Method for preparing high purity polysorbate 80 through esterification of oleic acid and mixture of respectively etherified starting materials

A polysorbate, high-purity technology, applied in the field of preparing high-purity polysorbate 80 by separately etherifying the starting materials and then mixing them with oleic acid esterification, can solve the problems of uncertainty, large experimental workload, etc., and achieve The effect of uniform ether chain, high purity and content reduction

Active Publication Date: 2012-02-15
南京威尔药业科技有限公司
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  • Abstract
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  • Claims
  • Application Information

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Problems solved by technology

Due to the huge amount of experimental work, it is impossible to determine which approach can actually solve this problem

Method used

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  • Method for preparing high purity polysorbate 80 through esterification of oleic acid and mixture of respectively etherified starting materials
  • Method for preparing high purity polysorbate 80 through esterification of oleic acid and mixture of respectively etherified starting materials

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Experimental program
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Effect test

Embodiment 1

[0032] Embodiment 1, the method for preparing high-purity polysorbate 80 after etherification and oleic acid esterification of starting materials respectively: add the sorbitol of the amount shown in table 1 in 3L stainless steel autoclave, 0.2g sodium hydroxide , after replacing with nitrogen, heat up and depressurize for dehydration, then use nitrogen to slowly press the amount of ethylene oxide shown in Table 1 into the autoclave for addition polymerization, control the speed of adding ethylene oxide, and maintain the temperature of the kettle at 140°C~ 150℃, pressure 0.4Kg / m 2 , after adding ethylene oxide, aged for 2 hours, the pressure in the kettle was reduced to normal pressure, the discharge was measured, and the hydroxyl value was sampled to obtain the sorbitol polyoxyethylene ether monomer.

[0033] In the same way, add 1,4-sorbitol and isosorbide to ethylene oxide for addition polymerization to obtain 1,4-sorbitol polyoxyethylene ether and isosorbide polyoxyethylen...

Embodiment 2

[0037] In a 1000ml three-necked flask, add a certain amount of PEA, PEB, and PEC respectively, and simply mix them evenly to obtain a mixed ether with a hydroxyl value in the range of 150mgKOH / g~200mgKOH / g. %) under the protection of nitrogen, stir and heat up to 220°C, heat preservation and dehydration reaction until the acid value is less than 2.0mgKOH / g. Cool down with decolorizing earth and diatomaceous earth, filter, and filter through a 0.22μ filter element to remove bacteria and remove pyrogens to obtain light yellow to colorless and transparent polysorbate 80. Sampling and analysis of chromaticity, hydroxyl value and saponification value. The experimental results are shown in Table 2:

[0038] Table 2 Experimental results of polysorbate 80

[0039]

[0040] Application test:

[0041] Accurately weigh 1.0 g of zedoary oil, 9 g of polysorbate 80, and 30 g of distilled water in a 50 ml glass ampoule, melt and seal the ampoule, and shake it in a shaker to mix well...

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Abstract

The invention provides a method for preparing high purity polysorbate 80 through esterification of oleic acid and a mixture of respectively etherified starting materials. The method comprises the steps of: subjecting high purity sorbitol and ethylene oxide to etherification so as to prepare sorbitol polyethenoxy ether (II); etherifying sorbitan to prepare sorbitan polyethenoxy ether (III); etherifying isosorbide for preparing isosorbide polyethenoxy ether (IV); mixing sorbitol polyethenoxy ether II, sorbitan polyethenoxy ether III, and isosorbide polyethenoxy ether IV, so as to make the obtained mixed polyether (V) with a hydroxyl value of 150mgKOH/g-200mgKOH/g; conducting an esterification reaction to the mixed polyether (V) and high purity oleic acid that are in a mass ratio of 2.3-3.4:1; carrying out post-treatment to the product, thus obtaining high purity polysorbate 80 (I). The polysorbate 80 prepared in the invention has high purity, more uniform ether chain in the molecular structure, substantially reduced free polyether and polyol ester content, and improved application performance, and it can also be used for injection preparations.

Description

technical field [0001] The invention relates to a new method for preparing high-purity polysorbate 80 through etherification of starting materials and esterification with oleic acid after mixing. Using optimized process conditions, sorbitol, 1,4 sorbitan and isosorbide polyoxyethylene ether were synthesized respectively. The three were mixed in a certain proportion and then esterified with oleic acid to obtain polysorbate 80. The method can better control the quality of each component in polysorbate 80, thereby preparing high-purity polysorbate 80 with better quality, which can meet the requirements of pharmaceutical use, especially injection preparations. Background technique [0002] Polysorbate 80 is sorbitol and its dehydration product, which is polymerized with about 20 moles of ethylene oxide, and the obtained sorbitan polyoxyethylene ether is esterified with oleic acid. It is an O / W type emulsification It is widely used in textile, food and other industries. In the p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08G65/332C08G65/28A61K47/34
Inventor 吴仁荣高正松陈新国彭文勇沈九四贾建国吴仰波
Owner 南京威尔药业科技有限公司
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