CN101332209A - Compound amino acid injection for treating hepatic encephalopathy - Google Patents
Compound amino acid injection for treating hepatic encephalopathy Download PDFInfo
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- CN101332209A CN101332209A CNA2007100287849A CN200710028784A CN101332209A CN 101332209 A CN101332209 A CN 101332209A CN A2007100287849 A CNA2007100287849 A CN A2007100287849A CN 200710028784 A CN200710028784 A CN 200710028784A CN 101332209 A CN101332209 A CN 101332209A
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Abstract
The present invention provides a compound amino acid injection with high Fischer rate for curing hepatic encephalopathy, which can rapidly lower the blood ammonia density. The present invention increases the weight parts of three branched amino acid and arginine and reduces the weight parts of sulfur amino acid and ammonia amino acid. The injection provided by the present invention is more conducive to regulating the plasma amino acid spectrum to be normal, increases the density of arginine, stably lowers the level of blood ammonia of the patient and improves the immunity of the organism, thus achieving the aim of rapidly improving the symptom of hepatic encephalopathy and replenishing nutrition. Therefore, the injection of the present invention has higher curing effect in improving hepatic encephalopathy.
Description
Technical field
The present invention relates to a kind of amino acid, specifically relate to a kind of Amino Acid Compound Injection for the treatment of hepatic encephalopathy.
Background technology
Hepatic encephalopathy (hepatic encephalopathy HE) claims in the past to be caused hepatic coma that by serious hepatopathy based on the syndrome of metabolism disorder, central nervous system function imbalance, its main clinical manifestation is disturbance of consciousness, behavioral disorder and stupor.Most of hepatic encephalopathy is to be caused by various liver cirrhosis, also can cause that pathogenesis is not clear fully so far by the door body shunt operation that improves portal hypertension.Many theories are arranged at present, this comprising research at most, it is the most certain that what certificate was arranged is the uneven theory of ammonia intoxication theory and amino acid metabolism.
According to the uneven theory of amino acid metabolism, the amino acid preparation of the various treatment hepatic encephalopathies of having gone on the market is successively developed in countries in the world, Aminosteril N-hepa8% as German fresenius1978 listing, the HepatAmine that U.S. American McGaw nineteen eighty-two goes on the market, the Aminoleban of the big tomb Co., Ltd. of Japan nineteen eighty-three listing and ministry standard Amino Acid Compound Injection (15AA) or the like, these mainly are according to write out a prescription of viewpoint of " content (be Fischer than) that improves branched-chain amino acid is with the treatment hepatic encephalopathy " of propositions such as the Fischer of the seventies, are applied in the hepatic encephalopathy symptom and the nutriture that have improved the patient to a certain extent clinically.
But along with going deep into of clinical application research, researcher has had further understanding to the origin cause of formation of hepatic encephalopathy, except the false neurotrasmitter theory that Fischer proposes, ammonia concentration is too high to be the main cause that causes hepatic encephalopathy equally, and product in the past all is only to focus on the Fischer ratio that improves amino acid.In order to reach ideal therapeutic effect, the Fischer of preparation in the Fischer ratio, also will reduce ammonia concentration than a suitable ratio will be arranged in further raising amino acid transfusion.
Summary of the invention
For solving the problem that prior art exists, the present invention proposes a kind of Fischer than Amino Acid Compound Injection high, that can comparatively fast reduce the treatment hepatic encephalopathy of ammonia concentration.
