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Purification process of meclofenoxate hydrochloride

A meclofenoxate hydrochloride and process technology, which is applied in the field of drug synthesis, can solve the problems of rare reports on the refining process, and achieve the effect of process stability

Inactive Publication Date: 2014-09-24
JIANGSU HI STONE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] In the production process of meclofenoxate hydrochloride, it is necessary to synthesize the crude product of meclofenoxate hydrochloride earlier, and then refine and make the meclofenoxil hydrochloride of finished product. However, in the prior art, methyl chloride hydrochloride of high quality and high yield There are few reports on the refining process of phenate

Method used

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  • Purification process of meclofenoxate hydrochloride

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Embodiment

[0029] Embodiment: the refinement of aseptic meclofenoxate hydrochloride (in batch 40kg).

[0030] (10) Before the start of production, check that there are no products, documents or materials unrelated to the production of this batch of products left over from the previous batch in the equipment and workplace, and the equipment is in a clean and ready-to-use state. The operator checks and confirms that the salt tank and delivery pump are in good condition; confirms that the pipelines, valves, decarbonization filters, plate and frame filters, precision filters, and sterilization filters are in good condition; checks and confirms that measuring instruments, monitoring instruments, auxiliary The appliance is in good condition;

[0031] (20) Operators clean and disinfect the reaction delivery system according to the operating procedures (SOP-EC-009);

[0032] (30) Weighing, the operator approves the batch production order and the remaining materials of the previous batch, and ap...

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Abstract

The invention discloses a purification process of meclofenoxate hydrochloride. The purification process of meclofenoxate hydrochloride includes the following steps that before production, detection instruments, production devices and work sites are detected and cleaned, salt shakers are started in a vacuum state, anhydrous ethanol is sucked into the salt shakers, crude meclofenoxate hydrochloride products are stirred and dissolve in the anhydrous ethanol, medicinal carbon is put into the salt shakers and mixed for decoloration, feed liquid is sterilized and filtered from the salt shakers level by level, input in a crystallization tank, cooled, crystallized and filtered, vacuum drying is conducted after two washing processes are finished, and cooling and discharge can be conducted after it is detected that moisture in crystals is below 0.5%. The purification process is stable, meclofenoxate hydrochloride with high quality and purity can be purified through the crude meclofenoxate hydrochloride products, and the yield can reach 80.0% to 88.0%.

Description

technical field [0001] The invention relates to the field of drug synthesis, in particular to a refining process of meclofenoxate hydrochloride. Background technique [0002] Meclofenoxate Hydrochloride, the chemical name of this product is 2-(dimethylamino)ethyl p-chlorophenoxy acetate hydrochloride, and its structural formula is [0003] , calculated as dry product, including C 12 h 16 ClNO 3 · HCl must not be less than 98.6%. This product is a white crystalline powder; slightly specific smell, bitter taste, easily soluble in water, soluble in chloroform, almost insoluble in ether. [0004] Meclofenoxate hydrochloride can promote the oxidation-reduction process of cells, enhance the utilization of carbohydrates, and regulate the metabolism of nerve cells. It is widely used in the treatment of coma, traumatic brain injury, disturbance of consciousness caused by stroke, Alzheimer's disease, and mental retardation in children. One of the central stimulants. [0005] I...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07C219/06C07C213/10
Inventor 王多平
Owner JIANGSU HI STONE PHARMA
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