A kind of bisacodyl tablet and preparation method thereof

A technology of saacodyl tablets and bisacodyl, which is applied in the field of medicine, can solve the problems of drug quality and drug efficacy stability, influence the therapeutic effect of bisacodyl, destroy the chemical structure of bisacodyl, etc. Balance, reduce water and electrolyte abnormalities with hypokalemia, and enhance immunity

Active Publication Date: 2022-04-22
药大制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Bisacodyl products currently on the market are generally enteric-coated tablets and suppositories. The base of bisacodyl suppositories generally uses water-soluble bases such as polyethylene glycols and glycerin gelatin, which will destroy the chemical structure of bisacodyl. Quality and stability pose certain risks, and suppositories are greatly affected by conditions such as temperature and humidity. Bisacodyl suppositories will undergo a series of changes in temperature and humidity during use, storage, and transportation, resulting in a decrease in the quality and efficacy of the drug. The stability is affected, so that the efficacy of reaching the lesion is reduced; some existing bisacodyl enteric-coated tablets have long disintegration time, poor absorption, low bioavailability, and poor compliance, which affect the therapeutic effect of bisacodyl to play
To this end, a bisacodyl tablet is provided, which has good drug quality and efficacy stability, high bioavailability, is convenient to take and carry, and can reduce diarrhea accompanied by functional enteropathy, abnormal water and electrolytes accompanied by hypokalemia , reduce the dependence on bisacodyl, avoid the need to increase the drug dose due to dependence on bisacodyl and severe constipation in the case of withdrawal

Method used

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  • A kind of bisacodyl tablet and preparation method thereof
  • A kind of bisacodyl tablet and preparation method thereof
  • A kind of bisacodyl tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] A kind of bisacodyl tablet, its preparation method comprises the following steps:

[0027] (1) First crush bisacodyl, sodium carboxymethyl starch, hypromellose, potassium bicarbonate, malic acid, pumpkin powder, millet starch, lactulose, bifidobacterium, and aloe extract respectively, and after 150- 200 mesh sieve filtration;

[0028] (2) Mix 12g of potassium bicarbonate and dissolve it in 12g of pure water. After heating to 40-50°C, add 14g of lactulose and 29g of pumpkin powder, stir at a speed of 450-600r / min, mix well, and then Dry on a fluidized bed at a temperature of 55-60°C, then grind and pulverize to 150-200 mesh to obtain mixture A;

[0029] (3) 8g of bifidobacteria, 10g of aloe extract, 20g of bisacodyl, 16g of malic acid and mixture A were stirred at a temperature of 15-20°C and a speed of 650-750r / min, and mixed uniformly to obtain mixture B;

[0030] (4) Dissolve 24g of millet starch in 60g of pure water, heat the temperature to 50-65°C and stir at a sp...

Embodiment 2

[0034] A kind of bisacodyl tablet, its preparation method comprises the following steps:

[0035] (1) First crush bisacodyl, sodium carboxymethyl starch, hypromellose, potassium bicarbonate, malic acid, pumpkin powder, millet starch, lactulose, bifidobacteria, and aloe extract respectively, and after 150- 200 mesh sieve filtration;

[0036] (2) Mix 15.2g of potassium bicarbonate and dissolve it in 12g of pure water. After heating to 40-50°C, add 10g of lactulose and 18g of pumpkin powder and stir at a speed of 450-600r / min, mix well, and then Dry on a fluidized bed at a temperature of 55-60°C, and then grind and pulverize to 150-200 mesh to obtain mixture A;

[0037] (3) 15g of bifidobacteria, 18g of aloe extract, 35g of bisacodyl, 19.2g of malic acid and mixture A were stirred at a temperature of 15-20°C and a speed of 650-750r / min, and mixed uniformly to obtain mixture B;

[0038] (4) Dissolve 15g of millet starch in 44g of pure water, heat the temperature to 50-65°C and s...

Embodiment 3

[0042] A kind of bisacodyl tablet, its preparation method comprises the following steps:

[0043] (1) First crush bisacodyl, sodium carboxymethyl starch, hypromellose, potassium bicarbonate, malic acid, pumpkin powder, millet starch, lactulose, bifidobacterium, and aloe extract respectively, and after 150- 200 mesh sieve;

[0044] (2) Mix 14.8g of potassium bicarbonate and dissolve it in 13g of pure water. After heating to 40-50°C, add 11g of lactulose and 21g of pumpkin powder and stir at a speed of 450-600r / min, mix well, and then Dry on a fluidized bed at a temperature of 55-60°C, and then grind and pulverize to 150-200 mesh to obtain mixture A;

[0045] (3) Stir 10.3g of bifidobacteria, 12.7g of aloe extract, 26.8g of bisacodyl, 48g of malic acid and mixture A at a temperature of 15-20°C and a speed of 650-750r / min, and mix uniformly to obtain a mixture B;

[0046] (4) Dissolve 16.5g of millet starch in 48g of pure water, heat the temperature to 50-65°C and stir at a sp...

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Abstract

The invention discloses a bisacodyl tablet and a preparation method thereof, comprising the following components, the main ingredients: 18-30 parts of bisacodyl, 10-18 parts of aloe extract, and 8-15 parts of bifidobacteria; Auxiliary materials: 18-30 parts of pumpkin powder, 15-25 parts of millet starch, 10-15 parts of lactulose, 8-12 parts of sodium carboxymethyl starch, 4-8 parts of hypromellose, 16-20 parts of malic acid , 12-16 parts of potassium bicarbonate; wherein, in each bisacodyl tablet: the content of bisacodyl is 13.1-22.2%, the content of aloe extract is 6.5-11.4%, and the content of bifidobacteria is 5.2% ~9.5%. The bisacodyl tablet of the present invention has good drug quality and drug effect stability, high bioavailability, and is convenient to take and carry; the preparation process is simple, the molding rate is high, the surface is smooth, and it is not easy to be sticky, which effectively guarantees the drug quality and drug quality. effective stability.

Description

technical field [0001] The invention relates to a bisacodyl tablet and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Bisacodyl is a stimulant laxative, which mainly acts on the large intestine. Clinically, it mainly stimulates the sensory nerve endings of the intestinal mucosa through direct contact to enhance intestinal reflex peristalsis, leading to defecation. Bisacodyl products currently on the market are generally enteric-coated tablets and suppositories. The base of bisacodyl suppositories generally uses water-soluble bases such as polyethylene glycols and glycerin gelatin, which will destroy the chemical structure of bisacodyl. Quality and stability pose certain risks, and suppositories are greatly affected by conditions such as temperature and humidity. Bisacodyl suppositories will undergo a series of changes in temperature and humidity during use, storage, and transportation, resulting in a decrease in the ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K9/20A61K36/896A61K36/886A61K47/46A61K47/36A61K47/12A61K47/02A61P1/10A61K35/745A61K31/4402A61K33/00
CPCA61K9/28A61K9/2068A61K9/2059A61K9/2009A61K9/2013A61K31/4402A61K36/896A61K36/886A61K35/745A61K33/00A61P1/10A61K2300/00
Inventor 郝静梅
Owner 药大制药有限公司
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