Clinical Nutrition - AMINOLEBAN INJECTION
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.
Description
Aminoleban Injection is a clear and colorless solution for injection with a pH of approximately 5.9 (mean value) and a specification value range of 5.5-6.5. The specific gravity at 20°C is 1.025, and the osmotic pressure ratio compared to physiological saline is approximately 3.
Composition
Each 1000 mL of Aminoleban Injection contains:
| Nutrient | Amount |
|---|---|
| Aminoacetic acid J.P. | 9.0 g |
| L-alanine U.S.P. | 7.5 g |
| L-arginine HCl J.P. | 7.3 g (L-arginine equivalent: 6.0 g) |
| L-cysteine HCl monohydrate U.S.P. | 0.4 g (L-cysteine equivalent: 0.3 g) |
| L-histidine HCl monohydrate J.P. | 3.2 g (L-histidine equivalent: 2.4 g) |
| L-isoleucine J.P. | 9.0 g |
| L-leucine J.P. | 11.0 g |
| L-lysine HCl J.P. | 7.6 g (L-lysine equivalent: 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 concentration | 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 |
| Sodium (Approx) | 14 mEq/L |
| Chloride (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.