Method of refining ambroxol hydrochloride for injection

A technology for ambroxol hydrochloride and ambroxol hydrochloride crude product, applied in the refining field of ambroxol hydrochloride for injection, can solve the problems such as high recovery cost of refined mother liquor, unsuitability for recovery and re-refining, waste of raw materials and the like

Active Publication Date: 2017-05-10
HEFEI JIUNUO MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the above methods are all at the cost of sacrificing the yield of refining. The test proves that the yield of the patent CN201110048193.4 is refined once with an aqueous alcohol solution and the yield of the patent CN201310045450.8 is less than 80%, and the refined mother liquor is due to high recovery costs. , are not suitable for recycling and refining, serious waste of raw materials

Method used

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  • Method of refining ambroxol hydrochloride for injection
  • Method of refining ambroxol hydrochloride for injection
  • Method of refining ambroxol hydrochloride for injection

Examples

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Embodiment 1

[0041] A method for refining ambroxol hydrochloride for injection, comprising the following steps: heating and refluxing the crude product of ambroxol hydrochloride with aqueous hydrochloric acid to dissolve, filtering, taking the filtrate for recrystallization, washing, and drying to obtain ambroxol hydrochloride for injection.

Embodiment 2

[0043] A method for refining ambroxol hydrochloride for injection, comprising the steps of: 1 kg of ambroxol hydrochloride crude product is heated and refluxed to dissolve with 0.01mol / L hydrochloric acid aqueous solution with a concentration of 8 L, filtered while hot, and the filtrate is stirred and cooled to 73.5° C., added Seed crystal 1g, stir and cool down to 30°C within 2h, then stop stirring, cool down to 0°C, stand for crystallization for 2h, filter to take the filter cake, wash with 200ml of water at 0°C, adjust the vacuum degree to 0.09MPa, adjust Temperature to 80° C., drying for 3 hours to obtain 0.91 kg of ambroxol hydrochloride for injection, the yield was 91.0%, and the purity was 100%.

Embodiment 3

[0045] A method for refining ambroxol hydrochloride for injection, comprising the steps of: 3kg of ambroxol hydrochloride crude product is heated and refluxed to dissolve with 27L concentration of 0.02mol / L hydrochloric acid aqueous solution, filtered while hot, and the filtrate is stirred and cooled to 72.5°C, added Seed crystal 1g, stir and cool down to 25°C within 3h, then stop stirring, cool down to 5°C, stand for crystallization for 3h, filter to get the filter cake, wash with 1L of water at 5°C, adjust the vacuum degree to 0.1MPa, adjust Temperature to 75°C, drying for 4h to obtain 2.74kg of ambroxol hydrochloride for injection, the yield was 91.3%, and the purity was 100%.

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Abstract

The invention discloses a method of refining ambroxol hydrochloride for injection; the method comprises the steps of heating crude ambroxol hydrochloride with hydrochloric acid solution, reflux-dissolving, filtering, recrystallizing filtrate, washing, and drying to obtain the ambroxol hydrochloride for injection. The method is simple to perform, low in cost, high in product purity and high in yield, impurities B can be effectively removed, the content of other single impurities can also be controlled to 0.01% and below, and all yields reach 90% and above.

Description

technical field [0001] The invention relates to the technical field of chemical medicine purification, in particular to a method for refining ambroxol hydrochloride for injection. Background technique [0002] Ambroxol Hydrochloride (Ambroxol Hydrochloride), the chemical name is trans-4-[(2-amino 3.5-dibromobenzyl) amino] cyclohexanol hydrochloride, the chemical structural formula is shown in the following formula I: [0003] [0004] Ambroxol hydrochloride is an expectorant, researched and developed by Boehringer Ingelheim, Germany. Ambroxol hydrochloride injection (trade name: Mucosolvan) was listed in Germany in the early 1980s. In June 2000, my country approved the import of Mucosolvan produced by Boehringer Ingelheim Pharmaceutical Factory. Ambroxol hydrochloride injection is mainly used clinically for: (1) the treatment of acute and chronic lung diseases accompanied by abnormal sputum secretion and poor sputum excretion function, such as acute exacerbation of chron...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C213/10C07C215/44
CPCC07C213/10C07C215/44
Inventor 蒋敏王旭吴标凌林
Owner HEFEI JIUNUO MEDICAL TECH
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