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Method for preparing high purity polysorbate 80 through synthesizing three effective components and mixing

An effective component, polysorbate technology, applied in the field of preparation of high-purity polysorbate 80, can solve problems such as uncertainty and large experimental workload, and achieve improved functionality, meet solubilization requirements, and improve application performance. Effect

Active Publication Date: 2012-02-15
NANJING WELL BIOCHEM
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  • Summary
  • Abstract
  • Description
  • 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 synthesizing three effective components and mixing
  • Method for preparing high purity polysorbate 80 through synthesizing three effective components and mixing
  • Method for preparing high purity polysorbate 80 through synthesizing three effective components and mixing

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Add the amount of sorbitol shown in Table 1 and 0.2g of sodium hydroxide in a 3L stainless steel autoclave. After replacing it with nitrogen, heat up and dehydrate under reduced pressure, then slowly press the amount of ethylene oxide shown in Table 1 into high pressure with nitrogen. Addition polymerization reaction is carried out in the kettle, the speed of adding ethylene oxide is controlled, the temperature of the kettle is maintained at 140°C~150°C, and the pressure is 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.

[0038] 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 polyoxyethylene ether monomer.

[0039] The experimental feed ratio, that is, the experimental results ar...

Embodiment 2

[0043] In a 1000ml three-neck flask, add a certain amount of sorbitol polyoxyethylene ether monomer, add a catalyst, high-purity oleic acid (content greater than 90%) under nitrogen protection, stir and heat up to 220 ° C, heat preservation and dehydration reaction until the acid value Until it is less than 2.0mgKOH / g, the polyoxyethylene sorbitol ether oleate component is obtained, the temperature is lowered, and samples are analyzed for chromaticity, hydroxyl value and saponification value.

[0044] According to the same method, a sorbitan polyoxyethylene ether monomer and an isosorbide polyoxyethylene ether monomer are esterified with high-purity oleic acid respectively to obtain a sorbitan polyoxyethylene ether oil Ester component, isosorbide polyoxyethylene ether oleate component, lower the temperature, take samples and analyze the chromaticity, acid value, hydroxyl value and saponification value.

[0045] The experimental feed ratio, that is, the experimental results are...

Embodiment 3

[0049] In a 1000 ml three-necked flask, a certain amount of polyoxyethylene sorbitan oleate component, polyoxyethylene sorbitan oleate component and polyoxyethylene isosorbide obtained in the above-mentioned examples were added respectively. For the ether oleate component, slowly heat up to no more than 60°C, stir for about 30 minutes until evenly mixed, post-treat with decolorizing earth and diatomaceous earth, filter, and filter through a 0.22μ filter element to sterilize and remove pyrogens to obtain a light yellow to Colorless and transparent high-purity polysorbate 80 (I).

[0050] The test results are shown in Table 3.

[0051] Table 3 Experimental results of polysorbate 80

[0052]

[0053] Solubilization test

[0054] Stir a certain amount of polysorbate 80 with a certain amount of ethanol solution of clove basil oil, menthol and borneol, dilute 10 times with distilled water, heat up to 60°C and stir evenly, cool down to room temperature, take 40ml of the liquid m...

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Abstract

The invention discloses a method for preparing high purity polysorbate 80 through synthesizing three effective components and mixing, comprising the following steps: carrying out etherification of high purity sorbitol and ethylene oxide to prepare sorbitol polyoxyethylene ether (II), and carrying out esterification of the sorbitol polyoxyethylene ether (II) and high purity oleic acid to obtain sorbitol polyoxyethylene ether oleate (V); carrying out etherification of high purity sorbitan and oxirane to obtain sorbitan polyoxyethylene ether (III), and carrying out esterification of the sorbitanpolyoxyethylene ether (III) and high purity oleic acid to obtain sorbitan polyoxyethylene ether oleate (VI); carrying out etherification of high purity isosorbide and oxirane to obtain isosorbide polyoxyethylene ether (IV), and carrying out esterification of the isosorbide polyoxyethylene ether (IV) and high purity oleic acid to obtain isosorbide polyoxyethylene ether oleate (VII); and mixing V, VI and VII and refining to obtain the high purity polysorbate 80 (I). The prepared polysorbate 80 disclosed herein has high content of effective components, low content of nonactive components and impurities, and improvement of the applicability, can be applied for injection preparation.

Description

technical field [0001] The present invention relates to a new method for preparing high-purity polysorbate 80. Using optimized process conditions, sorbitol polyoxyethylene ether oleate, 1,4 sorbitan polyoxyethylene ether oleate, Isosorbide polyoxyethylene ether oleate, the three are mixed in a certain proportion and then processed to obtain high-purity 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. technical background [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 pharmaceutical industry, polysorbate 80 is used as an emulsi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08G65/332C08G65/28A61K47/34
Inventor 高正松彭文勇沈九四吴仁荣陈新国贾建国吴仰波
Owner NANJING WELL BIOCHEM
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