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1/2 water citicoline sodium compound

A technology of citicoline sodium and compound, applied in the field of 1/2 water citicoline sodium compound and its preparation method, can solve the problems of poor product quality, waste of manpower, material resources, financial resources, competition and the like

Inactive Publication Date: 2019-01-08
王秀香
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The existence of these problems, on the one hand, leads to poor and unstable product quality, unsafe clinical medication and cannot compete with foreign imported raw materials, on the other hand, this situation will cause serious waste of manpower, material resources and financial resources

Method used

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  • 1/2 water citicoline sodium compound
  • 1/2 water citicoline sodium compound
  • 1/2 water citicoline sodium compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1: Preparation of 1 / 2 water citicoline sodium compound

[0031] Preparation Process:

[0032] Add 100 mL of purified water and 300 mL of acetone to the reactor and stir evenly. Weigh 100.11 g of the crude citicoline sodium, 0.10 g of calcium sodium edetate, and 0.10 g of sodium sulfite into the reactor, and stir at room temperature until dissolved. Add 0.25 g of activated carbon to it, stir and absorb for 30 min, and filter. Adjust the pH value of the filtrate to 2.0 with a 1mol / L hydrochloric acid solution, control the temperature at 15-20℃, slowly add 125 mL of isopropanol to the above solution, and control the temperature at 5-10℃ after the addition of isopropanol is complete. Let stand for 1.5h to crystallize, filter, wash the filter with isopropanol 80mL×2, put the filter into a vacuum drying oven (-0.09MPa) with phosphorus pentoxide for 24h, then heat to 60℃ and dry for 2.5h , Get 1 / 2 water citicoline sodium compound 96.21g.

[0033] result:

[0034] The infra...

Embodiment 2

[0037] Example 2: Preparation of 1 / 2 water citicoline sodium compound

[0038] Preparation Process:

[0039] Add 100 mL of purified water and 400 mL of acetone to the reactor and stir evenly. Weigh 100.05 g of the crude citicoline sodium, 0.12 g of calcium sodium edetate, and 0.12 g of sodium sulfite into the reactor, and stir at room temperature until dissolved. 0.31g of activated carbon was added to it, stirred and adsorbed for 30 minutes, and filtered. Adjust the pH value of the filtrate to 1.5 with 1mol / L hydrochloric acid solution, control the temperature at 15-20℃, slowly add 160mL of isopropanol to the above solution, when the isopropanol dripping is completed, control the temperature at 0-5℃ , Stand for 1h to crystallize, filter, wash the filter with isopropanol 80mL×2, put the filter into a vacuum drying oven (-0.09MPa) with phosphorus pentoxide for 24h, then heat to 70℃ and dry for 2h, 95.79 g of 1 / 2 water citicoline sodium compound was obtained.

[0040] result:

[0041...

Embodiment 3

[0044] Example 3: Preparation of Citicoline Sodium Lyophilized Preparation

[0045] Take the 1 / 2 water citicoline sodium compound prepared in Example 2, and use this raw material to prepare a citicoline sodium lyophilized preparation with a specification of 0.25 g.

[0046] prescription:

[0047]

[0048] Preparation Process:

[0049] 1. Liquid preparation

[0050] (1) Add 80% of the prescribed amount of water for injection into the dispensing tank;

[0051] (2) Add 1 / 2 of the prescription amount of citicoline sodium compound, stir to dissolve completely, and add water for injection to the full amount;

[0052] (3) Add 0.05% medicinal charcoal (for injection) to the medicinal solution, stir and absorb for 15 minutes;

[0053] (4) Filter and decarburize with 0.45μm filter membrane;

[0054] (5) Filter and decarburize with 0.22μm filter membrane.

[0055] 2. Filling: Fill in a medium borosilicate glass tubular injection bottle according to the theoretical filling volume, and press half the sto...

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Abstract

The invention relates to a 1 / 2 water citicoline sodium compound and a preparation method of the 1 / 2 water citicoline sodium compound, wherein each molar of citicoline sodium contains 1 / 2 molar of water. Specifically, the preparation method is as follows: adding a crude product of citicoline sodium, sodium calcium edetate and sodium sulfite into a mixed solution of purified water and acetone, stirring and dissolving; adding activated carbon, stirring, adsorbing, filtering; using an acid to regulate the pH of a filtrate, stirring evenly; slowing adding isopropanol dropwise into the above solution, standing, crystalizing, filtering, washing a filtered material, and drying to obtain the 1 / 2 water citicoline sodium compound. The 1 / 2 water citicoline sodium compound is good in flowability, low in impurity content and hygroscopicity, fast in dissolution and good in stability, and has a broader application prospect.

Description

Technical field [0001] The invention belongs to the technical field of chemical engineering medicine crystallization, and relates to a 1 / 2 water citicoline sodium compound and a preparation method thereof. Background technique [0002] Citicoline Sodium is the precursor of phospholipid phosphatidylcholine, and is an essential coenzyme for the synthesis of lecithin. Its molecular formula is C 14 H 25 N 4 NaO 11 P 2 , The molecular weight is 510.31, the CAS number is 33818-15-4, and the structural formula is: [0003] [0004] The current methods for preparing citicoline sodium include: (1) Chemical synthesis: using CMP (5'-cytidine acid) and phosphoric acid choline as reactants, p-toluenesulfonyl chloride as a condensing agent, in N-dimethyl Condensation preparation in the presence of formamide, 717 (Cl-) anion exchange column and 711 (Cl-) concentrated column separation liquid alcohol precipitation preparation of citicoline sodium, the disadvantage is that it is difficult to separ...

Claims

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Application Information

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IPC IPC(8): C07H19/10C07H1/00A61K31/7068A61P25/28A61P25/00
CPCC07B2200/13C07H1/00C07H19/10
Inventor 王秀香
Owner 王秀香
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