Amino acid injection and preparation method thereof

An injection and amino acid technology, applied in pharmaceutical formulations, medical preparations containing active ingredients, metabolic diseases, etc., can solve problems such as inability to control product quality more effectively, sterilization at the same time, and pain, and reduce clinical symptoms. Adverse reactions, ease of clinical use, and the effect of ensuring product quality

Active Publication Date: 2009-04-08
GUANGDONG LITAI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

For example, the compound amino acid injection (18AA), which is common in the market, has antioxidants greater than 0.5g/L, which greatly increases the adverse reactions in clinical use.
[0006] (2) Infusion pain: The currently commonly used compound amino acid injection (18AA) is not more effective in prescriptions without sodium hydroxide as a pH value regulator in the second volume six volumes of the "Ministry of Health Drug Standards" The quality of the control product, and the osmotic pressure is too high, causing pain during clinical infusion
[0007] (3) Inconvenient clinical use: In order to improve the utilization of amino acids in the body, ami

Method used

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  • Amino acid injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] (1) Weighing

[0051] Isoleucine 3.52g Glycine 7.60g

[0052] Leucine 4.90g Alanine 2.00g

[0053] Lysine hydrochloride 4.30g Glutamic acid 0.75g

[0054] Methionine 2.25g Aspartic Acid 2.50g

[0055] Phenylalanine 5.33g Proline 1.00g

[0056]Threonine 2.50g Serine 1.00g

[0057] Tryptophan 0.90g Tyrosine 0.25g

[0058] Valine 3.60g Cystine 0.10g

[0059] Arginine hydrochloride 5.00g Sodium bisulfate 0.4g

[0060] Histidine hydrochloride 2.50g

[0061] (2) Under the protection of nitrogen, add the above composition into about 700ml of water for injection, heat to 45-95°C at the same time, stir to dissolve, then use an appropriate amount of sodium hydroxide solution to adjust the pH value to 5.0-6.5, and then Add water for injection to make the solution to 1000ml, stir well and add 0.5g of activated carbon;

[0062] (3) After the above solution is decarbonized, it is filtered through 0.45 μm and 0.22 μm microporous filters successively, and then packed;

[0063...

Embodiment 2

[0066] (1) Weighing

[0067] Isoleucine 3.52g Glycine 7.60g

[0068] Leucine 4.90g Alanine 2.00g

[0069] Lysine Acetate 4.86g Glutamic Acid 0.75g

[0070] Methionine 2.25g Aspartic Acid 2.50g

[0071] Phenylalanine 5.33g Proline 1.00g

[0072] Threonine 2.50g Serine 1.00g

[0073] Tryptophan 0.90g Acyltyrosine 0.31g

[0074] Valine 3.60g Cystine 0.10g

[0075] Arginine 4.13g Sodium metabisulfite 0.4g

[0076] Histidine 1.85g

[0077] (2) Under the protection of nitrogen, add the above composition into about 700ml of water for injection, heat to 45-95°C at the same time, stir to dissolve, and then use an appropriate amount of glacial acetic acid to adjust the pH value to 5.0-6.5, and then inject Make the solution to 1000ml with water, stir well and add 0.5g activated carbon;

[0078] (3) After the above solution is decarbonized, it is filtered through 0.45 μm and 0.22 μm microporous filters successively, and then packed;

[0079] (4) Sterilize at 121°C for 12 minutes...

Embodiment 3

[0082] (1) Weighing

[0083] Isoleucine 2.11g Glycine 4.56g

[0084] Leucine 2.94g Alanine 1.20g

[0085] Methionine 1.35g Glutamic Acid 0.45g

[0086] Phenylalanine 3.20g Aspartic Acid 1.50g

[0087] Threonine 1.50g Proline 0.60g

[0088] Tryptophan 0.54g Serine 0.60g

[0089] Valine 2.16g Cystine 0.06g

[0090] Lysine hydrochloride 2.58g Tyrosine 0.15g

[0091] Arginine hydrochloride 3.00g Sodium bisulfate 0.02g

[0092] Histidine hydrochloride 1.50g

[0093] (2) Add the above composition into about 700ml of water for injection under the protection of nitrogen, heat to 45-95°C at the same time, stir to dissolve, then use an appropriate amount of sodium hydroxide to adjust the pH value to 5.0-6.5, and add Make the solution to 1000ml with water for injection, stir well and add 0.5g of activated carbon;

[0094] (3) After the above solution is decarbonized, it is filtered through 0.45 μm and 0.22 μm microporous filters successively, and then packed;

[0095] (4) Steri...

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Abstract

The invention discloses an amino acid injection, commonly known as propranolol, which relates to a pharmaceutical preparation containing 18 kinds of amino acids. The amino acid injection contains the following components per 1,000 milliliters: isoleucine, leucine, methionine, phenylalanine, threonine, tryptophan, valine, glycine, alanine, glutamic acid, aspartic acid, proline, serine, cystine, lysine hydrochloride or lysine acetate, arginine hydrochloride or arginine, histidine hydrochloride or histidine, tyrosine or acetyl tyrosine, and sodium bisulfite or sodium meta-bisulphite. The osmotic pressure ratio of the amino acid injection is lower than 1.8, which effectively reduces the pain for a patient in infusion; the added quantity of antioxidant is small, which can reduce the clinical adverse reactions; and an infusion bottle body is large, which is convenient to mix liquid in clinical application.

Description

【Technical field】 [0001] The invention belongs to an amino acid injection composed of 18 kinds of amino acids and an antioxidant - commonly known as proamine and a manufacturing method thereof. 【Background technique】 [0002] Proteins are the building blocks of cellular structures, act as biochemical catalysts, and are important regulators of gene expression. The basic unit of protein structure is the amino acid. The human body needs to take in a certain amount of protein every day to meet the needs of life activities. When it is unable to take in enough amount from the gastrointestinal tract for some reason, it must be supplemented by intravenous amino acid solution. [0003] Protein nutrition is of great significance to the prevention and treatment of diseases, especially after surgical trauma or postoperative, the protein decomposition or metabolism in the patient's body increases sharply, and nitrogen negative balance soon appears, which further deteriorates the conditi...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4172A61K31/198A61K31/401A61K31/405A61P3/02
Inventor 罗庆进
Owner GUANGDONG LITAI PHARM CO LTD
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