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Synthesis method of high-content sodium calcium edetate

A technology of calcium sodium edetate and synthetic liquid, applied in the field of medicine and chemical industry, can solve the problems of uneven water content of particles, decreased main content of finished products, poor stability, etc., and achieve the effects of high product quality, uniform quality and good stability.

Active Publication Date: 2022-03-18
NANJING CHEM REAGENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the particles produced by this method have uneven moisture and poor stability.
CN201010215861.3 provides a kind of aseptic calcium sodium edetate raw material medicine production process, promptly carry out spray-drying to obtain finished product under aseptic condition, this method lays particular emphasis on utilizing spray-drying process to reach the sterilization purpose of liquid medicine, due to process limitation only Accurate and quantitative edetate disodium and calcium carbonate can be added, and spray drying can be carried out directly after the reaction is completed. In the case of incomplete reaction or side reactions, the main content of the finished product will decrease and the impurities will increase.

Method used

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  • Synthesis method of high-content sodium calcium edetate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Dissolve 2kg of sodium hydroxide in 35kg of deionized water under stirring to obtain a sodium hydroxide solution with a concentration of 5.4wt%, and place it in a water bath at 60°C to keep it warm; slowly add ethylenediaminetetraacetic acid to it and keep stirring, ethylenediaminetetra The amount of acetic acid added was 7.3kg, the pH was adjusted to 4.5, and 2L of synthetic solution was taken out for later use. Calcium hydroxide was added to the above solution, the pH was adjusted to 11, and the reaction was continued for 30 minutes, then left to stand and filtered. Adjust the pH of the final synthesis solution to 7.1 with the spare synthesis solution taken out, and stir again for 30 minutes. Concentrate the synthetic liquid to 26°Bé (100°C), then add 30L of absolute ethanol, stir and stand for crystallization. The precipitated crystals were dispersed and suspended in dioxane / water (volume ratio 6:1) mixed solvent, and stirred at room temperature for 24 h. Filter, d...

Embodiment 2

[0036] Dissolve 2kg of sodium hydroxide in 35kg of deionized water under stirring to obtain a sodium hydroxide solution with a concentration of 5.4wt%, and place it in a water bath at 60°C to keep it warm; slowly add ethylenediaminetetraacetic acid to it and keep stirring, ethylenediaminetetra The amount of acetic acid added was 7.4kg, the pH was adjusted to 4.3, and 1.9L of synthetic solution was taken out for later use. Calcium hydroxide was added to the above solution, the pH was adjusted to 11, and the reaction was continued for 30 minutes, then left to stand and filtered. Adjust the pH of the final synthesis solution to 7.1 with the spare synthesis solution taken out, and stir again for 30 minutes. Concentrate the synthetic liquid to 26°Bé (100°C), then add 30L of absolute ethanol, stir and stand for crystallization. The precipitated crystals were dispersed and suspended in dioxane / water (volume ratio 6:1) mixed solvent, and stirred at room temperature for 24 h. Filter,...

Embodiment 3

[0038] Dissolve 2kg of sodium hydroxide in 35kg of deionized water under stirring to obtain a sodium hydroxide solution with a concentration of 5.4wt%, and place it in a water bath at 60°C to keep it warm; slowly add ethylenediaminetetraacetic acid to it and keep stirring, ethylenediaminetetra The amount of acetic acid added was 7.3kg, the pH was adjusted to 4.5, and 2L of synthetic solution was taken out for later use. Calcium oxide was added to the above solution, the pH was adjusted to 11, and the reaction was continued for 30 minutes, then left to stand and filtered. Adjust the pH of the final synthesis solution to 7.1 with the spare synthesis solution taken out, and stir again for 30 minutes. Concentrate the synthetic liquid to 26°Bé (100°C), then add 30L of absolute ethanol, stir and stand for crystallization. The precipitated crystals were dispersed and suspended in dioxane / water (volume ratio 6:1) mixed solvent, and stirred at room temperature for 24 h. Filter, dry a...

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Abstract

The invention relates to a preparation method of high-content sodium calcium edetate. According to the preparation method disclosed by the invention, the pharmaceutical adjuvant-grade sodium calcium edetate with high main component content, low impurity content, good stability and uniform quality is prepared by controlling the adding sequence of the raw materials, the dosage of the raw materials, the reaction temperature and the pH value of the synthetic liquid in the synthesis process and introducing an additional stabilizing treatment step. The preparation method is simple in step, low in cost, high in product quality and suitable for large-scale industrial application.

Description

technical field [0001] The invention relates to the field of medicine and chemical industry, in particular, the invention relates to a method for synthesizing high-content calcium sodium edetate. Background technique [0002] Calcium sodium edetate, also known as calcium disodium edetate hydrate, has the molecular formula C 10 h 12 CaN 2 Na 2 o 8 ·xH 2 O, molecular weight 374.27 (anhydrous), white crystalline or granular powder. Calcium and sodium edetate is mainly used clinically to treat inorganic lead poisoning, and it also has certain excretion-promoting effects on copper, zinc, iron, manganese, cadmium, vanadium and other heavy metals. In existing reports, disodium edetate / tetrasodium edetate and calcium carbonate or calcium hydroxide are mainly used as raw materials for synthesis, and solids are obtained by elution and crystallization, and then dried to obtain finished products. For example, in CN201210398429.1 and CN201710877525.7, the crystals are precipitated...

Claims

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Application Information

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IPC IPC(8): C07C227/18C07C227/40C07C227/42C07C229/76C07C229/16
CPCC07C227/18C07C227/40C07C227/42C07C229/76C07C229/16
Inventor 吴友建
Owner NANJING CHEM REAGENT
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