CN1736372A - Compound amino acid for injection and its preparation process - Google Patents
Compound amino acid for injection and its preparation process Download PDFInfo
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- CN1736372A CN1736372A CN 200510056485 CN200510056485A CN1736372A CN 1736372 A CN1736372 A CN 1736372A CN 200510056485 CN200510056485 CN 200510056485 CN 200510056485 A CN200510056485 A CN 200510056485A CN 1736372 A CN1736372 A CN 1736372A
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Abstract
The invention relates to medicinal compound amino acids for injection and the preparing process, wherein the formulation comprises eighteen kinds of amino acids freeze-dried powder, as well as excipient, auxiliary solvent, pH modifier, stabilizing agent for oxidation resistance and metal chelating agent.
Description
Technical field the present invention relates to pharmaceutical compound amino acid for injection and preparation method thereof.
Background technology aminoacid 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 organization healing, recovers normal physiological function.Be mainly used in the nutritional support of major surgery front and back clinically and supply with Disorder of Digestion and Absorption patient proteinaceous nutrient to become to grade.According to the difference of recipe quantity at present with listing amino acid (18AA) injection, amino acid (18AA-I) injection, amino acid (18AA-II) injection, amino acid (18AA-III), amino acid (18AA-IV), amino acid (18AA-V) injection amino acid (18AA-F) injection, Paediatric Amino Acid Compound injection series of products such as (18AA).
Compound recipe (18 kinds) aminoacid that is used for drug administration by injection of having gone on the market is at present gone up substantially and is common 250ml and 500ml glass bottle high-capacity injection, and common compound recipe (18 kinds) amino acid injection is in aqueous solution state all the time, and product must keep in Dark Place in cool place below 25 ℃.Producing or in storing process, rocking all oxidation and decomposition, particularly product easier oxidation and decomposition in the high temperature sterilize process easily under the conditions such as concussion, high temperature and illumination, causing that urticaria appears in some patient, the pruritus of shivering infusion reaction.High capacity glass bottle injection transportation simultaneously and storage cost height, damaged easily in transit, increase the selling cost of enterprise greatly, the big value of existing product volume is low in addition, general unit can't preserve product in strictness 25 ℃ of following conditions, so existing normal injection is difficult to guarantee product quality and stability.
Summary of the invention the present invention is intended to overcome problems such as existing compound recipe (18 kinds) aminoacid high-capacity injection poor stability and accumulating inconvenience, prepared injection use compound (18 kinds) aminoacid, improve compound recipe (18 kinds) amino acid whose stability and quality, reduced the selling cost of product simultaneously.Contain compound recipe (18 kinds) aminoacid lyophilized powder in injection use compound of the present invention (18 kinds) the aminoacid prescription, can also contain stabilizing agents such as excipient, cosolvent, pH regulator agent, antioxidation and metal chelating agent.
Every bottle of compound recipe of injection (18 kinds) aminoacid contains compound recipe (18 kinds) amino acid/11～6.25g, best 2.5～6.25g.Excipient, cosolvent are specially lactose, sorbitol, mannitol, xylitol, glucose, dextran, polyvidone, Macrogol 4000, sodium chloride, sodium dihydrogen phosphate, sodium hydrogen phosphate etc., can be separately, also can mix use in varing proportions, total consumption be recipe quantity 0～25%, be preferably 5～10%.The pH regulator agent is sodium bicarbonate, sodium carbonate, ammonia, sodium hydroxide., hydrochloric acid, acetic acid, sulphuric acid, lactic acid, citric acid, succinic acid, phosphoric acid, nitric acid, tartaric acid etc., can be separately, also can mix use in varing proportions, total consumption be recipe quantity 0～3%, be preferably 0～2%.Antioxidative stabilizer is vitamin C, sodium sulfite, sodium sulfite, sodium pyrosulfite, metal chelating agent edetate, citric acid and citrate, tartaric acid and tartrate, can be separately, also can mix use in varing proportions, total consumption be recipe quantity 0.005～1%, be preferably 0.01～0.6%, to improve the antioxygenic property and the stability of product.
