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Citicoline enteric coated preparation and its preparation method

A technology for citicoline and enteric-coated preparations, which is applied in the field of medicine and can solve the problems of inconvenient use for the recovery and treatment of brain diseases and the like

Inactive Publication Date: 2007-10-17
NAT INST OF PHARMA R & D CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, injections and freeze-dried powder injections have been mainly used clinically for a long time, which is very inconvenient for the recovery treatment of brain diseases.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Example 1: Prescription

[0016] Main and auxiliary materials Weight (g)

[0017] Citicoline sodium (calculated as dry product) 100.0

[0018] Polyacetylpyrrolidone K-30 5.0

[0019] Starch 25.0

[0020] Microcrystalline cellulose 60.0

[0021] Crospovidone XL-10 10.0

[0022] 50% ethanol appropriate amount

[0023] Magnesium Stearate Appropriate amount

[0024] Appropriate amount of coating material

[0025] Makes 1000 pieces

[0026] Preparation method:

[0027] ① Weigh polyacetylpyrrolidone, add 50% ethanol to make 5% polyacetylpyrrolidone ethanol solution, set aside;

[0028] ② Weigh the main drug, starch, microcrystalline cellulose, and crospovidone XL-10 according to the prescription amount, mix them uniformly by equal addition method, add an appropriate amount of 5% polyacetylpyrrolidone ethanol solution to make a soft material, and pass 20 Granulate with mesh sieve and dry at 60°C;

[0029] ③The granules were sieved with a 20-mesh sieve, added 5‰ of m...

Embodiment 2

[0031] Main and auxiliary materials Weight (g)

[0032] Citicoline sodium (calculated as dry product) 100.0

[0033] Starch 30.0

[0034] Microcrystalline cellulose 60.0

[0035] Crospovidone XL-10 10.0

[0036] 50% ethanol appropriate amount

[0037] Magnesium Stearate Appropriate amount

[0038] Makes 1000 capsules

[0039] Preparation method:

[0040] ① Fully mix the prescribed amount of citicoline, pregelatinized starch, and lactose, and prepare a soft material with an appropriate amount of 90% ethanol.

[0041] ② Granulate with a 20-mesh sieve, dry at 50°C, and granulate.

[0042] ③Add magnesium stearate, mix evenly, put into enteric-coated capsules, and obtain citicoline enteric-coated capsules.

[0043] The release test results show that the citicoline enteric-coated capsules do not disintegrate in artificial gastric juice, and the drug release rate is less than 5%, but disintegrate in artificial intestinal juice, and the release rate is greater than 95% within ...

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PUM

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Abstract

The invention relates to an intestines dissolved preparation comprising citicoline and preparation method thereof. In the present invention, the recipe amount of citicoline and routine auxiliary materials are prepared to be intestines dissolved preparation in preparation processing. Compared with other preparation, the invention is characterized in non-disintegration in the stomach, small dissolving-out speed, reduced stimulation to the stomach, high dissolving-out speed in the intestinal tract, convenient oral-taken, low production cost, without needing special apparatus, convenience in taking-along, transportation and oral-taken and stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an enteric-coated preparation of citicoline and a preparation method thereof. Background technique [0002] Citicoline is a normal component of the human body. The molecule contains choline and cytosine. It promotes the synthesis of lecithin in the body and plays a role in changing the physiological function of the meninges. At present, the clinical use of citicoline preparations is mainly used to improve brain function. Metabolism is a routine clinical drug in neurology and has the following characteristics: [0003] 1. Reduce cerebrovascular resistance, increase cerebral blood flow, promote brain substance metabolism, and improve cerebral circulation; [0004] 2. Enhance the function of the brainstem reticular structure, enhance the function of the pyramidal system, improve motor paralysis, promote lecithin synthesis, improve brain metabolism, and can be used in c...

Claims

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Application Information

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IPC IPC(8): A61K31/7068A61K9/20A61K9/48
Inventor 赵咏丽赵志惠徐小进杨东旭
Owner NAT INST OF PHARMA R & D CO LTD
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