New Synthesis Method of High Stability Bismuth Citrate Ranitidine

A technology of bismuth ranitidine citrate and synthesis method, which is applied in the field of synthesis of high stability bismuth ranitidine citrate, can solve the problems affecting the quality and drug properties of bismuth citrate ranitidine, and product approval. Problems such as the gap in secondary stability and the difficulty in the treatment of three wastes, etc., to achieve the effects of improving pharmacological properties and stability, improving quality and stability, and high product yield

Active Publication Date: 2021-01-19
JIANGSU HI STONE PHARMA
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Problems solved by technology

Existing synthesis methods mostly have defects such as high preparation cost, difficulty in treating the three wastes, and environmental pollution, and due to the physical and chemical factors of ranitidine itself, there are some problems in its stability, and there is a gap in the stability of product batches. Affect the quality and drug properties of bismuth citrate ranitidine

Method used

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  • New Synthesis Method of High Stability Bismuth Citrate Ranitidine

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Embodiment 1

[0033]Take by weighing 443g 2-[[[5-(dimethylamino)methyl-2-furan]methyl]sulfanyl]ethylamine and place it in a reaction kettle with a tail gas absorption device, add 590ml purified water thereto, and stir to configure into an aqueous solution with a molar concentration of 3.5 mol / L; weigh 307g of N-methyl-1-methylthio-2-nitroethyleneamine and place it in another reactor with a tail gas absorption device, and add 590ml of purified water to it Purified water, configured as a 3.5 mol / L aqueous solution;

[0034] First under stirring at a rate of 200r / min, 2-[[[5-(dimethylamino)methyl-2-furan]methyl]sulfanyl]ethanamine aqueous solution was added dropwise to N- Methyl-1-methylthio-2-nitroethyleneamine aqueous solution, and then continue to add 2-[[[5-(dimethylamino)methyl-2-furan]methanol under stirring at a rate of 60r / min Add the aqueous solution of base]sulfanyl]ethylamine dropwise to the aqueous solution of N-methyl-1-methylthio-2-nitroethyleneamine at a rate of 1.5mL / min, and ...

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Abstract

The invention discloses a novel synthesis method for high-stability ranitidine bismuth citrate. The method includes the steps of: 1) preparing a raw material solution; 2) performing a reaction to prepare ranitidine; 3) purifying the ranitidine; 4) performing a salt forming reaction; 5) discolorizing and sterilizing a product; and 6) producing a ranitidine bismuth citrate finish product. The novel synthesis method, through reasonable process design, can increase the quality and stability of ranitidine, thereby improving the pharmacologic property and stability of the ranitidine bismuth citrate. The novel synthesis method is low in raw material cost, has gentle process conditions, is good in controllability and yield, and is suitable for industrial production.

Description

technical field [0001] The invention relates to the technical field of medicine synthesis, in particular to a novel method for synthesizing high-stability bismuth citrate ranitidine. Background technique [0002] Bismuth citrate ranitidine is also known as ranitidine bismuth citrate, its English name is: RenitidineBismuchCitrate (English abbreviation: RBC); chemical name is: N-[2-[5-[(two Methylamino)methyl]-2-furylmethylthio]ethyl]-N-methyl-2-nitro-1,1-ethylenediamine 2-hydroxy-1,2,3-propanetrihydroxy bismuth salt (complex); its structural formula is: [0003] [0004] RBC has been used in clinical practice for nearly 20 years. It was first successfully developed by the British company GLAXO (Glaxo) for the treatment of gastric ulcer, duodenal ulcer, esophageal ulcer, etc. It can effectively inhibit gastric protein isoenzymes, and has the dual functions of ranitidine to inhibit acid secretion and bismuth salt to protect gastric mucosa against Helicobacter pylori, and i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D307/52C07C51/41C07C59/265
CPCC07D307/52
Inventor 王多平卫耿虎史加桂杨宇
Owner JIANGSU HI STONE PHARMA
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