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Lipoic acid capsules as well as preparation process and application thereof

A technology of lipoic acid and capsules, which is applied in the direction of capsule delivery, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of poor oral absorption of lipoic acid, low bioavailability, and large side effects, etc. Achieve the effects of improving in vitro dissolution rate, reducing the dosage of active ingredients and maintaining drug efficacy

Active Publication Date: 2012-07-18
JIANGSU WANHE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In view of the deficiencies in the prior art, the purpose of the present invention is to provide a lipoic acid capsule by studying the physicochemical properties of lipoic acid, to improve lipoic acid poor oral absorption, low bioavailability, large side effects, odor question

Method used

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  • Lipoic acid capsules as well as preparation process and application thereof
  • Lipoic acid capsules as well as preparation process and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] The preparation of embodiment 1 lipoic acid capsule

[0020] 1. Take 100 g of lipoic acid, micronize it, and pass it through a 200-mesh sieve to get lipoic acid fine powder.

[0021] 2. Put 50g of Poloxamer 237 in a suitable container, put it in a water bath at 49°C-50°C and heat it to a molten liquid state, add 100g of lipoic acid fine powder, and stir rapidly and fully at 49°C-50°C until it is evenly mixed. Let stand to remove air bubbles, spread the mixture into a thin layer and put it in a -5°C refrigerator for rapid cooling. After the mixture is completely solidified, take it out and pulverize, and place it in a vacuum dryer for drying at 35°C for 24 hours, and pulverize it through a 100-mesh sieve to obtain lipoic acid. Solid dispersion.

[0022] 3. Add microcrystalline cellulose 82g, lactose 10g, sodium carboxymethyl starch 8g, and magnesium stearate 4g to the lipoic acid solid dispersion in step 2, and the above-mentioned fillers, disintegrating agents, and lub...

Embodiment 2

[0023] The preparation of embodiment 2 lipoic acid capsules

[0024] 1. Take 100 g of lipoic acid, micronize it, and pass it through a 200-mesh sieve to get lipoic acid fine powder.

[0025] 2. Take 100g of Poloxamer 237 and put it in a suitable container, put it in a water bath at 49°C-50°C and heat it to a molten liquid state, add 100g of lipoic acid fine powder, and stir rapidly and fully at 49°C-50°C until the mixture is uniform. Let stand to remove air bubbles, spread the mixture into a thin layer and put it in a -5°C refrigerator for rapid cooling. After the mixture is completely solidified, take it out and pulverize, and place it in a vacuum dryer for drying at 35°C for 24 hours, and pulverize it through a 100-mesh sieve to obtain lipoic acid. Solid dispersion.

[0026] 3. Add microcrystalline cellulose 82g, lactose 10g, sodium carboxymethyl starch 8g, and magnesium stearate 4g to the lipoic acid solid dispersion in step 2, and the above-mentioned fillers, disintegrati...

Embodiment 3

[0027] The preparation of embodiment 3 lipoic acid capsules

[0028] 1. Take 100 g of lipoic acid, micronize it, and pass it through a 200-mesh sieve to get lipoic acid fine powder.

[0029] 2. Take 33.3g of Poloxamer 237 and put it in a suitable container, put it in a water bath at 49°C-50°C and heat it to a molten liquid state, add 100g of lipoic acid fine powder, and stir quickly and fully at 49°C-50°C until it is evenly mixed. , let stand to remove air bubbles, spread the mixture into a thin layer and put it in a -5℃ refrigerator for rapid cooling, after the mixture is completely solidified, take it out and pulverize, and place it in a vacuum dryer for drying at 35℃ for 24h, and pulverize it through a 100-mesh sieve to obtain sulfur Caprylic acid solid dispersion.

[0030] 3. Add microcrystalline cellulose 82g, lactose 10g, sodium carboxymethyl starch 8g, and magnesium stearate 4g to the lipoic acid solid dispersion in step 2, and the above-mentioned fillers, disintegrati...

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Abstract

The invention relates to lipoic acid capsules. The capsules comprise solid dispersoid. The solid dispersoid consists of lipoic acid and a carrier material. The carrier material is selected from poloxamer. According to the invention, the dissolution in vitro of a lipoic acid preparation is improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a solid oral preparation of a low-water-soluble medicine, in particular to a lipoic acid capsule and a preparation process thereof. Background technique [0002] Lipoic acid (lipoic acid)-1,2-dithiolane-3-valeric acid, also known as thioctic acid, is an active ingredient with antioxidant activity, which can eliminate free radicals that accelerate aging and cause disease , similar to vitamins, it is an enzyme existing in mitochondria. It enters cells after being absorbed in the intestinal tract in the body. It has both fat-soluble and water-soluble properties, so it can pass through the body without hindrance, reach any cell site, and provide the body with comprehensive efficacy. , is a fat-soluble and water-soluble universal antioxidant. It can be used to treat various conditions, such as hepatobiliary diseases, neuropathy of various causes, hypercholesterolemia...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/385A61K47/34A61P39/06
Inventor 陈建东颜利清
Owner JIANGSU WANHE PHARMA
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