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Preparation technology for procaine hydrochloride crystals

A technology for procaine hydrochloride and a preparation process, which is applied in the field of chemical crystallization, can solve the problems of reducing the product purity of procaine hydrochloride, high water solubility of procaine hydrochloride, low process yield, etc. Good fluidity and uniform crystal size distribution

Inactive Publication Date: 2015-05-13
HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This type of method has many steps, and because the water solubility of procaine hydrochloride is very large, the process yield is low
In addition, procaine is easily decomposed under strong acidic conditions, and the use of high-temperature concentrated hydrochloric acid in the existing crystallization process will reduce the purity of procaine hydrochloride products

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Add distilled water and procaine into the three-necked flask sequentially at a mass ratio of 100:30, heat in a water bath to 30°C, stir, and after the suspension is completely formed, slowly add dilute hydrochloric acid with a mass fraction of 10% until the solution is clear until. Then remove solid impurities by suction filtration, place the filtrate in a crystallizer, heat it in a water bath to 37°C, stir, and quickly add isopropanol, an entrainer with a volume of 30% of the solution in the crystallizer, into the crystallizer, and carry out vacuum azeotropic distillation. The vacuum degree in the crystallizer is maintained at 0.095MPa. When the distillate volume reaches 30% of the water volume, add the same volume of isopropanol. After adding 5 times, adjust the temperature in the crystallizer to 45°C and continue distillation. , after the water content of the solution in the crystallizer is lower than 3%, stop vacuum azeotropic distillation, carry out temperature-con...

Embodiment 2

[0021] Add distilled water and procaine hydrochloride into the there-necked flask successively according to the mass ratio of 100:15, heat in a water bath to 30°C, stir, and after the suspension is completely formed, slowly add dilute hydrochloric acid with a mass fraction of 20% until the solution Until clarification. Then remove solid impurities by suction filtration, place the filtrate in a crystallizer, heat it in a water bath to 38°C, stir, add 50% water volume entrainer butyl acetate to carry out vacuum azeotropic distillation, and maintain the vacuum degree in the crystallizer at 0.08MPa , continuously replenish the entrainer during the distillation process, keep the liquid level in the crystallizer unchanged, adjust the temperature in the crystallizer to 40°C after 2 hours, and continue the distillation until the water content of the solution in the crystallizer is lower than 8%. Stop the vacuum azeotropic distillation, carry out temperature-controlled cooling and crys...

Embodiment 3

[0023] Add distilled water and procaine into the three-necked flask in a mass ratio of 100:30, heat in a water bath to 35°C, stir, and after the suspension is completely formed, slowly add dilute hydrochloric acid with a mass fraction of 10% until the solution is clear until. Then remove solid impurities by suction filtration, place the filtrate in a crystallizer, heat it in a water bath to 40°C, stir, add the entrainer n-butanol into the crystallizer according to 25% of the water volume, and carry out vacuum azeotropic distillation. The vacuum degree is maintained at 0.08MPa, and the azeotropic agent is continuously replenished during the vacuum azeotropic distillation process to maintain the liquid level in the crystallizer. After the water content of the solution in the crystallizer is lower than 5%, the vacuum azeotropic distillation is stopped. Perform temperature-controlled cooling and crystallization, control the final cooling temperature at 1°C, let stand and age for 5...

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Abstract

The invention relates to a preparation technology for procaine hydrochloride crystals. The preparation technology comprises the following steps: distilled water and procaine are added into a three-neck flask successively at a mass ratio of 100:10-35; the three-neck flask is placed in a water bath; the mixture in the three-neck flask is stirred; after a suspension is formed, diluted hydrochloric acid with a mass fraction of 10%-20% is added until the solution is clear basically; then pumping filtration, crystallization and vacuum azeotropic distillation are carried out; finally temperature control cooling crystallization is carried out, then after filtration and drying, a procaine hydrochloride crystal product is obtained. The prepared procaine hydrochloride crystals have uniform size distribution, high purity, good fluidity and strong stability. The production cost is low and the operation is easy to control.

Description

technical field [0001] The invention belongs to the technical field of chemical crystallization, and in particular relates to a preparation process for procaine hydrochloride crystallization. Background technique [0002] Procaine hydrochloride, the English name is Procaine Hydrochloride, the CAS number is 50-05-8, and the molecular formula is C 13 h 21 ClN 2 o 2 . The relative molecular mass is 272.77. Procaine hydrochloride is white crystal or crystalline powder, odorless, slightly bitter taste, followed by numbness. Soluble in water, slightly soluble in ethanol, slightly soluble in chloroform, almost insoluble in ether. [0003] Procaine hydrochloride is a local anesthetic, which can temporarily block the conduction of nerve fibers and has an anesthetic effect. It has strong effect, low toxicity, no addiction, and short duration. However, it has weak penetrating power to skin and mucous membranes, and is not suitable for topical anesthesia. It is mainly used clinic...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07C229/60C07C227/42
Inventor 孙华刘宝树刘培华宋梦燕刘秀培
Owner HEBEI UNIVERSITY OF SCIENCE AND TECHNOLOGY
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