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Monosialotetrahexosyl ganglioside sodium for injection and preparation method thereof

A technology of ganglioside sodium and monosialic acid, which is applied in the field of medicine, can solve the problems of foreign body sensation, reduce compliance and comfort, and low drug load in patients, so as to reduce foreign body sensation, improve the quality of life, and improve the quality of life. good effect

Active Publication Date: 2012-08-22
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be known from the published literature that the drug loading capacity of the GM-1-PLGA microspheres prepared by the prior art is very low. In order to achieve the effective therapeutic window, a larger dose needs to be given during administration. There will be a foreign body sensation, which reduces compliance and comfort

Method used

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  • Monosialotetrahexosyl ganglioside sodium for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1, monosialotetrahexosyl ganglioside sodium for injection

[0020] 0.1 parts by weight of monosialotetrahexosyl ganglioside sodium and 0.3 parts by weight of gelatin are dissolved in 4 parts by volume of water, dissolved and mixed as the inner water (W1) phase; 5 parts by weight of polylactic acid- Glycolic acid (the ratio of lactide to glycolide in polylactic acid-glycolic acid is 75 / 25, molecular weight 6000) is dissolved in the dichloromethane of 40 volume parts as oil (O) phase; 5 weight parts of polyethylene Dissolve the alcohol in 500 parts of water for injection at 80°C as the external water (W2) phase; slowly drop the W1 phase into the O phase, emulsify at a high speed of 15000r / min for about 3-5min, cool to 10°C, and use it as the initial phase Milk, and added to the W2 phase, emulsified at 15000r / min high-speed oscillation for about 3-5min, kept at 5000r / min for 4h to evaporate dichloromethane, centrifuged at 10000r / min at high speed, washed 5 times...

Embodiment 2

[0021] Embodiment 2, monosialotetrahexosyl ganglioside sodium for injection

[0022] 0.1 parts by weight of monosialotetrahexosyl ganglioside sodium and 0.3 parts by weight of gelatin are dissolved in 4 parts by volume of water, dissolved and mixed as the inner water (W1) phase; 5 parts by weight of polylactic acid- Glycolic acid (the ratio of lactide and glycolide in polylactic acid-glycolic acid is 75 / 25, molecular weight 20000) is dissolved in the dichloromethane of 40 volume parts as oil (O) phase; 5 weight parts of polyethylene Dissolve the alcohol in 500 parts of water for injection at 80°C as the external water (W2) phase; slowly drop the W1 phase into the O phase, emulsify at a high speed of 15000r / min for about 3-5min, cool to 10°C, and use it as the initial phase Milk, and added to the W2 phase, emulsified at 15000r / min high-speed oscillation for about 3-5min, kept at 5000r / min for 4h to evaporate dichloromethane, centrifuged at 10000r / min at high speed, washed 5 tim...

Embodiment 3

[0023] Embodiment 3, monosialotetrahexosyl ganglioside sodium for injection

[0024]0.1 parts by weight of monosialotetrahexosyl ganglioside sodium and 0.3 parts by weight of gelatin are dissolved in 4 parts by volume of water, dissolved and mixed as the inner water (W1) phase; 5 parts by weight of polylactic acid- Glycolic acid (the ratio of lactide to glycolide in polylactic acid-glycolic acid is 75 / 25, molecular weight 35000) is dissolved in the dichloromethane of 40 volume parts as oil (O) phase; 5 weight parts of polyethylene Dissolve the alcohol in 500 parts of water for injection at 80°C as the external water (W2) phase; slowly drop the W1 phase into the O phase, emulsify at a high speed of 15000r / min for about 3-5min, cool to 10°C, and use it as the initial phase Milk, and added to the W2 phase, emulsified at 15000r / min high-speed oscillation for about 3-5min, kept at 5000r / min for 4h to evaporate dichloromethane, centrifuged at 10000r / min at high speed, washed 5 times...

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Abstract

The invention belongs to the technical field of medicines and specifically relates to monosialotetrahexosyl ganglioside sodium for injection and a preparation method thereof. The monosialotetrahexosyl ganglioside sodium for injection provided in the invention contains GM1, gelatin and PLGA (Polylacticcoglycollic Acid). A microsphere injection prepared from the monosialotetrahexosyl ganglioside sodium for injection provided by the invention is good in reproducibility and encapsulation ratio; the drug-loading rate is improved; the drug release is continuous and stable; the dosage at a time is obviously reduced and the foreign body sensation is reduced; effective blood concentration can be maintained for a long time; the shortcoming of administration every day is avoided; the life quality of a patient is improved; and the problem of the fluctuation of the blood concentration caused by the conventional preparations is solved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to monosialotetrahexosyl ganglioside sodium for injection and a preparation method thereof. Background technique [0002] Monosialotetrahexosyl ganglioside is a sialic acid-containing sphingolipid, which can accelerate the repair of damaged nerve cells, promote the growth and regeneration of nerve cells, improve nerve conduction, etc., and is mainly used for central and peripheral nervous system diseases It is considered to be one of the most effective drugs for the treatment of spinal cord injury (SCI) in clinical practice. At present, imported water injection needles have been listed on the market. The active ingredient is monosialotetrahexosyl ganglioside sodium (GM1) . [0003] Clinically, GM1 mainly treats SCI through long-term and high-dose repeated administration through the peripheral route. Although exogenous monosialotetrahexosyl ganglioside is fat-soluble and can pass th...

Claims

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Application Information

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IPC IPC(8): A61K31/7032A61K9/08A61K47/32A61P25/28
Inventor 赵志全冯中石其德赵震震张丽萍
Owner SHANDONG NEWTIME PHARMA
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