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Nicergoline pill and preparation method thereof

The technology of nicergoline tablet and main drug is applied in the field of tablet for treating vascular dementia and the field of preparation thereof, which can solve the requirement of high fluidity, compressibility and tableting equipment, affect product quality and curative effect, and increase production. cost, etc.

Inactive Publication Date: 2013-03-06
SHANDONG FANGMING PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Since Nicergoline is sensitive to heat and humidity, it is unstable during the granulation and drying process of the preparation, which will easily lead to a decrease in content and an increase in related substances, thereby affecting product quality and curative effect
The direct tableting process has high requirements on the fluidity, compressibility and tableting equipment of excipients, which significantly increases the production cost

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Nicergoline tablets, the prescription and preparation method of 1000 tablets are as follows:

[0019] prescription:

[0020] Nicergoline 10g

[0021] Starch 42g

[0022] Microcrystalline Cellulose 38g

[0023] Hypromellose 5g

[0024] 10%PVPk 30 80% ethanol solution appropriate amount

[0025] 2% hypromellose solution appropriate amount

[0026] Carboxymethyl Starch Sodium 4g

[0027] Magnesium Stearate 0.5%

[0028]

[0029] Makes 1000 pieces

[0030] Preparation:

[0031] 1. Raw and auxiliary materials are pulverized, passed through 80-100 mesh sieves respectively, and set aside.

[0032] 2. Accurately weigh starch, microcrystalline cellulose, and hydroxypropyl cellulose according to the prescription amount, mix them evenly, and mix them with 10% PVPk 30 80% ethanol solution is used as a binder to granulate, dried above 60°C, granulated with a 20-mesh sieve, and set aside.

[0033] 3. Accurately weigh...

Embodiment 2

[0037] Nicergoline tablets, the prescription and preparation method of 1000 tablets are as follows:

[0038] prescription:

[0039] Nicergoline 10g

[0040] Starch 30g

[0041] Lactose 50g

[0042] Hypromellose 5g

[0043] 10%PVPk 30 80% ethanol solution appropriate amount

[0044] 2% hypromellose solution appropriate amount

[0045] Carboxymethyl Starch Sodium 4g

[0046] Magnesium Stearate 0.5%

[0047]

[0048] Makes 1000 pieces

[0049] Preparation:

[0050] 1. Raw and auxiliary materials are pulverized, passed through 80-100 mesh sieves respectively, and set aside.

[0051] 2. Accurately weigh starch, lactose, and hydroxypropyl cellulose according to the prescription amount, mix them evenly, and use 10% PVPk 30 80% ethanol solution is used as a binder to granulate, dried above 60°C, granulated with a 20-mesh sieve, and set aside.

[0052] 3. Accurately weigh Nicergoline according to the prescription amoun...

Embodiment 3

[0056] Nicergoline tablets, the prescription and preparation method of 1000 tablets are as follows:

[0057] prescription:

[0058] Nicergoline 30g

[0059] Starch 40g

[0060] Microcrystalline Cellulose 70g

[0061] Hypromellose 7.5g

[0062] 10%PVPk 30 80% ethanol solution appropriate amount

[0063] 2% hypromellose solution appropriate amount

[0064] Carboxymethyl Starch Sodium 5g

[0065] Magnesium Stearate 0.5%

[0066]

[0067] Makes 1000 pieces

[0068] Preparation:

[0069] 1. Raw and auxiliary materials are pulverized, passed through 80-100 mesh sieves respectively, and set aside.

[0070] 2. Accurately weigh starch, microcrystalline cellulose, and hydroxypropyl cellulose according to the prescription amount, mix them evenly, and mix them with 10% PVPk 30 80% ethanol solution is used as a binder to granulate, dried above 60°C, granulated with a 20-mesh sieve, and set aside.

[0071] 3. Accurately we...

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PUM

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Abstract

The invention discloses a nicergoline pill and a preparation method thereof. Preparation comprises nicergoline, diluent, disintegrant, adhesive, lubricant and film coating premixing agent. The preparation method includes uniformly mixing the diluent with the internally added disintegrant; preparing blank particles in proper quantity by the adhesive, drying, pelleting and reserving; independently pelleting main drug by the proper adhesive, quickly drying, pelleting and reserving at lower temperature; uniformly mixing the main drug particles with the blank particles, adding externally added auxiliaries, mixing totally, pressing, coating a thin film and packaging. Accordingly, flowability of the particles is guaranteed, the drug can be dissolved beneficially, and more importantly, the problems that content of the main drug and the auxiliaries is lowered and relevant substances are increased due to the high drying temperature and long time in pelleting are avoided. Compared with the prior art, the nicergoline pill has the advantages of reasonable components, simplicity in process, unique preparation method, high dissolving degree, good stability of the preparation, low cost and the like.

Description

technical field [0001] The present invention relates to a tablet with α-receptor blocking effect and vasodilator effect, which is used for improving depression and affective disorder caused by sequelae of cerebral infarction, and for treating vascular dementia and its preparation method, which belongs to the pharmaceutical preparation technology field. Background technique [0002] my country has gradually entered into an aging country. It is estimated that from 2003 to 2010, my country's population aging will accelerate. The population over 60 years old in my country will increase to 173 million, and the proportion of the elderly population will rise to 12.54%. At the same time, demand for drugs to treat Alzheimer's disease brought on by an aging population has been growing steadily. Nicergoline has α-receptor blocking effect and vasodilation effect, which can strengthen the energy metabolism of brain cells, increase the utilization of oxygen and glucose; promote the conve...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/48A61P25/00A61P25/28
Inventor 王飞龙范兴山孟爱红陈曼
Owner SHANDONG FANGMING PHARMACEUTICAL CO LTD
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