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Galanthamine hydrobromide compound as well as preparation method and medicine compositions thereof

A technology of galantamine hydrobromide and compound, which is applied in the field of medicines in the field of medicine, can solve the problems of solvent residue, many separation steps, large amount of sewage, etc., and achieves the effects of improving yield and simplifying process operation.

Active Publication Date: 2014-12-03
天津梅花生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0020] Chinese patent CN200510013546.1 provides a new method using supercritical CO2 to extract galantamine from raw materials of Amaryllis or Leuculus genus, which solves the problem that the current organic solvent extraction method of galantamine has many separation steps, large amount of sewage and solvent Residue and other issues
[0023] In the research process, the galanthamine hydrobromide obtained by the method of the above-mentioned patent documents has a large number of impurities, a high total amount of impurities, and poor stability
The galantamine hydrobromide produced by the prior art has very strict requirements on storage and protection from light, and is inconvenient in use, storage and transportation

Method used

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  • Galanthamine hydrobromide compound as well as preparation method and medicine compositions thereof
  • Galanthamine hydrobromide compound as well as preparation method and medicine compositions thereof
  • Galanthamine hydrobromide compound as well as preparation method and medicine compositions thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0097] Preparation of galantamine hydrobromide compound

[0098] Add 2g of crude galantamine hydrobromide and 5ml of purified water into the reaction flask, stir and heat up to clear, add 25ml of methanol: acetone (1:1) into the reaction flask, stop adding, slowly cool down to room temperature Afterwards, a white solid precipitated slowly, left to crystallize for 24 hours, filtered, and the obtained solid was dried in a blast drying oven at 60°C to constant weight to obtain the galanthamine hydrobromide compound with a yield of 67.3% and a purity of 99.9%. Simple 0.09%, the X-diffraction pattern of embodiment 1 galanthamine hydrobromide compound sees figure 1 , the high performance liquid chromatogram of the galantamine compound is clearly calculated in figure 2 .

Embodiment 2

[0100] Preparation of galantamine hydrobromide compound

[0101] Add 2g of crude galantamine hydrobromide and 5ml of purified water into the reaction flask, stir and heat up until it becomes completely clear, add 25ml of methanol into the reaction flask, stop adding, cool slowly, and slowly precipitate a white solid after cooling down to room temperature , left to crystallize for 24 hours, filtered, and the obtained solid was dried in a blast drying oven at 60°C to constant weight to obtain the galanthamine hydrobromide compound with a yield of 61.3%, a purity of 99.9%, and a single compound of 0.09%.

Embodiment 3

[0103] Preparation of galantamine hydrobromide compound

[0104] Add 2 g of crude product galantamine hydrobromide and 5 ml of purified water into the reaction flask, stir and heat up until it is completely clear, add 25 ml of dichloromethane: acetone (1:3) into the reaction flask, stop adding, cool slowly, drop After reaching room temperature, a white solid was slowly precipitated, left to crystallize for 24 hours, filtered, and the obtained solid was dried in a blast drying oven at 60°C to constant weight to obtain the galantamine hydrobromide compound with a yield of 69.3% and a purity of 99.9% %, single impurity 0.09%.

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Abstract

The invention discloses a galanthamine hydrobromide compound as well as a preparation method and medicine compositions thereof. The galanthamine hydrobromide compound disclosed by the invention has the advantages of high chemical purity and good stability, wherein the maximum content of single impurity is below 0.1%; and the stability to light and heat is particularly good. The medicine compositions of the galanthamine hydrobromide compound, prepared by adopting special auxiliary materials, have the following more obvious advantages of being good in stability, easy to implement and remarkable in economic benefit, meeting the clinical needs, reducing the production cost and realizing the industrialization.

Description

technical field [0001] The invention relates to medicines in the field of medicine, in particular to a high-purity galantamine hydrobromide compound, a preparation method and a pharmaceutical composition. Background technique [0002] Alzheimer's disease is one of the common diseases of the elderly, mainly manifested as memory loss and recognition impairment, etc., and is a progressive neurodegenerative disorder. According to data, the incidence of Alzheimer's disease (Alzheimer's disease, referred to as: AD) accounts for about 10% among the elderly around 65 years old, and about 47% among the elderly over 85 years old. , Has become the fourth killer of mankind. The course of the disease is generally longer, about 3-20 years, so it brings a heavy burden to the society, family and patients, and brings great pain to the patients. Sanochemia Pharmazeutika AG (Vienna, Austria) announces the first acetylcholine ester inhibitor, Reminy1 (galantamine), to be marketed in Europe. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D491/107A61K31/55A61K9/20A61P25/28A61P21/04A61P21/00A61P25/02A61P25/14
CPCC07D491/107
Inventor 梅开忠黄欣
Owner 天津梅花生物医药科技有限公司
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