Laurinol purification method and lauromacrogol preparation method

A purification method and technology of lauryl alcohol, applied in the field of medicine and chemical industry, can solve the problems of not fully complying with the quality standards of the European Pharmacopoeia and the like

Inactive Publication Date: 2015-05-27
BEIJING WANCHENG WEIYE MEDICAL TECH
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] However, the preparation method of Shaanxi Tianyu Pharmaceutical Co., Ltd. has been verified during repeated tests that it cannot fully meet the quality standards of the European Pharmacopoeia
Although the purification method of Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd. can remove the incompletely reacted lauryl alcohol, so that the free lauryl alcohol, free polyethylene glycol, and other indicators in the finally obtained lauryl alcohol product meet the quality standards of the European Pharmacopoeia, but It is impossible to avoid the risk of by-products of impurities in lauryl alcohol (such as n-decyl alcohol, n-tetradecyl alcohol) and ethylene oxide

Method used

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  • Laurinol purification method and lauromacrogol preparation method
  • Laurinol purification method and lauromacrogol preparation method
  • Laurinol purification method and lauromacrogol preparation method

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0119] Preparation Example 1: Preparation of Lauryl Alcohol Purification Sample 1

[0120] Add 250g of lauryl alcohol and 250g of toluene into the reaction kettle, stir and mix well, then slowly raise the temperature to reflux state, control the temperature to keep the mixture in azeotropic state, and collect the distillation product under reduced pressure. The distillation product is first distilled at 100°C and controlled pressure ≤ -0.1Mpa until no liquid flows out, and then gradually heated up to 150°C-160°C and -0.1Mpa to continue vacuum distillation for 4-5 hours. Toluene is recovered and reused until the lauryl alcohol is completely distilled off.

[0121] According to the requirements of related substances in the imported drug registration standard lauromacrogol 400 injection (JX20120149), the test results are shown in Table 1 below.

[0122] Table 1

[0123] name

preparation example 2

[0124] Preparation Example 2: Preparation of Lauryl Alcohol Purification Sample 2

[0125] Add 350g of lauryl alcohol and 350g of toluene into the reaction kettle, stir and mix well, then slowly raise the temperature to reflux state, control the temperature to keep the mixture in azeotropic state, and collect the distillation product under reduced pressure. The distillation product is first distilled at 100°C and controlled pressure ≤ -0.1Mpa until no liquid flows out, and then gradually heated up to 150°C-160°C and -0.1Mpa to continue vacuum distillation for 4-5 hours. Toluene is recovered and reused until the lauryl alcohol is completely distilled off.

[0126] According to the requirements of related substances in the imported drug registration standard lauromacrogol 400 injection (JX20120149), the test results are shown in Table 2 below.

[0127] Table 2

[0128] name

preparation example 3

[0129] Preparation Example 3: Preparation of Lauryl Alcohol Purification Sample 3

[0130] Add 11kg of lauryl alcohol and 11kg of toluene into the reaction kettle, stir and mix well, then slowly raise the temperature to reflux state, control the temperature to keep the mixture in azeotropic state, and collect the distillation product under reduced pressure. The distillation product is first distilled at 100°C and controlled pressure ≤ -0.1Mpa until no liquid flows out, and then gradually heated up to 150°C-160°C and -0.1Mpa to continue vacuum distillation for 4-5 hours. Toluene is recovered and reused until the lauryl alcohol is completely distilled off.

[0131] According to the requirements of related substances in the imported drug registration standard lauromacrogol 400 injection (JX20120149), the test results are shown in Table 3 below.

[0132] table 3

[0133]

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Abstract

The invention relates to a preparation technology of lauromacrogol. The preparation technology takes lauryl alcohol, potassium hydroxide, oxirane, absolute ethyl alcohol and activated carbon as raw materials. The preparation technology is simple; no special equipment is required; a solvent can be recycled, so that the industrial production cost is lowered; potassium hydroxide serves as a catalyst, so that operation is simplified; the content of heavy metal is controlled easily according to a medicinal quality standard requirement; lauromacrogol is high in yield.

Description

technical field [0001] The invention belongs to the field of medicine and chemical industry, and relates to a method for purifying lauryl alcohol and a method for preparing lauryl alcohol. Background technique [0002] Lauryl alcohol, chemical name polyoxyethylene lauryl ether, molecular formula (C 2 h 4 O) n C 12 h 26 o It is used for emergency hemostasis and sclerotherapy of esophageal variceal bleeding under endoscopy; it can also be used for sclerotherapy of simple spider veins and reticular veins, hemangiomas, internal hemorrhoids and cystic diseases of the lower extremities. Because of its good clinical effect and low toxicity and side effects, it is widely used in clinical practice. The structural formula of lauromacrogol is as follows: [0003] [0004] The preparation principle of lauryl alcohol is mainly that lauryl alcohol and ethylene oxide polymerize under alkali-catalyzed conditions, and the reaction process is as follows: [0005] [0006] But, t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C31/125C07C29/82C07C43/11C07C41/03A61K31/765A61P9/14A61P35/00
CPCC07C29/82C07C31/125C07C41/03C07C43/11
Inventor 曹诚
Owner BEIJING WANCHENG WEIYE MEDICAL TECH
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