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Rapidly disintegrated nicergoline tablet and preparation method thereof

A nicergoline, fast technology, applied in the directions of pharmaceutical formulations, inactive medical preparations, coatings, etc., can solve the problems of incomplete disintegration, slow dissolution, etc., achieves good stability, rapid disintegration, and improved disintegrating effect

Active Publication Date: 2019-07-26
湖北科莱维生物药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] After testing, various types of microcrystalline cellulose that are currently available in the domestic market are used, such as PH101 with small particle size, PH200 with large particle size, PH301 with high density, KG802 with low density, and carboxymethyl cellulose with different viscosities. Sodium cellulose, such as low-viscosity 7LF PH, medium-viscosity 7MF PH, high-viscosity 7HF PH, adopts conventional methods, after mixing the auxiliary materials and main ingredients, adopts the Nicergoline tablets prepared by direct compression technology, or through wet method granulation, drying, granulation, sieving, tableting and other processes, the prepared Nicergoline tablets cannot be completely disintegrated, and the dissolution is slow.

Method used

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  • Rapidly disintegrated nicergoline tablet and preparation method thereof
  • Rapidly disintegrated nicergoline tablet and preparation method thereof
  • Rapidly disintegrated nicergoline tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] The prescription composition (10mg specification) in the preparation of table 1 embodiment 1 nicergoline tablet

[0046]

[0047] Note: 1. Microcrystalline cellulose, sodium carboxymethylcellulose and purified water are all added 5% higher according to the prescription amount to offset the loss in the granulation process; 2. When preparing the coating solution, prepare 10% more to offset the coating process loss.

[0048] 2. Preparation process

[0049] (1) Granulation of microcrystalline cellulose and sodium carmellose

[0050] Granulation: Weigh microcrystalline cellulose and carmellose sodium according to 105% of the prescription amount, place them in the wet mixing granulator, set the speed of the stirring paddle and the speed of the shearing paddle, start the wet mixing granulator, Dry mix for 2 minutes. After the dry mixing time is up, keep the wet mixing granulator in the open state, and click the atomization and water addition button to atomize and add wat...

Embodiment 2

[0065] The prescription composition (5mg specification) in the preparation of table 2 embodiment 2 nicergoline tablets

[0066]

[0067] Note: 1. Microcrystalline cellulose, sodium carboxymethylcellulose and purified water are all added 5% higher according to the prescription amount to offset the loss in the granulation process; 2. When preparing the coating solution, prepare 10% more to offset the coating process loss.

Embodiment 3

[0069] The prescription composition (30mg specification) in the preparation of table 3 embodiment 3 nicergoline tablets

[0070]

[0071] Note: 1. Microcrystalline cellulose, sodium carboxymethylcellulose and purified water are all added 5% higher according to the prescription amount to offset the loss in the granulation process; 2. When preparing the coating solution, prepare 10% more to offset the coating process loss.

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Abstract

The invention relates to a preparation method of a rapidly disintegrated nicergoline tablet. The method comprises a necessary key step: that is, microcrystalline cellulose-sodium carboxymethylcellulose granules are first prepared by a wet granulation method and then mixed with other auxiliary materials, so that the prepared nicergoline tablet can be rapidly disintegrated by the granules. The tableting process provided by the invention is a powder direct compression process: the prepared microcrystalline cellulose-sodium carboxymethylcellulose granules, nicergoline, dibasic calcium phosphate and magnesium stearate are directly mixed; and then tabletting, coating and aluminum-plastic packaging are executed to obtain a finished product. Each inspection index of the nicergoline tablet preparedby the method is qualified, the disintegration time is less than or equal to 2 minutes, and the nicergoline tablet can rapidly and completely disintegrate in an inspected dissolution medium to realize rapid dissolution. A disintegrating agent easily absorbing moisture is not used in the prescription, and the prepared nicergoline tablet has excellent stability. The preparation method of the nicergoline tablets p is novel in method and simple in process, and well solves the problems of no disintegration and poor stability of the existing marketed nicergoline tablets.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a preparation method of a rapidly disintegrating tablet, in particular to a preparation method of a rapidly disintegrating nicergoline tablet. Background technique [0002] With the aging of the population in society, memory and cognitive decline are inevitable physiological phenomena of normal aging, while dementia, mild cognitive impairment and normal aging are different degrees of cognitive decline in the elderly, neurological diseases It has become a major killer threatening human health. Taking dementia as an example, senile dementia, also known as Alzheimer's disease, has become the fourth biggest killer of the elderly after cardiovascular disease, malignant tumor and stroke. The disease is a primary degenerative encephalopathy, which occurs in old age and pre-senile age, and doubles with age. Over 60 years old, the prevalence rate is 4% to 8%, and it inc...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K47/38A61K31/48A61P25/28
CPCA61K9/2054A61K9/2077A61K9/2095A61K9/2866A61K31/48A61P25/28
Inventor 周立明张晓轩白培锋武晶晶刘少华张莉张树生董进臣
Owner 湖北科莱维生物药业有限公司
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