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Preparation method of ethionamide tablet

A technology of ethionamide tablets and ethionamide, which is applied in the field of medicine, can solve the problems of large difference in tablet weight, poor fluidity, and difficulty in crushing and sieving, and achieve the effect of small difference in tablet weight and quality control

Inactive Publication Date: 2013-12-25
TIANJIN KUNJIAN BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The properties of ethionamide raw material are needle-like crystals with poor fluidity and are not easy to be crushed and sieved. Therefore, the tablets prepared by conventional methods have large differences in tablet weight, and it is difficult to control the quality of the drug.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] A preparation method of ethionamide tablets, comprising the steps of: (preparing 1000 ethionamide tablets)

[0021] (1) Weighing: ethionamide raw material drug 250g; microcrystalline cellulose (filler) 25g; lactose (filler) 30g; croscarmellose sodium (disintegrant) 15g; povidone (Binder) 10g; Talc powder (glidant) 6.25g; Magnesium stearate (lubricant) 1g;

[0022] (2) Mix ethionamide raw material and talc powder for 2 minutes, crush and pass through a 100-mesh standard sieve, add microcrystalline cellulose, lactose, croscarmellose sodium and povidone, mix for 3 minutes, add The total prescription amount is 6% absolute ethanol, the above materials are wet-mixed, granulated with a 14-mesh standard sieve, dried at 60°C for 20 minutes, granulated with a 16-mesh standard sieve, crushed and passed through a 80-mesh standard sieve, Add magnesium stearate, mix well, and press into tablets to obtain the product.

[0023] Tablet weight difference: ±2%

Embodiment 2

[0025] A preparation method of ethionamide tablets, comprising the steps of: (preparing 1000 ethionamide tablets)

[0026] (1) Weighing: ethionamide raw material drug 250g; microcrystalline cellulose (filler) 30g; lactose (filler) 20g; croscarmellose sodium (disintegrant) 20g; povidone (Binder) 10g; Talc powder (glidant) 6.25g; Magnesium stearate (lubricant) 1g;

[0027] (2) Mix ethionamide raw material and talc powder for 2 minutes, crush and pass through a 100-mesh standard sieve, add microcrystalline cellulose, lactose, croscarmellose sodium and povidone, mix for 3 minutes, add The total prescription amount is 6% absolute ethanol, the above materials are wet-mixed, granulated with a 14-mesh standard sieve, dried at 60°C for 20 minutes, granulated with a 16-mesh standard sieve, crushed and passed through a 80-mesh standard sieve, Add magnesium stearate, mix well, and press into tablets to obtain the product.

[0028] Tablet weight difference: ±4%

Embodiment 3

[0030] A preparation method of ethionamide tablets, comprising the steps of: (preparing 1000 ethionamide tablets)

[0031] (1) Weighing: ethionamide raw material drug 250g; pregelatinized starch (filler) 15g; lactose (filler) 25g; croscarmellose sodium (disintegrant) 25g; povidone (Binder) 15g; Talc powder (glidant) 6.25g; Magnesium stearate (lubricant) 1g;

[0032] (2) Mix ethionamide raw material and talc powder for 2 minutes, crush and pass through a 100-mesh standard sieve, add pregelatinized starch, lactose, croscarmellose sodium and povidone, mix for 3 minutes, add The total prescription amount is 6% absolute ethanol, the above materials are wet-mixed, granulated with a 14-mesh standard sieve, dried at 60°C for 20 minutes, granulated with a 16-mesh standard sieve, crushed and passed through a 80-mesh standard sieve, Add magnesium stearate, mix well, and press into tablets to obtain the product.

[0033] Tablet weight difference: ±3.5%

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PUM

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Abstract

The invention discloses a preparation method of an ethionamide tablet, and the preparation method comprises the following steps: (1) weighing the following raw materials by weight: 250 parts of ethionamide; 40-55 parts of a filler; 15-25 parts of a disintegrating agent; 10-15 parts of a binder; 6.25 parts of a flow aid and 1 part of a lubricant; and (2) mixing the ethionamide and the flow aid, crushing, sieving by a 100 mesh standard sieve, adding the filler, the disintegrating agent and the binder for mixing, adding an auxiliary solvent with an amount being 6% of the total amount of the formula for wet granulation, baking at the temperature of 60DEG C for 20min, trimming granules by a 16-20 mesh standard sieve, adding the lubricant, and tabletting to obtain the ethionamide tablet. By using the preparation method of the invention, crushing and sieving of ethionamide raw material drug is convenient, the prepared tablet is small in tablet weight difference, and the quality of the drug is well controlled.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to a preparation method of an anti-tuberculosis medicine. Background technique [0002] Tuberculosis (Tuberculosis, TB) is a worldwide problem, with a high incidence and strong infectivity, especially the special transmission route through respiratory droplets is not easy to control, and it is extremely harmful to society. Because it is transmitted through the respiratory tract, as long as the breath is still there, the infection cannot be fundamentally avoided. Due to the use of antibiotics, the incidence of TB was once reduced, but in the 1980s, tuberculosis resurged again, especially in developing countries, where the incidence and mortality of tuberculosis have remained high. Since 1993, the World Health Organization (WHO) has declared a global tuberculosis emergency. According to the data released by WHO, there are 8 to 10 million people infected with Mycobacterium tuberculosis every y...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/44A61P31/06
Inventor 毛慧华王雅琼王超
Owner TIANJIN KUNJIAN BIOLOGICAL PHARMA
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