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Method for refining ranitidine base

A technology of ranitidine base and ranitidine hydrochloride, which is applied in the field of separation and purification of fine chemicals, can solve the problems of low product purity, ineffective separation and gap between ranitidine base and impurities, and achieve improvement Effects of safety, stable properties, and improved purity

Active Publication Date: 2018-05-11
SHANXI YUNPENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is still a gap between the quality of this variety and the original drug in China, the product purity is low, and the ranitidine base and impurities cannot be effectively separated during the crystallization process

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Add 100g of ranitidine base crude product (purity 99.6%), 60g of isopropanol, and 180g of petroleum ether into the reaction bottle, heat up to 42°C and dissolve, then become clear, keep warm for 30 minutes, slowly cool down to 20°C, the solution starts Precipitate crystals, continue to cool down to 0°C, keep warm for crystallization for 3 hours, filter to obtain a wet product, and dry naturally to obtain refined ranitidine base. Liquid chromatograph analysis shows that the maximum purity of ranitidine base after refining is 0.020%, and the purity is 99.95%.

Embodiment 2

[0030] Add 100g of ranitidine base crude product (purity 99.6%), 80g of isopropanol, and 200g of methyl isobutanol into the reaction bottle, heat up to 42°C and dissolve, then become clear, keep warm for 30 minutes, and slowly cool down to 20°C , the solution begins to precipitate crystals, continue to cool down to 0 ° C, keep warm for crystallization for 3 hours, filter to obtain a wet product, and dry naturally to obtain refined ranitidine base. Liquid chromatograph analysis shows that the maximum purity of ranitidine base after refining is 0.013%, and the purity is 99.95%.

Embodiment 3

[0032] Add 100g of ranitidine base crude product (purity 99.6%), 60g of absolute ethanol, and 180g of methyl tert-butyl ether into the reaction bottle, heat up to 40°C and dissolve, then become clear, keep warm for 30 minutes, and slowly cool down to 20°C ℃, the solution begins to precipitate crystals, continue to cool down to 0 ℃, keep warm and crystallize for 3 hours, filter with suction to obtain a wet product, and dry naturally to obtain refined ranitidine base. Liquid chromatograph analysis shows that the maximum purity of ranitidine base after refining is 0.010%, and the purity is 99.95%.

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Abstract

The invention relates to the technical field of separation and purification of fine chemicals, and more concretely relates to a method for refining ranitidine base. By using a mixed solvent prepared from an intensive polar solvent and a weak polar solvent, the dissolvability of ranitidine base and impurities in the solvent is different, so that the ranitidine base and the impurities can be effectively separated during a crystallization process, and an obtained refined product is high in purity and stable in property. After analyzing the ranitidine base refined through the method provided by the invention through a liquid chromatograph, the purity of the ranitidine base is not less than 99.0 percent, the total impurity is not larger than 0.15 percent, and the single impurity is not larger than 0.05 percent. A ranitidine hydrochloride product obtained through salifying the ranitidine base prepared and purified through the method provided by the invention has the purity reaching and beingsuperior to the quality level of an original drug, so that the safety of the drug during a use process is further improved.

Description

technical field [0001] The invention relates to the technical field of separation and purification of fine chemicals, more specifically, to a method for refining ranitidine base. Background technique [0002] Ranitidine is currently the most widely used drug for the treatment of ulcer disease. Developed by the British Glaxo (glaxo) company. It was synthesized by British Price in 1976, and its pharmacology was clarified by Bradshaw in 1979. In 1980, Berstad reported that it was effective for duodenal ulcer. Apps in hundreds of countries. my country was produced by Shanghai Sixth Pharmaceutical Factory in 1985. [0003] This variety of raw materials has been used for more than 20 years at home and abroad. The preparations have been in oral dosage forms such as capsules and tablets. Its quality standards have been included in USP, BP, EP, JP, CP and other pharmacopoeias. The effectiveness and effectiveness are fully verified and clear. However, there is still a gap between...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D307/52
CPCC07D307/52
Inventor 何达云乔建锋高彬张国才
Owner SHANXI YUNPENG PHARMA
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