CN102429902B - Pharmaceutical composition of alanyl glutamine and compound amino acid - Google Patents
Pharmaceutical composition of alanyl glutamine and compound amino acid Download PDFInfo
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- CN102429902B CN102429902B CN 201110267409 CN201110267409A CN102429902B CN 102429902 B CN102429902 B CN 102429902B CN 201110267409 CN201110267409 CN 201110267409 CN 201110267409 A CN201110267409 A CN 201110267409A CN 102429902 B CN102429902 B CN 102429902B
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Abstract
The invention relates to a pharmaceutical composition of alanyl glutamine aseptic frozen-dried powder for injection and compound amino acid injection, particularly a combined application package, comprising alanyl glutamine aseptic frozen-dried powder for injection, water for injection, and compound amino acid injection. When the pharmaceutical composition is used, the alanyl glutamine aseptic frozen-dried powder for injection is dissolved with water for injection, and then is mixed with compatible amino acid injection or transfusion containing amino acid, and intravenous infusion is used. The combined application package disclosed herein avoids the influence to quality caused by quality discrepancy of different factories when the combination is used, and greatly increases the safety of application of patients.
Description
Technical field
The present invention relates to the pharmaceutical composition of a kind of alanyl glutamine and amino acid, be specifically related to the applied in any combination packing of the aseptic freeze-dried powder of a kind of injection alanyl glutamine and Amino Acid Compound Injection, belong to medical technical field.
Background technology
L-glutaminate (L-Glutamine, Gln) is essential amino acid in a kind of body, also is the maximum aminoacid of people's in-vivo content, has important function at protein, nucleic acid in synthesizing.The content of Gln in blood plasma accounts for 20% of free amino acid total amount up to 0.8～0.9 mM/l.Gln is the energy source of the metabolically active cells such as intestinal epithelial cell, renal cells and immunologically competent cell; The nitrogenous source vehicle that is considered to body is transported nitrogenous source between each tissue in vivo, and the critical functions such as noxious substance such as ammonia are removed in performance.
Alanyl glutamine discharges L-glutaminate through the dipeptidase effect in vivo rapid the decomposition, supplies with the synthetic or energy expenditure use of body material, and its bioavailability height does not have summation.
The injection alanyl glutamine is the aseptic freeze-dried powder of alanyl glutamine, is white or off-white color sterilized powder, is a kind of parenteral nutrition medicine, for the patient who accepts parenteral nutrition provides glutamine.Alanyl glutamine is by the development of German Fresenius company, and import in 1999 claims again glutamine dipeptide to China.
Alanyl glutamine generally is with compatible Freamine Ⅲ or contains amino acid whose transfusion and dissolve by 0.2g/ml and be called a volume before infusion, then with the carrier solution infusion.1 volume alanyl glutamine should mix with the carrier solution of 5 volumes (for example: the 20g/100ml alanyl glutamine should add at least 500ml carrier solution) at least.Dosage is decided according to catabolic degree and amino acid whose requirement.Supplying with amino acid whose maximal dose every day for parenteral nutrition is the 2g/kg body weight, and alanine and the glutamine amount supplied with by alanyl glutamine should count.The amount of amino acid of supplying with by alanyl glutamine should not surpass 20% of whole aminoacid quantity delivereds.
At present, it all is respectively from different manufacturer's buyings by medication unit that domestic compatibility about injection alanyl glutamine and Amino Acid Compound Injection is used, compatibility arrives together during clinical practice, like this because the difference of manufacturer causes the widely different of drug quality, compatibility is used and has been had a strong impact on final drug quality, has further affected patient's treatment.
Patent documentation CN201223558Y discloses the double-chamber transfusion bag of a kind of splendid attire amino acid injection and alanyl glutamine injection, but alanyl glutamine exists with the form of solution, places for a long time unstablely, can produce degraded.The people such as Zhou Xin research points out that alanyl glutamine adds Amino Acid Compound Injection and causes hepatic injury, and this also is the extensive use that is unfavorable for alanyl glutamine and aminoacid combination.
In order to overcome the insoluble technical problem that the combination of alanyl glutamine and amino acid exists in the prior art, the inventor has proposed a kind of new alanyl glutamine and pharmaceutical composition and the application packages thereof of amino acid.
