredient and auxiliary materials are fully mixed in a wet state. Fully dry the above wet material in a blast drying oven, and sieve after drying. The obtained granules are fully mixed with lubricants and glidants to obtain intermediates. After measuring the content of the intermediates, calculate the tablet weight according to the content of the intermediates and then press the tablets. Control the hardness of the tablets at 2-5kg / cm 2 . The average hardness of the...

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Abstract

The invention aims to provide a compound oral disintegrating tablet preparation which is composed of tranilast and salbutamol sulfate, and a preparation method thereof. The adopted specific technical proposal for achieving the purpose of the invention is as follows: the compound tranilast oral disintegrating tablet preparation is characterized in that the formula of the preparation is composed of the following components by parts by weight (by 1000 tablets): 80.0g of tranilast, 2.4g of salbutamol sulfate, 5-30g of disintegrant, 10-80g of filling agent, 5-25g of effervescing agent, 0.5-20g of flavoring agent and 0.3-3g of lubricant. The compound oral disintegrating tablet preparation which is prepared by the method can solve the shortcomings of the two drugs on the pharmacological effects during the treatment process of bronchial asthma and allow the compound oral disintegrating tablet preparation to relieve the asthma instantly and maintain and consolidate the effect; furthermore, the compound oral disintegrating tablet preparation has convenient administration, rapid onset of action, high bioavailability and good taste. The preparation method of the preparation has simple steps and low cost.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an orally disintegrating tablet for treating mild and moderate bronchial asthma and chronic asthmatic bronchitis and a preparation method thereof, in particular to a compound trarnister orally disintegrating tablet and a preparation method thereof. Background technique [0002] Tranilast, Li Chuanbei. It is a yellowish white crystalline powder, odorless. The melting point is 267-269°C. Insoluble in water, soluble in alkaline aqueous solution. Made from β-(3,4-dimethoxyphenyl)acrylic acid, it is an anti-allergic drug. It can be used to prevent and treat bronchial asthma, allergic rhinitis, allergic dermatitis, etc. The preparations include tablets and capsules. [0003] Tranister is an allergic mediator blocker, which can inhibit the degranulation of mast cells and the release of allergic mediators caused by allergens and other stimuli, thereby inhibiting the release o...

Claims

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Application Information

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IPC IPC(8): A61K31/196A61K9/20A61K47/32A61K47/38A61P11/00A61P11/06A61K31/137
Inventor 张华刘瑶茅仁刚叶晓平张雷
Owner SHANGHAI NORMAL UNIVERSITY
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