Acetylglutamine and its injection and preparation method

A technology of acetylglutamine and injection, which is applied in the preparation of acetylglutamine, acetylglutamine injection and the preparation of the injection, and can solve the problems of poor product quality stability, low purity of acetylglutamine, and unqualified rate of clarity And other problems, to achieve high stability, shorten the reaction time, shorten the effect of preparation time

Active Publication Date: 2018-04-13
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Because acetylglutamine is easy to degrade during the preparation process or after long-term storage, the existing acetylglutamine generally has problems such as low purity, poor product quality stability, strong irritation of the liquid, and high failure rate of clarity, which is not conducive to clinical promotion.

Method used

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  • Acetylglutamine and its injection and preparation method
  • Acetylglutamine and its injection and preparation method
  • Acetylglutamine and its injection and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] This embodiment provides a kind of acetylglutamine compound, such as figure 1 As shown, the characteristic peaks in the X-ray powder diffraction pattern obtained by measuring the acetylglutamine using Cu-Kα rays are displayed at 2θ of 9.2, 11.3, 14.5, 15.6, and 19.8.

Embodiment 2

[0051] This embodiment provides a kind of preparation method of acetylglutamine compound, specifically comprises the following steps:

[0052] (1) Dissolve glutamine in water, stir to dissolve, adjust the pH to 8.5 with 2mol / L sodium hydroxide solution, add acetyl chloride dropwise under ice bath conditions (the molar ratio of acetyl chloride to glutamine is 2:1 ), while dropping 2mol / L sodium hydroxide solution to control the reaction solution pH8.5, continue to control the reaction solution pH8.5 after adding acetyl chloride, stir in an ice bath (600 rpm) for 1 hour reaction, after the reaction, add 2mol / L hydrochloric acid solution to adjust the pH to 1.5 to obtain solution A.

[0053] (2) At room temperature, a mixture of ethanol and acetone (mass ratio of 2:1) was added to solution A, and the amount of the ethanol-acetone mixture added was twice the volume of solution A. Stir and mix well, let it stand, filter, wash twice with a mixture of ethanol and acetone, and dry un...

Embodiment 3

[0055] This embodiment provides a kind of preparation method of acetylglutamine compound, specifically comprises the following steps:

[0056] (1) Dissolve glutamine in water, stir to dissolve, adjust pH8 with 2mol / L sodium hydroxide solution, add acetyl chloride dropwise under ice bath conditions, and simultaneously drop 5mol / L sodium hydroxide solution to control reaction solution pH8, After adding acetyl chloride, continue to control the pH of the reaction solution to 8, stir in an ice bath (600 rpm) and react for 1.5 hours. After the reaction, add 5 mol / L hydrochloric acid solution to adjust the pH to 2 to obtain solution A.

[0057] (2) At room temperature, a mixture of ethanol and acetone (mass ratio of 1:1) was added to solution A, and the amount of the ethanol-acetone mixture added was twice the volume of solution A. Stir and mix well, let it stand, filter, wash twice with a mixture of ethanol and acetone, and dry under reduced pressure (30°C, 10h) to obtain the obtain...

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Abstract

The invention relates to the field of pharmaceutical preparations, and provides acetylglutamine, its preparation method, acetylglutamine injection and the preparation method of the injection. In the preparation of the acetylglutamine, acetyl chloride is used instead of acetic anhydride, so that the reaction speed is accelerated, the time is shortened, and the yield is greatly improved, and the yield is over 95%. The preparation process of the compound of the invention does not need to add activated carbon, which reduces adsorption loss, simplifies the treatment process, and reduces the cost. The obtained compound is a new crystal, and the clinical application effect is more ideal. At the same time, this application has made specific improvements to the preparation method of acetylglutamine injection, such as changing from the traditional concentrated-dilute preparation to one-step preparation, simplifying the batching process, shortening the preparation time, and controlling the water temperature of the water for injection for preparation. The level of related substances in the product is controlled. Higher quality preparations can be obtained to ensure the safety of medication for patients.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, and provides a method for preparing acetylglutamine, acetylglutamine injection and the preparation method of the injection. Background technique [0002] Acetylglutamine is the acetyl compound of glutamine, which can improve nerve cell metabolism, maintain nerve stress ability and reduce blood ammonia, and can pass through the blood-brain barrier. It is used for brain trauma coma, hepatic coma, hemiplegia, high paraplegia, Sequelae of poliomyelitis, sequelae of traumatic brain injury, mental retardation, nervous headache and low back pain, etc. [0003] Acetyl glutamine, its chemical name is: N-acetyl-1-glutamine. Properties: white crystalline powder, soluble in water, slightly soluble in ethanol. Molecular formula: C 7 h 12 N 2 o 4 , molecular weight: 188.18, chemical structure is: [0004] [0005] CN201110214372.0 discloses an acetylglutamine compound, wherein the acetylglu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07C237/22C07C231/24C07C231/02A61K9/08A61K47/12A61K47/02A61P25/00A61P1/16A61P25/02A61P29/00A61P31/14
Inventor 曾培安曾灿丽吴健民刘兵兵贺莲李多娇
Owner KAMP PHARMA
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