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Preparation method of aceglutamide

A technology for the preparation of acetylglutamine and injection, which is applied in the field of drug preparation and preparation of acetylglutamine injection, which can solve the problems that the product cannot meet the new standard and the increase of related substances, and achieve the effect of reducing product risk and simple method

Active Publication Date: 2011-04-20
SHANGHAI ZHAOHUI PHARMA +1
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] Since the quality standard of acetylglutamine injection was included in the 2010 edition of "Chinese Pharmacopoeia", the inspection of related substances was specially added. Therefore, the product prepared by the above method can no longer meet the new standard, and the preparation method needs to be improved
Because acetylglutamine injection is an injection, it is necessary to ensure the sterility of the product. Therefore, in the case that the aseptic production cannot be ensured, the inventor tested using a terminal sterilization method of 116°C for 30 minutes. Although such treatment has achieved aseptic indicators, but the relevant substances have increased significantly, but still cannot meet the new standard requirements

Method used

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  • Preparation method of aceglutamide

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 Preparation of acetylglutamine injection: (batch number 100201)

[0035] serial number

ingredients

Prescription volume per 10,000 ml (5,000 sticks)

1

Acetylglutamine

500g

2

sodium hydroxide

90-130g

3

Water for Injection

up to 10,000 ml

[0036] (1) Put 60%-70% of the prepared amount of water for injection at a temperature of 40-42° C. into a beaker, add weighed sodium hydroxide and stir.

[0037] (2) Add the weighed acetylglutamine and stir at 40-42°C.

[0038] (3) Add water for injection to the full amount, and stir at 40-42°C.

[0039] (4) The solution is first filtered with a titanium filter (model RT-TL), and then sequentially passed through 0.45 μm and 0.2 μm microporous membrane filters;

[0040] (5) 10% acetic acid or 10% sodium hydroxide solution to adjust the pH value to the range of 5.0-6.5. (6) After measuring the content of the intermediate product of acetylglutamine injec...

Embodiment 2

[0045] Example 2 Preparation of Acetylglutamine Injection (Lot No. 100202)

[0046] The composition and preparation method are the same as in Example 1, but the water temperature of the water for injection in step (1) and the stirring temperature in step (2) are 35-37°C.

Embodiment 3

[0047] Example 3 Preparation of Acetylglutamine Injection (Lot No. 100301)

[0048] The composition and preparation are the same as in Example 1, but the water temperature of the water for injection in step (1) and the stirring temperature in step (2) are 38-39°C.

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Abstract

The invention provides a preparation method of aceglutamide. By utilizing the new method provided by the invention, the defect of the relevant substances of the aceglutamide due to the existing method can be overcome. In the method, the temperature of 70-80 DEG C of the prepared water for injection is improved into the water temperature of 35-42 DEG C; and after the product is subjected to detection, an accelerated test, a long term stability test and the like, a data result shows that all indexes of the relevant substance, content and the like of the aceglutamide can reach the standard of the China Pharmacopeia 2010 edition after the new method provided by the invention is adopted. The method provided by the invention is simple and practicable and is suitable for industrial production on a large scale.

Description

Technical field: [0001] The invention relates to a pharmaceutical preparation, in particular to a preparation method of the medicine, in particular to a preparation method of acetylglutamine injection. Background technique: [0002] Acetylglutamine is a drug for improving brain function, which can improve nerve cell metabolism, maintain nerve stress ability and reduce blood ammonia, and improve brain function. Clinically, it is mainly used for coma, paralysis, mental decline, and memory impairment caused by hepatic coma, hemiplegia, high paraplegia, sequelae of poliomyelitis, and neurosurgery. Currently, acetylglutamine injection is commonly used. [0003] The composition of acetylglutamine injection is as follows: [0004] ingredients Per 10,000ml prescription volume 1 Acetylglutamine 500g 2 sodium hydroxide 90-130g 3 Water for Injection up to 10,000 ml [0005] The preparation method of existing a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/198A61K47/02A61P25/00
Inventor 熊洁付林王燕厉昌卫
Owner SHANGHAI ZHAOHUI PHARMA
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