Double sodium valproate orally disintegrating tablets and preparation method thereof

Abstract

The invention discloses a divalproex sodium orally disintegrating tablet and a preparation method thereof. The principal medicine of the orally disintegrating tablet is divalproex sodium and the accessories are microcrystalline cellulose, mannitol, lactose, polyacrylic resin II, cross linked polyvinylpyrrolidone, sodium cyclamate, menthol and aerosil. The divalproex sodium orally disintegrating tablet of the invention can effectively cure falling sickness and vesania, can prevent hemicrania and has the advantages of convenient taking, good taste, fast disintegration, quick absorption and high biological availability. The divalproex sodium orally disintegrating tablet provides convenience for old people, children or patients having difficulty in swallowing and people having inconvenience to get water.

Description

1. Technical field

[0001] The invention relates to an oral pharmaceutical preparation for treating epilepsy, mania and preventing migraine and a preparation method thereof, in particular to a divalproex sodium orally disintegrating tablet capable of rapid disintegration, release and good taste, and its preparation method. Preparation. 2. Background technology

[0002] Divalproex sodium is a new generation of valproic acid derivatives, which is mainly used clinically to treat epilepsy, mania and prevent migraine. Epilepsy is a major worldwide health problem, affecting approximately 1% to 2% of the world's population. At present, there are 40 million epilepsy (EP) patients in the world, and there are about 6 million epilepsy patients in China, and 380,000 new epilepsy patients are discovered every year. Most of them are children and teenagers, and they are more harmful to humans. Until now, the best way to treat epilepsy is long-term application of antiepileptic drugs. [...

Examples

Embodiment 1

[0035] The orally disintegrating tablet of divalproex sodium comprises main ingredients and auxiliary materials, and is characterized in that it is formulated according to the following weight percentages: 10% of main ingredients and 90% of auxiliary materials.

[0036] Divalproex Sodium 25g (10%)

[0037] Microcrystalline Cellulose 37.5g (20%)

[0038] Mannitol 92.5g (37%)

[0039] Lactose 55g (22%)

[0040] Polyacrylic resin II 12.5g (5%)

[0041] Cross-linked polyvinylpyrrolidone 7.5g (3%)

[0042] Cyclamate 2.5g(1%)

[0043] Menthol 2.5(1%)

[0044] Micronized silica gel 2.5(1%)

[0045]

[0046] A total of 1000 tablets were produced

[0047] Among them, lactose and mannitol are fillers, microcrystalline cellulose and cross-linked polyvinylpyrrolidone are disintegrants, polyacrylic acid resin II, cyclamate and menthol are flavoring agents, and micronized silica gel is a glidant.

[0048] The preparation method of divalpro...

Embodiment 2

[0058]The orally disintegrating tablet of divalproex sodium comprises main ingredients and auxiliary materials, and is characterized in that it is formulated according to the following weight percentages: 20% of main ingredients and 80% of auxiliary materials.

[0059] Divalproex Sodium 50g (20%)

[0060] Microcrystalline Cellulose 32.5g (13%)

[0061] Mannitol 110g (38%)

[0062] Lactose 45g (15%)

[0063] Polyacrylic resin II 12.5g (5%)

[0064] Cross-linked polyvinylpyrrolidone 12.5g (5%)

[0065] Cyclamate 2.0g(1%)

[0066] Menthol 2.5(1%)

[0067] Micronized silica gel 5.0(2%)

[0068]

[0069] A total of 1000 tablets were produced

[0070] Among them, lactose and mannitol are fillers, microcrystalline cellulose and cross-linked polyvinylpyrrolidone are disintegrants, polyacrylic acid resin II, cyclamate and menthol are flavoring agents, and micronized silica gel is a glidant.

[0071] The preparation method of divalproex sod...

Embodiment 3

[0081] The orally disintegrating tablet of divalproex sodium comprises main ingredients and auxiliary materials, and is characterized in that it is formulated according to the following weight percentages: 30% of main ingredients and 70% of auxiliary materials.

[0082] Divalproex Sodium 75g (30%)

[0083] Microcrystalline Cellulose 25g (10%)

[0084] Mannitol 100g (40%)

[0085] Lactose 12.5g (5%)

[0086] Polyacrylic resin II 12.5g (5%)

[0087] Cross-linked polyvinylpyrrolidone 12.5g (5%)

[0088] Cyclamate 2.0g(1%)

[0089] Menthol 2.5(1%)

[0090] Micronized silica gel 7.5(3%)

[0091]

[0092] A total of 1000 tablets were produced

[0093] Among them, lactose and mannitol are fillers, microcrystalline cellulose and cross-linked polyvinylpyrrolidone are disintegrants, polyacrylic acid resin II, cyclamate and menthol are flavoring agents, and micronized silica gel is a glidant.

