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Method for refining salbutamol sulfate

A technology for salbutamol sulfate and refined products, which is applied in the field of separation and purification of fine chemicals, can solve problems such as the inability to meet the quality requirements of preparations, and achieve the effects of stable properties and high purity

Inactive Publication Date: 2015-10-28
SHANXI YUNPENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The quality standards of salbutamol sulfate stipulated in the Chinese Pharmacopoeia cannot meet the quality requirements of all preparations, especially the products of spray preparations and injections, because the products of spray preparations and injections are prone to change during the storage period, so there is an urgent need to improve the quality of salbutamol sulfate Standards to ensure that the quality of injections and spray preparations meets the requirements throughout the product cycle

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] A kind of method for refining salbutamol sulfate, put 20kg of salbutamol sulfate crude product, 72kg of purified water in clean barrel, stir until dissolving completely, filter, obtain salbutamol sulfate filtrate, standby; Get 10 clean barrels in addition, add 28.5kg of each barrel respectively Acetone; add 9.2kg of salbutamol sulfate filtrate to each barrel respectively, and let it stand for crystallization at room temperature for 4 hours; transfer the crystallization feed liquid into the centrifuge (feeding needs to be added in a small amount several times), and open the centrifuge until there is no liquid at the discharge port When flowing out, use 20kg of acetone to wash the filter cake; continue to centrifuge for 30 minutes, turn off the centrifuge, and discharge; put the centrifugal wet product in a clean stainless steel tray, spread it evenly, and let the acetone dry naturally for more than 3 hours; put the tray into In a drying oven, the temperature is controlled...

Embodiment 2

[0017] A method for refining salbutamol sulfate, dissolving the crude product of salbutamol sulfate in purified water, the weight ratio of salbutamol sulfate and water is 1:3.6, filtering to obtain the salbutamol sulfate filtrate, for subsequent use; adding 3 times of the crude product of salbutamol sulfate to the salbutamol sulfate filtrate The weight of acetone is crystallized at room temperature, and the crystallization time is 4 hours; the crystallization liquid is poured into the centrifuge, and the feeding needs to be added in small amounts several times. When the centrifuge is turned on until no liquid flows out from the discharge port, the filter cake is washed with acetone Until the filtrate is clear; continue to centrifuge for 30 minutes, turn off the centrifuge, and discharge; put the centrifugal wet product in a clean stainless steel plate, spread it evenly, and dry the acetone naturally for more than 3 hours; put the material plate in the drying box and control the ...

Embodiment 3

[0020] A method for refining salbutamol sulfate, dissolving the crude product of salbutamol sulfate in purified water, the weight ratio of salbutamol sulfate and water is 1:3.6, filtering to obtain the salbutamol sulfate filtrate, for subsequent use; adding 4 times of the crude product of salbutamol sulfate to the salbutamol sulfate filtrate The weight of acetone is crystallized at room temperature, and the crystallization time is 4 hours; the crystallization liquid is poured into the centrifuge, and the feeding needs to be added in small amounts several times. When the centrifuge is turned on until no liquid flows out from the discharge port, the filter cake is washed with acetone Until the filtrate is clear; continue centrifuging for 40 minutes, turn off the centrifuge, and discharge; put the centrifugal wet product in a clean stainless steel plate, spread it evenly, and let the acetone dry naturally for 5 hours; put the material plate in a drying box and control the temperatu...

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PUM

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Abstract

The invention relates to a method for refining salbutamol sulfate and belongs to the technical field of fine chemical separation and purification. The method for refining the salbutamol sulfate aims to achieve the technical purposes that the technique is simple and the purity of refined products is high. According to the technical scheme, the method for refining the salbutamol sulfate comprises the steps that crude salbutamol sulfate is dissolved in purified water, filtering is conducted, and thus salbutamol sulfate filter liquor is obtained for later use, wherein the weight ratio of the salbutamol sulfate and water is 1:3.6; acetone with the weight being three times to four times that of the crude salbutamol sulfate is added into the filter liquor, and crystallization is conducted for four hours at the normal temperature; crystallized liquor is poured into a centrifugal machine, the liquor is added multiple times in the way that a small amount of liquor is added each time, the centrifugal machine is started till no liquor flows out from a discharge outlet, and a filter cake is washed by means of acetone till the filter liquor is clear; centrifugation continues to be conducted for half an hour, the centrifugal machine is stopped, and discharging is conducted; a centrifuged wet product is contained in a clean stainless steel tray and evenly spread flat, and the acetone is naturally dried for more than three hours; the tray is placed in a drying box to be dried for more than four hours by controlling the temperature to be 70-80 DEG C, and then sieving is conducted by means of a 40-mesh sieve.

Description

technical field [0001] The invention relates to a method for refining albuterol sulfate, which belongs to the technical field of separation and purification of fine chemicals. Background technique [0002] Salbutamol sulfate is called 1-(4-hydroxy-3-hydroxymethylphenyl)-2-(tert-butylamino)ethanol sulfate, which is suitable for bronchial asthma, wheezing bronchitis and emphysema, etc. Mists are inhaled, while prophylaxis can be given orally. The main function is to selectively excite the β2-receptor on the bronchial smooth muscle, relax the bronchial smooth muscle, and relieve the spasm of the bronchial smooth muscle. Adverse reactions: Mainly stimulate the heart and central nervous system, such as headache, dizziness, insomnia, occasionally muscle and finger tremors, palpitations, blood pressure fluctuations, etc. Long-term use can produce drug resistance and may aggravate asthma. [0003] In the quality standard of salbutamol sulfate contained in the first supplement of ...

Claims

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Application Information

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IPC IPC(8): C07C215/60C07C213/10
Inventor 文献江
Owner SHANXI YUNPENG PHARMA
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