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Preparation method of polyoxyl[40]stearate

A technology of stearic acid polyoxyl and stearic acid, which is applied in the field of preparation of stearic acid polyoxyl ester, can solve the problems of being difficult to meet the application requirements of downstream preparation manufacturers, unable to meet the preparation requirements, poor drug stability, etc. Effects of reduced chromaticity and conductivity, improved stability, and ease of operation

Inactive Publication Date: 2018-06-19
辽宁奥克药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Yet, because the production technique of stearic acid manufacturer is definite at present, cause the composition of stearic acid product to also be fixed usually, the polyoxyl (40) stearate with its synthesis has only a definite melting time limit, It is difficult to meet the different application requirements of downstream preparation manufacturers
In addition, too high potassium and sodium ion impurities in polyoxyl (40) stearate may easily lead to poor stability of the drug and deepening of the color of the drug, which cannot meet the needs of the preparation.
At present, there is no literature report about the melting time limit research and refining process of pharmaceutical polyoxyl (40) stearate

Method used

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  • Preparation method of polyoxyl[40]stearate
  • Preparation method of polyoxyl[40]stearate
  • Preparation method of polyoxyl[40]stearate

Examples

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preparation Embodiment 1

[0030] In terms of mass percentage, 71.1 g of raw materials (commercial name: Baomile 1840, purchased from: Tyko Palm Chemical (Zhangjiagang) Co., Ltd.) with stearic acid content ω=40% are put into the autoclave, and the catalyst hard Potassium fatty acid 0.5g, seal the reaction kettle, replace with nitrogen three times, maintain the slight positive pressure in the kettle with nitrogen, then raise the temperature to 110°C-120°C, add a small amount of ethylene oxide to 0.3-0.4MPa, after the reaction pressure drops significantly, Continue to add ethylene oxide to maintain the reaction pressure of 0.4~0.5MPa, and the reaction temperature is 120°C~130°C, until 440g of ethylene oxide is added, the reaction temperature is maintained, and the stirring and aging is continued until the pressure of the pressure gauge drops to no longer drops. Cool down to room temperature and discharge to obtain polyoxyl (40) stearate.

preparation Embodiment 2

[0032] In terms of mass percentage, the stearic acid content ω 1 = 40% of raw material 1 (trade name: Permiral 1840, purchased from: Tyko Palm Chemicals (Zhangjiagang) Co., Ltd.) and stearic acid content of ω 2 =65% of the raw material 2 (commercial name: Baomi Le 1865, purchased from: Tyco Palm Chemical (Zhangjiagang) Co., Ltd.) is formulated into 71.1 g of raw material with a stearic acid content of 41% and puts it into the reactor, and adds catalyst stearin Potassium acid potassium 0.5g, closed reaction kettle, nitrogen replacement three times, nitrogen to maintain a slight positive pressure in the kettle, then raise the temperature to 110°C-120°C, add a small amount of ethylene oxide to 0.3-0.4MPa, after the reaction pressure drops significantly, continue Add ethylene oxide to maintain the reaction pressure of 0.4-0.5MPa, and the reaction temperature is 120°C-130°C until 440g of ethylene oxide is added, maintain the reaction temperature, continue to stir and mature until t...

preparation Embodiment 3-21

[0034] The preparation method of the polyoxyl (40) stearate obtained in Preparation Example 3-21 is the same as in Preparation Example 1, except that the stearic acid content is different in the prepared raw materials. See Table 1 for details.

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Abstract

The invention provides a preparation method of polyoxyl[40]stearate, and the preparation method is as follows: taking n kinds of raw materials with different stearic acid contents by mass percentage,measuring the stearic acid contents of raw material 1, raw material 2, raw material n to record as omega 1, omega 2...omega n; recording melting change time limit of the desired polyoxyl[40] stearateas T in minutes, adjusting the ratio of the raw materials to meet the formula of T=100*Sigma (m1 omega 1+m2 omega 2... +mn omega n) / Sigma (m1+m2...+mn), wherein m1, m2...mn are respectively the masses of the raw materials; and under the condition of a basic catalyst, performing ethoxylation of the raw materials mixed well in the ratio and ethylene oxide to obtain the polyoxyl[40]stearate. The method can accurately control the melting change time limit of the polyoxyl[40]stearate according to actual needs, and reduces the product color and conductivity of the polyoxyl[40]stearate by a furtherrefining method, thereby satisfying different application needs of downstream preparation manufacturers.

Description

technical field [0001] The invention belongs to the field of medicine and chemical industry, and relates to a preparation method of polyoxyl (40) stearate, in particular to a method for preparing polyoxyl (40) stearate with controllable melting time limit. Background technique [0002] Polyoxyl (40) stearate is a nonionic surfactant, and the raw material stearic acid used in its synthesis is mainly the stearic acid (C 18 Acid), palmitic acid, oleic acid, etc., are mainly used as solubilizers and excipients in the field of medicine, and are mainly used as suppositories for external use. [0003] The disintegration of the suppository depends on the body temperature and the secretion of the cavity to dissolve it. Determining the melting time limit of the suppository can ensure that the maximum effective drug concentration can be achieved at a suitable body temperature, suitable cavity environment and the best effective treatment time; and can ensure that the suppository Bioava...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08G65/26C08G65/30
CPCC08G65/2615C08G65/30
Inventor 朱建民刘兆滨仲崇纲陈杨英王洋
Owner 辽宁奥克药业股份有限公司