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A kind of ganglioside sustained-release tablet and preparation method thereof

A technology for ganglioside and sustained-release tablets, which is applied in nervous system diseases, pharmaceutical formulations, medical preparations containing active ingredients, etc., can solve the problems of inconvenient use, non-standard production, high price, etc. High, low price, low cost of raw materials

Active Publication Date: 2021-01-01
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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  • A kind of ganglioside sustained-release tablet and preparation method thereof
  • A kind of ganglioside sustained-release tablet and preparation method thereof
  • A kind of 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 a 100-mesh sieve, mix mechanically, and mix 5% povidone Spray the aqueous solution in...

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 the upper punch is 14.8mm, and the ...

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 aqueous solution into the mixture for 40-mesh sieve granulation. After granulation, sp...

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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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Patent Type & Authority Patents(China)
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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