Lansoprazole sodium

A technology of lansoprazole sodium and acetone, applied in the B crystal form lansoprazole sodium and its preparation field, can solve the problems of lansoprazole sodium damage, product quality impact, etc.

Inactive Publication Date: 2010-09-01
NANJING HAIRUN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In addition, the A crystal form lansoprazole sodium solid particle prepared by the technology disclosed in CN1683367 is relatively large, and it is difficult to crush by ordinary methods (mortar, etc.), and mechanical equipment such as a universal pulverizer is required to obtain even particle lansoprazole Sodium, but crushing with a pulverizer will release a certain amount of heat, especially when the production volume is large, the heat generated by the equipment will cause certain damage to lansoprazole sodium and produce impurities, which will affect the product quality

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] The preparation of B crystal form lansoprazole sodium:

[0033] Dissolve 5 g of crystal form A lansoprazole sodium in 15 ml of water, add 75 ml of acetone, stir evenly, then add 150 ml of diethyl ether dropwise to crystallize the solution, crystallize at about 10°C for 2 hours, filter, and dry under reduced pressure at 40°C to obtain crystal B Type lansoprazole sodium 4.5g, yield: 90%. HPLC detection content: 99.92%.

[0034] Attach the preparation method of A crystal form lansoprazole sodium:

[0035]A crystal form lansoprazole sodium can prepare lansoprazole sodium according to a general method such as being similar to the method (EP124495) for preparing omeprazole sodium from omeprazole or adopting the technology disclosed in patent CN1660092, CN1683367, CN1810245 .

[0036] Add 400ml of water and 21.6g of sodium hydroxide (0.54mol) to the reaction flask, stir to dissolve, cool to room temperature, add lansoprazole 200g (0.54mol), and stir until completely dissolv...

Embodiment 2

[0060] The preparation of B crystal form lansoprazole sodium:

[0061] Dissolve 5 g of crystal form A lansoprazole sodium in 10 ml of water, add 40 ml of acetone, stir evenly, then add 40 ml of diethyl ether dropwise to crystallize the solution, crystallize at about 10°C for 2 hours, filter, and dry under reduced pressure at 35°C for 4 hours to obtain B The crystalline form of lansoprazole sodium is 4.2 g, and the yield is 84%. HPLC detection content: 99.88%.

Embodiment 3

[0063] The preparation of B crystal form lansoprazole sodium:

[0064] Dissolve 5 g of crystal form A lansoprazole sodium in 5 ml of water, add 30 ml of acetone, stir evenly, then add dropwise 90 ml of diethyl ether to crystallize the solution, crystallize at about 0°C for 2 hours, filter, and dry under reduced pressure at 50°C for 4 hours to obtain B The crystalline form of lansoprazole sodium is 4.4g, and the yield is 88%. HPLC detection content: 99.86%.

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Abstract

The inventive sodium lansoprazole relates to a B crystal form sodium lansoprazole, a relative preparation method and an application. The sodium lansoprazole is characterized in that the sodium lansoprazole is in B crystal form, whose X-ray diffraction pattern has characteristic peaks at the 2theta angle of 5.20, 13.82, 15.66, 16.78, 19.30, 20.12, 20.56, 21.00, 25.96, 28.70 and 30.4. The preparation method comprises (a) dissolving sodium lansoprazole of A crystal form via water at 0.5-5 powered mass, adding acetone and mixing uniformly, adding ether to crystallize the solution, wherein the amount of added acetone is 1-10 times of the volume of the water solution, the amount of added ether is 0.5-5 times of acetone, and the crystallization temperature is -10DEG C to 30DEG C, (b) separating the crystallization solution, drying in vacuum to obtain B crystal form sodium lansoprazole, wherein the drying temperature is 20-60DEG C. The B crystal form sodium lansoprazole can be used to preparethe drug of gastrointestinal disease.

Description

technical field [0001] What the present invention lansoprazole sodium relates to is a kind of B crystal form lansoprazole sodium and its preparation method, application. Background technique [0002] Substituted 2-(2-pyridylmethyl)sulfinyl-1H-benzimidazole derivatives are well known gastric proton pump inhibitors. These benzimidazole derivatives include lansoprazole, omeprazole, pantoprazole and rabeprazole, etc. They have the same function of inhibiting gastric acid secretion, so they are often used as anti-ulcer agents. [0003] The chemical name of lansoprazole is 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl-1H- Benzimidazole], the structural formula is: [0004] [0005] Lansoprazole was first developed and marketed by Takeda Corporation of Japan. It is mainly used clinically in the treatment of gastric ulcer, duodenal ulcer, anastomotic ulcer, Helicobacter pylori (Hp) infection, reflux esophagitis, gastrinoma and other diseases. treat. [00...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D401/12A61K31/4439A61P1/04
Inventor 宗在伟赵俊陈祥峰魏佳
Owner NANJING HAIRUN PHARM CO LTD
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