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Method for preparing standard of nisoldipine

A technology for nisoldipine and standard products, which is applied in the field of preparation of nisoldipine compound standard products, can solve the problems such as the inability to obtain high-purity nisoldipine standard products, and achieves the effects of simple operation, high product purity and stable process.

Inactive Publication Date: 2007-12-26
SHANDONG XINHUA PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But all can not obtain the high-purity nisoldipine standard substance

Method used

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  • Method for preparing standard of nisoldipine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] In a 250ml four-necked reaction flask equipped with a stirrer and a thermometer, 30g of nisoldipine crude product was added in the dark, 60ml of acetone was added, and the temperature was raised to reflux for dissolution under stirring. After the dissolution was completed, heat filtered, and the filtrate was crystallized under stirring to 3-5° C., filtered, washed with cold acetone, and dried to obtain 25.5 g (yield 85%, purity 99.67%) of nisoldipine.

Embodiment 2

[0017] According to Example 1, 30g of nisoldipine crude product was dissolved in 240ml of acetone to obtain 25.3g (yield 84.3%, purity 99.62%) of nisoldipine.

Embodiment 3

[0019] In a 250ml four-necked reaction flask equipped with a stirrer and a thermometer, 30g of nisoldipine crude product was added in the dark, 60ml of acetone was added, and the temperature was raised to reflux for dissolution under stirring. After dissolving, hot filter to crystallize in 75 milliliters of absolute ethanol under stirring, cool to 3~5 ℃, filter, wash with cold acetone, dry to obtain 24.3g (81%, purity 99.83%) nisoldipine.

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Abstract

This invention provides a novel method for preparing standard nisoldipine product. The method comprises: dissolving crude nisoldipine into C3-6 lower ketone and recrystallizing, or dissolving crude nisoldipine into C3-6 lower ketone, mixing with C3-6 lower alcohol, and recrystallizing. The method has such advantages as stable process, easy operation, high product purity (above 99.5%), and no pollution.

Description

technical field [0001] The invention relates to a preparation method of a nisoldipine compound standard product. Background technique [0002] Nisodipine of the following structural formula is a calcium antagonist. It can selectively inhibit vascular smooth muscle, reduce myocardial oxygen consumption, and blood pressure will decrease significantly with the increase of dose. For antihypertensive, antianginal and atypical angina. [0003] [0004] Several processes for the preparation of nisoldipine have been described in the literature so far. But all can not obtain the high-purity nisoldipine standard substance. Contents of the invention [0005] The technical problem to be solved by the present invention is to provide a new refining method for preparing nisoldipine standard product, which has stable process, simple operation, high product purity and no pollution. [0006] The preparation method of nisoldipine standard substance of the present invention is characte...

Claims

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Application Information

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IPC IPC(8): C07D211/90
Inventor 朱连博王冲徐英
Owner SHANDONG XINHUA PHARMA CO LTD
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