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Acid and alkali neutralization granulating method of effervescent

An effervescent, acid-base technology, applied in pharmaceutical formulations, bulk delivery, drug delivery, etc., can solve the problems of complex production process, low production efficiency, and high production cost, and achieve simplified process, improved production efficiency, and acidity difference. small effect

Active Publication Date: 2013-09-25
JILIN AODONG YANBIAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The invention provides an acid-base neutralization granulation method for effervescent tablets to solve the existing problems of complex production process, low production efficiency, poor stability, production limitations, poor tablet formation, uneven disintegration, and high production cost

Method used

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  • Acid and alkali neutralization granulating method of effervescent
  • Acid and alkali neutralization granulating method of effervescent
  • Acid and alkali neutralization granulating method of effervescent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] Embodiment 1: paracetamol effervescent tablet

[0044] Granulation part:

[0045]

[0046] Mixing part:

[0047]

[0048] Production steps:

[0049] 1. Add acetaminophen, anhydrous citric acid, and sodium bicarbonate to the granulation kettle, stir and mix for 10 minutes at a stirring speed of 60 rpm;

[0050] 2. Weigh the povidone K30 in the granulation agent and put it in the liquid preparation tank, mix 95% ethanol and purified water to make the granulation agent and pour it into the spray tank, and spray the liquid into the stirring state in the kettle at a uniform speed In the material, the spraying flow rate is 1.2L / min. After the liquid is sprayed, the speed of the stirring paddle is 80rpm, stirring for 5 minutes, and at the same time, the cross cutter device is turned on for cutting and stirring. To form relatively uniform particles, the operating room temperature is 18°C ​​and the relative humidity is less than 30%;

[0051] 3. Start the vacuum and st...

Embodiment 2

[0053] Embodiment 2: carbocisteine ​​effervescent tablet

[0054] Granulation part:

[0055]

[0056]

[0057] Mixing part:

[0058] Sweetener 6.00kg

[0059] Spice 3.00kg

[0060] Production steps:

[0061] 1. Add anhydrous sodium citrate, anhydrous citric acid, sodium bicarbonate, and carbocisteine ​​to the granulation kettle, stir and mix for 10 minutes at a stirring speed of 60 rpm;

[0062] 2. Weigh the povidone K30 in the granulation agent and put it in the liquid preparation tank, mix 95% ethanol and purified water to make the granulation agent and pour it into the spray tank, and spray the liquid into the stirring state in the kettle at a uniform speed In the material, the spray flow rate is 1.0L / min. After the liquid is sprayed, the speed of the stirring paddle is 70rpm, and the stirring is carried out for 4 minutes. At the same time, the cross cutter device is turned on for cutting and stirring. To form relatively uniform particles, the operating room temp...

Embodiment 3

[0065] Embodiment 3: zinc gluconate effervescent tablet

[0066] Granulation part:

[0067]

[0068] Mixing part:

[0069] Sweetener 14.00kg

[0070] Spice 4.00kg

[0071] Production steps:

[0072] 1. Add anhydrous citric acid, sodium bicarbonate, anhydrous sodium citrate, and zinc gluconate into the granulation kettle, stir and mix for 9 minutes at a stirring speed of 70 rpm.

[0073] 2. Mix and dissolve povidone K30 and 95% ethanol to make a granulation agent and pour it into the spray tank, and spray the liquid into the stirred material in the tank at a uniform speed. The spray flow rate is 1.1L / min. After spraying, the speed of the stirring paddle is 60rpm, stirring for 3 minutes, and at the same time, the cross cutter device is turned on for cutting and stirring, and the cutter speed is set at 800 rpm. After cutting, more uniform particles are formed. The temperature of the operating room is 26°C , the relative humidity is less than 30%;

[0074] 3. Start the va...

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Abstract

The invention relates to an acid and alkali neutralization granulating method of an effervescent, belonging to the pharmaceutical field, comprising the following steps: adding main materials into a granulating kettle to stir; preparing a granulating agent; connecting a liquid tank; starting a spray pump to spray granulating agent liquid into materials at a stirring state in the kettle at constant speed; cutting, stirring; drying and cooling system; discharging and granulating. According to the invention, acid and alkali are not granulated independently in sub-steps so as to simplify process, increase production efficiency, save energy, and shorten granulating time by more than a quarter; and the method can effectively avoid potential safety hazards caused by overlarge concentration of ethanol, and can ensure production process is safe without special explosion-proof facilities.

Description

technical field [0001] The invention belongs to the field of pharmacy. Background technique [0002] Effervescent agent refers to a special dosage form containing sodium bicarbonate and organic acid, which can produce gas when it meets water and is effervescent. It is commonly known as dry liquid preparation. According to the traditional classification method of pharmaceutical dosage forms, effervescent agent belongs to the traditional classification The special dosage forms in various dosage forms are listed in each dosage form. There are mainly effervescent tablets, effervescent granules, effervescent powder, effervescent suppositories, etc. According to the route of administration, it can be divided into oral effervescent agents and external effervescent agents. Oral effervescent preparations undergo an acid-base reaction in water before taking them, and disintegrate quickly, which is beneficial to improving the bioavailability of the medicine. Its predecessor forms ar...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K9/46
Inventor 李秀林张守君许加胜
Owner JILIN AODONG YANBIAN PHARM CO LTD
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