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Preparation method of improved di-lysine-aspirin

A technology of lysine and lysine, applied in the directions of medical preparations containing active ingredients, pharmaceutical formulations, organic active ingredients, etc., can solve the problems of easy decomposition, poor product stability, increased drug irritation and sensitization, etc. problem, to achieve the effect of good fluidity, improved crystal form, reduced irritation and sensitization

Active Publication Date: 2010-01-27
BENGBU BBCA MEDICINE SCI DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Most of the existing lysine-pirin manufacturing methods have the problem of poor product stability, and salicylic acid is easily decomposed, resulting in increased irritation and sensitization of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] a. Weigh 3kg of aspirin into the reaction kettle, then add 15kg of absolute ethanol, stir to dissolve, and the dissolution temperature is 30°C;

[0025] b. The above-mentioned aspirin ethanol solution is cooled to 15° C., and quickly added (the addition time is controlled within 1 minute) 9.23 kg (DL-lysine mass concentration) of 25% DL-lysine water solution and aspirin mass is 1: 1.3), at this moment the temperature of the system rises to about 20°C;

[0026] c. Stir and crystallize for about 5 minutes, keep the low temperature during the period, and then add 9 kg of absolute ethanol;

[0027] d. Cool down to within 10°C, stir and grow the crystal for 1 hour, filter the crystal, and wash the crystal once with an appropriate amount of absolute ethanol;

[0028] e. Vacuum-dry the crystals at 40°C for 12 hours, and pack separately to obtain 4.5 kg of the product, with a yield of about 85%.

[0029] The obtained lysine-pirin product is in accordance with the Ministry of ...

Embodiment 2

[0031] a. Weigh 3kg of aspirin into the reaction kettle, then add 14kg of absolute ethanol, stir to dissolve, and the dissolution temperature is 28°C;

[0032] b. the above-mentioned aspirin ethanol solution is cooled to 20 DEG C, and the DL-lysine aqueous solution 6.67kg (the quality of DL-lysine) that has been prepared is 30% in mass percent concentration is quickly added (the addition time is controlled within 3 minutes). The mass of aspirin and aspirin is 1:1.5), and the temperature of the system rises to about 25°C at this time;

[0033] c. Stir and crystallize for about 10 minutes, keep the low temperature during the period, and then add 10kg of absolute ethanol;

[0034] d. Cool down to less than 10°C, stir and grow the crystal for 0.5 hours, filter the crystal, and wash the crystal twice with an appropriate amount of absolute ethanol;

[0035] e. Vacuum-dry the crystals at 40°C for 12 hours, and pack separately to obtain 4.2kg of the product, with a yield of 84%.

[...

Embodiment 3

[0038] a. Weigh 3kg of aspirin into the reaction kettle, then add 15kg of absolute ethanol, stir to dissolve, and the dissolution temperature is 29°C;

[0039] b. the above-mentioned aspirin ethanol solution is cooled to 25 ℃, and the DL-lysine aqueous solution 7.29kg (the quality of DL-lysine is and aspirin mass is 1:1.4), at this moment, the temperature of the system rises to about 28°C;

[0040] c. Stir and crystallize for about 10 minutes, keep the low temperature during the period, and then add 10kg of absolute ethanol;

[0041] d. Lower the temperature to within 10°C, stir and grow the crystal for 1.5 hours, filter the crystal, and wash the crystal twice with an appropriate amount of absolute ethanol;

[0042] e. Vacuum-dry the crystals at 40°C for 12 hours, and pack separately to obtain 4.4kg of the product with a yield of 85%.

[0043] The obtained lysine-pirin product is in accordance with the standard test of Ministry of Public Health, Ministry of Public Health, Mi...

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PUM

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Abstract

The invention discloses a preparation method of improved di-lysine-aspirin, comprising the following steps: adding a DL-lysine aqueous solution with the mass percentage concentration being 25-30 percent to an alcobolic solution of aspirin at the temperature of 15-25 DEG C; enabling the mass ratio of DL-lysine to aspirin to be 1:(1.3-1):1.5; mixing and crystallizing for 5-15 minutes; then adding precipitation alcohol with the mass being 3-4 times of aspirin; reducing the temperature within 10 DEG C, and mixing and culturing crystal for 0.5-1.5 hours; filtering and then obtaining crystal; and washing the crystal by an amount of absolute ethyl alcohol for 1-2 times. The invention enables the acid value of a product to be reduced below 6.0 by changing the mixture ratio of reactants, enables the crystal fluidity of the product to be enhanced by changing the flow acceleration of materials and enables the appearance and free oxybenzoic acid of the product to be improved by reducing the temperature of the whole system, thereby reducing the acrimony and the sensitization of medicines and improving the quality of aspirin.

Description

technical field [0001] The invention relates to an improved preparation method of lysine pyrin. Background technique [0002] Lyspirin is a double salt of aspirin (acetylsalicylic acid) and lysine. It is a new antipyretic and analgesic drug. The drug has the advantages of fast onset, small side effects, significant curative effect, and no addiction , is the drug of choice for antipyretic analgesia in children and secondary and tertiary analgesia in cancer patients. The Ministry of Health promulgates western medicine standards (Volume 4 of the second part) stipulates: [0003] English name of LYSINE ACETYLSALICYLATE: LYSINE ACETYLSALICYLATE [0004] Molecular formula and molecular weight: C 15 h 22 N 2 o 6 326.36 [0005] Lyspirin is DL-lysine acetylsalicylate. Contains acetylsalicylic acid (C 9 h 8 o 4 ) should be 54.10 ~ 56.30%; containing lysine (C 6 h 14 N 2 o 2 ) should be 43.90~45.70%. [0006] 【Properties】This product is white crystal or crystalline ...

Claims

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Application Information

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IPC IPC(8): C07C229/26C07C69/157A61K31/616A61K31/198A61P29/00
Inventor 陈文婕江立新赵辉张谨陈昀
Owner BENGBU BBCA MEDICINE SCI DEV
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