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A technology of injection and serine, which can be used in drug combination, pharmaceutical formulation, drug delivery, etc., can solve the problems of unqualified antihypertensive substances, harm to patients, affecting the qualified rate of products, etc.
Active Publication Date: 2014-06-11
TIANJIN JINYAO GRP
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Such as antibiotics, traditional Chinese medicine injections, amino acids, polypeptides, etc., compound amino acid injection (18AA-I), 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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[0014] 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 hydrochloric acid. (If the pH is qualified, you don’t need to add more)
[0015] Described injection adopts following method to prepare
[0016] 1) Take 50% to 80% 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, cysteine hydrochloride and fully stir until completely dissolved, add the prescribed amount of pH regulator (the pH regulator is not added in Example 7-8), and adjust the pH value with sodium hydroxide solution ...
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Abstract
The invention relates to a compound amino acid injection (18AA-I) composition. Each 1000ml of the compound amino acid injection composition contains 2.8-3.5g of isoleucine, 3.5-4.0g of serine, 1.7-2.5g of glycine, 6.0-6.5g of lactamine, 1-1.5g of methionine, 1-1.5g of tryptophan, 6.5-7.5g of leucine, 3.7-4.3g of aspartic acid, 0.5-1.0g of N-acetyl-L-tyrosine, 5.2-5.8g of proline, 2.5-3.0g of phenylalanine, 3.1-3.8g of valine, 7.7-8.3g of lysine acetate, 6.8-7.3g of glutamic acid, 1.7-2.5g of histidine, 3.7-4.5g of arginine, 3.4-4.0g of threonine and 0.5-1.5g of 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, such as the existing 18 kinds of amino acid compound injection with the general name of children's compound amino acid injection (18AA-I), and its formula is 1000ml per 1000ml Contains 3.1g of isoleucine, 3.8g of serine, 2.1g of glycine, 6.3g of alanine, 1.3g of methionine, 1.4g of tryptophan, 7.0g of leucine, 4.1g of aspartic acid, N -Acetyl-L-tyrosine 0.6g, proline 5.6g, phenylalanine 2.7g, valine 3.6g, acetate lysine 7.9g, glutamic acid 7.1g, histidine 2.1g, essence Amino acid 4.1g, threonine 3.6g, cysteine hydrochloride 1.0g. [0003] According to the existing regulations, all injections from animals, plants, microbial fermentation extracts, and histamine or h...
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