Lipoic acid tablet and preparation method thereof

A technology of lipoic acid tablets and lipoic acid, which is applied in the fields of anti-toxic agents, pill delivery, and pharmaceutical formulations, can solve the problems of low production cost, high proportion of the main drug, easy sticking of lipoic acid tablets, etc., and achieve high production efficiency , product quality is stable, and the effect of reducing the dose of a single dose

Pending Publication Date: 2021-02-26
SHANDONG QIDU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Another object of the present invention is to provide a kind of preparation method of lipoic acid tablet, and this method production process is simple, and auxiliary material type and consumption are few and main ingredient ratio is high, and production cost is low, solves the problem that lipoic acid tablet sticks easily problem, suitable for industrial production

Method used

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  • Lipoic acid tablet and preparation method thereof
  • Lipoic acid tablet and preparation method thereof
  • Lipoic acid tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Described lipoic acid tablet, prescription (1000 consumptions) is as follows:

[0037]

[0038] The mass percent content of the film coating is 3.5%.

[0039] Its preparation method is specifically:

[0040] Put lipoic acid and hypromellose into the high-efficiency mixing granulator, first run at low speed (stirrer 100RPM, flying knife 1500RPM) for 120 seconds, add 150g of purified water, continue to run for 180 seconds, and finally run at high speed (stirrer 150RPM, flying knife Knife 3000RPM) for 30 seconds to produce wet granules. After the wet granules are dried in a hot air circulation drying oven, the granules are sized by a crushing and sizing machine, starch and sodium stearyl fumarate are added, and mixed by a hopper mixer. Just coat it.

[0041] The prepared lipoic acid tablet has smooth and smooth appearance without sticky punch, the disintegration time measured by the disintegration test is 2 minutes, and the dissolution rate measured by the dissolutio...

Embodiment 2

[0043] Described lipoic acid tablet, prescription (1000 consumptions) is as follows:

[0044]

[0045] The mass percent content of the film coating is 3.5%.

[0046] Its preparation method is specifically:

[0047] Put lipoic acid and povidone into the high-efficiency mixing granulator, first run at low speed (100RPM for stirring paddle, 1500RPM for flying knife) for 120 seconds, add 150g of purified water, continue running for 180 seconds, and finally run at high speed (150RPM for stirring paddle, 3000RPM for flying knife) ) for 30 seconds to prepare wet granules. After the wet granules are dried in a hot air circulation drying oven, the granules are sized by a crushing and sizing machine, and low-substituted hydroxypropyl cellulose and sodium stearyl fumarate are added, mixed by a hopper mixer, and then compressed into tablets. Finally, the substrate can be coated.

[0048] The prepared lipoic acid tablet has smooth and clean appearance without sticky punch, the disint...

Embodiment 3

[0050] Described lipoic acid tablet, prescription (1000 consumptions) is as follows:

[0051]

[0052] The mass percent content of the film coating is 3.5%.

[0053] Its preparation method is specifically:

[0054] Put lipoic acid and hydroxypropyl cellulose into the high-efficiency mixing granulator, first run at low speed (100RPM of stirring blade, 1500RPM of flying knife) for 120 seconds, add 150g of purified water, continue to run for 180 seconds, and finally run at high speed (150RPM of stirring blade, 150RPM of flying knife 3000RPM) for 30 seconds to produce wet granules. After the wet granules are dried in a hot air circulation drying oven, the granules are sized by a crushing and sizing machine, microcrystalline cellulose and sodium stearyl fumarate are added, and mixed by a hopper mixer. The substrate can be coated.

[0055] The prepared lipoic acid tablet has smooth and clean appearance without sticky punch, the disintegration time measured by the disintegratio...

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a lipoic acid tablet and a preparation method thereof. The tablet comprises a tablet core and afilm coating, the tablet core contains lipoic acid, an adhesive, a filler and a lubricant, and the preparation method comprises the following steps: carrying out dry mixing on a lipoic acid raw material and the adhesive, adding water for granulation, adding the filler and the lubricant after drying, granulating, carrying out total mixing, tabletting, and coating to obtain the product. The lipoicacid tablet is simple in formula composition, has good product stability, good dissolution, and better product quality; the production operation is simple and easy to implement, the variety and dosageof auxiliary materials are small, the main drug proportion is high, the cost is low, the problem that lipoic acid tablets are prone to sticking is solved, and the preparation method is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a lipoic acid tablet and a preparation method thereof. Background technique [0002] Lipoic acid (lipoic acid), the chemical name is 1,2-dithiolane-3-pentanoic acid, and the molecular formula is C 8 h 12 S 2 o 2 , is a vitamin that is both water-soluble and fat-soluble. [0003] The chemical structural formula of lipoic acid is as follows: [0004] [0005] 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 , It has a good preventive effect on chronic complications of diabetes. Lipoic acid enters the cells after being absorbed by the intestines in the body. It has both fat-...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K47/38A61K47/26A61K31/385A61P39/06
CPCA61K9/28A61K9/2054A61K9/2018A61K31/385A61P39/06
Inventor 付清爽白臣生路静成佳慧
Owner SHANDONG QIDU PHARMA
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