Summary of the invention
One of purpose of the present invention provides a kind of new alanyl glutamine and the pharmaceutical composition of amino acid, comprises the aseptic freeze-dried powder of alanyl glutamine and Amino Acid Compound Injection.
One of purpose of the present invention, the applied in any combination packing of the aseptic freeze-dried powder of a kind of injection alanyl glutamine and Amino Acid Compound Injection is provided, comprise the aseptic freeze-dried powder of injection alanyl glutamine and Amino Acid Compound Injection, and both are the production of same pharmaceutical factory.
Further, also can comprise the aseptic freeze-dried powder of injection alanyl glutamine, water for injection and Amino Acid Compound Injection in this assembly packaging, the quality influence that has been caused by the mass discrepancy of different manufacturers production when having avoided that compatibility is used together like this, greatly improved the safety that the patient uses, to the buying of medication unit with make up a prescription very large convenience also is provided, saved cost simultaneously.
Applied in any combination packing provided by the invention, usage is added the Amino Acid Compound Injection mix homogeneously for first the aseptic freeze-dried powder of injection alanyl glutamine being dissolved fully with water for injection first, and intravenous drip gets final product.
As the present invention's one preferred embodiment, packing specification of the present invention is injection alanyl glutamine aseptic freeze-dried powder 10g, water for injection 50ml and Amino Acid Compound Injection 250ml.
As the present invention's one preferred embodiment, packing specification of the present invention is injection alanyl glutamine aseptic freeze-dried powder 20g, water for injection 100ml and Amino Acid Compound Injection 500ml.
Injection alanyl glutamine provided by the invention is the aseptic freeze-dried powder of white or off-white color.Its preparation method is:
(1) in ten thousand grades of clean area proportioning room, alanyl glutamine is dissolved in water for injection, be made into about 20% solution, add the medicinal carbon of dosing amount about 0.5% (w/v), stirring and adsorbing 20 minutes, the coarse filtration decarburization, through 0.22 μ m microporous filter membrane fine straining, then be sub-packed in the lyophilizing pallet, the medicinal liquid liquid level thickness is no more than 2cm again, lyophilization gets the aseptic freeze-dried powder of alanyl glutamine.
(2) at hundred grades of clean areas, the control relative humidity is lower than about 45%, carries out aseptic subpackagedly with automatic packer, jumps a queue, and rolls lid.
The sterilized water for injection of water for injection provided by the invention for making by the injection production technology.Its preparation method is: get fresh water for injection fill, and sealing, sterilization, and get final product.
Amino Acid Compound Injection provided by the invention is 18 kinds of sterile water solutions that crystalline amino acid is formulated, concrete component comprises tyrosine 0.11-0.35g, alanine 1.88-6.20g, leucine 3.79-12.50g, proline 1.0-3.3g, isoleucine 1.7-5.6g, glycine 3.24-10.70g, phenylalanine 2.83-9.35g, tryptophan 0.39-1.30g, valine 1.36-4.50g, methionine 1.06-3.50g, Aspartic Acid 1.15-3.80g, cysteine 0.44-1.00g, glutamic acid 1.97-6.50g, arginase 12 .63-7.90g, histidine 2-6g, lysine hydrochloride 3.33-12.40g, threonine 1.97-6.50g, serine 0.67-2.20g, disodium edetate 0.1-0.2g, sodium sulfite 1-2g, sorbitol 20-40g, water for injection 1000ml.
The preparation method of Amino Acid Compound Injection of the present invention is:
(1) about 60% water for injection of getting about full dose boils and adds an amount of sorbitol and make dissolving, adds about 0.15% (g/ml) active carbon again and boils 20 minutes, returns 20 minutes after-filtration of filter decolouring and enters rare filling of joining.
(2) filter passes into nitrogen after entering Sorbitol solution immediately in the dilute preparing tank, 0.15 (g/ml) active carbon of using that adds again simultaneously other about full dose 40% boils 20 minutes pretreated water for injection of absorption and Sorbitol solution merging, opens when cooling water makes amalgamation liquid be cooled to 60 ℃ to begin to feed intake.
(3) first the disodium edetate of an amount of mix homogeneously and the stabilizing agent of sodium sulfite are divided into halves, a copy of it stabilizing agent is dropped in the amalgamation liquid, then by above-mentioned prescription order each aminoacid is dropped into one by one and make dissolving, should control temperature during to tryptophan can drop into below 50 ℃ about, aminoacid feeds intake complete, adds another part stabilizing agent and cystine.
