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Ganglioside sustained release tablet and preparation method thereof

A ganglioside and slow-release tablet technology, which is applied in nervous system diseases, pharmaceutical formulas, medical preparations containing active ingredients, etc., can solve problems such as inconvenient use, irregular production, single supply, etc., and achieve safety High, low price, low raw material cost effect

Active Publication Date: 2018-11-16
四川奇格曼药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In June 2017, the State Food and Drug Administration conducted an unannounced inspection of monosialotetrahexosylganglioside sodium injection "Remodeling Jie" produced by the TRB factory in Brazil, and decided to stop importing the product due to irregular production. At present, ganglioside sodium nervous system drugs have a single and tense supply trend
[0007] At present, only monosialotetrahexosylganglioside sodium injection is sold in the domestic and foreign markets, and the injection needs to be carried out in a hospital, which is inconvenient to use, expensive, and has relatively large limitations. Therefore, if a convenient Ganglioside drugs that patients can supplement anytime and anywhere have important social and national strategic significance

Method used

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  • Ganglioside sustained release tablet and preparation method thereof
  • Ganglioside sustained release tablet and preparation method thereof
  • Ganglioside sustained release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Preparation of Example 1 Ganglioside Sustained-release Tablets (300mg / tablet, 1000 tablets were prepared):

[0035] Tablet prescription:

[0036] Element

Dosage

content

Sodium Monosialotetrahexosylganglioside

55g

16.77％

Ethyl cellulose

180g

54.88％

Hypromellose Phthalate

45g

13.72％

arginine

12g

3.66％

Povidone

13g

3.96％

lactose

20g

6.10％

Magnesium stearate

3g

0.91％

gross weight

328g

100％

[0037] Coating Solution Prescription:

[0038] Element

Dosage

content

Hypromellose

20g

80％

polyethylene glycol 6000

2g

8％

talcum powder

2g

8％

Iron Oxide Red

1g

4％

Total

25g

100％

[0039] Sustained-release tablet preparation process:

[0040] (1) Preparation of tablet core: pulverize monosialotetrahexosylganglioside sodium, lactose, ethyl cellulose, and arginine, pass through ...

Embodiment 2

[0042] The preparation of embodiment 2 ganglioside sustained-release tablets

[0043] Tablet prescription:

[0044]

[0045]

[0046] Coating Solution Prescription:

[0047] Element

Dosage

content

Hypromellose

20g

80％

polyethylene glycol 6000

2g

8％

talcum powder

2g

8％

Iron Oxide Red

1g

4％

Total

25g

100％

[0048] making process:

[0049] (1) Preparation of tablet core: pulverize monosialotetrahexosylganglioside sodium, lactose, ethyl cellulose, and arginine, pass through a 100-mesh sieve, mix mechanically, and mix 5% povidone Spray the aqueous solution into the mixture for 40-mesh sieve granulation. After granulation, spray 8% hypromellose phthalate ethanol solution to coat the granules, and dry at 60°C until the moisture content is 1.8%. , add magnesium stearate to the above dry granules, sieve through a 20-mesh sieve, place the granules in a granulator and mix evenly, the height of t...

Embodiment 3

[0051] The preparation of embodiment 3 ganglioside sustained-release tablets

[0052] Tablet prescription:

[0053] Element

Dosage

content

Sodium Monosialotetrahexosylganglioside

55g

16.67％

Ethyl cellulose

170g

51.52％

Hypromellose Phthalate

55g

16.67％

arginine

10g

3.03％

Povidone

15g

4.55％

lactose

22g

6.67％

Magnesium stearate

3g

0.91％

gross weight

330g

100％

[0054] Coating Solution Prescription:

[0055] Element

Dosage

content

Hypromellose

20g

80％

polyethylene glycol 6000

2g

8％

talcum powder

2g

8％

Iron Oxide Red

1g

4％

Total

25g

100％

[0056] making process:

[0057] (1) Preparation of tablet core: pulverize monosialotetrahexosylganglioside sodium, lactose, ethyl cellulose, and arginine, pass through a 100-mesh sieve, mix mechanically, and mix 5% povidone Spray the ...

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Abstract

The invention discloses a ganglioside sustained release tablet and a preparation method thereof. The ganglioside sustained release tablet is prepared from monosialoganglioside and specific pharmaceutical auxiliary materials through a specific method. The process is simple, the cost is low, the medicine price can be effectively reduced, and the burden of a patient is relieved. Meanwhile, the prepared sustained release tablet is good in sustained-release effect, the patient can carry medicine at any time for medicine supplementing, and the sustained-release tablet is convenient to use.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to ganglioside sustained-release tablets. Background technique [0002] Gangliosides, a class of glycosphingolipids containing sialic acid, are components of mammalian cell membranes and are particularly abundant in the nervous system. Its common name is monosialotetrahexosyl ganglioside sodium. It is mainly used for the treatment of traumatic or vascular lesions of the central nervous system, such as brain injury, spinal cord injury, ischemic and hemorrhagic cerebrovascular accident and Parkinson's disease. Its chemical structure is as follows: [0003] [0004] With the acceleration of the development process of the global aging society, governments of various countries have paid more attention to nervous system-related diseases. Japan and the United States successively issued the "Guiding Principles for Stroke Treatment" and "Guidelines for Early Treatment of Adult...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/22A61K31/7032A61P25/00A61P9/10A61P25/16
CPCA61K9/2866A61K31/7032A61P9/10A61P25/00A61P25/16
Inventor 姚静张宪胡伟杨琴飞李豫俭曾奇祥
Owner 四川奇格曼药业有限公司
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