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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, ulceration, and whole body rash, and achieve the occurrence of adverse reactions. rate reduction effect

Active Publication Date: 2015-07-15
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 the biological raw material-pig brain, monosialotetrahexosylganglioside sodium has more adverse reactions, especially allergies related to the formation of impurities, pollutants, additives, viruses or special metabolites in the drug reactions, severe allergic reactions may 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

[0040] The preparation of embodiment 1 monosialotetrahexosyl ganglioside sodium

[0041] First mash the fresh pig brain, treat it with acetone at -10°C to obtain a precipitate, and bake it at 80°C to obtain acetone powder; extract the acetone powder three times with a chloroform-methanol mixture with a volume ratio of 2:1 to obtain acetone powder. Extracting solution: the extracting solution is carried out folch distribution with 0.10 volumes of water, the organic layer is discarded, and the aqueous layer is retained to obtain a supernatant; the supernatant is added with 1 weight part of sodium hydroxide, hydrolyzed for 5 hours at room temperature, and acetic acid Neutralize to pH 8, intercept with a molecular membrane with a molecular weight cut-off of 30,000-50,000, and obtain the filtrate; adjust the pH of the filtrate to 4 with acetic acid, hydrolyze at 60°C for 10 hours (pasteurization), cool the hydrolyzate, and oxidize with hydrogen Adjust the pH to neutral with sodium,...

Embodiment 2

[0043] The preparation of embodiment 2 monosialotetrahexosyl ganglioside sodium

[0044] The basic steps are the same as in Example 1, the difference is the parameter value. 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 with acetic acid to pH 7, intercept with a molecular membrane with a molecular weight cut-off of 30,000-50,000, and obtain the filtrate; adjust the pH of the filtrate to 3 with acetic acid, hydrolyze at 70°C for 8 hours (pasteurizat...

Embodiment 3

[0046] The quality standard of embodiment 3 raw material porcine brain

[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.

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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] The preparation method of Monosialotetrahexosylganglioside Sodium (GM1) is generally divided into two steps of extraction and purification. Purification methods broadly include: [0003] 1. CN 1814610A discloses a method for separating monosialotetrahexosyl ganglioside by using macroporous resin. [0004] 2. The purification steps disclosed in CN 1353112A 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. CN 1158295C announced the combination of ultrafiltration membrane separation technology, Iatrobeads and DEAE Sephadex A 25 column chromatography, and high performance liquid chromatography technology, with a purity of more than 95%. [000...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07H15/10C07H1/08
Inventor 蔡南桂
Owner HUNAN SAILONG PHARMA