[0094] The preparation method of divalproex sod...

1. Technical field

[0001] The invention relates to an oral pharmaceutical preparation for treating epilepsy, mania and preventing migraine and a preparation method thereof, in particular to a divalproex sodium orally disintegrating tablet capable of rapid disintegration, release and good taste, and its preparation method. Preparation. 2. Background technology

[0002] Divalproex sodium is a new generation of valproic acid derivatives, which is mainly used clinically to treat epilepsy, mania and prevent migraine. Epilepsy is a major worldwide health problem, affecting approximately 1% to 2% of the world's population. At present, there are 40 million epilepsy (EP) patients in the world, and there are about 6 million epilepsy patients in China, and 380,000 new epilepsy patients are discovered every year. Most of them are children and teenagers, and they are more harmful to humans. Until now, the best way to treat epilepsy is long-term application of antiepileptic drugs. [...

Examples

Embodiment 1

[0035] The orally disintegrating tablet of divalproex sodium comprises main ingredients and auxiliary materials, and is characterized in that it is formulated according to the following weight percentages: 10% of main ingredients and 90% of auxiliary materials.

[0036] Divalproex Sodium 25g (10%)

[0037] Microcrystalline Cellulose 37.5g (20%)

[0038] Mannitol 92.5g (37%)

[0039] Lactose 55g (22%)

[0040] Polyacrylic resin II 12.5g (5%)

[0041] Cross-linked polyvinylpyrrolidone 7.5g (3%)

[0042] Cyclamate 2.5g(1%)

[0043] Menthol 2.5(1%)

[0044] Micronized silica gel 2.5(1%)

[0045]

[0046] A total of 1000 tablets were produced

[0047] Among them, lactose and mannitol are fillers, microcrystalline cellulose and cross-linked polyvinylpyrrolidone are disintegrants, polyacrylic acid resin II, cyclamate and menthol are flavoring agents, and micronized silica gel is a glidant.

[0048] The preparation method of divalpro...

Embodiment 2

[0058]The orally disintegrating tablet of divalproex sodium comprises main ingredients and auxiliary materials, and is characterized in that it is formulated according to the following weight percentages: 20% of main ingredients and 80% of auxiliary materials.

[0059] Divalproex Sodium 50g (20%)

[0060] Microcrystalline Cellulose 32.5g (13%)

[0061] Mannitol 110g (38%)

[0062] Lactose 45g (15%)

[0063] Polyacrylic resin II 12.5g (5%)

[0064] Cross-linked polyvinylpyrrolidone 12.5g (5%)

[0065] Cyclamate 2.0g(1%)

[0066] Menthol 2.5(1%)

[0067] Micronized silica gel 5.0(2%)

[0068]

[0069] A total of 1000 tablets were produced

[0070] Among them, lactose and mannitol are fillers, microcrystalline cellulose and cross-linked polyvinylpyrrolidone are disintegrants, polyacrylic acid resin II, cyclamate and menthol are flavoring agents, and micronized silica gel is a glidant.

[0071] The preparation method of divalproex sod...

Embodiment 3

[0081] The orally disintegrating tablet of divalproex sodium comprises main ingredients and auxiliary materials, and is characterized in that it is formulated according to the following weight percentages: 30% of main ingredients and 70% of auxiliary materials.

[0082] Divalproex Sodium 75g (30%)

[0083] Microcrystalline Cellulose 25g (10%)

[0084] Mannitol 100g (40%)

[0085] Lactose 12.5g (5%)

[0086] Polyacrylic resin II 12.5g (5%)

[0087] Cross-linked polyvinylpyrrolidone 12.5g (5%)

[0088] Cyclamate 2.0g(1%)

[0089] Menthol 2.5(1%)

[0090] Micronized silica gel 7.5(3%)

[0091]

[0092] A total of 1000 tablets were produced

[0093] Among them, lactose and mannitol are fillers, microcrystalline cellulose and cross-linked polyvinylpyrrolidone are disintegrants, polyacrylic acid resin II, cyclamate and menthol are flavoring agents, and micronized silica gel is a glidant.

[0094] The preparation method of divalproex sod...

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