The present invention is achieved in that
The Amino Acid Compound Injection that the present invention treats hepatic encephalopathy comprises following components in part by weight:
L-isoleucine 11.95～13.89
L-leucine 12.00～14.50
L-valine 11.50～13.00
L-lysine acetate 4.60～6.20
L-methionine 0.30～0.60
L-phenylalanine 0.00～0.40
L-threonine 2.80～2.90
L-tryptophan 0.85～0.95
L-alanine 11.00～11.50
L-arginine 18.50～22.68
L-Aspartic Acid 0.10～0.30
L-histidine 3.95～4.95
L-proline 6.50～7.50
L-serine 3.40～3.60
L-tyrosine 0.25～0.65
Glycine 7.00～7.50
L-cysteine 0.20～0.40
Sodium sulfite 0.20～0.40
The Amino Acid Compound Injection of described treatment hepatic encephalopathy preferably includes following components in part by weight:
L-isoleucine 12.12
L-leucine 12.45
L-valine 11.73
L-lysine acetate 5.20
L-methionine 0.58
L-phenylalanine 0.39
L-threonine 2.82
L-tryptophan 0.92
L-alanine 11.07
L-arginase 12 0.26
L-Aspartic Acid 0.26
L-histidine 4.08
L-proline 6.98
L-serine 3.42
L-tyrosine 0.52
Glycine 7.11
L-cysteine 0.32
Sodium sulfite 0.32
The Amino Acid Compound Injection of described treatment hepatic encephalopathy can comprise following components in part by weight:
L-isoleucine 11.95
L-leucine 14.50
L-valine 11.50
L-lysine acetate 4.60
L-methionine 0.60
L-phenylalanine 0.00
L-threonine 2.80
L-tryptophan 0.85
L-alanine 11.00
L-arginine 18.50
L-Aspartic Acid 0.10
L-histidine 3.95
L-proline 7.50
L-serine 3.40
L-tyrosine 0.65
Glycine 7.00
L-cysteine 0.20
Sodium sulfite 0.20
The Amino Acid Compound Injection of described treatment hepatic encephalopathy can comprise following components in part by weight:
L-isoleucine 13.89
L-leucine 12.00
L-valine 13.00
L-lysine acetate 6.20
L-methionine 0.30
L-phenylalanine 0.40
L-threonine 2.90
L-tryptophan 0.95
L-alanine 11.00
L-arginine 18.50
L-Aspartic Acid 0.30
L-histidine 4.95
L-proline 6.50
L-serine 3.60
L-tyrosine 0.25
Glycine 7.00
L-cysteine 0.40
Sodium sulfite 0.40
The present invention compares with the similar preparation of prior art and has the following advantages:
(1) increases the weight portion of three kinds of branched-chain amino acid relatively, improved the Fischer ratio.Simple branched-chain amino acid (BCAA) preparation is applied to acute hepatoencephalopathy and has become conventional, but as the amino acid preparation that replenishes hepatic insufficiency patient nutrition simultaneously, also want the overall balance of considered amino acid, the Fischer ratio of Japan Aminoleban, U.S. HepatAmine, Amino Acid Compound Injection (15AA) (former Hepat Amine) is 37.05, and among the present invention Fischer than being about 1.5 times of above-mentioned injection.Experiment shows that the present invention can correct the unusual of aminogram in the hepatic insufficiency patient blood preferably, improves amino acid whose metabolism in the brain, promotes the metabolism of ammonia in the brain.
(2) improved the weight portion of arginine (Arg).According to the ammonia intoxication theory, the ammonia intoxication that the ammonia metabolism disorder causes is the main pathogenesis of hepatic encephalopathy, and the reason that removing blood ammonia or releasing blood ammonia increase is the major measure of treatment hepatic encephalopathy.Arginine content is Japanese Aminoleban, U.S. HepatAmine, Amino Acid Compound Injection (15AA) 2.56 times in the injection of the present invention.Arginine is the important amino acid in the ornithine cycle, can promote ammonia synthesis carbamide, thereby reduces ammonia concentration.Experiment shows that patient's ammonia concentration decrease speed is higher than other same verieties behind use the present invention, aspect the reduction ammonia concentration effect is preferably being arranged.
In addition, arginine has the immunization of strengthening body.The immunologic function majority of Hepatic Cirrhosis reduces, operation wound and Hepatic Cirrhosis, especially hepatitis interstitialis chronica will be the patient of operation on liver or portal hypertension shunt operation, and some indexs of embodiment body's immunity such as serum insulin growth factor-1 (IGF-1), T cell subsets comprise CD
3, CD
4Or the like all descend, and after using arginine, the effect of being significantly improved.
(3) reduced the weight portion of sulfur-containing amino acid and ammonia exogenous amino acid.Avoiding too much using some is another main points of hepatopathy people nutritional support to the disadvantageous sulfur-containing amino acid of hepatopathy people, because of a little, has reduced the weight portion of methionine (Met) among the present invention.Other aspects have also reduced the weight portion of serine (Ser), threonine (Thr), glycine (Gly), lysine (Lys), histidine (His), Aspartic Acid ammonia exogenous amino acids such as (Asp).
(4) clinical effectiveness is definite, and side effect is little.
The specific embodiment
Below in conjunction with specific embodiment the present invention is further detailed
Embodiment 1
Following component is pressed the row weight portion place distilled water for injection to dissolve, the pH value of regulating this Freamine is put into solution in bottle or the plastic bag after the aseptic filtration to neutral, nitrogen-filled seal, and heat sterilization makes the present embodiment injection according to a conventional method.
