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Preparation process of high-concentration compound amino acid injection

A technology for the preparation of compound amino acids and injections, which is applied in the field of preparation of high-concentration compound amino acid injections. It can solve the problems of excessive decline in the content of tryptophan, unstable quality of amino acid injections, and yellowish color of high-concentration compound amino acid injections. and other problems, to achieve stable product quality, avoid yellowing of color and content decline, and good dissolution effect

Active Publication Date: 2013-12-25
HUAREN PHARMACEUTICAL CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The present invention provides a high-concentration compound amino acid injection preparation process for solving the problems of yellow color of high-concentration compound amino acid injection, excessive decrease in the content of tryptophan, etc., and unstable quality of amino acid injection during storage. Reasonable, the quality of the produced products is stable and reliable

Method used

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  • Preparation process of high-concentration compound amino acid injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Follow the steps below to prepare high-concentration compound amino acid injection:

[0063] 1. Preparation tank and pipeline pretreatment

[0064] (1) Passivation treatment: prepare a proper amount of 1% sodium hydroxide solution at 70°C and circulate it for 40 minutes to clean the concentrated preparation tank, thin preparation tank and preparation pipeline, dilute the lotion with water for injection, and rinse it. The test results of the water sample meet the requirements according to the standard of water for injection; prepare an appropriate amount of 8% nitric acid solution at 50°C and circulate it for 60 minutes to clean the concentrated preparation tank, dilute preparation tank and preparation pipeline, dilute the lotion with water for injection, rinse, and take After flushing, the test results of the water samples meet the requirements according to the standard of water for injection;

[0065] (2) Removal of metal ions: add an appropriate amount of water for i...

Embodiment 2

[0093] Follow the steps below to prepare high-concentration compound amino acid injection:

[0094] 1. The preparation tank and pipeline pretreatment are the same as in Example 1.

[0095] 2. Injection preparation process

[0096] Weigh 17 kinds of amino acids according to the following formula in 1000ml of 15% compound amino acid injection:

[0097] Lysine acetate 11.8 g

[0098] Leucine 10.4 g

[0099] Phenylalanine 10.4 g

[0100] Valine (valine) 9.60 g

[0101] Histidine 8.94 g

[0102] Isoleucine 7.49 g

[0103] Methionine 7.49 g

[0104] Threonine 7.49 g

[0105] Tryptophan 2.50 g

[0106] Alanine 21.7 g

[0107] Arginine (arginine) 14.7 g

[0108] Glycine 10.4 g

[0109] Proline (proline) 8.94 g

[0110] Glutamic acid 7.49 g

[0111] Serine (serine) 5.92 g

[0112] Aspartic acid (aspartic acid) 4.34 g

[0113] Tyrosine (tyrosine) 0.39g

[0114] Glacial acetic acid (glacial acetic acid) amount

[0115] Add water for injection to 1000ml

[0116] Add 50% o...

Embodiment 3

[0122] Follow the steps below to prepare high-concentration compound amino acid injection:

[0123] 1. The preparation tank and pipeline pretreatment are the same as in Example 1.

[0124] 2. Injection preparation process

[0125] Weigh 17 kinds of amino acids according to the following formula in 1000ml of 15% compound amino acid injection:

[0126] Lysine acetate 11.8 g

[0127] Leucine 10.4 g

[0128] Phenylalanine 10.4 g

[0129] Valine (valine) 9.60 g

[0130] Histidine 8.94 g

[0131] Isoleucine 7.49 g

[0132] Methionine 7.49 g

[0133] Threonine 7.49 g

[0134] Tryptophan 2.50 g

[0135] Alanine 21.7 g

[0136] Arginine (arginine) 14.7 g

[0137] Glycine 10.4 g

[0138] Proline (proline) 8.94 g

[0139] Glutamic acid 7.49 g

[0140] Serine (serine) 5.92 g

[0141] Aspartic acid (aspartic acid) 4.34 g

[0142] Tyrosine (tyrosine) 0.39g

[0143] Glacial acetic acid (glacial acetic acid) amount

[0144] Add water for injection to 1000ml

[0145] Add 55%...

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Abstract

The invention provides a preparation process of high-concentration compound amino acid injection. The preparation process of the high-concentration compound amino acid injection is characterized by comprising the following steps of (1) pretreatment by preparation tanks and pipelines; (2) injection preparation process; (3) filling; (4) sterilization; and (5) packaging. The injection preparation process comprises the following steps of grouping and charging according to different amino acid solubilities and solubility characteristics, and dissolving in batches at the water temperature of 70 DEG C according to the difficulty level; closing the preparation tanks after complete dissolution, extracting air in a thick mixing tank and a thin mixing tank respectively until the pressures in the tanks are negative pressures, and introducing high-purity nitrogen into the tanks until the pressures are positive pressures; meanwhile flushing activated carbon in a titanium bar back into the thick mixing tank by water for injection; and then removing carbon for a medicine liquid in the thick mixing tank by the titanium bar, transferring the medicine liquid to the thin mixing tank, and making up to volume by the rest water for injection with prescribed dose to full quantity after the transferring is completed. The problems that the high-concentration compound amino acid injection is yellow in color, the content of tryptophan and the like is lowered excessively, and the amino acid injection is unstable in quality during a storage period are solved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical products, and mainly relates to a preparation method of 15% compound amino acid injection (17AA), specifically a preparation process of high-concentration compound amino acid injection. Background technique [0002] In recent years, amino acid infusion has become one of the most commonly used drugs in modern medical technology, and its clinical application is expanding day by day. Its application ranges from nutritional support agents to liver disease, kidney disease and children's infusions, varieties, [0003] The speed of output development exceeds that of any series of varieties in the same period. [0004] 15% Compound Amino Acid Injection (17AA) is a balanced amino acid concentrate, which is clinically used to flexibly prepare complex nutritional infusions. It is characterized by high concentration (as high as 15% amino acid concentration), nitrogen content per unit volume High, the...

Claims

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Application Information

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IPC IPC(8): A61K31/4172A61K9/08A61P3/02A61K31/401A61K31/198A61K31/405A61J1/10
Inventor 齐乐
Owner HUAREN PHARMACEUTICAL CO LTD
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