Specific embodiment the present invention can be illustrated with the following examples
Embodiment 1 compound amino acid for injection (18AA-V)
Arginine hydrochloride 28.9g histidine monohydrochloride 24.6g
Leucine 379g isoleucine 170g
Lysine hydrochloride 333g phenylalanine 283g
Threonine 197g valine 136g
Methionine 106g tryptophan 39g
Glycine 324g alanine 188g
Proline 100g tyrosine 11g
Serine 67g cysteine hydrochloride 44g
Aspartic Acid 115g glutamic acid 197g
Sodium sulfite 50g mannitol 200g
Water for injection
In right amount
Make 1000 bottles
Preparation method: with above 18 seed amino acids, mannitol is added in the water for injection, stirring down, the adding sodium sulfite makes material dissolution and transfers pH3.5～6.0, or sodium sulfite added in the water for injection dissolve, add 18 seed amino acids, mannitol, stirring makes material dissolution and transfers pH3.5～6.0, or mannitol added in the water for injection dissolve, add sodium sulfite, 18 seed amino acids, stirring makes material dissolution and transfers pH3.5～6.0, add the injection-use activated carbon of 0.01-0.5%, stirred the filtering active carbon 15-30 minute, medicinal liquid is again through 0.45 μ m and 0.22 μ m filtering with microporous membrane, filtrate quantitatively is sub-packed in the vial, places freezer dryer, is cooled to-25 ℃～-30 ℃ and keeps after 2 hours, be cooled to-40 ℃～-45 ℃ again, open vacuum, slowly be warming up to-5 ℃～0 ℃ sublimation drying, stop drying less than 1% to moisture, lyophilization is finished, and gland is packed promptly.
Embodiment 2 injection Paediatric Amino Acid Compounds
Arginine 41g histidine 21g
Leucine 70g isoleucine 31g
Lysine acetate 79g phenylalanine 27g
Threonine 36g valine 36g
Methionine 13g tryptophan 14g
Glycine 21g alanine 63g
Proline 56g N-acetyl-L-tyrosine 1.1g
Serine 38g cysteine hydrochloride 10g
Aspartic Acid 41g glutamic acid 71g
Sodium pyrosulfite 25g mannitol 100g
Water for injection
In right amount
Make 1000 bottles
Preparation method: with above 18 seed amino acids, mannitol is added in the water for injection, stirring down, the adding sodium pyrosulfite makes material dissolution and transfers pH3.5～6.0, or sodium pyrosulfite added in the water for injection dissolve, add 18 seed amino acids, mannitol, stirring makes material dissolution and transfers pH3.5～6.0, or mannitol added in the water for injection dissolve, add sodium pyrosulfite, 18 seed amino acids, stirring makes material dissolution and transfers pH3.5～6.0, add the injection-use activated carbon of 0.01-0.5%, stirred the filtering active carbon 30 minutes, medicinal liquid is again through 0.45 μ m and 0.22 μ m filtering with microporous membrane, filtrate quantitatively is sub-packed in the vial, places freezer dryer, is cooled to-25 ℃～-30 ℃ and keeps after 2 hours, be cooled to-40 ℃～-45 ℃ again, open vacuum, slowly be warming up to-5 ℃～0 ℃ sublimation drying, stop drying less than 1% to moisture, lyophilization is finished, and gland is packed promptly.
Claims (7)
1, injection use compound (18 kinds) aminoacid and preparation method thereof.Contain in injection use compound (18 kinds) the aminoacid prescription, compound recipe (18 kinds) aminoacid also can contain stabilizing agents such as excipient, cosolvent, pH regulator agent, antioxidation and metal chelating agent.Characteristics are to have improved the stability and the quality of amino acid.
2, the described injection use compound of claim 1 (18 kinds) aminoacid dosage form, prescription and preparation method.
3, every bottle of the described injection use compound of claim 1 (18 kinds) aminoacid prescription contains 1～6.25g, is preferably 2.5～6.25g.
4, the described injection use compound of claim 1 (18 kinds) aminoacid prescription contains excipient, cosolvent, specifically can be lactose, sorbitol, mannitol, xylitol, glucose, dextran, polyvidone, Macrogol 4000, sodium chloride, sodium dihydrogen phosphate, sodium hydrogen phosphate etc., can be separately, also can mix use in varing proportions, total consumption be recipe quantity 0～25%, be preferably 5～10%.
5, the described injection use compound of claim 1 (18 kinds) aminoacid prescription can contain the pH regulator agent, specifically can be sodium bicarbonate, sodium carbonate, ammonia, sodium hydroxide., hydrochloric acid, acetic acid, sulphuric acid, lactic acid, citric acid, succinic acid, phosphoric acid, nitric acid, tartaric acid etc., sodium bicarbonate, sodium carbonate, ammonia, sodium hydroxide. etc., can be separately, also can mix use in varing proportions, total consumption be recipe quantity 0～3%, be preferably 0.1～2%.