L-isoleucine 12.12
L-leucine 12.45
L-valine 11.73
L-lysine acetate 5.20
L-methionine 0.58
L-phenylalanine 0.39
L-threonine 2.82
L-tryptophan 0.92
L-alanine 11.07
L-arginase 12 0.26
L-Aspartic Acid 0.26
L-histidine 4.08
L-proline 6.98
L-serine 3.42
L-tyrosine 0.52
Glycine 7.11
L-cysteine 0.32
Sodium sulfite 0.32
Embodiment 2
Prepare the injection of following component and weight portion by embodiment 1 method.
L-isoleucine 11.95
L-leucine 14.50
L-valine 11.50
L-lysine hydrochloride 4.60
L-methionine 0.60
L-phenylalanine 0.00
L-threonine 2.80
L-tryptophan 0.85
L-alanine 11.00
L-arginine 18.50
L-Aspartic Acid 0.10
L-histidine 3.95
L-proline 7.50
L-serine 3.40
L-tyrosine 0.65
Glycine 7.00
L-cysteine 0.20
Sodium sulfite 0.20
Embodiment 3
Prepare the injection of following component and weight portion by embodiment 1 method.
L-isoleucine 13.89
L-leucine 12.00
L-valine 13.00
L-lysine acetate 6.20
L-methionine 0.30
L-phenylalanine 0.40
L-threonine 2.90
L-tryptophan 0.95
L-alanine 11.00
L-arginine 18.50
L-Aspartic Acid 0.30
L-histidine 4.95
L-proline 6.50
L-serine 3.60
L-tyrosine 0.25
Glycine 7.00
L-cysteine 0.40
Sodium sulfite 0.40
Further set forth the beneficial effect of injection of the present invention below by concrete clinical experiment.
One, contrast clinical experiment
(1) research method
1, object of study:
The chronic hepatic insufficiency patient of hepatic encephalopathy (≤II level or subclinical) and/or hyperammonemia (the blood ammonia value surpasses 0.5 times of the normal value upper limit).
This ratio of studying male among the 123 routine patients mostly is 91/123 (74.0%), the range of age 27～70 years old, average 53 years old, with hbv-liver cirrhosis (87 examples, 70.7%) is main, wherein hepatic encephalopathy I～II level 27 examples (21.9%), patients with subclinical hepatic encephalopathy 58 examples (47.2%), numeral connects unusual 98 examples in test 121 examples, and (81.0%, 2 example connects test, hyperammonemia (blood ammonia exceeds 1.5 times of upper limits of normal) 58 examples (47.2%) for the illiteracy can't carry out numeral.
The 123 routine patients that enter statistical analysis are by accepting research medicine (seminar) and accepting control drug (matched group) grouping relatively, comprise age, sex ratio, body weight, blood pressure, the hepatopathy cause of disease, and hepatopathy level index, comprise that encephalopathy classification, numeral connect test classification, hyperammonemia case etc., two groups of differences of statistical test do not have significance, have comparability.
2, clinical study design:
Prediction, at random, single blind, parallel, contrast, multicenter.Seven days observing times, wherein administration time is six days.
Medication: intravenous drip injection of the present invention or contrast recurrence due to taking drug side's amino acid injection (15AA), once a day, and a 500ml, the infusion time is 3 hours.
Clinical effectiveness index; Hepatic encephalopathy classification, numeral connect test, ammonia concentration.
Clinical effectiveness reference index: objective indicators such as asterixis, blood plasma aminogram, prealbumin, transferrins, total protein, albumin.
Clinical safety index: vital sign index, clinical examination value and general reaction, local response and adverse events.
3, clinical research medicine
Research medicine: injection of the present invention (embodiment 1)
Control drug: Amino Acid Compound Injection (15AA)
(2) safety research result
In whole medication process, all in normal range, two groups do not have significant difference to the variation of seminar and two groups of patients' of matched group vital sign (body temperature, heart rate, respiratory frequency, blood pressure).
Two groups of blood leukocytes, platelet, the every index of liver function, renal function, electrolyte, blood glucose are being treated front and back no significant difference, no significant difference between two groups.
Seminar's adverse reaction rate is little, and degree is light, and fraction defective is 8.33%, and matched group is 10.94%, and seminar does not have bad incident and withdraws from research, has shown the good clinical application security.
