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Compound amino acid injection (15HBC) composition

A technology for injections and valine, which is applied in the direction of drug combinations, pharmaceutical formulas, and medical preparations with non-active ingredients, etc. It can solve problems such as unqualified antihypertensive substances, affecting product qualification rate, and harm to patients

Active Publication Date: 2013-03-27
湖北津药药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Such as antibiotics, traditional Chinese medicine injections, amino acids, polypeptides, etc., compound amino acid injection (15HBC), as an injection containing histidine in the formula, after heat sterilization, its antihypertensive substances are prone to unqualified problems. Affect the qualification rate of the product, and easily cause potential harm to patients, so reducing the content of its antihypertensive substances has become a problem to be solved in the prior art

Method used

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  • Compound amino acid injection (15HBC) composition

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Embodiment Construction

[0014] In the embodiment, the injection is prepared in 10000ml, and the subpackage adopts 250ml glass bottles. Sterilization is performed by autoclaving at 105°C for 40 minutes. After adding the pH regulator, use 0.1M sodium hydroxide solution or hydrochloric acid to adjust the pH to 5.5-6.5 (if the pH is qualified, it is not necessary to add more).

[0015] Described injection adopts following method to prepare

[0016] 1) Take 70% to 75% of the prescribed amount of water for injection, heat it to 45-50°C under nitrogen protection, add lysine acetate, arginine, and histidine and stir until completely dissolved, add the prescribed amount of lactic acid or For other pH regulators, use hydrochloric acid to adjust the pH value to 5.0~5.5, and then add tryptophan, cysteine ​​hydrochloride, leucine, isoleucine, valine, methionine, threonine, alanine Amino acid, proline, serine, glycine, phenylalanine, and sodium metabisulfite are fully stirred to dissolve completely, and water fo...

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Abstract

The invention relates to a compound amino acid injection (15HBC) composition. Each 1000ml of the compound amino acid injection composition contains 7-8g of isoleucine, 8-9g of valine, 3.5-4.5g of leucine, 4-5g of lysine or 5-6g of lysine acetate, 5-6g of arginine, 1-2g of histidine, 2-3g of methionine, 3-4g of serine, 3-4g of phenylalanine, 6-7g of proline, 1.5-2.5g of threonine, 3-4g of glycine, 0.5-1g of tryptophan and 0.05-0.25g of L-cysteine hydrochloride, and is characterized in that each 1000ml of the injection further contains 0.5-1g of lactic acid.

Description

Technical field: [0001] The invention relates to an amino acid-containing injection and a manufacturing method thereof. Background technique: [0002] Amino acids are the basic units that make up proteins. Compound amino acid injection, as an intravenous nutrient, is widely used in nutritional support therapy. For example, the existing compound injection of 15 kinds of amino acids with the general name of compound amino acid injection (15HBC) has a formula of 1000ml containing Amino acid 7.66g, Valine 8.86g, Leucine acid 4.00g, Lysine 4.10g (Lysine acetate 5.80g), Arginine 5.80g, Histidine 1.60g, Methionine 2.50g , Serine 3.30g, Phenylalanine 3.20g, Proline 6.30g, Threonine 2.00g, Glycine 3.30g, Tryptophan 0.90g, L-cysteine ​​hydrochloride<0.20g [0003] According to the existing regulations, all injections from animals, plants, microbial fermentation extracts, and histamine or histamine-like substances may be mixed in the production process, and an antihypertensive sub...

Claims

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Application Information

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IPC IPC(8): A61K31/4172A61K31/405A61K31/401A61K31/198A61K31/195A61K47/12A61P3/02
Inventor 何光杰袁英柏德昌杨柳
Owner 湖北津药药业股份有限公司
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