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Acetyl-gastrodine oral disintigration tablet for sedation, soporific and nervous headache

A technology for acetyl gastrodin and orally disintegrating tablets, which is applied in the field of acetyl gastrodin orally disintegrating tablets and their preparation, can solve the problems of poor tablet compressibility, disadvantage, and poor tablet strength, and achieves a feasible process and good practicability. , the effect of easy operation

Inactive Publication Date: 2005-01-12
刘智
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In recent years, there are many orally disintegrating tablets developed at home and abroad, which have become a development direction of oral dosage forms. The currently developed orally disintegrating tablets cannot meet the clinical needs of patients with various etiologies, and their preparation methods Each has its own advantages and disadvantages, and the orally disintegrating tablet represented by the "freeze-drying method" disintegrates fastest in the oral cavity, but the strength of the tablet is poor, and the tablet is easily broken, which is not suitable for industrialized production and is inconvenient for patients to use. Also can not satisfy the demand of market; Other preparation methods of orally disintegrating tablets have " heating sublimation method " and direct tableting method, although they have overcome the shortcoming of the poor intensity of tablet, most when patient uses, oral cavity feels No gritty and unacceptable uncomfortable feeling or too long disintegration time, especially the orally disintegrating tablets prepared by the heating sublimation method may still have residual sublimable substances, which are chemical substances that are not conducive to health; "directly In the preparation process of "tablet compression method", the tablet's compressibility is poor, so that the difference in tablet appearance or tablet weight is not easy to meet the requirements of the Pharmacopoeia for tablets, which limits the development of orally disintegrating tablets

Method used

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  • Acetyl-gastrodine oral disintigration tablet for sedation, soporific and nervous headache
  • Acetyl-gastrodine oral disintigration tablet for sedation, soporific and nervous headache

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Product Name: Acetyl Gastrodin Orally Disintegrating Tablets

[0051] Specification: 25mg / tablet

[0052] Formula 1: Acetyl gastrodin 25g

[0053] Lactose 65g

[0054] Cross-linked polyvinylpyrrolidone (CPVP) 4g

[0055] Citric acid 0.5g

[0056] Aspartame 1g

[0057] Flavor powder 0.5g

[0058] Magnesium stearate 0.5g

[0059] Preparation method: Mix acetylgastrodin, lactose, cross-linked polyvinylpyrrolidone, citric acid, and aspartame evenly, make 20-mesh granules with water, dry at 60°C for 4-6 hours, mix the dried granules with lubricant After magnesium fatty acid and flavor powder are mixed evenly, pass through a 18-mesh sieve for granulation. The total weight of the main drug and auxiliary materials is about 96.5g. Each tablet contains 25mg of the main drug and about 71.5mg of auxiliary materials. The theoretical tablet weight is about: 96.5mg / piece. Compress 1000 tablets on a tablet press. The disintegration time of the tablet prepared in Example 1 was...

Embodiment 2

[0062] Product Name: Acetyl Gastrodin Orally Disintegrating Tablets

[0063] Specification: 50mg / tablet

[0064] Recipe 2: Acetyl Gastrodin 50g

[0065] Mannitol 100g

[0066] Croscarmellose Sodium 10g

[0067] Tartaric acid 2g

[0068] Stevioside 1g

[0069] 5% polyvinylpyrrolidone ethanol solution appropriate amount

[0070] Magnesium stearate 0.5g

[0071] Preparation method: First, take a certain amount of polyvinylpyrrolidone and dissolve it with 30-90% ethanol to form a 5% (weight / volume, W / V) concentration of polyvinylpyrrolidone ethanol solution. Then measure an appropriate amount of the solution, add acetylgastrodin, stir to dissolve all the medicine in the polyvinylpyrrolidone ethanol solution, add tartaric acid and stevioside, and stir to dissolve into a clear solution. Mix mannitol and croscarmellose sodium evenly, pass through a 120-mesh sieve, add the prepared clear solution into it, stir to make a soft material, m...

Embodiment 3

[0074] Product Name: Acetyl Gastrodin Orally Disintegrating Tablets

[0075] Specification: 100mg / tablet

[0076] Formula 3: Acetyl Gastrodin 100g

[0077] Mannitol 150g

[0078] Cross-linked polyvinylpyrrolidone (CPVP) 6g

[0079] Croscarmellose Sodium 8g

[0080] Citric acid 3g

[0081] Aspartame 0.2g

[0082] 5% polyvinylpyrrolidone ethanol solution appropriate amount

[0083] Magnesium Stearate 1g

[0084] Preparation method: The main ingredient is mixed evenly with all auxiliary materials, and then directly pressed into tablets.

[0085] The disintegration time of the tablet of Example 3 detected by the method for measuring the disintegration time limit of Example 1 is 10 seconds.

[0086] In Example 1, Example 2, and Example 3, an appropriate amount of essence or mint or one of the effervescent agents, or their mixture, can be added to the granules or mixed powder before tablet compression to make the tablet di...

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Abstract

An oral disintegrating tablet of acegastrodine for treating insomnia and nervous headache is prepared from acegastrodine, souring agent, excipient, and disintegrant.

Description

technical field [0001] The invention relates to pharmaceutical preparations in the field of medicine, in particular to an orally disintegrating acetylgastrodin tablet for sedation, hypnosis and nervous headaches and a preparation method thereof. technical background [0002] The pharmacological effects of acetylgastrodin show that it enhances the inhibitory process of the cerebral cortex, presents a brain wave pattern of central inhibition, and has a central sedative and hypnotic effect. The sedative index is 1.77 times stronger than gastrodin, and it is the second-generation product of gastrodin. And it has analgesic effect, can increase cerebral blood flow and relieve cerebral vasospasm; and has no obvious effect on electrocardiogram and blood pressure. The clinical indications of this product are: sedation and sleep aid. For insomnia and headache caused by anxiety, tension, excitement and chronic fatigue. This product is safe in medication, has low adverse reactions, is...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/7034A61P25/04A61P25/06A61P25/20
Inventor 刘智张执一
Owner 刘智
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