(3) study on the efficiency result
1, the variation of blood plasma aminogram:
Treatment back phenylalanine levels seminar descends, and matched group rises, and two groups there was a significant difference, and significant difference P is 0.008.With the treatment before compare, seminar all has rising and difference that significance,statistical is arranged at isoleucine, leucine, alanine, arginine, cysteine, glutamic acid, proline etc., and matched group only proline and glycine ascending water flat there was a significant difference, seminar's phenylalanine levels descends and also reaches critical state (p=0.086) statistically
Table 1 is for treating front and back aminogram ratio, the result show seminar's branched-chain amino acid level obviously rise (with the treatment before compare, p=0.000), the meta ascensional range is 52.82 μ mol/L, and the matched group lowering of concentration, the meta fall is 8.81 μ mol/L, and two groups there was a significant difference (p=0.000).Aromatic amino acid concentration descends in seminar, meta fall 7.08 μ mol/L, and matched group has rising, 13.7%, two group of difference of meta ascensional range has significance (p=0.016).The Fischer ratio that shows in the table 1 more can clearly illustrate research thing treatment hepatic encephalopathy, improve the advantage of amino acid structure, seminar treatment after 6 days branched-chain amino acid and aromatic amino acid bring up to 4.32 than (Fischer than) by 3.71, increase rate is 0.61, improve percentage ratio and reach 52.22% (median, scope 19.05-101.50%), matched group then have and 9.48% descend (the meta excursion-17.8-1.47%)
Table 1. aminogram ratio
| The blood plasma aminogram | Seminar (N=21) | Matched group (N=24) |
| After treating before the treatment of branched-amino acid concentration | ? 719.64±117.37 787.20±146.54 | ? 823.94±133.81 795.16±161.93 |
| After treating before the treatment of aromatic amino acid concentration | ? 205.07±40.57 194.47±42.66 | ? 222.11±33.90 232.62±41.07 |
| After Fisher treats than treatment is preceding | ? 3.71±1.31 4.32±1.58 | ? 3.83±1.01 3.55±1.09 |
2, nitrogen balance:
45 routine patients variation in nitrogen balance level and the therapeutic process (21 people of seminar have wherein been measured, matched group 24 people), the result shows that positive nitrogen balance all appears in seminar and matched group, but seminar is higher than matched group, (accumulation nitrogen balance median is respectively 1.80 and 1.40), two groups of differences have significance (P=0.076).
Two, open clinical trial
(1) safety results
Have 9 examples and untoward reaction occurs in total statistics case 243 examples, the adverse events rate is 3.7%, transference cure after the drug withdrawal.
(2) validity result
Injection of the present invention is 78.2% to the chronic hepatic insufficiency patient's that shows as hepatic encephalopathy effective percentage, is 64.7% to the chronic hepatic insufficiency patient's that shows as hyperammonemia effective percentage.
Injection of the present invention in sum more helps regulating the blood plasma aminogram and is tending towards normal, increased arginic concentration, make the stable decline of patient's blood ammonia levels, improved the immunity of body simultaneously, thereby reach the rapid purpose of improving hepatic encephalopathy symptom and extra-nutrition, curative effect is higher improving aspect the hepatic encephalopathy degree.
Claims (4)
1. Amino Acid Compound Injection for the treatment of hepatic encephalopathy, it is characterized in that: described Amino Acid Compound Injection comprises following components in part by weight:
L-isoleucine 11.95～13.89
L-leucine 12.00～14.50
L-valine 11.50～13.00
L-lysine acetate 4.60～6.20
L-methionine 0.30～0.60
L-phenylalanine 0.00～0.40
L-threonine 2.80～2.90
L-tryptophan 0.85～0.95
L-alanine 11.00～11.50
L-arginine 18.50～22.68
L-Aspartic Acid 0.10～0.30
L-histidine 3.95～4.95
L-proline 6.50～7.50
L-serine 3.40～3.60
L-tyrosine 0.25～0.65
Glycine 7.00～7.50
L-cysteine 0.20～0.40
Sodium sulfite 0.20～0.40
2. a kind of Amino Acid Compound Injection for the treatment of hepatic encephalopathy as claimed in claim 1, it is characterized in that: described Amino Acid Compound Injection comprises following components in part by weight:
L-isoleucine 12.12
L-leucine 12.45
L-valine 11.73
L-lysine acetate 5.20
L-methionine 0.58
L-phenylalanine 0.39
L-threonine 2.82
L-tryptophan 0.92
L-alanine 11.07
L-arginase 12 0.26
L-Aspartic Acid 0.26
L-histidine 4.08
L-proline 6.98
L-serine 3.42
L-tyrosine 0.52
Glycine 7.11
L-cysteine 0.32
Sodium sulfite 0.32
3. a kind of Amino Acid Compound Injection for the treatment of hepatic encephalopathy as claimed in claim 1, it is characterized in that: described Amino Acid Compound Injection comprises following components in part by weight:
L-isoleucine 11.95
L-leucine 14.50
L-valine 11.50
L-lysine acetate 4.60
L-methionine 0.60
L-phenylalanine 0.00
L-threonine 2.80
L-tryptophan 0.85
L-alanine 11.00
L-arginine 18.50
L-Aspartic Acid 0.10
L-histidine 3.95
L-proline 7.50
L-serine 3.40
L-tyrosine 0.65
Glycine 7.00
L-cysteine 0.20
Sodium sulfite 0.20
4. a kind of Amino Acid Compound Injection for the treatment of hepatic encephalopathy as claimed in claim 1, it is characterized in that: described Amino Acid Compound Injection comprises following components in part by weight:
L-isoleucine 13.89
L-leucine 12.00
L-valine 13.00
L-lysine acetate 6.20
L-methionine 0.30
L-phenylalanine 0.40
L-threonine 2.90
L-tryptophan 0.95
L-alanine 11.00
L-arginine 18.50
L-Aspartic Acid 0.30
L-histidine 4.95
L-proline 6.50
L-serine 3.60
L-tyrosine 0.25
Glycine 7.00
L-cysteine 0.40
Sodium sulfite 0.40.
