CN1615906A - 18 compound amino acid injection and its preparing method - Google Patents

18 compound amino acid injection and its preparing method Download PDF

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Publication number
CN1615906A
CN1615906A CN 200410066699 CN200410066699A CN1615906A CN 1615906 A CN1615906 A CN 1615906A CN 200410066699 CN200410066699 CN 200410066699 CN 200410066699 A CN200410066699 A CN 200410066699A CN 1615906 A CN1615906 A CN 1615906A
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China
Prior art keywords
filter
injection
sorbitol
minutes
active carbon
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CN 200410066699
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Chinese (zh)
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濮毅华
孙国建
俞锋
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Individual
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Individual
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Priority to CN 200410066699 priority Critical patent/CN1615906A/en
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Abstract

The compound amino acid injection as one medicine for complementing body's protein nutrients consists of 18 kinds of amino acids, including tyrosine, leucine, isoleucine, phenylalanine, etc. and sorbic alcohol. It may enter to body tissue cell safely and effectively to participate the synthetic metabolism of protein, promote tissue healing and restore body's normal function.

Description

18 compound amino acid injection and preparation method thereof
The present invention relates to a kind of medicaments injection of additional human body protein nutrition, is by 18 seed amino acids and the formulated sterile solution for injection of sorbitol.
People have many diseases or need the rehabilitation of amounts of protein with the promotion health of nourishing before and after medical operatings.Adopt the way of oral supplementation nutrition mostly, but some disease and wounded or disabled large-area burns as hyperpyrexia and body surface, scald etc. cause the protein famine; Have since before and after gastrointestinal dysfunction and the gastrointestinal procedures to the proteinic obstacle that is absorbed with, all can not orally ingestible protein.
The purpose of this invention is to provide a kind of 18 compound amino acid injection that replenishes human body protein safely and effectively, to promote the quick rehabilitation of human body.
The main feature of 18 compound amino acid injection of the present invention is:
1. amino acid transfusion is supplied with under the competent situation at energy, can enter histiocyte, participates in proteinic anabolism, obtains positive nitrogen balance, and generates enzyme, hormone, antibody, structural protein, promotes tissue to exceed and closes, and recovers normal physiological function.
2. amino acid drug is used for the protein Deficiency of Intake, and aminoacid such as absorption obstacle can not satisfy the patient of organism metabolism needs.
3. also can be used for improving the nutriture of patients after surgery.
18 compound amino acid injection of the present invention is realized by following formula proportion and preparation technology.
Formula proportion:
1. tyrosine 0.18kg~0.27kg 13. alanine 1.44kg~2.16kg
2. leucine 3.528kg~5.292kg 14. proline 0.72kg~1.08kg
3. isoleucine 2.534kg~3.8kg 15. glycine 5.472kg~8.208kg
4. phenylalanine-3,4-quinone .838kg~5.756kg 16. tryptophan 0.778kg~1.166kg
5. valine 2.592kg~3.888kg 17. methionine 1.62kg~2.43kg
6. Aspartic Acid 1.8kg~2.7kg 18. cystine 24g~36g
7. glutamic acid 0.54kg~0.81kg 19.EDTA 40g~60g
