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Mini-pill type nicergoline capsule and preparation method thereof

A technology of nicergoline and pellets, applied in the field of medicine, can solve the problems of insufficient release of active ingredients, low absolute bioavailability, complicated production process, etc., and achieves improving bioavailability, avoiding photodecomposition of drugs, and increasing utilization. area effect

Inactive Publication Date: 2015-05-20
ZHEJIANG CHANGDIAN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tablets have the problem of difficult dissolution, and the absolute bioavailability of Nicergoline is less than 5%
Although injections have the advantages of fast onset of action and high bioavailability, their production process is complicated, the cost is high, and at the same time, it is inconvenient to use, prone to toxic and side effects, and adverse reactions
Although the current capsules are convenient to take, there are problems such as large irritation to the stomach, insufficient and timely release of active ingredients, low utilization rate, poor stability, and prone to toxic and side effects.

Method used

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  • Mini-pill type nicergoline capsule and preparation method thereof
  • Mini-pill type nicergoline capsule and preparation method thereof
  • Mini-pill type nicergoline capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] A micropill type nicergoline capsule is a sustained-release preparation. The micropill type nicergoline capsule is composed of a capsule shell and nicergoline pellets contained in the capsule shell. To the outside, there are blank core, main drug layer and pigment layer. The weight of the main drug layer is 15% of the blank core, and the weight of the pigment layer is 0.5% of the total weight of the blank core and the main drug layer. The diameter of the blank core is 1.2 mm, the particle size of nicergoline pellets is 14-24 mesh, and each capsule contains 15 mg of nicergoline.

[0027] The preparation method of above-mentioned pellet type Nicergoline capsule, comprises the following steps:

[0028] Preparation of main drug layer coating

[0029]Take 400 grams of purified water, slowly add 37.5 grams of hydroxypropyl methylcellulose under stirring, after the dissolution is complete, add 28.1 grams of anhydrous sodium carbonate, 9.4 grams of Tween-80, and 28.1 grams of ...

Embodiment 2

[0034] A micropill type nicergoline capsule is a sustained-release preparation. The micropill type nicergoline capsule is composed of a capsule shell and nicergoline pellets contained in the capsule shell. To the outside, there are blank core, main drug layer and pigment layer. The weight of the main drug layer is 25% of the blank core, and the weight of the pigment layer is 0.7% of the total weight of the blank core and the main drug layer. The diameter of the blank core is 1.1 mm, the particle size of nicergoline pellets is 14-24 mesh, and each capsule contains 20 mg of nicergoline.

[0035] The preparation method of above-mentioned pellet type Nicergoline capsule, comprises the following steps:

[0036] Preparation of main drug layer coating

[0037] Take 600 grams of purified water, slowly add 63.4 grams of hydroxypropyl methylcellulose under stirring, after the dissolution is complete, add 49.3 grams of anhydrous sodium carbonate, 17.6 grams of Tween-80, and 49.3 grams o...

Embodiment 3

[0042] A micropill type nicergoline capsule is a sustained-release preparation. The micropill type nicergoline capsule is composed of a capsule shell and nicergoline pellets contained in the capsule shell. To the outside, there are blank core, main drug layer and pigment layer. The weight of the main drug layer is 40% of the blank core, and the weight of the pigment layer is 0.8% of the total weight of the blank core and the main drug layer. The diameter of the blank core is 1.0 mm, the particle size of nicergoline pellets is 14-24 mesh, and each capsule contains 25 mg of nicergoline.

[0043] The preparation method of above-mentioned pellet type Nicergoline capsule, comprises the following steps:

[0044] Preparation of main drug layer coating

[0045] Take 1000 grams of purified water, slowly add 103 grams of hydroxypropyl methylcellulose under stirring, after the dissolution is complete, add 82 grams of anhydrous sodium carbonate, 30.8 grams of Tween-80, and 82 grams of do...

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Abstract

The invention discloses a mini-pill type nicergoline capsule and a preparation method thereof. The mini-pill type nicergoline capsule is a sustained-release preparation and is prepared from a capsule shell and a nicergoline mini-pill accommodated in the capsule shell, wherein the nicergoline mini-pill sequentially comprises an empty pill core, a main drug layer and a pigmented layer from inside to outside; the main drug layer accounts for 15-60 percent of the empty pill core, and the pigmented layer accounts for 0.5-1 percent of the total weight of the empty pill core and the main drug layer. The mini-pill type nicergoline capsule has the advantages of small stimulation to intestines and stomach, high utilization rate, high stability, less toxic or side effects and capability of fully releasing effective components in time.

Description

technical field [0001] The invention relates to a nicergoline capsule and a preparation method thereof, in particular to a pellet-type nicergoline capsule of drug sustained and controlled release preparation and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Nicergoline, the English name is nicergoline, the chemical name is 10α-methoxy-1,6-dimethylergoline-8β-methanolyl 5″-bromonicotinate, the molecular formula is C24H26BrN3O3, and the molecular weight is 484.39. [0003] Nicergoline is an alpha-adrenergic blocking vasodilator. Nicergoline can increase the blood flow of cerebral arteries (especially in the ischemic area) by inhibiting the tension of vasoconstriction and sympathetic nerves, and can increase the utilization rate of brain cells to grape and oxygen. Receptor activation, antihypertensive and anti-platelet aggregation. [0004] Nicergoline is used for the treatment of acute or chronic cerebrovascular dis...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/48A61K47/38A61P9/10A61P27/16A61P1/08A61P27/02A61P25/00A61P25/28
Inventor 陈宇东张蓬蒋晨来杭佳廖衍
Owner ZHEJIANG CHANGDIAN PHARMA
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