(4) slowly add to regulate pH value 5.8-6.2 with about 10% caustic lye of soda, add adding to the full amount of water for injection, add 0.15% (g/ml) active carbon and stir decolouring 20 minutes, circulating filtration 30 minutes.
(5) filter qualified to visible foreign matters after, fill, sealing, sterilization and get final product.
The present invention also provides the applied in any combination of the aseptic freeze-dried powder of a kind of injection alanyl glutamine and Amino Acid Compound Injection to be packaged in application in the preparation treatment amino acids nutritional supplementation medicine, has the human body protein of promotion Metabolism of Normal, correct negative nitrogen balance, replenish protein, the effect of accelerating wound.
Alanyl glutamine and amino acid make up extensive use in the prior art, but both exist with liquid form, particularly the injection of alanyl glutamine decomposes in the easier generation of duration of storage, so after remixing use, produces the side effect that is difficult to expect.
More seriously, the people such as Zhou Xin research points out that alanyl glutamine adds Amino Acid Compound Injection and causes hepatic injury, by studying for a long period of time of inventor, produce basic reason that liver decreases and also be quality owing to the injection of the injection of alanyl glutamine and amino acid and change and cause.
Therefore, because the dissolubility of partial amino-acid is relatively poor, the inadaptable freeze-dried powder of making of Amino Acid Compound Injection, the inventor produced will easier generation degraded the alanyl glutamine injection make the independent preservation of freeze-dried powder, the comparative test by has hereinafter proved that product of the present invention has the side effect that unforeseeable reduction liver decreases.
Benefit of the present invention:
(1) applied in any combination of the present invention packing is by same manufacturer production, and the quality influence of having avoided when compatibility is used together the mass discrepancy by different manufacturers production to cause has improved the safety that the patient uses greatly.
(2) applied in any combination of the present invention packing has been saved cost to the buying of medication unit with make up a prescription very large convenience also is provided.
(3) applied in any combination of the present invention packing matching while using is of great benefit to the stability of each drug alone, can improve clinical practice quality and the bioavailability of medicine.
The specific embodiment
Embodiment 1The preparation of assembly packaging medicine
Combination: injection alanyl glutamine aseptic freeze-dried powder 10g, water for injection 50ml and Amino Acid Compound Injection 250ml
Preparation process:
1, the preparation of injection alanyl glutamine
(1) in ten thousand grades of clean area proportioning room, the 1000g alanyl glutamine is injected water 5000ml dissolving, be made into 20% solution, add the medicinal charcoal of 25g, stirring and adsorbing 20 minutes, the coarse filtration decarburization, through 0.22 μ m microporous filter membrane fine straining, then be sub-packed in the lyophilizing pallet, the medicinal liquid liquid level thickness is no more than 2cm again, lyophilization gets the aseptic freeze-dried powder of alanyl glutamine.
(2) hundred grades of clean areas, under hundred grades of conditions, the control relative humidity is lower than 45%, carries out aseptic subpackagedly with automatic packer, and the 10g/ bottle is jumped a queue, and rolls lid.
2, the preparation of water for injection
Get fresh water for injection fill, 10ml/ props up, sealing, and 121 ℃ of pressure sterilizings 20 minutes, and get final product.
3, the preparation of Amino Acid Compound Injection
(1) gets 60L water for injection and boil and add sorbitol 2000g and make dissolving, add again the 90g active carbon and boiled 20 minutes, return 20 minutes after-filtration of filter decolouring and enter rare filling of joining.
(2) filter passes into nitrogen after entering Sorbitol solution immediately in the dilute preparing tank, adds other 40L simultaneously again and begins to feed intake through boiling 20 minutes pretreated water for injection of absorption and Sorbitol solution merging with the 60g active carbon, opening when cooling water makes amalgamation liquid be cooled to 60 ℃.
(3) part that first the disodium edetate 10g of mix homogeneously and sodium sulfite 200g is divided into two, a copy of it is dropped in the amalgamation liquid, then in order with tyrosine 0.11g, alanine 1.88g, leucine 3.79g, proline 1.0g, isoleucine 1.7g, glycine 3.24g, phenylalanine 2.83g, tryptophan 0.39g, valine 1.36g, methionine 1.06g, Aspartic Acid 1.15g, cysteine 0.44g, glutamic acid 1.97g, arginase 12 .63g, histidine 2g, lysine hydrochloride 3.33g, threonine 1.97g, serine 0.67g, drop into one by one and make dissolving, should control temperature during to tryptophan and can drop into below 50 ℃, aminoacid feeds intake complete, adds another part stabilizing agent and cystine.