6, the described injection use compound of claim 1 (18 kinds) aminoacid prescription can contain stabilizing agents such as antioxidation and metal chelating agent, be specially vitamin C, sodium sulfite, sodium sulfite, sodium pyrosulfite, cysteine hydrochloride, edetate, citric acid and citrate, tartaric acid and tartrate, can be separately, also can mix use in varing proportions, total consumption be recipe quantity 0～1%, be preferably 0.01～0.6%, to improve the antioxygenic property of product.
7, injection use compound (18 kinds) aminoacid method for making contains amino acid 18AA, 18AA-I, 18AA-II, 18AA-III, 18AA-IV, 18AA-V, 18AA-F, children's 18AA.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510056485 CN1736372A (en) | 2005-03-24 | 2005-03-24 | Compound amino acid for injection and its preparation process |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510056485 CN1736372A (en) | 2005-03-24 | 2005-03-24 | Compound amino acid for injection and its preparation process |
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| CN1736372A true CN1736372A (en) | 2006-02-22 |
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| CN 200510056485 Pending CN1736372A (en) | 2005-03-24 | 2005-03-24 | Compound amino acid for injection and its preparation process |
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Cited By (9)
| 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 |
| 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 |
| CN102481266A (en) * | 2009-09-28 | 2012-05-30 | 李日薰 | Pharmaceutical Composition For Treating And Preventing Diseases Involving Joints And Connective Tissue |
| CN102973557A (en) * | 2012-12-13 | 2013-03-20 | 天津金耀集团有限公司 | Compound amino acid injection (18AA-III) composition |
| CN102988358A (en) * | 2012-12-13 | 2013-03-27 | 天津金耀集团有限公司 | Compound amino acid injection (18AA-IV) composition |
| CN102988360A (en) * | 2012-12-13 | 2013-03-27 | 天津金耀集团有限公司 | Compound amino acid injection (15HBC) composition |
| CN103006643A (en) * | 2011-09-28 | 2013-04-03 | 辽宁海思科制药有限公司 | Compound injection containing 18 amino acids and preparation method thereof |
| CN104208702A (en) * | 2014-08-20 | 2014-12-17 | 广东利泰制药股份有限公司 | Application of pH modifier in preparing compound amino acid injection and preparation method |
| CN104644567A (en) * | 2013-11-18 | 2015-05-27 | 北京众和民健医药科技有限公司 | Ornithine-aspartate freeze-dried powder for injection and preparation method thereof |
-
2005
- 2005-03-24 CN CN 200510056485 patent/CN1736372A/en active Pending
Cited By (11)
| 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 |
| CN102481266A (en) * | 2009-09-28 | 2012-05-30 | 李日薰 | Pharmaceutical Composition For Treating And Preventing Diseases Involving Joints And Connective Tissue |
| CN102481266B (en) * | 2009-09-28 | 2015-01-07 | 李日薰 | Pharmaceutical Composition For Treating And Preventing Diseases Involving Joints And Connective Tissue |
| 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 |
| CN103006643A (en) * | 2011-09-28 | 2013-04-03 | 辽宁海思科制药有限公司 | Compound injection containing 18 amino acids and preparation method thereof |
| CN103006643B (en) * | 2011-09-28 | 2014-01-22 | 辽宁海思科制药有限公司 | Compound injection containing 18 amino acids and preparation method thereof |
| CN102973557A (en) * | 2012-12-13 | 2013-03-20 | 天津金耀集团有限公司 | Compound amino acid injection (18AA-III) composition |
| CN102988358A (en) * | 2012-12-13 | 2013-03-27 | 天津金耀集团有限公司 | Compound amino acid injection (18AA-IV) composition |
| CN102988360A (en) * | 2012-12-13 | 2013-03-27 | 天津金耀集团有限公司 | Compound amino acid injection (15HBC) composition |
| CN104644567A (en) * | 2013-11-18 | 2015-05-27 | 北京众和民健医药科技有限公司 | Ornithine-aspartate freeze-dried powder for injection and preparation method thereof |
| CN104208702A (en) * | 2014-08-20 | 2014-12-17 | 广东利泰制药股份有限公司 | Application of pH modifier in preparing compound amino acid injection and preparation method |
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