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Arginine glutamate injection pharmaceutical composition and preparation method thereof

A technology of arginine glutamic acid and composition, applied in the field of medicine, can solve the problems of high content of main impurities, increased risk of adverse reactions of patients, difficult control of preparation quality, etc., and achieves the effect of easy control

Inactive Publication Date: 2018-08-28
LIAONING HAISCO PHARMACEUTICAL CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The technical problem to be solved by the present invention is: due to factors such as high main impurity content and unclear impurities in the existing arginine glutamic acid injection, the quality of the preparation is not easy to control, which increases the risk of adverse reactions when the patient uses the drug. This invention provides a kind of arginine glutamic acid injection pharmaceutical composition

Method used

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  • Arginine glutamate injection pharmaceutical composition and preparation method thereof
  • Arginine glutamate injection pharmaceutical composition and preparation method thereof
  • Arginine glutamate injection pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example 1

[0032] The preparation of preparation example 1 main impurity acetate:

[0033] Take an appropriate amount of arginine acetate, add concentrated ammonia water to dissolve completely. Reflux at 100°C for 25 hours, add an appropriate amount of concentrated ammonia water every 4 hours, follow and monitor the reaction by HPLC, until the peak area of ​​arginine in the HPLC is normalized to account for about 0.5%. At 100°C, add 0.1% activated carbon and filter. The filtrate was rotary evaporated to dryness, added methanol, cooled to 0°C, filtered to obtain the main impurity acetate, off-white powder, and the purity was greater than 99.0% by HPLC analysis. The chemical characteristics of the main impurity acetate are as follows:

[0034] Molecular formula: C 8 h 16 N 4 o 3 ; MS m / z (int): 157 [M+H-CH 3 COOH]; 1 H-NMR (DMSO-d6, 800MHz): δ8.23 (1H, s, NH), 5.50 (3H, brs, NH3), 6.04 (2H, brs, NH 2 ), 3.11 (1H,m,CH-NH 3 ), 3.10 (2H, m, CH 2 -N), 1.4-2.1(4H,m,CH 2 -CH 2 ), 1....

preparation example 2

[0035] The preparation of preparation example 2 reference substance solution

[0036] Take an appropriate amount of the pharmaceutical composition of arginine glutamic acid injection, dilute it 10 times with water, and dilute it with mobile phase to a solution containing about 5 mg per 1 mL or directly use mobile phase to a solution containing about 5 mg per 1 mL. The reference substance solution was prepared by diluting the above solution 100 times.

preparation example 3

[0037] The preparation of preparation example 3 main impurity reference substance solution

[0038] Take an appropriate amount of the main impurity reference substance, add mobile phase and dilute it into a solution containing about 2 mg per 1 mL (calculated as lactam), as the main impurity control stock solution, and prepare the impurity reference solution according to the impurity content in the sample during use (the main impurity content is between The limit of quantitation is within the range of 0.005%, and the stock solution is diluted into a control solution containing 0.1 μg of the main impurity per 1 mL;

[0039] In the range of 0.0025% to 0.05%, the stock solution is diluted to a main impurity control solution containing 1 μg per 1 mL; above 0.05%, the stock solution is diluted to a main impurity control solution containing 20 μg per 1 mL).

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Abstract

The invention relates to an arginine glutamate injection pharmaceutical composition and a preparation method thereof. The injection is prepared from arginine glutamate, water for injection and an acidifying or alkalizing agent; the pH value of the injection is 5.2 to 6.0; the concentration of the injection is 0.01 to 1g / ml. The preparation method comprises the following steps: dissolving the arginine glutamate with the water for injection; adjusting the pH value with the acidifying or alkalizing agent; decoloring with active carbon; performing volume fixing, split charging and sterilization. The injection is used for treating hyperammonemia caused by acute and chronic liver diseases such as liver cirrhosis, fatty liver and hepatitis. The injection provided by the invention has the characteristics of low impurity content, easiness in controlling quality, higher safety in clinical application and the like.

Description

technical field [0001] The invention belongs to the field of medicine and relates to a pharmaceutical preparation and a preparation method thereof, in particular to an arginine glutamic acid injection pharmaceutical composition and a preparation method thereof. Background technique [0002] Arginine glutamic acid is a double salt of arginine and glutamic acid, which was first developed by Ajinomoto Corporation of Japan and first listed in Japan in 1960. Arginine glutamic acid can be decomposed into arginine and glutamic acid through intravenous input into the body, of which arginine participates in the ornithine cycle in the human body, promotes the formation of urea, and makes the ammonia produced in the human body transform through the ornithine cycle Glutamine can be combined with excessive ammonia in the blood to form non-toxic glutamine, which will dissociate ammonia in the kidney through the action of glutaminase and excreted in urine. The combination of arginine and ...

Claims

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Application Information

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IPC IPC(8): A61K31/198A61K9/08A61P1/16A61P3/00
CPCA61K31/198A61K9/0019A61K9/08A61P1/16A61P3/00A61K2300/00
Inventor 李麒麟
Owner LIAONING HAISCO PHARMACEUTICAL CO LTD
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