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Preparation method of monosialotetrahexosyl ganglioside sodium with high purity

A technology of sodium ganglioside and monosialic acid, which is applied in the preparation of sugar derivatives, sugar derivatives, sugar derivatives, etc., can solve the problems of many adverse reactions and ulcers, and achieve the effect of reducing the incidence of adverse reactions

Active Publication Date: 2014-01-22
HUNAN SAILONG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to its origin from pig brain, a biological raw material, monosialotetrahexosylganglioside sodium has more adverse reactions, especially allergic reactions related to the formation of impurities, pollutants, additives, viruses or special metabolites in the drug , Severe allergic reactions can cause rashes all over the body, especially on the mucous membranes, and there are ulcers

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Fresh pig brains were crushed first, treated with acetone at -10°C to obtain a precipitate, and baked at 80°C to obtain acetone powder; the acetone powder was extracted three times with a chloroform-methanol mixture with a volume ratio of 2:1 to obtain acetone powder. extract liquid; the extract liquid is carried out fo l c h distribution with 0.10 volume of water, the organic layer is discarded, and the water layer is retained to obtain a supernatant; the supernatant is added with 1 weight part of sodium hydroxide, and hydrolyzed at room temperature for 5 hours, Acetic acid was neutralized to pH 8, intercepted by a molecular membrane with a molecular weight cut-off of 30,000-50,000 to obtain a filtrate; the filtrate was adjusted to pH 4 with acetic acid, hydrolyzed at 60°C for 10 hours (pasteurization method), the hydrolyzed solution was cooled, and hydrogen Adjust the pH to neutral with sodium oxide, centrifuge, and dry to obtain the dry powder of crude total fat.

[...

Embodiment 2

[0044] The basic steps are the same as in Example 1, the difference is the parameter values. The specific preparation method is as follows: first mash the fresh pig brain, treat it with acetone at -15°C to obtain a precipitate, bake it at 75°C to obtain acetone powder; extract the acetone powder with a mixture of chloroform and methanol at a volume ratio of 3:1 5 times, the extract was obtained; the extract was folch distributed with 0.15 volumes of water, the organic layer was discarded, and the water layer was retained to obtain the supernatant; the supernatant was added with 3 parts by weight of sodium hydroxide, at room temperature Hydrolyze for 4 hours, neutralize to pH 7 with acetic acid, intercept with a molecular membrane with a molecular weight cut-off of 30,000-50,000, and obtain a filtrate; adjust the pH of the filtrate to 3 with acetic acid, and hydrolyze at 70°C for 8 hours (pasteurization), and the hydrolyzate Cool, adjust the pH to neutral with sodium hydroxide,...

Embodiment 3

[0047] 1.1 Source

[0048] The meat joint factory that complies with the national food hygiene regulations uses live pigs that have passed the quarantine inspection, regardless of sex.

[0049] 1.2 Quality Standards

[0050] 1) It must be a healthy pig brain with a quarantine certificate;

[0051] 2) Store in a fresh state at ≤-18°C for one year;

[0052] 3) The appearance of the pig brain should be complete and clean, with fresh color, no peculiar smell, and no polluting impurities;

[0053] 4) After the pig brain is cut open, it should be in good texture, without lumps, atrophy, necrosis, hemorrhage, inflammation and other lesions.

[0054] 5) It should meet the food hygiene and bacterial inspection requirements stipulated by the state.

[0055] The above-mentioned embodiments are only descriptions of preferred implementations of the present invention, and are not intended to limit the scope of the present invention. Without departing from the design spirit of the presen...

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PUM

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Abstract

The invention relates to a preparation method of monosialotetrahexosyl ganglioside sodium with high purity. The method comprises the following steps: extracting and purifying fresh pig brains taken as raw materials, wherein the extracting step comprises the steps of preparation of acetone powder, extraction of total lipids of tissues, folch distribution, virus removal and acid-hydrolysis virus inactivation; the purifying step comprises the steps of desalination, silica gel chromatography, reversed phase chromatography, concentration, acetone recrystallization and freeze-drying. The method has the beneficial effects that the adverse effect occurrence rate of an injection prepared from the monosialotetrahexosyl ganglioside sodium with the high purity is decreased by 47% according to the tracking statistics of 100 users after the virus removal and the acid-hydrolysis virus inactivation are carried out on the injection under a specific pH condition.

Description

technical field [0001] The invention belongs to the field of pharmacy, in particular to a method for preparing high-purity monosialotetrahexosyl ganglioside sodium. Background technique [0002] Monosialotetrahexosylganglioide Sodium (Monosialotetrahexosylganglioide Sodium, GM1) is generally divided into two steps: extraction and purification. Purification methods broadly include: [0003] 1. CN1814610A discloses a method for separating monosialotetrahexosyl ganglioside by using macroporous resin. [0004] 2. The purification steps disclosed in CN1353112A are as follows: the crude product is subjected to ion exchange column chromatography and reverse phase column chromatography, and the purity of the obtained GM1 is greater than 98%. [0005] 3. CN1158295C announced the combination of ultrafiltration membrane separation technology, Iatrobeads and DEAE Sephadex A25 column chromatography, and high performance liquid chromatography technology, with a purity of more than 95%. ...

Claims

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Application Information

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IPC IPC(8): C07H15/10C07H1/08
Inventor 蔡南桂
Owner HUNAN SAILONG PHARMA
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