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|---|---|---|---|
| CN2007100287849A CN101332209B (en) | 2007-06-25 | 2007-06-25 | Compound amino acid injection for treating hepatic encephalopathy |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2011021926A1 (en) * | 2009-08-21 | 2011-02-24 | N.V. Nutricia | Regulating the amino acid pool used for the acute-phase protein synthesis |
| CN108721596A (en) * | 2018-06-29 | 2018-11-02 | 复旦大学附属中山医院 | A kind of compound amino acid vitamin injection and its application |
| US10471034B2 (en) | 2016-12-19 | 2019-11-12 | Axcella Health Inc. | Amino acid compositions and methods for the treatment of liver diseases |
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| CN115996645A (en) * | 2020-06-30 | 2023-04-21 | 庆尚国立大学校 产学协力团 | Composition for preventing, improving or treating diseases caused by nitration of tyrosine in protein comprising tyrosine as active ingredient |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6867193B1 (en) * | 1999-01-19 | 2005-03-15 | Nipro Corporation | Amino acid-containing albumin preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2011021926A1 (en) * | 2009-08-21 | 2011-02-24 | N.V. Nutricia | Regulating the amino acid pool used for the acute-phase protein synthesis |
| WO2011021938A2 (en) | 2009-08-21 | 2011-02-24 | N.V. Nutricia | Regulating the amino acid pool used for the acute-phase protein synthesis |
| WO2011021938A3 (en) * | 2009-08-21 | 2011-08-18 | N.V. Nutricia | Regulating the amino acid pool used for the acute-phase protein synthesis |
| US11602511B2 (en) | 2016-12-19 | 2023-03-14 | Axcella Health Inc. | Amino acid compositions and methods for the treatment of liver diseases |
| US10471034B2 (en) | 2016-12-19 | 2019-11-12 | Axcella Health Inc. | Amino acid compositions and methods for the treatment of liver diseases |
| US11129804B2 (en) | 2016-12-19 | 2021-09-28 | Axcella Health Inc. | Amino acid compositions and methods for the treatment of liver diseases |
| US10660870B2 (en) | 2017-08-14 | 2020-05-26 | Axcella Health Inc. | Compositions and methods for the treatment of liver diseases and disorders associated with one or both of hyperammonemia or muscle wasting |
| US10682325B2 (en) | 2017-08-14 | 2020-06-16 | Axcella Health Inc. | Compositions and methods for the treatment of liver diseases and disorders associated with one or both of hyperammonemia or muscle wasting |
| US11571404B2 (en) | 2017-08-14 | 2023-02-07 | Axcella Health Inc. | Compositions and methods for the treatment of liver diseases and disorders associated with one or both of hyperammonemia or muscle wasting |
| US10973793B2 (en) | 2018-06-20 | 2021-04-13 | Axcella Health Inc. | Compositions and methods for the treatment of fat infiltration in muscle |
| US10596136B2 (en) | 2018-06-20 | 2020-03-24 | Axcella Health Inc. | Compositions and methods for the treatment of fat infiltration in muscle |
| CN108721596A (en) * | 2018-06-29 | 2018-11-02 | 复旦大学附属中山医院 | A kind of compound amino acid vitamin injection and its application |
| CN115996645A (en) * | 2020-06-30 | 2023-04-21 | 庆尚国立大学校 产学协力团 | Composition for preventing, improving or treating diseases caused by nitration of tyrosine in protein comprising tyrosine as active ingredient |
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