Preparation method of stable lipoic acid tablet

A technology of lipoic acid tablets and lipoic acid, which is applied in the directions of non-active ingredients medical preparations, active ingredients-containing medical preparations, pharmaceutical formulas, etc., can solve problems such as increased production costs, increased polymer growth, and decreased stability and dissolution. , to achieve the effect of improving product stability, improving particle fluidity, and improving particle roundness

Active Publication Date: 2021-07-30
YABAO PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the raw material of lipoic acid has a low melting point, and the heat generated by the equipment during the crushing process will easily lead to melting of the material or growth of the polymer, and the use of low-temperature crushing will increase the production cost
There are many types of excipients in this prescription (including binders, fillers, disintegrants and lubricants), and the ratio is high. It is necessary to take multiple tablets at a time or increase the diameter of the tablet. These methods will bring inconvenience to the patient. It is a difficult problem, and it will also increase the cost. It has been proved by experiments that the use of wet granulation does not change the loose state of raw materials, and it is easy to cause sticking and punching of compressed tablets. The long-term test stability of the product decreases, and the dissolution of related substances increases significantly.

Method used

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  • Preparation method of stable lipoic acid tablet
  • Preparation method of stable lipoic acid tablet
  • Preparation method of stable lipoic acid tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Prepare 10% hydroxypropyl cellulose aqueous solution as adhesive. Weigh 600g of lipoic acid, place it in a wet granulator, turn on the stirring blade at 400rpm, and the shear knife at 2000rpm, mix for 1 minute, spray 200g of binder solution into granulation, pass through a 18-mesh sieve for granulation, and fluidized bed 40 ℃ drying for 30 minutes, 18-mesh sieve granulation.

[0033] Put the dry granules in a mixer, add 156g of low-substituted hydroxypropyl cellulose and 15g of magnesium stearate and mix for 5 minutes, then granulate with a dry granulator, set the pressure at 3MPa, the speed of the roller is 10rpm, and the speed of the granulator is 70rpm. 18 mesh sieve for granulation.

[0034] Add 9g of magnesium stearate, mix for 5 minutes, use special-shaped punched tablets with a diameter of 8*18mm, the tablet weight is 800mg, and the temperature of the material before tableting is kept below 25°C.

[0035] Set the air inlet temperature to 70°C, and use 12% coati...

Embodiment 2

[0038] Prepare 11% hypromellose aqueous solution as adhesive. Weigh 600g of lipoic acid and 115g of microcrystalline cellulose, place them in a wet granulator, turn on the stirring blade at 400rpm, and the shear knife at 2000rpm, mix for 2 minutes, spray 190g of binder solution into granules, and pass through an 18-mesh sieve. Granules were dried in a fluidized bed at 40°C for 30 minutes, and granulated with a 18-mesh sieve.

[0039] Put the dry granules in a mixer, add 40.1g of low-substituted hydroxypropyl cellulose and 9g of magnesium stearate and mix for 5 minutes, then granulate with a dry granulator, set the pressure at 3MPa, the speed of the roller is 10rpm, and the speed of the granulator is 70rpm , 18 mesh sieve granulation.

[0040]Add 15g of magnesium stearate, mix for 5 minutes, use special-shaped punched tablets with a diameter of 8*18mm, and the weight of the tablet is 800mg. Before tableting, the temperature of the material is lowered to below 25°C.

[0041] ...

Embodiment 3

[0044] Weigh 600g of lipoic acid, 60g of low-substituted hydroxypropyl cellulose, and 25g of hydroxypropyl cellulose, place them in a wet granulator, turn on the stirring blade at 400rpm, and the shearing knife at 2000rpm, mix for 1 minute, and use 50% ethanol solution as a wetting agent, spray an appropriate amount of wetting agent solution to granulate, pass through a 16-mesh sieve for granulation, dry in a fluidized bed at 35°C for 40 minutes, and granulate with a 18-mesh sieve.

[0045] Put the dry granules in a mixer, add 96g of low-substituted hydroxypropyl cellulose and 9g of magnesium stearate and mix for 5 minutes, then granulate with a dry granulator, set the pressure at 3MPa, the speed of the pressing roller is 10rpm, and the speed of the granulator is 80rpm. 18 mesh sieve for granulation.

[0046] Add 10g of magnesium stearate, mix for 5 minutes, use special-shaped punched tablets with a diameter of 8*18mm, and the weight of the tablet is 800mg. Before tableting, ...

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Abstract

The invention aims to provide a preparation method of a lipoic acid tablet. Wet granulation and dry granulation are adopted for secondary granulation, no sticking occurs in the tabletting process after granulation, a toxic organic solvent is not used in the production process, and the obtained product is good in stability.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a preparation method of stable lipoic acid tablets. Background technique [0002] Lipoic acid was launched in Germany in 1955. It has dual characteristics of water solubility and fat solubility, can reach any cell part of the body, has strong antioxidant effect, and is called "universal" antioxidant. Lipoic acid can scavenge free radicals, chelate metal ions and participate in the regeneration (reduction) of other antioxidants in the body. [0003] Foreign evidence-based medical research has consistently shown that lipoic acid is safe and effective. American ADA guidelines (American Diabetes Association guidelines), European EASD (European Society of Cardiology and European Association for the Study of Diabetes joint guidelines) all regard lipoic acid as the first-line drug for the prevention and treatment of diabetic complications, and the "Guide...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/38A61K31/385A61P3/10A61P25/00
CPCA61K9/28A61K9/2054A61K9/2095A61K31/385A61P3/10A61P25/00
Inventor 戚永明田瑞琼李婉云徐从飞
Owner YABAO PHARMA GRP CO LTD
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