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Aceglutamide freeze-drying powder injection preparation with double auxiliary materials for injection

A technology of acetylglutamine and freeze-dried powder injection, which is applied in the field of pharmaceutical preparations and preparations. It can solve the problems of low product clarity and solution color pass rate, high drying temperature, and long freeze-drying time. Improved color pass rate, lower drying temperature, and better product quality

Inactive Publication Date: 2018-03-20
刘兴付
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Since the commercially available acetylglutamine freeze-dried powder for injection is only mannitol as an excipient during production, it has the disadvantages of long freeze-drying time during production, high drying temperature, high energy consumption, and low qualified rate of finished product clarity and solution color. shortcoming

Method used

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  • Aceglutamide freeze-drying powder injection preparation with double auxiliary materials for injection
  • Aceglutamide freeze-drying powder injection preparation with double auxiliary materials for injection
  • Aceglutamide freeze-drying powder injection preparation with double auxiliary materials for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1, acetylglutamine freeze-dried powder for injection, in 1000 bottles

[0026] Prescription (specification: 0.25g / bottle):

[0027]

[0028] Preparation Process:

[0029] a) Dissolve the prescribed amount of mannitol in water for injection, place it in a constant temperature water bath and stir with a magnetic stirrer at a temperature of 50°C until it is completely dissolved, then add the prescribed amount of hydroxyethyl starch 130 / 0.4 and the prescribed amount respectively Keep the temperature of 50° C. and continue to stir until all the acetylglutamine is dissolved, and then make the volume to 2000 ml with water for injection, and adjust the pH value of the solution to 5.5.

[0030] b) The above solution is circulated and filtered successively through 0.45 μm and 0.22 μm filter membranes for 30 minutes;

[0031] c) Sampling inspection, determine the filling volume and pour it into a cleaned and sterilized vial, put it into a vacuum freeze dryer after ...

Embodiment 2

[0032] Embodiment two, acetylglutamine freeze-dried powder for injection, in 1000 bottles

[0033] Prescription (specification: 0.25g / bottle):

[0034]

[0035] Preparation Process:

[0036] a) Dissolve the prescribed amount of mannitol in water for injection, place it in a constant temperature water bath and stir with a magnetic stirrer at a temperature of 50°C until it is completely dissolved, then add the prescribed amount of hydroxyethyl starch 130 / 0.4 and the prescribed amount respectively Keep the temperature of 50° C. and continue to stir until all the acetylglutamine is dissolved, and then make the volume to 2000 ml with water for injection, and adjust the pH value of the solution to 5.5.

[0037] b) The above solution is circulated and filtered successively through 0.45 μm and 0.22 μm membranes for 30 minutes.

[0038] c) Sampling inspection, determine the filling volume and pour it into a cleaned and sterilized vial, put it into a vacuum freeze dryer after half-...

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Abstract

The invention provides a acetylglutamine freeze-dried powder injection for injection with double auxiliary materials, relates to the field of pharmaceutical preparations and preparation methods, and mainly solves the problem of freeze-drying of the auxiliary materials in the production formula of the acetylglutamine freeze-dried powder injection for injection in the prior art during production. The disadvantages of long drying time, high drying temperature and high energy consumption. The acetylglutamine freeze-dried powder for injection uses double excipients. The excipients include mannitol and hydroxyethyl starch 130 / 0.4. The weight ratio of alcohol and hydroxyethyl starch 130 / 0.4 is 100:80‑100:100. The acetylglutamine freeze-dried powder injection for injection is prepared by using the above-mentioned main drug and auxiliary materials. The acetylglutamine freeze-dried powder for injection provided by the invention is stable in quality, safe and effective, simple in production process, short in freeze-drying time during production, low in drying temperature and low in energy consumption.

Description

Technical field: [0001] The invention relates to the field of pharmaceutical preparations and preparation methods, in particular to a acetylglutamine freeze-dried powder for injection with double auxiliary materials and a preparation method thereof. Background technique: [0002] Acetylglutamine Lyophilized Powder for Injection The main drug, acetylglutamine, is the acetylated compound of glutamine, which is decomposed into glutamic acid γ-aminobutyric acid (GABA) after passing through the blood-cerebrospinal fluid barrier. Glutamate is involved in the transmission of information in the central nervous system. Gamma-aminobutyric acid can antagonize the excitatory toxic effect of glutamate, improve nerve cell metabolism, maintain nerve stress ability and reduce blood ammonia, and improve brain function. This product is mainly used to promote the recovery of comatose patients after neurosurgery (such as brain tumors, craniocerebral trauma, cerebrovascular diseases, etc.). Tr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/198A61K47/36A61K47/26A61P25/00A61P25/28A61P25/18A61P25/24
CPCA61K31/198A61K9/0019A61K9/19A61K47/26A61K47/36
Inventor 刘兴付
Owner 刘兴付
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