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Preparation method for monosialotetrahexosyl ganglioside sodium injection

A technology of ganglioside sodium and monosialic acid, which is applied in the field of pharmaceutical preparations, can solve problems such as undefined operation process and process parameters, complicated production process, and product quality differences, and achieve good application prospects, less impurities, clarification effect

Active Publication Date: 2013-03-27
哈药集团股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Since monosialotetrahexosyl ganglioside sodium is a biological product extracted from pig brain, in order to keep its injection safe and stable, avoid allergies and other side effects, the production process must be controlled at multiple levels, resulting in complex production process, There are many intermediate links and high cost. At the same time, the existing preparation methods do not have a clear definition of the operation process and process parameters, resulting in differences in product quality.

Method used

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  • Preparation method for monosialotetrahexosyl ganglioside sodium injection
  • Preparation method for monosialotetrahexosyl ganglioside sodium injection
  • Preparation method for monosialotetrahexosyl ganglioside sodium injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] Take accurately weighed disodium hydrogen phosphate 23.8g, sodium dihydrogen phosphate 4.43g, and sodium chloride 160g, add the proportioned amount of 50% (10L), stir and dissolve in water for injection at a temperature of 40°C, and then accurately weigh the Add 200 g of monosialotetrahexosylganglioside sodium raw material into the above solution at a temperature of 40° C., and stir at 900 rpm for more than 10 minutes until completely dissolved. Add 0.1% activated carbon (W / V), stir and adsorb at 900rpm for 30 minutes. Decarbonize with a 0.45μm metal filter. Add water for injection to a dosage of 95% (19L), adjust the pH value to 7.4-7.6 with a concentration of about 1.0mol / L sodium hydroxide solution or hydrochloric acid, add water for injection to make up to 20L; filter, fill, plug and cap , 121 ℃, 20 minutes rotating water bath sterilization, light inspection, packaging.

Embodiment 2

[0046] Take accurately weighed disodium hydrogen phosphate 23.8g, sodium dihydrogen phosphate 4.43g, and sodium chloride 160g, add 50% (10L) of the proportioning amount, and stir to dissolve the water for injection at a temperature of 60°C, and then dissolve the precisely weighed single Add 200 g of sialotetrahexosylganglioside sodium into the phosphate solution at a temperature of 60° C., rotate at 1000 rpm, and stir for 30 minutes until completely dissolved. Add 0.1% activated carbon (W / V), stir and adsorb at 1000rpm for 15 minutes. Decarbonize with a 0.45μm metal filter. Add water for injection to 95% of the dosage, adjust the pH value to 7.4-7.6 with a concentration of about 0.5mol / L sodium hydroxide solution or hydrochloric acid, and add water for injection to make up to 20L. Filtration, filling, plugging and capping, sterilizing in a rotating water bath at 121°C for 30 minutes, light inspection, and packaging.

Embodiment 3

[0048] The related substances of Monosialotetrahexosylganglioside Sodium Injection are tested as follows:

[0049] HPLC method, chromatographic conditions: use amino-bonded silica gel as filler, acetonitrile-tetrahydrofuran-0.1mol / L phosphoric acid solution (66:8:34) as mobile phase, flow rate 1.0ml / min, injection volume 20μl, detection The wavelength should be 205nm.

[0050] System suitability test: Take the reference substance solution (1), the reference substance solution (2), the reference substance solution (3) and the test solution and mix them in equal amounts. Shake well as a system suitability test solution. Precisely measure 40 μl and inject it into the liquid chromatograph, and record the chromatogram. Based on the monosialotetrahexosyl ganglioside sodium peak, the number of theoretical plates should not be less than 1000, and the separation between the main peak and the adjacent impurity peaks should be greater than 1.5.

[0051]Preparation of related substance...

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Abstract

The invention relates to a preparation method for a monosialotetrahexosyl ganglioside sodium injection. The method comprises the following steps of 1) weighing disodium hydrogen phosphate, sodium dihydrogen phosphate and sodium chloride, adding half amount of injection water, heating to a temperature of 40 DEG C to make the above material dissolved, and thus an auxiliary material solution is obtained; 2) weighing a raw material of monosialotetrahexosyl ganglioside sodium, adding into the above auxiliary material solution, and stirring until the is completely dissolved; 3) adding 20 g of activated carbon, stirring for 30 minutes, and filtering out the activated carbon; 4) supplementing the injection water until the volume of the injection water is 19 L, adjusting a pH value to 7.4-7.6 by using sodium hydroxide or hydrochloric acid, and supplementing the injection water until the volume of the injection water is 20 L; and 5) sterilizing for 20 minutes at the temperature of 121 DEG C by using rotary water bath sterilization after loading.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a monosialotetrahexosyl ganglioside sodium injection with stable quality, safe and effective and a preparation method thereof. Background technique [0002] Gangliosides (GLS), also known as N substance, are a group of sialic acid-containing glycosphingolipids. The molecules are composed of hydrophobic ceramides and hydrophilic sialic acid-containing oligosaccharide chains, and are widely distributed in various vertebrates. On the cell membrane of tissues, the nervous system is the most abundant; it is usually divided into GM (monosialoganglioside), GD (disialoganglioside) and GT (trisialoganglioside) according to the number of sialic acid glycosides), etc.; and according to the number of sugar groups, GM is divided into GM1 (containing 4 sugar groups), GM2 (containing 3 sugar groups) and GM3 (containing 2 sugar groups) [0003] Monosialotetrahexosyl ganglioside (GM-1)...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/7032A61K47/02G01N30/02A61P25/00A61P25/16
Inventor 袁淑杰王丽娜李金花户巧芬戚亮李超刘恒李郑武高晶宋紫玉
Owner 哈药集团股份有限公司
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