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Polysorbate 80 for injection, and preparation method thereof

A technology of polysorbate and sorbitol, applied in the field of polysorbate 80 for injection and its preparation, can solve problems such as adverse reactions and allergic reactions

Inactive Publication Date: 2019-12-20
HUBEI GEDIAN HUMANWELL PHARMA EXCIPENTS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to overcome the defect of adverse reactions (such as anaphylaxis, hemolytic reaction) in the clinical use of polysorbate 80 for injection in the prior art, and provide a kind of polysorbate 80 for injection and preparation thereof method

Method used

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  • Polysorbate 80 for injection, and preparation method thereof
  • Polysorbate 80 for injection, and preparation method thereof
  • Polysorbate 80 for injection, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～11

[0060] The synthesis of embodiment 1~11 polysorbate 80

Embodiment 1

[0062] Put 100 g of sorbitan oleate (Example 12), 100 g of polyethylene glycol 300 and 145 g of polyethylene glycol 400 into the reaction kettle, and add 0.1 g of sulfuric acid. React in vacuum at 115°C for 3.5h, and control the vacuum degree to be greater than 0.099Mpa. After the reaction is finished, the reaction solution is filtered with a 0.22um filter membrane and a plate-and-frame filter, and polysorbate 80 for injection is obtained after sterilization.

[0063] Through mass spectrometry detection, the obtained polysorbate 80 for injection does not contain impurities with a molecular weight greater than 2000.

[0064] According to nuclear magnetic detection, the ratio of methyl H of polysorbate 80 oleic acid for injection to methylene H of polyoxyethylene ether chain segment is 1:23.54. In theory, the ratio of methyl H of polysorbate 80 oleic acid to methylene H of polyoxyethylene ether segment is 3:40; since polysorbate 80 is a polymer, the ratio of the two will not be...

Embodiment 2

[0066] Put 400g of sorbitan oleate (Example 13), 400g of polyethylene glycol 300, 400g of polyethylene glycol 400 and 120g of polyethylene glycol 600 into the reaction kettle, and add 16.8g of phosphoric acid. React in vacuum at 125°C for 6.5h, and control the vacuum degree to be greater than 0.099Mpa. After the reaction, the reaction solution was filtered with a 0.22um filter membrane and a plate-and-frame filter, and polysorbate 80 for injection was obtained after sterilization. Its mass spectrum and NMR were basically the same as in Example 1.

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Abstract

The invention discloses polysorbate 80 for injection, and a preparation method thereof. The preparation method comprises: in the presence of a catalyst, carrying out an etherification reaction on sorbitan oleate and polyethylene glycol to obtain polysorbate 80, wherein the polyethylene glycol is one or a plurality of materials selected from polyethylene glycol 300, polyethylene glycol 400 and polyethylene glycol 600, a mass ratio of the polyethylene glycol 300 to the sorbitan oleate is a, a mass ratio of the polyethylene glycol 400 to the sorbitan oleate is b, a mass ratio of the polyethyleneglycol 600 to the sorbitan oleate is c, a is more than or equal to 0 and less than or equal to 2.93, b is more than or equal to 0 and less than or equal to 2.20, c is more than or equal to 0 and lessthan or equal to 1.47, and a, b and c are not 0 at the same time. According to the present invention, the product has advantages of low allergy and hemolysis risks and high safety.

Description

technical field [0001] The present invention relates to a kind of polyester 80 for injection and its preparation method. Background technique [0002] Polysorbate 80, also known as Tween 80, in the pharmaceutical industry, polysorbate 80 is used as a dispersant and solubilizer for drugs with low water solubility, among which high-purity polysorbate 80 can be used as a solubilizer for injection preparations. Polysorbate 80 is used as a solubilizer in traditional Chinese medicine injections, and polysorbate 80 is an excellent protein protectant in biological preparations that have developed rapidly in recent years. As an excipient frequently used in injections, the safety of polysorbate 80 is very important. Therefore, the 2015 edition of the "Chinese Pharmacopoeia" included the product of injection grade polysorbate 80, which improved the quality standard of the product in terms of oleic acid content, impurities, color, saponification value, and peroxide value. [0003] The...

Claims

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Application Information

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IPC IPC(8): C08G65/332A61K47/26
CPCA61K9/0019A61K47/26C08G65/3328
Inventor 张阳洋李盛曹金黄虎冉文华肖舒文朱智刚李文文刘淦田佳
Owner HUBEI GEDIAN HUMANWELL PHARMA EXCIPENTS
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