Amino Acids Injection for Hepatic Encephalopathy
(Special Formula 8% Amino Acids Injection)
Etiologically the onset of hepatic encephalopathy has been related to excess
ammonia, short-chain fatty acids and mercaptans. Recent studies have emphasized the importance of other contributory factors involved in severe hepatic impairment: disturbance of the free amino acid pattern in plasma characterized by an increase of phenylalanine, tryptophan, tyrosine and methionine, and a decrease of branched-chain amino acids such as leucine, isoleucine and valine.
 
The disturbance of the free plasma amino acids pattern causes disturbances in the transport of amino acids across the blood-brain barrier, increasing synthesis of false neurotransmitters in the brain, resulting in the disturbance of the overall cerebral amine metabolism. This disturbance of cerebral amine metabolism is suspected to be the major cause of hepatic encephalopathy.
 
With these findings as background information, Fischer et al developed a special formula of amino acids, containing high concentrations of branched-chain amino acids and low concentrations of phenylalanine, tryptophan and methionine, without tyrosine, to correct the disturbance of the plasma free amino acids pattern. They have conducted experimental and clinical studies of the special formula for the treatment of hepatic encephalopathy and demonstrated that the normalization of the plasma free amino acids pattern is effective in improving hepatic encephalopathy. ^1-3)

AMINOLEBAN injection is prepared with an amino acids composition identical to that of Fischer's formula. Clinical studies have shown that the injection is effective in correcting plasma amino acids concentration and the clinical symptoms of hepatic encephalopathy.
 

DESCRIPTION

AMINOLEBAN injection is a clear and colorless solution for injection. pH: Approx. 5.9 (mean value obtained immediately after manufacture and 5.5- 6.5 (specification value)
Specific gravity (20OC): 1.025.
Osmotic pressure ratio (to physiological saline): Approx. 3
 

COMPOSITION

Each 1000 mL of AMINOLEBAN injection contains:
Aminoacetic acid J.P. ...................................................  9.0 g
L-alanine  U.S.P. ............................................................ 7.5 g
L-arg inine HCI  J.P. .................................................................  7.3 g
(L-ar ginine equ ival ent) ...................................................  (6.0 g)
L-cysteine HCI monohydrate  U.S.P. .................................... 0.4 g
(L-cysteine equivalent)  ........................................................... (0.3 g)
L-histidine HCI monohydrate   J.P.  ....................................... 3.2 g
(L-histidine equ ival ent)   ................................................. (2. 4 g)
L-isoleucine  J.P.  ..........................................................   9.0 g
L-leucine  J.P.  ...............................................................  11 .0 g
L-lysine HCI  J.P.  ..........................................................   7.6 g
(L-lysine equ ival ent) ......................................................... (6.1 g)
L-methionine J.P. ............................................................ 1.0 g
L-phenylalanine J.P. ........................................................ 1.0 g
L-proline  U.S.P.   ....................................................................... 8.0 g
L-serine U.S.P. ................................................................ 5.0 g
L-threonine J.P. ............................................................... 4.5 g
L-tryptophan J.P. ............................................................. 0.7 g
L-valine  J.P.   ................................................................. 8.4 g
Water for injection U.S.P. ................................................  q.s.
 
Amino acids                               7.99% (w/v)
Branched-chain amino acids         35.5% (w/w) of total amino acids
Fischer’s Ratio*                       37.05
E/N ratio                                    1.09
Total Nitrogen                             12.2 g/L
Na (Approx)                                14 mEq/L
CI  (Approx)                               94 mEq/L
 
* Molar ratio of (valine+leucine+isoIeucine) / (tyrosine+phenylalanine) This product contains Sodium bisulfite 0.3 g/L as a stabilizer.
Sodium hydroxide is used as a pH adjuster

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