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Pharmaceutical composition containing 18 kinds of amino acid

A technology of amino acids and compositions, applied in the field of medicine, can solve problems such as huge investment, achieve the effect of solving oxygen re-dissolution, eliminating process loopholes, and inhibiting re-dissolution

Active Publication Date: 2009-05-27
福州凯瑞医药咨询有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] It is worth pointing out that the vast majority of compound amino acid injection manufacturers in my country do not yet have the process conditions and equipment for the whole production process of nitrogen protection. There are still uncertainties about whether the goal will be achieved

Method used

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  • Pharmaceutical composition containing 18 kinds of amino acid
  • Pharmaceutical composition containing 18 kinds of amino acid
  • Pharmaceutical composition containing 18 kinds of amino acid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] 1. Prescription:

[0072] Arginine Hydrochloride 28.9g Histidine Hydrochloride 24.6g Leucine 37.9g

[0073] Isoleucine 17.0g Lysine Hydrochloride 33.3g Phenylalanine 28.3g

[0074] Threonine 19.7g Valine 13.6g Methionine 10.6g

[0075] Tryptophan 3.9g Glycine 32.4g Alanine 18.8g

[0076] Proline 10.0g Tyrosine 1.1g Serine 6.7g

[0077] Cysteine ​​Hydrochloride 4.4g Aspartic Acid 11.5g Glutamic Acid 19.7g

[0078] Xylitol 500g Citric acid 1g Water for injection

[0079] The total amount of injection solution is 10000ml

[0080] 2. Preparation process

[0081] (1) take by prescription 18 kinds of amino acids and / or its salt and xylitol and citric acid;

[0082] (2) Add 80% hot water for injection into the preparation tank, heat above 95°C, keep warm and fill with nitrogen for more than 30 minutes, keep the temperature at 80°C-85°C, add citric acid under the protection of nitrogen flow, stir and dissolve;

[0083] (3) put the above-mentioned weighed leucine, isoleu...

Embodiment 2

[0087] 1. Prescription:

[0088] Arginine Hydrochloride 231.2g Histidine Hydrochloride 196.8g Leucine 303.2g

[0089] Isoleucine 136g Lysine Hydrochloride 266.4g Phenylalanine 226.4g

[0090] Threonine 157.6g Valine 108.8g Methionine 84.8g

[0091] Tryptophan 31.2g Glycine 259.2g Alanine 150.4g

[0092] Proline 80g Tyrosine 8.8g Serine 53.6g

[0093] Cysteine ​​Hydrochloride 35.2g Aspartic Acid 92g Glutamic Acid 157.6g

[0094] Xylitol 4000g Citric acid 10g Water for injection

[0095] The total amount of injection is 100000ml

[0096] (1) take by prescription 18 kinds of amino acids and / or its salt and xylitol and citric acid;

[0097] (2) Add 80% hot water for injection into the preparation tank, heat above 95°C, keep warm and fill with nitrogen for more than 30 minutes, keep the temperature at 80°C-85°C, add citric acid under the protection of nitrogen flow, stir and dissolve;

[0098] (3) put the above-mentioned weighed leucine, isoleucine, tyrosine, methionine, phe...

Embodiment 3

[0102] 1. Prescription:

[0103] Arginine Hydrochloride 231.2g Histidine Hydrochloride 295.2g Leucine 379g

[0104] Isoleucine 204g Lysine Hydrochloride 266.4g Phenylalanine 283g

[0105] Threonine 236.4g Valine 108.8g Methionine 106g

[0106] Tryptophan 46.8g Glycine 259.2g Alanine 188g

[0107] Proline 120g Tyrosine 8.8g Serine 67g

[0108] Cysteine ​​Hydrochloride 52.8g Aspartic Acid 92g Glutamic Acid 197g

[0109] Xylitol 5000g Citric acid 25g Water for injection Appropriate amount

[0110] The total amount of injection is 100000ml

[0111] 2. Preparation process

[0112] (1) take by prescription 18 kinds of amino acids and / or its salt and xylitol and citric acid;

[0113] (2) Add 80% water for injection into the preparation tank, heat above 95°C, keep warm and fill with nitrogen for 30 minutes, keep the temperature at 80°C-85°C, add citric acid under the protection of nitrogen flow, stir and dissolve;

[0114] (3) put the above-mentioned weighed leucine, isoleucin...

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Abstract

The invention discloses a pharmaceutical composition containing 18 amino acids. The pharmaceutical composition is characterized in that a compound amino acid injection (18AA-V) with varied concentration is prepared by using the following components according to the following ratios of parts by weight: 2.89 of arginine hydrochloride, 2.46 of histidine hydrochloride, 3.79 of leucine, 1.70 of isoleucine, 3.33 of lysine hydrochloride, 2.83 of phenylalanine, 1.97 of threonine, 1.36 of valine, 1.06 of methionine, 0.39 of tryptophan, 3.24 of glycine, 1.88 of alanine, 1.00 of proline, 0.11 of tyrosine, 0.67 of serine, 0.44 of cysteine hydrochloride, 1.15 of aspartic acid, 1.97 of glutamic acid, 50 of xylitol, 0.10 to 0.30 of citric acid and injection water with proper amount. The pharmaceutical composition does not contain a sulfite antioxidant so that the pharmaceutical composition is clinically used in a safer manner. After an accelerated test and a quality test, results show that the pharmaceutical composition is as stable as or more stable than like products (18AA-V) which are sold in the markets and contain sulfites.

Description

technical field [0001] The invention belongs to the technical field of medicine, and more specifically relates to a pharmaceutical composition containing 18 kinds of amino acids and a preparation method thereof. Background technique [0002] The pharmaceutical composition containing 18 kinds of amino acids is a sterilized aqueous solution prepared from 18 kinds of amino acids plus auxiliary materials, and is clinically used for parenteral nutrition. [0003] Since amino acids are very unstable in solution, they are easily oxidized to produce a series of complex substances harmful to the human body. Since the compound amino acid injection was put into production and use in the 1960s, in order to ensure the stability of the product, sulfite compounds with unique antioxidant properties, such as sodium bisulfite and sodium metabisulfite, must be added. Since people did not understand the harm of such substances to the human body at that time, manufacturers usually added them in...

Claims

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Application Information

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IPC IPC(8): A61K31/4172A61K31/198A61K31/401A61K31/405A61P3/02
Inventor 郑飞雄
Owner 福州凯瑞医药咨询有限公司
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