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Oral alpha-lipoic acid disintegrant tablet and its preparing method

A technology for oral disintegrating tablets and lipoic acid, which is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and antidote, etc., can solve the problems such as no reports related to alpha-lipoic acid orally disintegrating tablets are found, and achieve fast absorption. , high bioavailability, the effect of preventing deafness

Inactive Publication Date: 2006-11-08
SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, α-lipoic acid is only used in injection and capsule dosage forms, and no relevant reports on α-lipoic acid orally disintegrating tablets have been found

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1. Preparation of α-lipoic acid orally disintegrating tablets

[0025] prescription:

[0026] 1. Main drug - α-lipoic acid 100.0g

[0027] 2. Taste masking agent - gelatin 20.0g

[0028] 3. Filling agent - lactose 55.0g

[0029] 4. Flavoring agent - aspartame 3.0g

[0030] 5. Disintegrant—cross-linked polyvinylpyrrolidone 10.0g

[0031] Microcrystalline Cellulose 90.0g

[0032] 6. Lubricant—magnesium stearate 3.0g

[0033] 7. Effervescent agent - sodium bicarbonate 69.0g

[0034] Preparation:

[0035] 1. Take α-lipoic acid, gelatin, lactose, aspartame, and sodium bicarbonate and pass through a 60-mesh sieve for later use.

[0036] 2. Take an appropriate amount of distilled water to dissolve gelatin, add α-lipoic acid, lactose, aspartame and sodium bicarbonate under stirring, stir in a 70°C water bath, evaporate to dryness, crush, and pass through a 60-mesh sieve for later use.

[0037] 3. Take cross-linked polyvinylpyrrolidone and microcryst...

Embodiment 2

[0042] Example 2. Preparation of α-lipoic acid orally disintegrating tablets

[0043] prescription:

[0044] 1. Main drug - α-lipoic acid 100.0g

[0045] 2. Taste masking agent - gelatin 25.0g

[0046] 3. Filler - Mannitol 90.0g

[0047] 4. Flavoring agent - aspartame 5.0g

[0048] Adenosine 5.0g

[0049] 5. Disintegrant——Cross-linked polyvinylpyrrolidone 20.0g

[0050] Microcrystalline Cellulose 90.0g

[0051] Low-substituted hydroxypropyl cellulose 10.0g

[0052] 6. Lubricant—magnesium stearate 5.0g

[0053] Preparation:

[0054] 1. Take α-lipoic acid, gelatin, mannitol, aspartame, and adenosine and pass through a 60-mesh sieve for later use.

[0055] 2. Take an appropriate amount of distilled water to dissolve the gelatin, add α-lipoic acid under stirring, stir in a water bath at 70°C, evaporate to dryness, pulverize, and pass through a 60-mesh sieve for later use.

[0056] 3. Take mannitol, aspartame, and adenosine, mix them even...

Embodiment 3

[0062] Example 3. Preparation of α-lipoic acid orally disintegrating tablets

[0063] prescription:

[0064] 1. Main drug - α-lipoic acid 100.0g

[0065] 2. Taste masking agent - polyvinylpyrrolidone 10.0g

[0066] 2. Filler——Xylitol 110.0g

[0067] 3. Flavoring agent - aspartame 4.0g

[0068] Orange Flavor 3.0g

[0069] 4. Disintegrant—cross-linked polyvinylpyrrolidone 15.0g

[0070] Low-substituted hydroxypropyl cellulose 25.0g

[0071] 5. Lubricant—magnesium stearate 3.0g

[0072] 6. Effervescent agent - sodium bicarbonate 80.0g

[0073] Preparation:

[0074] 1. Take α-lipoic acid, xylitol, aspartame, orange flavor and sodium bicarbonate and pass through a 60-mesh sieve for later use.

[0075] 2. Take α-lipoic acid, aspartame, orange flavor and sodium bicarbonate, granulate with polyvinylpyrrolidone, pulverize, and pass through a 60-mesh sieve for later use.

[0076] 3. Take xylitol, cross-linked polyvinylpyrrolidone, and low-substituted hy...

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Abstract

The present invention relates to a kind of oral alpha-lipoic acid disintegrant tablet with fast disintegration and its preparation process. The oral alpha-lipoic acid disintegrant tablet includes alpha-lipoic acid as main medicine component, stuffing, disintegrating agent, corrective, masking agent, lubricant, effervesce agent and other medicinal excipient. It is prepared through a specific preparation process. It has fast disintegration and good taste, and is suitable for taking without water and for patient with dysphagia. It is used for delaying senility, treating diabetic polyneuropathy, and preventing and treating noise, senility and drug caused deafness.

Description

technical field [0001] The invention relates to a new type of pharmaceutical dosage form, specifically an orally disintegrating α-lipoic acid tablet and the Preparation. Background technique [0002] α-lipoic acid (LA), also known as lipoic acid, is a vitamin whose chemical name is 1,2-dithiolane-3-pentanoic acid, which is soluble in both water and fat . α-lipoic acid is the most effective of the known natural antioxidants, which can regenerate endogenous antioxidants, such as vitamin E, vitamin C, coenzyme Q10, glutathione and α-lipoic acid itself, known as For "antioxidant antioxidants". In animal and plant tissues, α-lipoic acid is often covalently bound to the ε-amino group of lysine residues in protein molecules, and exists in the form of amide bonds. The plant with the highest alpha-lipoic acid content is spinach, followed by tomato and cabbage; in animals, liver and kidney tissues have the highest alpha-lipoic acid content. α-lipoic acid is a cofactor of pyruvate...

Claims

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Application Information

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IPC IPC(8): A61K31/385A61K9/20A61P3/10A61P39/06
Inventor 高静高申储藏管斐陈建明吴娟吕莹
Owner SECOND MILITARY MEDICAL UNIV OF THE PEOPLES LIBERATION ARMY