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Refining method and system of medical intermediate

A refining method and refining system technology, applied in the field of refining methods and systems of pharmaceutical intermediates, can solve problems such as lack of standardization of process operations, difficulty in product quality control, lack of standard operating procedures, etc., to avoid inconsistent product quality, Control product quality and ensure the effect of stability

Pending Publication Date: 2021-12-14
丽江映华生物药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, due to its complex production process, the existing process is difficult to ensure the accuracy of mold dehydrogenation, lack of standard operating procedures, and the lack of standardization of process operations makes it difficult to control product quality

Method used

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  • Refining method and system of medical intermediate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A method for refining a pharmaceutical intermediate, comprising the following steps:

[0028] 1. Preparation before feeding: Check whether the equipment is running normally, whether the pipeline is smooth, and there is no foreign matter in the tank. Prepare all raw and auxiliary materials according to the amount of feeding. The specifications and proportions of the raw materials used are shown in Table 1. Check whether they are qualified Certificate, and two people to check, everything is normal before feeding.

[0029] 2. Decolorization: pump 700kg of acetone into the decolorization tank, open the tank cover, put in 100kg of pharmaceutical intermediates, and then put in 2kg of activated carbon, cover the tank cover, turn on the steam in the jacket, stir and reflux for 1 hour for decolorization;

[0030] 3. Filtration: Check the filter pipe and filter, lay out the filter bag and filter paper, vacuum filter the system to the concentration kettle, and pre-clean the decolo...

Embodiment 2

[0035] A method for refining a pharmaceutical intermediate, comprising the following steps:

[0036] 1. Preparation before feeding: Check whether the equipment is running normally, whether the pipeline is smooth, and there is no foreign matter in the tank. Prepare all raw and auxiliary materials according to the amount of feeding. The specifications and proportions of the raw materials used are shown in Table 1. Check whether they are qualified Certificate, and two people to check, everything is normal before feeding.

[0037] 2. Decolorization: pump 700kg of acetone into the decolorization tank, open the tank cover, put in 100kg of pharmaceutical intermediates, and then put in 2kg of activated carbon fiber, cover the tank cover, turn on the steam in the jacket, stir and reflux for 1 hour for decolorization;

[0038] 3. Filtration: Check the filter pipe and filter, lay out the filter bag and filter paper, vacuum filter the system to the concentration kettle, and pre-clean the ...

Embodiment 3

[0043] A method for refining a pharmaceutical intermediate, comprising the following steps:

[0044] 1. Preparation before feeding: Check whether the equipment is running normally, whether the pipeline is smooth, and there is no foreign matter in the tank. Prepare all raw and auxiliary materials according to the amount of feeding. The specifications and proportions of the raw materials used are shown in Table 1. Check whether they are qualified Certificate, and two people to check, everything is normal before feeding.

[0045] 2. Decolorization: pump 700kg of acetone into the decolorization tank, open the tank cover, put in 100kg of pharmaceutical intermediates, and then put in 2kg of zeolite, cover the tank cover, turn on the steam in the jacket, stir and reflux for 1 hour for decolorization;

[0046] 3. Filtration: Check the filter pipe and filter, lay out the filter bag and filter paper, vacuum filter the system to the concentration kettle, and pre-clean the decolorization ...

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Abstract

The invention provides a refining method and system of a medical intermediate. The refining method comprises the following steps: S1, pumping acetone, the medical intermediate and an adsorption material into a decoloring tank to obtain a mixture, and stirring and refluxing for decoloring; S2, performing vacuum filtration on the decolored mixture, and adding the decolored mixture into a concentration kettle; S3, concentrating the mixture in the concentration kettle, then stirring and cooling, and standing until a crystallized product is obtained; and S4, centrifugally washing the crystallized product with acetone for several times, and drying for finishing refining. By adopting the technical scheme, a pharmaceutical intermediate refining production standard operation specification is established, pharmaceutical intermediate refining production operation is standardized, pharmaceutical intermediate refining purity stability is effectively guaranteed, product quality inconsistency is avoided, product quality is effectively controlled, and the method and the system are suitable for large-scale production.

Description

technical field [0001] The invention belongs to the technical field of refining pharmaceutical intermediates, in particular to a method and system for refining pharmaceutical intermediates. Background technique [0002] Since 2000, the growth rate of the global generic drug market has caught up with and exceeded the growth rate of the global pharmaceutical market. Key drivers of market growth. In the next 5-10 years, the generic drug market will still maintain a high growth rate and become an important growth pillar of the global pharmaceutical market, especially the pharmaceutical market of developing countries. [0003] Pharmaceutical intermediates are some chemical raw materials or chemical products used in the process of drug synthesis. They are key raw materials for the production of chemical raw materials. As an important part of fine chemical industry, pharmaceutical intermediates have gradually become the focus and core of the development of chemical industry in var...

Claims

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Application Information

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IPC IPC(8): C07C213/10
CPCC07C213/10C07C67/56C07C67/52C07C319/28C07D403/12C07D471/04C07D321/06C07D213/65C07C51/47C07C51/43C07D215/227C07C45/79C07C45/81C07D231/38C07D213/84C07C315/06C07D213/73C07D213/80C07D213/68C07J1/0011C07J1/0096C07J1/0025C07C215/08C07C69/72C07C323/36C07C217/84C07C57/58C07C47/565C07C317/44C07C53/19C07C69/63C07C69/716C07C317/04
Inventor 谭志云王钱钢杨宗禄谭建权
Owner 丽江映华生物药业有限公司
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