(4) slowly add to regulate pH value 5.8 with 10% caustic lye of soda, add adding to the full amount of water for injection, add the 150g active carbon and stir decolouring 20 minutes, circulating filtration 30 minutes.
(5) filter qualified to visible foreign matters after, fill, 250ml/ bottle, sealing, 121 ℃ of pressure sterilizings 20 minutes, and get final product.
Embodiment 2The preparation of assembly packaging medicine
Combination: injection alanyl glutamine freeze-dried powder 20g, water for injection 100ml and Amino Acid Compound Injection 500ml
Preparation process:
1, the preparation of injection alanyl glutamine
(1) in ten thousand grades of clean area proportioning room, the 2000g alanyl glutamine is injected water 10000ml dissolving, be made into 20% solution, add the medicinal charcoal of 50g, stirring and adsorbing 20 minutes, the coarse filtration decarburization, through 0.22 μ m microporous filter membrane fine straining, then be sub-packed in the lyophilizing pallet, the medicinal liquid liquid level thickness is no more than 2cm again, lyophilization gets the aseptic freeze-dried powder of alanyl glutamine.
(2) hundred grades of clean areas, under hundred grades of conditions, the control relative humidity is lower than 45%, carries out aseptic subpackagedly with automatic packer, and the 20g/ bottle is jumped a queue, and rolls lid.
2, the preparation of water for injection
Get fresh water for injection fill, 20ml/ props up, sealing, and 121 ℃ of pressure sterilizings 20 minutes, and get final product.
3, the preparation of Amino Acid Compound Injection
(1) gets 60L water for injection and boil and add sorbitol 4000g and make dissolving, add again the 90g active carbon and boiled 20 minutes, return 20 minutes after-filtration of filter decolouring and enter rare filling of joining.
(2) filter passes into nitrogen after entering Sorbitol solution immediately in the dilute preparing tank, adds other 40L simultaneously again and begins to feed intake through boiling 20 minutes pretreated water for injection of absorption and Sorbitol solution merging with the 60g active carbon, opening when cooling water makes amalgamation liquid be cooled to 60 ℃.
(3) part that first the disodium edetate 20g of mix homogeneously and sodium sulfite 100g is divided into two, a copy of it is dropped in the amalgamation liquid, then in order with tyrosine 0.35g, alanine 6.20g, leucine 12.50g, proline 3 .3g, isoleucine 5.6g, glycine 10.70g, phenylalanine 9.35g, tryptophan 1.30g, valine 4.50g, methionine 3.50g, Aspartic Acid 3.80g, cysteine 1.00g, glutamic acid 6.50g, arginine 7.90g, histidine 6g, lysine hydrochloride 12.40g, threonine 6.50g, serine 2.20g, drop into one by one and make dissolving, should control temperature during to tryptophan and can drop into below 50 ℃, aminoacid feeds intake complete, adds another part stabilizing agent and cystine.
(4) slowly add to regulate pH value 6.2 with 10% caustic lye of soda, add adding to the full amount of water for injection, add the 150g active carbon and stir decolouring 20 minutes, circulating filtration 30 minutes.
(5) filter qualified to visible foreign matters after, fill, 500ml/ bottle, sealing, 121 ℃ of pressure sterilizings 20 minutes, and get final product.
Experimental example 3The clinical application test
The be admitted to hospital patient of the pharmaceutical composition that uses alanyl glutamine and amino acid of 20 examples is investigated, one group for using alanyl glutamine injection and Amino Acid Compound Injection (with the isocyatic commercially available prod of the product of embodiments of the invention 1, Shandong Lukang Cisen Pharmaceutical Co., Ltd produces, lot number 20101101) 10 examples (being called for short combination 1), another group is for using the aseptic freeze-dried powder of injection alanyl glutamine and Amino Acid Compound Injection (product of the embodiment of the invention 1) 10 examples (being called for short combination 2).Two groups of compositions medicines that use are same lot number, and be after the date of manufacture 6 months service time.Using the course for the treatment of is 3 days, respectively two groups of patient's liver functions is checked that 10 routine patient's average test results are as follows before and after using:
Table 1 liver function test result
Can be found out by above result, 10 routine patient's medications of using combination 1 alanyl glutamine injection and Amino Acid Compound Injection after 3 days liver function occur unusually, change larger; And the every detection index variation of the 10 routine patients that use the combination aseptic freeze-dried powder of 2 injection alanyl glutamines and Amino Acid Compound Injection is very little, and abnormal phenomena does not appear in liver function.
