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Thioctic acid dispersible tablet and preparation method thereof

A technology of lipoic acid and dispersible tablets, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc., can solve the problems of lipoic acid prone to stains and stickiness, and overcome stickiness. Shock phenomenon, high dispersion uniformity, simple production process

Active Publication Date: 2016-01-27
JIANGSU SHENLONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The purpose of the present invention is to solve the problem that lipoic acid easily produces stains and sticky punches in the process of direct compression, thereby preparing a lipoic acid dispersible tablet with good dispersion uniformity and stability, thereby completing the present invention

Method used

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  • Thioctic acid dispersible tablet and preparation method thereof
  • Thioctic acid dispersible tablet and preparation method thereof
  • Thioctic acid dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Prescription (per 1000 tablets):

[0057]

[0058] Pretreatment of raw and auxiliary materials: Micronize lipoic acid, disintegrating agent, binder and lubricant respectively, and pass through a 120-mesh sieve for pretreatment to obtain fine powder.

[0059] Preparation of adhesive: prepare 2% (W / V) hypromellose aqueous solution and set aside.

[0060] Granulation: Weigh lipoic acid, low-substituted hydroxypropyl cellulose, and sodium carboxymethyl starch in the prescribed amount, mix in a high-speed wet mixing granulator for 300 seconds, add 2% hypromellose aqueous solution, and start with low-speed Run for 60 seconds, then run at high speed for 120 seconds, wet granulate with a 30-mesh sieve of a swing granulator, transfer to a fluidized bed to dry until the granule moisture is between 1-2%, and pass through a 24-mesh sieve to dry and granulate ;

[0061] Addition: Weigh the prescription amount of talcum powder and micropowder silica gel and mix with the above gr...

Embodiment 2

[0064] Prescription (per 1000 tablets)

[0065]

[0066] Pretreatment of raw and auxiliary materials: Micronize lipoic acid, disintegrating agent, binder and lubricant respectively, and pass through a 120-mesh sieve for pretreatment to obtain fine powder.

[0067] Preparation of adhesive: prepare 2% (W / V) hypromellose aqueous solution and set aside.

[0068] Granulation: Weigh lipoic acid, low-substituted hydroxypropyl cellulose, and sodium carboxymethyl starch in the prescribed amount, mix in a high-speed wet mixing granulator for 300 seconds, add 2% hypromellose aqueous solution, and start with low-speed Run for 60 seconds, then run at high speed for 120 seconds, wet granulate with a 30-mesh sieve of a swing granulator, transfer to a fluidized bed to dry until the granule moisture is between 1-2%, and pass through a 24-mesh sieve to dry and granulate ;

[0069] Addition: Weigh the prescription amount of talcum powder and micropowder silica gel and mix with the above gra...

Embodiment 3

[0072] Prescription (per 1000 tablets)

[0073]

[0074]

[0075] Pretreatment of raw and auxiliary materials: Micronize lipoic acid, disintegrating agent, binder and lubricant respectively, and pass through a 120-mesh sieve for pretreatment to obtain fine powder.

[0076] Preparation of adhesive: prepare 2% (W / V) aqueous solution of hydroxypropylmethylcellulose, and set aside.

[0077] Granulation: Weigh lipoic acid, low-substituted hydroxypropyl cellulose, and sodium carboxymethyl starch in the prescribed amount, mix in a high-speed wet mixing granulator for 300 seconds, add 2% hypromellose aqueous solution, and start with low-speed Run for 60 seconds, then run at high speed for 120 seconds, wet granulate with a 30-mesh sieve of a swing granulator, transfer to a fluidized bed to dry until the granule moisture is between 1-2%, and pass through a 24-mesh sieve to dry and granulate ;

[0078] Addition: Weigh the prescription amount of talcum powder and micropowder silic...

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Abstract

The invention provides a thioctic acid dispersible tablet and a preparation method thereof. The thioctic acid dispersible tablet contains thioctic acid, a disintegrating agent, a binder and a lubricant, wherein the lubricant does not contain magnesium stearate.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a lipoic acid dispersible tablet and a preparation method thereof. Background technique [0002] Lipoic acid (lipoicacid), the chemical name is 1,2-dithiolane-3-pentanoic acid, is a vitamin that is soluble in both water and fat. Lipoic acid is a natural product isolated from pig liver by Reed for the first time in 1951. It participates in the tricarboxylic acid cycle as a coenzyme in the body, not only participates in the metabolic process of glucose, but also directly mediates the distribution of insulin-regulated glucose in peripheral tissues , At the same time, it also has the effect of scavenging free radicals, and has a good preventive effect on chronic complications of diabetes. [0003] The chemical structural formula of lipoic acid is as follows: [0004] [0005] At present, the formulations of lipoic acid on the market mainly include injections, tablets a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/385A61K47/38A61P3/10A61P39/06
Inventor 秦勇徐成陈远东陈建芳康振华游剑蔡雄
Owner JIANGSU SHENLONG PHARMA
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