WO2020001203A1 - Solution d'injection de vitamine d'acide aminé composée et son utilisation - Google Patents
Solution d'injection de vitamine d'acide aminé composée et son utilisation Download PDFInfo
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- WO2020001203A1 WO2020001203A1 PCT/CN2019/087884 CN2019087884W WO2020001203A1 WO 2020001203 A1 WO2020001203 A1 WO 2020001203A1 CN 2019087884 W CN2019087884 W CN 2019087884W WO 2020001203 A1 WO2020001203 A1 WO 2020001203A1
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- Prior art keywords
- vitamin
- amino acid
- injection
- compound amino
- acid vitamin
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Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4172—Imidazole-alkanecarboxylic acids, e.g. histidine
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4415—Pyridoxine, i.e. Vitamin B6
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- A61K31/00—Medicinal preparations containing organic active ingredients
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- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
- A61K31/51—Thiamines, e.g. vitamin B1
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- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7135—Compounds containing heavy metals
- A61K31/714—Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/05—Dipeptides
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A—HUMAN NECESSITIES
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- A—HUMAN NECESSITIES
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A—HUMAN NECESSITIES
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- A61P39/00—General protective or antinoxious agents
Definitions
- the invention relates to the technical field of biomedicine, in particular to a compound amino acid vitamin injection and application thereof.
- Amino acids are the basic unit of protein.
- Compound amino acid injection as an intravenous nutritional agent, is widely used in nutritional support treatment.
- the amino acid compound injection commonly known as compound amino acid injection (15HBC)
- compound amino acid injection has a formula that contains 7.66 g of isoleucine and valine per 1000 ml.
- Acid 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, phenylpropyl Amino acid 3.20g, proline 6.30g, threonine 2.00g, glycine 3.30g, tryptophan 0.90g, L-cysteine hydrochloride ⁇ 0.20g.
- the amino acid compound injection commonly called compound amino acid injection (18AA-II), has a formula of 1.98 g of leucine, 1.43 g of isoleucine, 1.83 g of valine, 4.08 g of alanine, and 250 ml per 250 ml.
- Chinese patent 2012105433005 uses lactic acid as a pH regulator to reduce the pressure-reducing substance of injection solution after high temperature sterilization.
- Chinese patent 2014102294531 discloses a pharmaceutical composition of compound amino acid injection (17AA-I), which is used for patients with insufficient protein intake, malabsorption and other amino acids that cannot meet the metabolic needs of the body, improving the nutritional status and metabolic properties of patients after surgery.
- each 1000ml contains the main drug component: 0.696-1.05 g of L-isoleucine; 0.94-1.42 g of L-leucine; 1.11-1.68 g of L-lysine, or L -Lysine acetate 1.57-2.36 g; L-methionine or methionine 0.896-1.35 g; L-phenylalanine 0.82-1.24 g; L-threonine 0.896-1.35 g; L-color Glycine 0.34-0.52 g; L-arginine 2.315-3.48 g, or L-arginine acetate 3.11-4.61 g; L-valine 0.76-1.14 g; glycine 2.58-3.88 g; L-histidine 0.58-0.88 g; L-tyrosine 0.13-0.20 g; L-alanine 4.26-6.40 g; L-proline 2.32-3.48 g;
- the invention aims at the characteristics of patients during perioperative anesthesia, and in accordance with the concept of accelerated rehabilitation surgery, develops a compound amino acid vitamin injection for inhibiting catabolism, promoting anabolic metabolism, and producing heat and heat, improving body energy metabolism and immune function, and accelerating The patient recovered.
- a second object of the present invention is to provide the use of the compound amino acid vitamin injection as described above.
- a compound amino acid vitamin injection wherein each 1000 ml of the injection contains a main drug component:
- Vitamin B6 1-100mg
- Vitamin B1 0-50mg
- Vitamin B12 0-100 ⁇ g.
- the main component of the injection solution per 1000 ml is: L-leucine: 20.6 g,
- Vitamin B6 10mg
- Vitamin B1 0mg
- Vitamin B12 0 ⁇ g.
- the injection solution further contains 0.3-0.8 g of sodium bisulfite per 1000 ml.
- the injection solution further contains 0.5 g of sodium bisulfite per 1000 ml.
- the injection also contains Na + of 80 mmol / L or less.
- the injection solution further contains Cl -of 80 mmol / L or less.
- the injection solution uses glacial acetic acid to adjust the pH value to 5.5-7.0.
- the compound amino acid vitamin injection of the present invention is designed for the characteristics of energy metabolism of patients during perioperative anesthesia. It is designed to have specific amino acid components and ratios, and the addition of B vitamins, each component has a comprehensive effect, which can significantly inhibit catabolism and promote Anabolic, heat-generating insulation, improving the body's material energy metabolism and immune function, speeding up patient recovery after surgery.
