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Preparation method of pharmaceutic adjuvant grade Glyceryl Behenate

A technology of glyceryl behenate and pharmaceutical excipients, which is applied in the field of drug synthesis, can solve the problems of unsuitable pharmaceutical excipient grade glyceryl behenate, etc., and achieve the effects of less "three wastes", convenient product refining, and simple operation

Active Publication Date: 2013-05-15
JIANGXI ALPHA HI TECH PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, above-mentioned document method can not be used for directly preparing pharmaceutical excipient grade glyceryl behenate
[0005] At present, there are no literature and patent reports on the production process of pharmaceutical grade glyceryl behenate at home and abroad, only the synthesis of similar derivatives

Method used

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  • Preparation method of pharmaceutic adjuvant grade Glyceryl Behenate

Examples

Experimental program
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Effect test

Embodiment 1

[0024] Put 50.1kg of behenic acid and 13.5kg of glycerin (molar ratio is 1:1) into the glass-lined reactor, heat up to 105°C for dehydration reaction for 10 hours (control acid value1 H-NMR; 13 C-NMR; C-H correlation spectrum; long-range C-H correlation spectrum confirms that it is a mixture of monoester, diester and triester.

Embodiment 2

[0026] Put 50.0kg behenic acid and 10.0kg glycerin (molar ratio is 1.35:1) into the glass-lined reactor, heat up to 120°C for dehydration reaction for 8 hours (control acid value 1 H-NMR; 13 C-NMR; C-H correlation spectrum; long-range C-H correlation spectrum confirms that it is a mixture of monoester, diester and triester.

Embodiment 3

[0028] Put 51.2kg of behenic acid and 8.6kg of glycerol (molar ratio: 1.6:1) into the glass-lined reactor, heat up to 140°C for dehydration reaction for 8 hours (control acid value 1 H-NMR; 13 C-NMR; C-H correlation spectrum; long-range C-H correlation spectrum confirms that it is a mixture of monoester, diester and triester.

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Abstract

The invention relates to the field of drug synthesis, and specifically relates to a preparation method of a pharmaceutic adjuvant grade Glyceryl Behenate. The method provided by the invention comprises the following steps: (1) adding behenic acid and glycerol into a reactor and thoroughly stirring; (2) directly heating for a dehydration and esterification reaction; (3) adding active carbon for decolorization, and filtering while hot; and (4) adding purified water, cooling for crystallization, centrifuging, drying and crushing to obtain the pharmaceutic adjuvant grade Glyceryl Behenate. The invention employs direct dehydration esterification of behenic acid and glycerol to prepare the Glyceryl Behenate, without addition of a catalyst as in a conventional esterification reaction, such as sulfuric acid, p-toluene sulfonic acid and solid acid; no other reaction solvent needs to be added; besides, the product is convenient for refining. The process produces little ''three wastes'', has simple operation and yield higher than 89%, and is suitable for industrial production; and the quality of the prepared Glyceryl Behenate can meet the requirements of pharmaceutic adjuvant grade.

Description

technical field [0001] The invention relates to the field of drug synthesis, in particular to a preparation method of pharmaceutical excipient grade glyceryl behenate. Background technique [0002] Glyceryl behenate is a nonionic surfactant with emulsifying, dispersing, defoaming and lubricating effects; it can be used as an emulsifier and emulsion stabilizer for the preparation of emulsions, creams, and ointments. The main use of glyceryl behenate in pharmaceuticals is as a lubricant in the manufacture of tablets, pills, granules and capsules; as a dispersant, it is also widely used in solid, semi-solid and liquid preparations; it can also be used Used in sustained-release tablets, and as the matrix of water-soluble drug sustained-release preparations. [0003] At present, the methods for synthesizing glyceryl behenate are as follows: 1. Reacting glycerin and acetone to obtain mesityl glycerol, then reacting with behenic acid to obtain isopropenylglycerol behenate, further...

Claims

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Application Information

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IPC IPC(8): C07C69/30C07C67/08
Inventor 缪志毅黄云生刘飞
Owner JIANGXI ALPHA HI TECH PHARMA
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