Method for synthesizing high-purity polysorbate-80

A technology of polysorbate and synthesis method, applied in chemical instruments and methods, transportation and packaging, dissolution, etc., can solve the problem of poor color of polysorbate-80 (I), low purity of polysorbate-80, and product quality Difficult to control and other problems, to achieve the effect of perfect emulsification and solubilization performance, good clinical safety, and less harmful impurities
CN101701065AActive Publication Date: 2010-05-05NANJING WELL BIOCHEM
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
NANJING WELL BIOCHEM
Publication Date
2010-05-05

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Abstract

The invention relates to a method for synthesizing high-purity polysorbate-80. The polysorbate-80 (I) is a partial esterified product of a sorbitan ethyoxyl compound and oleic acid. The method comprises the following steps of: (1) partially dehydrating sorbitol as a raw material under the action of an acid catalyst in a state of vacuum to obtain sorbitan (II); (2) carrying out addition polymerization on the sorbitan (II) and oxirane under the action of a base catalyst to obtain sorbitan polyethenoxy ether (III), wherein the addition number of the oxirane is 20; (3) reacting the sorbitan polyethenoxy ether (III) with the high-purity oleic acid under the action of an esterifying catalyst and refining to obtain the high-purity polysorbate-80. The invention leads the emulsifying and solubilizing performance of products to be more perfect and the quality of the products to easily meet the requirement of an injection class and has easily controlled quality and good stability; and the high-purity polysorbate-80 has lower blood dissolving rate in same concentration, and predictable and safer clinical use by being used as an auxiliary material for injection.
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Description

technical field

[0001] The invention relates to a chemical synthesis method, in particular to a synthesis method of high-purity polysorbate-80 (I). Background technique

[0002] Polysorbate-80 (I), also known as polyoxyethylene (20) sorbitan monooleate, it is a kind of hydrophilic nonionic surfactant, because it has better solubilizing effect, in When preparing injections of poorly soluble drugs, it is often used as a cosolvent, emulsifier and stabilizer.

[0003] The synthetic method of (I) reported in the literature usually has the following two kinds:

[0004] Method 1: Sorbitol and oleic acid undergo simultaneous dehydration and esterification reactions under the action of a basic catalyst to obtain sorbitan monooleate, which is then condensed with 20 mole fractions of ethylene oxide to obtain polysorbate- 80(I).

[0005] Method 2: Sorbitol is first dehydrated under the action of an acidic or alkaline catalyst to obtain sorbitan, then esterified with oleic acid to obt...

Claims

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