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Compound amino acid injection composition suitable for liver disease patient

A compound amino acid, a technology for patients with liver disease, applied in the direction of drug combination, anhydride/acid/halide active ingredients, pharmaceutical formulations, etc., can solve problems such as inability to achieve nitrogen balance, reduce the incidence of adverse reactions, chemical stability The effect of lowering blood ammonia levels

Inactive Publication Date: 2008-02-13
费森尤斯卡比华瑞制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the report of Holm et al., compared with the infusion containing only BCAA, the infusion containing BCAA and a small amount of phenylalanine, tryptophan and methionine has a more obvious correction effect on the patient's amino acid level and can achieve positive nitrogen balance; 80g amino acid / Postoperative patients in the daily dose group achieved nitrogen balance within 2 weeks, while postoperative patients in the 50g amino acid / day dose group could not achieve nitrogen balance

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] Weigh each amino acid raw material according to the following table:

[0058] Ingredient Weight

[0059] L-Isoleucine 8.32g

[0060] L-Leucine 10.472g

[0061] L-Lysine Acetate 7.768g

[0062] L-Methionine 0.88g

[0063] Acetylcysteine ​​0.56 g

[0064] L-Phenylalanine 0.704g

[0065] L-Threonine 3.52g

[0066] L-Tryptophan 0.56g

[0067] L-valine 8.064g

[0068] L-Arginine 8.576g

[0069] L-Histidine 2.24g

[0070] Glycine 4.656 g

[0071] L-alanine 3.712g

[0072] L-Proline 4.584g

[0073] L-serine 1.792g

[0074] Rinse all production equipment with water for injection. During the whole production process, the product must be protected by nitrogen gas filtered with a pore size of 0.22 μm.

[0075] Put the weighed amino acid raw material into the preparation tank. Vacuum the preparation tank until the vacuum degree reaches more than 80%, and then fill it with nitrogen to positive pressure after vacuuming.

[0076] Under the protection of nitrogen, add 7...

Embodiment 2

[0083] Weigh each amino acid raw material according to the following table:

[0084] Ingredient Weight

[0085] L-Isoleucine 10.40g

[0086] L-Leucine 13.09g

[0087] L-Lysine Acetate 9.71g

[0088] L-Methionine 1.10g

[0089] Acetylcysteine ​​0.70 g

[0090] L-Phenylalanine 0.88g

[0091] L-Threonine 4.40g

[0092] L-Tryptophan 0.70g

[0093] L-Valine 10.08g

[0094] L-Arginine 10.72g

[0095] L-Histidine 2.80g

[0096] Glycine 5.82 g

[0097] L-alanine 4.64g

[0098] L-Proline 5.73g

[0099] L-serine 2.24g

[0100] Rinse all production equipment with water for injection. During the whole production process, the product must be protected by nitrogen gas filtered with a pore size of 0.22 μm.

[0101] Put the weighed amino acid raw material into the preparation tank. Vacuum the preparation tank until the vacuum degree reaches more than 80%, and then fill it with nitrogen to positive pressure after vacuuming.

[0102] Under the protection of nitrogen, add 780-820...

Embodiment 3

[0109] Weigh each amino acid raw material according to the following table:

[0110] Ingredient Weight

[0111] L-Isoleucine 12.48g

[0112] L-Leucine 15.708g

[0113] L-Lysine Acetate 11.652g

[0114] L-Methionine 1.32g

[0115] Acetylcysteine ​​0.84 g

[0116] L-Phenylalanine 1.056g

[0117] L-Threonine 5.28g

[0118] L-Tryptophan 0.84g

[0119] L-Valine 12.096g

[0120] L-Arginine 12.864 g

[0121] L-Histidine 3.36g

[0122] Glycine 6.984 g

[0123] L-alanine 5.568 g

[0124] L-Proline 6.876g

[0125] L-serine 2.688g

[0126] Rinse all production equipment with water for injection. During the whole production process, the product must be protected by nitrogen gas filtered with a pore size of 0.22 μm.

[0127] Put the weighed amino acid raw material into the preparation tank. Vacuum the preparation tank until the vacuum degree reaches more than 80%, and then fill it with nitrogen to positive pressure after vacuuming.

[0128] Under the protection of nitrogen,...

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Abstract

The present invention comprises a compound amino acid injection and the preparation method. The characteristics of the injection are as follows. The prescription comprises most human essential amino acid and non essential amino acid. Content of branched chain amino acid (BCAA) in each amino acid is high, and content of the aromatic amino acid (AAA) is low. Content of arginine is high. The prescription comprises the acetylcysteine. The compound amino acid injection is prepared under strict control of aerobic environment, which makes the product in accordance with quality requirement without any antioxidant. The production is applicable in the patients with hepatic disease, which is in accordance with specific requirement for AAA restriction. No antioxidant is added in the prescription, which can effectively reduce incidence rate of adverse reaction in clinical application.

Description

technical field [0001] The invention discloses a compound amino acid injection composition containing 15 kinds of amino acids and a preparation method thereof. The prescription of the compound amino acid injection composition is suitable for liver disease patients. Background technique [0002] Malnutrition is a recurring problem in patients with chronic liver disease. Malnutrition is very common in patients with chronic liver disease due to the reduction of dietary protein intake in patients with chronic liver disease, and chronic liver disease itself is a chronic wasting disease and can cause nutritional metabolism disorders in patients. Among the malnutrition that occurs, "protein-energy malnutrition (PEM)" is the most common type. The survey found that the incidence of PEM in patients with liver cirrhosis is as high as 20-60%. [0003] Malnutrition is very common in patients with chronic liver disease, and it is closely related to liver dysfunction, attack rate and mor...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/198A61K31/19A61K31/401A61K31/405A61K31/4172A61P1/16
Inventor 马涛
Owner 费森尤斯卡比华瑞制药有限公司
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