8. arginine hydrochloride 3.6kg~5.4kg 20. sulfurous acid ammonia sodium 400g~600g
9. histidine monohydrochloride 1.98kg~2.97kg 21. sorbitol 40kg~60kg
10. lysine hydrochloride 3.096kg~4.644kg 22. sodium hydroxide 0.96kg~1.44kg
11. threonine 1.8kg~2.7kg 23. active carbon 1.6kg~2.4kg
12. serine 0.72kg~1.08kg
Preparation technology:
1. 50% (about 5,000,000 ml) water for injection of getting about full dose boils the adding sorbitol makes dissolving, adds 0.1% (W/N) active carbon (0.5kg) again and boils 15 minutes, returns the filter decolouring and pumps into rare pot of joining after 15 minutes.
2. rare joining feeds N after pumping into sorbitol liquid in the pot immediately 2, 50% (about 500,000 ml) that pump into simultaneously other about full dose again adsorb 15 minutes pretreated water for injection and the merging of sorbitol liquid through boiling with 0.1% (W/N) active carbon (0.5kg), open when cooling water makes amalgamation liquid be cooled to 65 ℃ to begin to feed intake.
3. elder generation is with EDAE, the NaHSO of mix homogeneously 3The stabilizing agent part that is divided into two, a copy of it is dropped in the amalgamation liquid, will be equipped with aminoacid by above-mentioned prescription order then and drop into one by one and make dissolving, should control temperature during to tryptophan and can drop into below 50 ℃, aminoacid feeds intake and finishes, and adds another part stabilizing agent and cystine.Slowly add to regulate pH value 5.8~6.2 with 10% caustic lye of soda (about 1200ml), add and add to the full amount of water for injection, add 0.1% (W/N) active carbon (1kg) and stir decolouring 15 minutes, (returning filter holds in both hands or the titanium rod with the core filter to return filter 30 minutes, external filter paper is wrapped), after mensuration pH value and light transmittance (more than 98.5%) were qualified, it was to be filled to pump into storage liquid pot.
4. treat to feed N immediately after medicinal liquid pumps into storage liquid pot 2, then through the fill after clear and bright of 3 flint glass F filter sticks and 0.65mm microporous filter membrane fine straining.(in case of necessity filter membranes of putting one deck 0.65mm more.)
5. should be respectively during fill before fill in the bottle in the empty bottle and after the fill space pour nitrogen, the time must not be less than every bottle 10 seconds.Therefore just must take to control filling speed such as methods such as manual fills.(bottle interior remaining oxygen of measuring with good conditionsi is no more than 5%)
6. seal 110 ℃ of sterilizations (vial accumbency during sterilization) in 35 minutes.Promptly get 18 compound amino acid injection of the present invention.
For the formula proportion and the preparation technology that further specify 18 compound amino acid injection of the present invention, embodiments of the invention are as follows:
Formula proportion:
1. tyrosine 0.225kg 13. alanine 1.8kg
2. leucine 4.41kg 14. proline 0.9kg
3. isoleucine 3.168kg 15. glycine 6.84kg
4. phenylalanine 4.797kg 16. tryptophan 0.972kg
5. valine 3.24kg 17. methionine 2.025kg
6. Aspartic Acid 2.25kg 18. cystine 30g
7. glutamic acid 0.675kg 19.EDTA 50g
8. arginine hydrochloride 4.5kg 20. sulfurous acid ammonia sodium 500g
9. histidine monohydrochloride 2.475kg 21. sorbitol 50kg
10. lysine hydrochloride 3.87kg 22. sodium hydroxide 1.2kg
11. threonine 2.25kg 23. active carbon 2kg
12. serine 0.9kg
According to above-mentioned preparation technology's 1 to 6 operation, promptly get 18 compound amino acid injection of the present invention.

Claims (2)