Liver function recovery is normal after patient's drug withdrawal of combination 1, illustrate that combination 1 alanyl glutamine injection and Amino Acid Compound Injection can produce damage to patient's liver function, this is because make up alanyl glutamine injection in 1, that form with solution exists, and alanyl glutamine poor stability in aqueous solution, be easy to degraded, its catabolite causes hepatocyte impaired; The form that makes up the aseptic freeze-dried powder of alanyl glutamine in the aseptic freeze-dried powder of 2 injection alanyl glutamines and the Amino Acid Compound Injection and be with solid exists, stablized by contrast a lot, so the abnormal liver function phenomenon do not occur.
Claims (3)
1. drug regimen application packages that contains alanyl glutamine and amino acid, it is characterized in that alanyl glutamine is the aseptic freeze-dried powder of injection alanyl glutamine, amino acid is injection, wherein, Amino Acid Compound Injection is 18 kinds of sterile water solutions that crystalline amino acid is formulated, and concrete component comprises tyrosine 0.11-0.35g, alanine 1.88-6.20g, leucine 3.79-12.50g, proline 1.0-3.3g, isoleucine 1.7-5.6g, glycine 3.24-10.70g, phenylalanine 2.83-9.35g, tryptophan 0.39-1.30g, valine 1.36-4.50g, methionine 1.06-3.50g, Aspartic Acid 1.15-3.80g, cysteine 0.44-1.00g, glutamic acid 1.97-6.50g, arginase 12 .63-7.90g, histidine 2-6g, lysine hydrochloride 3.33-12.40g, threonine 1.97-6.50g, serine 0.67-2.20g, disodium edetate 0.1-0.2g, sodium sulfite 1-2g, sorbitol 20-40g, water for injection 1000ml.
2. drug regimen application packages that contains alanyl glutamine and amino acid is characterized in that comprising the aseptic freeze-dried powder 10g of injection alanyl glutamine claimed in claim 1, amino acid claimed in claim 1 is injection 250ml and water for injection 50ml.
3. drug regimen application packages that contains alanyl glutamine and amino acid is characterized in that comprising the aseptic freeze-dried powder 20g of injection alanyl glutamine claimed in claim 1, amino acid claimed in claim 1 is injection 500ml and water for injection 100ml.
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Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103071145B (en) * | 2011-10-25 | 2014-06-25 | 杭州长典医药科技有限公司 | N(2)-L-alanyl-L-glutamine/compound amino acid injection (18AA-V) pharmaceutical composite preparation |
| 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 |
| CN102698247B (en) * | 2012-06-20 | 2013-07-10 | 海南灵康制药有限公司 | Glutamine dipeptide and compound amino acid medicinal composition prepared with solvent crystallization 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 |
| CN103610652B (en) * | 2013-11-27 | 2015-09-09 | 海南通用康力制药有限公司 | A kind of preparation method of alanyl glutamine lyophilized powder |
| CN104940195A (en) * | 2015-05-14 | 2015-09-30 | 海南圣欣医药科技有限公司 | Pharmaceutical composition containing alanyl glutamine and compound amino acid |
| CN108721596B (en) * | 2018-06-29 | 2021-09-21 | 复旦大学附属中山医院 | Compound amino acid vitamin injection and application thereof |
| CN110404048A (en) * | 2019-09-05 | 2019-11-05 | 复旦大学附属中山医院 | Double peptide injections of a kind of amino acid and its preparation method and application |
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| CN100428931C (en) * | 2004-08-02 | 2008-10-29 | 陶灵刚 | N(2)-L-alanyl-L-glutamine injection and its preparation method |
| CN1615906A (en) * | 2004-09-27 | 2005-05-18 | 俞锋 | 18 compound amino acid injection and its preparing method |
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