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Gastrodine oral disintigration tablet with sedation hypnotic and analgesis function

A technology of orally disintegrating tablets and gastrodin, which is applied in the field of gastrodin orally disintegrating tablets and its preparation, can solve problems such as disadvantages, poor tablet compressibility, and poor tablet strength, and achieve good practicability, process feasibility, and quality stable effect

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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  • Gastrodine oral disintigration tablet with sedation hypnotic and analgesis function
  • Gastrodine oral disintigration tablet with sedation hypnotic and analgesis function

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Product Name: Gastrodin Orally Disintegrating Tablets

[0051] Specification: 25mg / tablet

[0052] Formula 1: 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 gastrodin, 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 stearin After the magnesium 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 25 mg of the main drug and about 71.5 mg of auxiliary materials. The theoretical tablet weight is about 96.5 mg / tablet . Compress 1000 tablets on a tablet press. The disintegration time of the tablet prepared in Example 1 was detected b...

Embodiment 2

[0062] Product Name: Gastrodin Orally Disintegrating Tablets

[0063] Specification: 50mg / tablet

[0064] Recipe 2: 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 gastrodin, 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, make 20-mesh granu...

Embodiment 3

[0074] Product Name: Gastrodin Orally Disintegrating Tablets

[0075] Specification: 100mg / tablet

[0076] Recipe 3: 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] Tablets measured by hardness tester are 2.5-3kg / cm 2 (n=10), the disintegration time in the oral cavity was less than 10 seconds.

[0086] The disintegration time detected by the method for measuring the disintegration time limit in Example 1 was 11 seconds.

[0087] In Example 1, Example 2, and Example 3, an appropriate amount of essence or mint or one of the effervescent agents, or their mixtu...

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Abstract

An oral disintegrating tablet of gastrodine for treating neurasthenia, neurasthenia syndrome and angioneurotic headache is prepared from gastrodine, souring agent, excipient and disintegrant.

Description

technical field [0001] The invention relates to pharmaceutical preparations in the field of medicine, in particular to a gastrodin orally disintegrating tablet with sedative, hypnotic and analgesic effects and a preparation method thereof. technical background [0002] Gastrodin can restore the imbalance between the excitatory and inhibitory processes of the cerebral cortex, and produce central inhibitory effects such as sedation, sleep and analgesia; gastrodin can also dilate blood vessels, improve myocardial microcirculation, increase myocardial nutritional blood flow and improve oxygen supply capacity. Clinically used for neurasthenia, neurasthenia syndrome and angioneurotic headache (such as migraine, trigeminal neuralgia, occipital neuralgia, etc.), vertigo and hyperlipidemia. [0003] Medical research shows that with the development of science and technology and the accelerated pace of work and life, people's sleep quality is gradually declining, and the rate of insomn...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/7034A61P25/20
Inventor 刘智张执一黄武军
Owner 刘智
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