1, the present invention is by 18 seed amino acids and the formulated sterile solution for injection of sorbitol.Realize by following formula proportion and preparation technology.It is characterized in that:
1. tyrosine 0.18kg~0.27kg 13. alanine 1.44kg~2.16kg
2. leucine 3.528kg~5.292kg 14. proline 0.72kg~1.08kg
3. isoleucine 2.534kg~3.8kg 15. glycine 5.472kg~8.208kg
4. phenylalanine-3,4-quinone .838kg~5.756kg 16. tryptophan 0.778kg~1.166kg
5. valine 2.592kg~3.888kg 17. methionine 1.62kg~2.43kg
6. Aspartic Acid 1.8kg~2.7kg 18. cystine 24g~36g
7. glutamic acid 0.54kg~0.81kg 19.EDTA 40g~60g
8. arginine hydrochloride 3.6kg~5.4kg 20. sulfurous acid ammonia sodium 400g~600g
9. histidine monohydrochloride 1.98kg~2.97kg 21. sorbitol 40kg~60kg
10. lysine hydrochloride 3.096kg~4.644kg 22. sodium hydroxide 0.96kg~1.44kg
11. threonine 1.8kg~2.7kg 23. active carbon 1.6kg~2.4kg
12. serine 0.72kg~1.08kg
Preparation technology:
A. 50% (about 5,000,000 m1) water for injection of getting about full dose boils the adding sorbitol makes dissolving, adds 0.1% (W/N) active carbon (0.5kg) again and boils 15 minutes, returns the filter decolouring and pumps into rare pot of joining after 15 minutes.
B. rare joining feeds N after pumping into sorbitol liquid in the pot immediately 2, 50% (about 500,000 ml) that pump into simultaneously other about full dose again adsorb 15 minutes pretreated water for injection and the merging of sorbitol liquid through boiling with 0.1% (W/N) active carbon (0.5kg), open when cooling water makes amalgamation liquid be cooled to 65 ℃ to begin to feed intake.
C. elder generation is with EDAE, the NaHSO of mix homogeneously 3The stabilizing agent part that is divided into two, a copy of it is dropped in the amalgamation liquid, by above-mentioned prescription order each aminoacid is dropped into one by one then and make dissolving, should control temperature during to tryptophan and can drop into below 50 ℃, phenalgin acid feeds intake and finishes, and adds another part stabilizing agent and cystine.Slowly add to regulate pH value 5.8~6.2 with 10% caustic lye of soda (about 1200ml), add and add to the full amount of water for injection, add 0.1% (W/N) active carbon (1kg) and stir decolouring 15 minutes, (returning filter holds in both hands or the titanium rod with the core filter to return filter 30 minutes, external filter paper is wrapped), after mensuration pH value and light transmittance (more than 98.5%) were qualified, it was to be filled to pump into storage liquid pot.
D. treat to feed N immediately after medicinal liquid pumps into storage liquid pot 2, then through the fill after clear and bright of 3 flint glass F filter sticks and 0.65mm microporous filter membrane fine straining.(in case of necessity filter membranes of putting one deck 0.65mm more.)
E. should be respectively during fill before fill in the bottle in the empty bottle and after the fill space pour nitrogen, the time must not be less than every bottle 10 seconds.Therefore just must take to control filling speed such as methods such as manual fills.(bottle interior remaining oxygen of measuring with good conditionsi is no more than 5%)
F. seal 110 ℃ of sterilizations (vial accumbency during sterilization) in 35 minutes.Promptly get 18 compound amino acid injection of the present invention.
2. formula proportion and the preparation technology according to best among formula proportion described in the claim 1 and the preparation technology is as follows:
1. tyrosine 0.225kg 13. alanine 1.8kg
2. leucine 4.41kg 14. proline 0.9kg
3. isoleucine 3.168kg 15. glycine 6.84kg
4. phenylalanine 4.797kg 16. tryptophan 0.972kg
5. valine 3.24kg 17. methionine 2.025kg
6. Aspartic Acid 2.25kg 18. cystine 30g
7. glutamic acid 0.675kg 19.EDTA 50g
8. arginine hydrochloride 4.5kg 20. sulfurous acid ammonia sodium 500g
9. histidine monohydrochloride 2.475kg 21. sorbitol 50kg
10. lysine hydrochloride 3.87kg 22. sodium hydroxide 1.2kg
11. threonine 2.25kg 23. active carbon 2kg
12. serine 0.9kg
Operate according to the preparation technology A to F described in the claim 1, promptly get 18 compound amino acid injection of the present invention.
CN 200410066699 2004-09-27 2004-09-27 18 compound amino acid injection and its preparing method Pending CN1615906A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
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Application Number Priority Date Filing Date Title
CN 200410066699 CN1615906A (en) 2004-09-27 2004-09-27 18 compound amino acid injection and its preparing method

Publications (1)

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CN1615906A true CN1615906A (en) 2005-05-18