- the compound amino acid vitamin injection of the present invention meets the characteristics of material energy metabolism of patients during perioperative anesthesia, has high utilization rate and good clinical effect.
- the invention is safe and efficient, and can be used in the whole process before, during and after surgery.
- the present invention refers to changes in stress, immunity, metabolism, etc. during the perioperative anesthesia of the human body, and uses innovative formulas to respond to the concept of accelerated rehabilitation surgery, which inhibits catabolism, promotes anabolic metabolism, generates heat and heat, and improves body energy metabolism and Immune function for the purpose of accelerating recovery.
- Branched-chain amino acids are essential amino acids, which are involved in sugar, fat, protein metabolism and energy balance through various pathways, and can improve amino acid metabolism disorders.
- glutamine and alanine account for about 70%
- branched chain amino acids are involved in de novo synthesis of glutamine and alanine. If the supplement is insufficient, protein synthesis and metabolism will be seriously affected.
- B vitamins are directly involved in material energy metabolism.
- vitamin B6 is involved in amino acid metabolism such as transamination, decarboxylation, side chain cleavage, dehydration, and transsulfidation. Supplementation can promote the use of amino acids.
- Arginine has better nitrogen-saving effect and enhanced immune effect.
- Amino acids in the other components of the injection play a balance and supplementary role.
- Compound amino acid vitamin injection includes: L-leucine: 20.6g, L-isoleucine: 12.2g, L-valine: 15.2g, L-alanyl-L-glutamine : 25g, L-threonine: 2g, L-lysine (acetate): 3.8g, L-methionine: 3g, L-phenylalanine: 2.8g, L-tryptophan: 1g, L -Arginine: 12g, L-histidine: 2.4g, vitamin B6: 10mg, sodium bisulfite 0.5g, adjust the pH to 5.5-6.5 with glacial acetic acid, and add water for injection to a total of 1000ml.
- Method of use Intravenous infusion at 4-8kJ ⁇ kg -1 ⁇ h -1 during the operation, and 1.2-2.0g / kg infusion per day after the operation.
- L-leucine 40g, L-isoleucine: 30g, L-valine: 30g, L-alanyl-L-glutamine: 10g, L-threonine: 5g, L-lysine Amino acid (acetate): 5g, L-methionine: 2g, L-phenylalanine: 3g, L-tryptophan: 0.5g, L-arginine: 5g, L-histidine: 1g, Vitamin B6: 1mg, vitamin B1: 1mg, vitamin B12: 100 ⁇ g, sodium bisulfite 0.3g, Na + 10mmol / L, Cl - 10mmol / L, adjust the pH to 5.5-7.0 with glacial acetic acid, and add water for injection to the total The amount is 1000ml. Method of use: Intravenous infusion at 4-8kJ ⁇ kg -1 ⁇ h -1 during the operation, and 1.2-2.0g / kg infusion per day after the operation.
- L-leucine 5g, L-isoleucine: 2g, L-valine: 2g, L-alanyl-L-glutamine: 5g, L-threonine: 1g, L-lysine Amino acid (acetate): 1g, L-methionine: 1g, L-phenylalanine: 1g, L-tryptophan: 8g, L-arginine: 30g, L-histidine: 10g, vitamins B6: 8mg, vitamin B1: 10mg, vitamin B12: 100 ⁇ g, sodium bisulfite 0.8g, Na + 80mmol / L, Cl - 80mmol / L, adjust the pH to 5.5-7.0 with glacial acetic acid, and add water for injection to the total 1000ml.
- Method of use Intravenous infusion at 4-8kJ ⁇ kg -1 ⁇ h -1 during operation, and 1.2-2.0g / kg infusion per day after operation.
- L-leucine 5g, L-isoleucine: 10g, L-valine: 2g, L-alanyl-L-glutamine: 90g, L-threonine: 1g, L-lysine Amino acid (acetate): 10g, L-methionine: 1g, L-phenylalanine: 10g, L-tryptophan: 0.5g, L-arginine: 30g, L-histidine: 1g, Vitamin B6: 100mg, Vitamin B1: 50mg, Vitamin B12: 100 ⁇ g, sodium bisulfite 0.3g, Na + 80mmol / L, Cl - 80mmol / L, adjust the pH to 5.5-7.0 with glacial acetic acid, and add water for injection to the total The amount is 1000ml. Method of use: Intravenous infusion at 4-8kJ ⁇ kg -1 ⁇ h -1 during the operation, and 1.2-2.0g / kg infusion per day after the operation.
