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Sustained release preparation of phenytoin sodiumslow release

A slow-release preparation, the technology of phenytoin sodium, is applied in the direction of cardiovascular system diseases, inorganic non-active ingredients, polymer compound non-effective ingredients, etc., which can solve the problems of not causing sedative and hypnotic effects, exacerbation, etc., to reduce the frequency of medication and improve the effectiveness or adaptive effects

Inactive Publication Date: 2007-08-15
刘凤鸣
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therapeutic dose does not cause sedative and hypnotic effects. Animal experiments have proved that this product has a selective antagonism effect on the tonic phase of super-strong electric shock and convulsions, but it is ineffective or intensified on the clonic phase, so it has a good effect on epileptic grand mal seizures. not effective for absence seizures

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] The preparation of embodiment 1-phenytoin sustained-release tablet (1)

[0051] Method: Take 100 grams of phenytoin sodium, 50 grams of hydroxypropyl cellulose, 15 grams of hypromellose, 10 grams of lactose, 10 grams of microcrystalline cellulose, 1 gram of carbomer, and 30 grams of polyethylene glycol 4000. Mix evenly, granulate by dry method, add magnesium stearate to mix, and compress into tablets to obtain a finished product with a drug content of 100 mg / tablet. Then the dissolution rate of the phenytoin sodium sustained-release tablet (1) in 900 ml of water at 37° C. was measured. After release measurement, the results are shown in Table 1, which meets the requirements.

[0052] Table 1 Dissolution of phenytoin sustained-release tablets (1)

[0053] Sampling time (hours)

Embodiment 2

[0054] The preparation of embodiment 2-phenytoin sustained-release tablets (2)

[0055] Method: Take 100 grams of phenytoin sodium, 10 grams of hydroxypropyl cellulose, 20 grams of stearyl alcohol, 15 grams of hypromellose, 1 gram of carbomer, and 10 grams of lactose, pass through 80-mesh sieve, grind and mix well , adding a 95% ethanol solution of 10% polyvinylpyrrolidone as a binder and stirring to make a soft material, granulating through a 16-mesh sieve, drying the granules at room temperature for 2 hours, granulating through a 16-mesh sieve, and then adding stearic acid 4.5 grams of magnesium, 2 grams of micro-powder silica gel, mixed evenly, and tableted to obtain a finished product, the drug content is 100 mg / tablet. Then the dissolution rate of the phenytoin sustained-release tablet (2) in 900 ml of water at 37° C. was measured. After release measurement, the results are shown in Table 2, which meets the requirements.

[0056] Table 2 Dissolution of phenytoin sustain...

Embodiment 3

[0058] The preparation of embodiment 3-phenytoin sustained-release tablets (3)

[0059] Method: Take 100g of phenytoin sodium, 35g of hypromellose, 5g of microcrystalline cellulose, and 1g of carbomer respectively, pass through a 80-mesh sieve, mix well, add a 95% ethanol solution of 10% polyvinylpyrrolidone as The binder is stirred to make a soft material, granulated through a 16-mesh sieve, dried at 60°C for 1 hour, granulated through a 16-mesh sieve, then added with 2.5 grams of magnesium stearate, mixed evenly, and pressed into tablets to obtain a finished product with a drug content 100mg / tablet. Then the dissolution rate of the phenytoin sustained-release tablet (3) in 900 ml of water at 37° C. was measured. After release measurement, the results are shown in Table 3, meeting the requirements.

[0060] Table 3 Dissolution of phenytoin sustained-release tablets (3)

[0061] Sampling time (hours)

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PUM

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Abstract

The invention discloses a slow release preparation of Phenytoinum Natricum and its preparing process, wherein the raw materials of the invention include Phenytoinum Natricum of a predetermined proportion, slow release matrix material and medicinal material, the preparation can be prepared into solid dispersing agent, wherein the medicament can be released slowly and continuously after being administrated, the effective concentration in blood can be maintained, and long action can be achieved. The advantages of the invention include decreased frequency of medicinal administration, improved patient's adaptability, lowered blood concentration peak-valley, increased medicinal effect and safety, and reduced total medicinal dose, thereby optimum curative effect can be achieved through minimum dose, thus the preparation is more suitable for patients.

Description

[0001] [technical field] the present invention relates to the slow-release preparation of phenytoin sodium and preparation method thereof. [Background technique] [0002] The research and development of sustained-release preparations has a history of more than 40 years. It releases slowly and at a non-constant rate as required in a prescribed environment. Prolonged formulation. This kind of preparation can make the human body maintain this kind of blood drug concentration for a long time, instead of dropping rapidly like ordinary preparations, so as to avoid the "peak and valley" phenomenon that occurs when common preparations are frequently administered, and ensure the safety of the drug. Sexuality, effectiveness or adaptability have been improved, thereby reducing the number of medications, which greatly facilitates patients, especially patients who have been taking medication for a long time. Commonly used oral dosage forms include matrix tablets, microporous coated surfac...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/48A61K47/02A61K47/12A61K47/34A61K47/38A61K47/42A61K47/44A61K31/4166A61P9/06A61K47/10
Inventor 刘凤鸣
Owner 刘凤鸣
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