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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102145009A (en) * 2010-12-29 2011-08-10 山东鲁抗辰欣药业有限公司 Octadeca compound amino acid injection and preparation method thereof
CN102302489A (en) * 2011-07-14 2012-01-04 青岛华仁药业股份有限公司 Preparation method of compound amino acid injection
CN102357094A (en) * 2011-08-19 2012-02-22 福建天泉药业股份有限公司 Pharmaceutical composition containing eighteen amino acids
CN101015501B (en) * 2007-02-28 2012-03-07 华瑞制药有限公司 Injection composition of fat milk, amino acid and glucose packed with three-cavity bag and preparing method thereof
CN102429902A (en) * 2011-09-09 2012-05-02 海南灵康制药有限公司 Pharmaceutical composition of alanyl glutamine and compound amino acid
CN102631665A (en) * 2012-04-19 2012-08-15 海南灵康制药有限公司 Pharmaceutical composition of alanyl glutamine injection and compound amino acid injection
CN102698248A (en) * 2012-06-20 2012-10-03 海南灵康制药有限公司 Medicine composition prepared from alanyl glutamine and compound amino acid by utilizing spray drying method
CN102743378A (en) * 2012-07-30 2012-10-24 李慧 Composition containing eighteen amino acids
CN103301120A (en) * 2013-06-24 2013-09-18 华仁药业股份有限公司 Preparation method of compound amino acid injection
CN103508077A (en) * 2012-06-25 2014-01-15 贵州益佰制药股份有限公司 Medicine packaging system and kit for intravenous administration
CN103690533A (en) * 2013-12-27 2014-04-02 宜昌三峡制药有限公司 Method for improving light transmittance of compound amino acid injection

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101015501B (en) * 2007-02-28 2012-03-07 华瑞制药有限公司 Injection composition of fat milk, amino acid and glucose packed with three-cavity bag and preparing method thereof
CN102145009A (en) * 2010-12-29 2011-08-10 山东鲁抗辰欣药业有限公司 Octadeca compound amino acid injection and preparation method thereof
CN102302489A (en) * 2011-07-14 2012-01-04 青岛华仁药业股份有限公司 Preparation method of compound amino acid injection
CN102357094A (en) * 2011-08-19 2012-02-22 福建天泉药业股份有限公司 Pharmaceutical composition containing eighteen amino acids
CN102429902A (en) * 2011-09-09 2012-05-02 海南灵康制药有限公司 Pharmaceutical composition of alanyl glutamine and compound amino acid
CN102631665B (en) * 2012-04-19 2013-09-25 海南灵康制药有限公司 Pharmaceutical composition of alanyl glutamine injection and compound amino acid injection
CN102631665A (en) * 2012-04-19 2012-08-15 海南灵康制药有限公司 Pharmaceutical composition of alanyl glutamine injection and compound amino acid injection
CN102698248A (en) * 2012-06-20 2012-10-03 海南灵康制药有限公司 Medicine composition prepared from alanyl glutamine and compound amino acid by utilizing spray drying method
CN102698248B (en) * 2012-06-20 2013-09-25 海南灵康制药有限公司 Medicine composition prepared from alanyl glutamine and compound amino acid by utilizing spray drying method
CN103508077A (en) * 2012-06-25 2014-01-15 贵州益佰制药股份有限公司 Medicine packaging system and kit for intravenous administration
CN102743378A (en) * 2012-07-30 2012-10-24 李慧 Composition containing eighteen amino acids
CN103301120A (en) * 2013-06-24 2013-09-18 华仁药业股份有限公司 Preparation method of compound amino acid injection
CN103301120B (en) * 2013-06-24 2014-12-24 华仁药业股份有限公司 Preparation method of compound amino acid injection
CN103690533A (en) * 2013-12-27 2014-04-02 宜昌三峡制药有限公司 Method for improving light transmittance of compound amino acid injection
CN103690533B (en) * 2013-12-27 2015-10-21 宜昌三峡制药有限公司 A kind of method improving light transmittance of compound amino acid injection

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