- L-leucine 40g, L-isoleucine: 2g, L-valine: 30g, L-alanyl-L-glutamine: 5g, L-threonine: 5g, L-lysine Amino acid (acetate): 1g, L-methionine: 12g, L-phenylalanine: 1g, L-tryptophan: 8g, L-arginine: 2g, L-histidine: 10g, vitamins B6: 10mg, vitamin B1: 10mg, vitamin B12: 100 ⁇ g, sodium bisulfite 0.8g, Na + 10mmol / L, Cl - 10mmol / L, adjust the pH to 5.5-7.0 with glacial acetic acid, and add water for injection to the total 1000ml.
- Method of use Intravenous infusion at 4-8kJ ⁇ kg -1 ⁇ h -1 during the operation, and 1.2-2.0g / kg infusion per day after the operation.
- L-leucine 30g, L-isoleucine: 20g, L-valine: 20g, L-alanyl-L-glutamine: 40g, L-threonine: 4g, L-lysine Amino acid (acetate): 8g, L-methionine: 10g, L-phenylalanine: 8g, L-tryptophan: 6g, L-arginine: 20g, L-histidine: 8g, vitamins B6: 2mg, vitamin B1: 4mg, vitamin B12: 40 ⁇ g, sodium bisulfite 0.6g, Na + 60mmol / L, Cl - 60mmol / L, adjust the pH to 5.5-7.0 with glacial acetic acid, and add water for injection to the total 1000ml.
- Method of use Intravenous infusion at 4-8kJ ⁇ kg -1 ⁇ h -1 during operation, and 1.2-2.0g / kg infusion per day after operation.
- the perioperative anesthesia patients' energy storage substances (glycogen, protein, fat) are mobilized to provide substrates for energy supply, tissue repair, and synthesis of new proteins, etc., and continue to the rehabilitation period, resulting in strong catabolism, Skeletal muscles are wasted, urine nitrogen is increased, negative nitrogen balance is produced, and the body's inflammation and immune response are prone to imbalance.
- proteins due to central and peripheral insulin resistance, and free fatty acids and ketone bodies produced by lipolysis, proteins (amino acids) are safe and effective substances for energy supply during perioperative anesthesia.
- Branched-chain amino acids are essential amino acids. They participate in sugar, fat, protein metabolism and energy balance through a variety of pathways, and can improve amino acid metabolism disorders.
- glutamine and alanine account for about 70%, and branched chain amino acids are involved in de novo synthesis of glutamine and alanine. If the supplement is insufficient, protein synthesis and metabolism will be seriously affected.
- B vitamins are directly involved in material energy metabolism.
- vitamin B6 participates in amino acid metabolism such as transamination, decarboxylation, side chain cleavage, dehydration, and transsulfidation. Supplementation can promote the use of amino acids.
- Arginine has a better nitrogen-saving effect and enhances the immune effect.
- the compound amino acid vitamin injection of the present invention is designed to meet the energy metabolism needs of perioperative anesthesia patients.
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- Pharmacology & Pharmacy (AREA)
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Abstract
La présente invention concerne une solution d'injection de vitamine d'acide aminé composée et son utilisation. La solution d'injection de vitamine d'acide aminé composée comprend pour 1000 mL : 5 à 40 g de L-leucine, 2 à 30 g de L-isoleucine, 2 à 30 g de L-valine, 5 à 90 g de L-alanyl-L-glutamine, 1 à 5 g de L-thréonine, 1-10 g de L-lysine, 1 à 12 g de L-méthionine, 1 à 10 g de L-phénylalanine, 0,5 à 8 g de L-tryptophane, 2 à 30 g de L-arginine, 1 à 10 g de L-histidine, 1 à 100 mg de vitamine B6, 0 à 50 mg de vitamine B1, et 0 à 100 μg de vitamine B12. La présente invention concerne des changements de stress, d'immunisation, de métabolisme ou similaires dans une période périopératoire humaine, et permet d'inhiber le catabolisme, de favoriser l'anabolisme, de produire de la chaleur et de maintenir la chaleur, d'améliorer le métabolisme énergétique des substances et l'immunité du corps, et d'aider à la rééducation.
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CN114601846A (zh) * | 2020-12-03 | 2022-06-10 | 河北科星药业有限公司 | 一种畜用复合维生素氨基酸注射液及其制备方法和应用 |
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CN110404048A (zh) * | 2019-09-05 | 2019-11-05 | 复旦大学附属中山医院 | 一种复方氨基酸双肽注射液及其制备方法和应用 |
CN114469941A (zh) * | 2020-10-27 | 2022-05-13 | 河北科星药业有限公司 | 用于畜疾病防治的复合氨基酸注射液及其制备方法和应用 |
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