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A compound amino acid, injection technology, applied in the directions of drug combination, drug delivery, pharmaceutical formulation, etc., can solve the problems of patient harm, unqualified antihypertensive substances, affecting product qualification rate, etc.
Inactive Publication Date: 2013-03-20
TIANJIN JINYAO GRP
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Such as antibiotics, traditional Chinese medicine injections, amino acids, polypeptides, etc., compound amino acid injection (18AA-III), as an injection containing histidine in the formula, after heat sterilization, its antihypertensive substances are prone to unqualified problems, affect the pass rate of products, 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
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[0013] In the embodiment, the prescription in the following table is the feed amount calculated by 10000ml, and the subpackage adopts 250ml glass bottles. Sterilization was performed by autoclaving at 105°C for 45 minutes. After adding the pH regulator, adjust the pH to 5.5-6.5 with 0.1M sodium hydroxide solution or 0.1M hydrochloric acid. (If the pH is qualified, you don’t need to add more)
[0014] Described injection adopts following method to prepare
[0015] 1) Take 70% to 75% of the prescribed amount of water for injection, and add leucine, isoleucine, valine, methionine, phenylalanine, threonine, alanine, Proline, serine, aspartic acid, glutamic acid, arginine, lysine acetate, histidine, glycine and tryptophan make it fully soluble. Then add N-acetyl-L-tyrosine, fully stir cysteine hydrochloride until completely dissolved, add the prescribed amount of pH regulator (no pH regulator is added in Example 7-8), adjust with sodium hydroxide solution or hydrochloric acid ...
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Abstract
The invention relates to a compound amino acid injection (18AA-III) composition. Each 1000ml of compound amino acid injection (18AA-III) composition contains 5.0-6.0g of isoleucine, 7.5-8.0g of arginine, 12-13g of leucine, 3.5-4.0g of aspartic acid, 12-13g of l-Lysine acetate salt, 0.8-1.5g of cysteine, 3.0-4.0g of methionine, 6.0-7.0g of glutamic acid, 9.0-9.5g of phenylalanine, 5.5-6.5 of histidine, 6.0-7.0 of threonine, 3.0-3.5g of praline, 1-1.5g of trytophan, 2-2.5g of serine, 4-5g of valine, 0.1-0.5g of tyrosine, 6.0-6.5g of alanine and 10-11g of glycine. The compound amino acid injection (18AA-III) composition is characterized in that each 1000ml of injection 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 a nutritional supplement for intravenous injection, is widely used in nutritional support therapy. For example, the compound injection of eighteen kinds of amino acids with the common name of compound amino acid injection (18AA-IIII) has a formula of 1000ml containing Isoleucine 5.6g, Arginine 7.9g, Leucine 12.5g, Aspartic Acid 3.8g, Acetate Lysine 12.4g, Cysteine 1.0g, Methionine 3.5g, Glutamic Acid 6.5g, phenylalanine 9.35g, histidine 6.0g, threonine 6.5g, proline 3.3g, tryptophan 1.3g, serine 2.2g, valine 4.5g, tyrosine 0.35g, Alanine 6.2g, glycine 10.7g, sodium bisulfite 0.5g. According to the existing regulations, all injections from animals, plants, microbial fermentation extracts, and histamine or histamine-like substances may ...
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