Pantoprazole compound, preparation methods and pharmaceutical preparations thereof

A technology for pantoprazole and pharmaceutical preparations, applied in the field of pharmaceutical compounds, can solve problems such as discoloration and polymerization, and achieve the effects of stable water content, low impurities and simple operation

Active Publication Date: 2012-11-28
杭州澳亚生物技术股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, in clinical use of pantoprazole sodium, discoloration and polymerization often occur due to factors such as solvent and dissolution time, which limit the clinical application of pantoprazole sodium

Method used

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  • Pantoprazole compound, preparation methods and pharmaceutical preparations thereof
  • Pantoprazole compound, preparation methods and pharmaceutical preparations thereof
  • Pantoprazole compound, preparation methods and pharmaceutical preparations thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Get 100 grams of crude pantoprazole sodium salt and dissolve it in 600ml of acetone solution with a volume fraction of 98%, and heat the solution to 55°C; then add 1g of activated carbon for adsorption and decolorization, and then cool the solution to 35°C, and then carry out suction filtration Concentrate the filtrate to 350ml under reduced pressure, then add 400ml of ethyl acetate and 200ml of chloroform, stir (60 rpm) and cool down to -2°C, stir for 60min until a large amount of crystals are precipitated; Temperature 40°C, -0.05MPa, vacuum dry for 3.5h. The described pantoprazole sodium compound can be obtained.

[0041] The obtained pantoprazole sodium compound entity is as follows through X-ray diffraction spectrum figure 1 As shown, it can be seen from the figure that the X-diffraction diagram of the compound entity of the present embodiment is expressed at 9.5 °, 10.4 °, 11.6 °, 13.1 °, 13.8 °, 14.2 °, 15.0 °, 15.3 °, 15.9 ° in the 2θ angle , There are peaks at...

Embodiment 2

[0043] Get 100 grams of crude pantoprazole sodium salt and dissolve it in 650ml of acetone solution with a volume fraction of 98%, and heat the solution to 55°C; then add 1g of activated carbon to carry out adsorption decolorization, and then cool the solution to 38°C, then carry out suction filtration Concentrate the filtrate to 380ml under reduced pressure, then add 400ml of ethyl acetate and 200ml of chloroform, stir (70 rpm) and cool down to 1°C, stir for 60min until a large amount of crystals are precipitated; 43°C, -0.05MPa, vacuum dry for 4h. The described pantoprazole sodium compound entity can be obtained.

[0044] The obtained pantoprazole sodium compound entity has the same melting point and X-ray diffraction spectrum as in Example 1.

Embodiment 3

[0046]Get 100 grams of crude pantoprazole sodium salt and dissolve it in 700 ml of acetone solution with a volume fraction of 98%, and heat the solution to 55°C; then add 1g of activated carbon to carry out adsorption decolorization, and then cool the solution to 40°C, then carry out suction filtration Concentrate the filtrate to 400ml under reduced pressure, then add 400ml of ethyl acetate and 200ml of chloroform, stir (80 rpm) and cool down to 3°C, stir for 60min until a large amount of crystals are precipitated; 45°C, -0.05MPa, vacuum dry for 4h. The described pantoprazole sodium compound entity can be obtained.

[0047] The obtained pantoprazole sodium compound entity has the same melting point and X-ray diffraction spectrum as in Example 1.

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Abstract

The invention belongs to the technical field of pharmaceutical compounds, and relates to a pantoprazole sodium compound entity, especially a pantoprazole sodium crystal form, preparation methods and pharmaceutical preparations thereof. The pantoprazole sodium compound is crystal, and measured by X-diffraction powder diffraction, and the diffraction pattern has the following diffraction angles (2Theta) in turn: 9.5 degrees, 10.4 degrees, 11.6 degrees, 13.1 degrees, 13.8 degrees, 14.2 degrees, 15.0 degrees, 15.3 degrees, 15.9 degrees, 16.5 degrees, 17.5 degrees, 18.0 degrees and 18.2 degrees. The pantoprazole sodium compound entity may be associated with a variety of lyophilization supporting agents and the prepared lyophilized powder for injection has good solubility, good clarity and low content of related substances, etc. simultaneously the use level of the used lyophilization supporting agent is relatively less, the cost of the products is reduced, and the stability and quality of the products are improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical compounds, and relates to a pantoprazole sodium compound entity, specifically a crystal form of pantoprazole sodium, a preparation method and a pharmaceutical preparation thereof. Background technique [0002] Pantoprazole sodium, the chemical name is 5-difluoromethoxy-2-{[(3,4-dimethyl-2-pyridyl)-methyl]sulfinyl}-1H-benzimidazole sodium Hydrate, its molecular formula is: C16H14F2N3NaO4S·H2O, its molecular weight is 423.37. [0003] The clinical application of pantoprazole sodium: pantoprazole sodium is used for the treatment of duodenal ulcer, gastric ulcer and reflux esophagitis, combined with antibiotics can eradicate HP (Helicobact-erpylori Helicobacter pylori) infection, It can also prevent gastric and duodenal ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs). A number of foreign studies have shown that it is similar to omeprazole in the treatment of duodenal ulcer, gastric ulc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D401/12A61K9/19A61K31/4439A61P1/04
Inventor 傅苗青
Owner 杭州澳亚生物技术股份有限公司
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