Preparation method of lysine carbocisteine

A technology of lysine carbocisteine ​​and carbocisteine, which is applied in the field of preparation of lysine carbocisteine, which can solve the problem of affecting the quality and yield of the final product, poor particle size of the product, and caking of the final product, etc. problems, achieve consistent purity, uniform particles, and reduce environmental pressure

Inactive Publication Date: 2018-10-30
ZHEJIANG SANMEN HYGECON PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, there is no pharmaceutical factory in China, and the Italian DompeFarmaceutic S.p.A. company is producing as the original research factory abroad, but they adopt the method of rapid crystallization in organic solvents, which will easily lead to the adhesion of the final product, and it is not easy to operate such as centrifugal drying, resulting in product particles If the degree is not good, it will affect the quality and yield of the final product
The patent number is EP0546272A1. The yield of lysine carbocisteine ​​crystallized by ethanol method is only about 90%, and the purity is only 99.5%.

Method used

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  • Preparation method of lysine carbocisteine
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preparation example Construction

[0019] The invention provides a kind of preparation method of lysine carbocisteine, comprising the following steps:

[0020] Mixing L-lysine and carbocisteine ​​aqueous solution, a salt-forming reaction occurs, and a salt-forming product system is obtained;

[0021] The salt-forming product system is spray-dried to obtain lysine carbocisteine.

[0022] In the present invention, unless otherwise specified, the components of all raw materials are commercially available products well known to those skilled in the art.

[0023] The invention mixes L-lysine and carbocisteine ​​aqueous solution to generate a salt-forming reaction to obtain a salt-forming product system. In the present invention, the mass concentration of the carbocisteine ​​aqueous solution is preferably 10%-50%, more preferably 20%-45%, and most preferably 30%-40%.

[0024] In the present invention, the molar ratio of L-lysine and carbocisteine ​​in the aqueous carbocisteine ​​solution is preferably 1:(0.8-1.2), ...

Embodiment 1

[0034] Mix 5.1 kg of carbocisteine ​​(HPLC purity 99.9%) and 13.9 kg of a 30% L-lysine aqueous solution at a mass concentration of 13.9 kg, and carry out a salt-forming reaction at 25° C. under stirring for 2 hours to obtain a salt-forming product system.

[0035] Add the salt-forming product system into the hopper of the spray dryer, set the air inlet temperature to 100°C, the air outlet temperature to 80°C, and the atomization frequency to 1000rpm, start the spray dryer, turn on the induced draft fan, and start heating. When the tuyere temperature reached 100°C and the air outlet temperature reached 80°C, the atomizer and the peristaltic pump were turned on, and the rotating speed of the peristaltic pump was controlled to be 20rpm, and spray drying was carried out to obtain lysine carbocisteine ​​10kg (HPLC purity 99.9%), Yield 98%.

[0036] figure 2 Be the particle size distribution figure of described lysine carbocisteine, figure 1 For reference, the patent No. is the p...

Embodiment 2

[0038] Mix 5.1 kg of carbocisteine ​​(HPLC purity 99.8%) and 13.9 kg of 30% L-lysine aqueous solution at a mass concentration of 13.9 kg, and carry out a salt-forming reaction at 25° C. under stirring for 2 hours to obtain a salt-forming product system.

[0039] Add the salt-forming product system into the hopper of the spray dryer, set the air inlet temperature to 120°C, the air outlet temperature to 100°C, and the atomization frequency to 2000rpm, start the spray dryer, turn on the induced draft fan, and start heating. When the tuyere temperature reached 120°C and the air outlet temperature reached 80°C, the atomizer and peristaltic pump were turned on, and the rotating speed of the peristaltic pump was controlled to be 30rpm, and spray drying was carried out to obtain 9.95kg of carbocisteine ​​lysine (HPLC purity 99.8%) , yield 97%.

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Abstract

The invention provides a preparation method of lysine carbocisteine. The preparation method comprises the following steps: mixing L-lysine with a carbocisteine water solution to generate salt formingreaction, so as to obtain a salt forming product system; and carrying out spray drying on the salt forming product system, so as to obtain lysine carbocisteine. According to the preparation method, afinished product can be obtained without separation and purification through a solvent-out crystallization method, prepared lysine carbocisteine does not contain residues of organic solvents such as methanol, ethanol and acetone, the product does not have solvent residue and is uniform in particles, the impurity is not generated during the spray drying, the purity of lysine carbocisteine is accordant with that of raw material carbocisteine, and the yield is high. According to the records of an embodiment, the yield of lysine carbocisteine is 98%, and meanwhile, a large number of organic solvents are not used in the preparation method, so that the production cost can be remarkably lowered, and the environment pressure can be reduced.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a preparation method of carbocisteine ​​lysine. Background technique [0002] The chemical name of lysine carbocisteine ​​is L-lysine-S-carboxymethyl-L-cysteine ​​salt, which is an amino acid compound salt product. Originated in the late 1980s, it was invented and launched by the Italian company Dompe Farmaceutic S.p.A. Lysine carbocisteine ​​optimizes the defects and singleness of monomeric amino acids in terms of physical and chemical properties and physiological functions. It not only has the pharmacological effects of the two monomeric amino acids, but also can be widely used in Used in food, medicine, health products and cosmetics and other fields. [0003] In recent years, the international development of such products has become the mainstream, and so far, carbocisteine ​​lysine has been widely used in the treatment of gastrointestinal diseases in dozens of ...

Claims

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Application Information

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IPC IPC(8): C07C319/20C07C319/28C07C323/58C07C227/40C07C229/26
CPCC07C319/20C07B2200/07C07C227/40C07C319/28C07C323/58C07C229/26
Inventor 王涛陈文斌盛景新贾春祥
Owner ZHEJIANG SANMEN HYGECON PHARMA CO LTD
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