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Refining method and application of polyoxyethylated castor oil

A technology of polyoxyethylene castor and refining method, which is applied in the directions of medical preparations containing active ingredients, pharmaceutical formulas, non-active ingredients of oil/fat/wax, etc. High problems, to achieve the effect of easy stirring and filtration, shortening the filtration process, and reducing oxidized impurities

Pending Publication Date: 2021-05-11
微研优仿医药科技(江苏)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the pH value of the corresponding preparation is significantly lower than that of the original preparation, which is quite different from the original preparation, which significantly affects the performance of the preparation.
[0003] In addition, the traditional method of refining polyoxyethylene (35) castor oil has disadvantages such as poor fluidity, which makes it difficult to stir and filter, which makes it require high equipment, long process cycle, and low yield. (35) Inorganic acid or organic acid still needs to be added to the preparation prepared by mixing castor oil with API (paclitaxel) and other excipients to maintain the stability of the preparation and ensure the shelf life

Method used

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  • Refining method and application of polyoxyethylated castor oil
  • Refining method and application of polyoxyethylated castor oil
  • Refining method and application of polyoxyethylated castor oil

Examples

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Effect test

Embodiment 1

[0053] Example 1 : present embodiment provides a kind of refining method of polyoxyethylene castor oil, and it comprises the steps:

[0054] (1) 3kg of polyoxyethylene (35) castor oil (BASF production) is placed in a 10L reaction flask, then 0.3kg of acidic alumina (SIGMA) is added, and 0.15kg of silicon-magnesium adsorbent (magnesium silicate, Sinopharm ), the absolute ethanol of 6L;

[0055] (2) Replace the air in the bottle with nitrogen, protect it with nitrogen, stir at 40°C for 4 hours, and then filter out the solid matter to obtain the filtrate;

[0056] (3) The filtrate was mixed with 7320 cation exchange resin and stirred at room temperature for 2 hours, and then the cation exchange resin was filtered off to obtain filtrate 2;

[0057] (4) The filtrate two was concentrated under reduced pressure at 45° C. to remove ethanol to obtain refined polyoxyethylene (35) castor oil.

Embodiment 2

[0058] Example 2 : present embodiment provides a kind of refining method of polyoxyethylene castor oil, and it comprises the steps:

[0059] (1) 3kg of polyoxyethylene (35) castor oil (BASF production) is placed in a 10L reaction flask, then 0.3kg of acidic alumina (SIGMA) is added, and 0.15kg of silicon-magnesium adsorbent (magnesium silicate, Sinopharm ), the absolute ethanol of 2L;

[0060] (2) Replace the air in the bottle with nitrogen, protect it with nitrogen, stir at 40°C for 4 hours, and then filter out the solid matter to obtain the filtrate;

[0061] (3) The filtrate was mixed with 7320 cation exchange resin and stirred at room temperature for 2 hours, and then the cation exchange resin was filtered off to obtain filtrate 2;

[0062] (4) The filtrate two was concentrated under reduced pressure at 45° C. to remove ethanol to obtain refined polyoxyethylene (35) castor oil.

Embodiment 3

[0063] Example 3 : present embodiment provides a kind of refining method of polyoxyethylene castor oil, and it comprises the steps:

[0064] (1) 3kg of polyoxyethylene (35) castor oil (produced by BASF) is placed in a 10L reaction flask, and then 0.15kg of silicon-magnesium-type adsorbent (magnesium silicate, Chinese medicine) and 6L of absolute ethanol are added;

[0065] (2) Replace the air in the bottle with nitrogen, protect it with nitrogen, stir at 40°C for 4 hours, and then filter out the solid matter to obtain the filtrate;

[0066] (3) The filtrate was mixed with 732 cation exchange resin and stirred at room temperature for 2 hours, and then the cation exchange resin was filtered off to obtain filtrate 2;

[0067] (4) The filtrate two was concentrated under reduced pressure at 45° C. to remove ethanol to obtain refined polyoxyethylene (35) castor oil.

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Abstract

The invention relates to the technical field of fine chemical engineering, in particular to a refining method of polyoxyethylated castor oil. The method comprises the following steps of: (1) placing polyoxyethylated castor oil in a container, and then adding an adsorbent and an anhydrous alcohol solvent; (2) stirring for 2-6 hours at the temperature of 20-55 DEG C in a nitrogen environment, and filtering out solid components to obtain filtrate; (3) mixing the filtrate with ion exchange resin, stirring at room temperature for at least one hour, and removing the ion exchange resin to obtain filtrate II; and (4) concentrating the filtrate II at 40-50 DEG C under reduced pressure to remove the alcohol solvent. According to the refining method of the polyoxyethylated castor oil, a solvent is added on the basis of traditional refining, so that the fluidity of a mixed material system becomes better, stirring and filtering are easy, the requirement for equipment is lowered, the process period is shortened, and industrial production is facilitated.

Description

technical field [0001] The invention relates to the technical field of fine chemicals, in particular to a method for refining polyoxyethylene castor oil. Background technique [0002] Polyoxyethylene (35) castor oil is an auxiliary material of paclitaxel injection, and its preparation method, especially the refining method, is very important. In the existing patent literature, there are records of treating polyoxyethylene castor oil with inorganic adsorbents, but there are problems such as stirring and filtering difficulties, difficult production and low yield, only 75% to 80%. Moreover, the carboxylate of polyoxyethylene castor oil obtained by the applicant after reproducing the scheme in its examples was not significantly reduced, and the pH of the preparation after compatibility with paclitaxel was significantly higher than that of the original research and the stability was poor, which failed to solve the problem of paclitaxel injection before refining. The problem of p...

Claims

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Application Information

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IPC IPC(8): C08G65/30A61K31/337A61K9/08A61K47/44
CPCC08G65/30A61K31/337A61K9/0019A61K9/08A61K47/44
Inventor 杨晓栋赵国新徐震亚秦秋明
Owner 微研优仿医药科技(江苏)有限公司
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