Compound amino acid injecta, and preparation method and detection method thereof

Abstract

The invention discloses compound amino acid injecta, which contains arginine hydrochloride, histidine monohydrochloride, leucine, isoleucine, lysine hydrochloride and the like; meanwhile, the invention further discloses a preparation method of the compound amino acid injecta (18AA); in the event of ensuring the product quality, the compound amino acid injecta has the characteristics of saving energy and enhancing efficacy; by means of repetitive verification on precision, detection limit, quantitation limit, linear range and the like, a simple, convenient, rapid and reliable method with cleaning verification is ensured; furthermore, the residual quantity of antioxygen, namely sodium hydrogensulfite, in the compound amino acid injecta and sulphate ion generated by degrading sodium hydrogensulfite are detected according to an ion chromatography principle, thus, the amount of the antioxygen charged in the raw material proportioning can be accurately measured, and the stability of the raw material proportioning process is judged according to the measurement result; and a detection method of the compound amino acid injecta provided by the invention is an online derivative amino acid content measuring method, the speed is rapid, and the method is applied to large-scale detection.

Description

technical field

[0001] The invention relates to an injection and a preparation method and a detection method thereof, in particular to a compound amino acid injection and a preparation method and a detection method thereof. Background technique

[0002] Compound Amino Acid Injection (18AA) is an amino acid infusion. Under the condition of sufficient energy supply, it participates in the synthesis and metabolism of protein, obtains positive nitrogen balance, and generates enzymes, hormones, antibodies and structural proteins, promotes tissue healing and restores normal physiological functions It is mainly suitable for patients with protein deficiency of total parenteral nutrition and severe protein loss caused by various reasons such as surgery and burns.

[0003] At present, the production process of compound amino acid injection (18AA) is mostly based on the solubility, and the intolerant amino acid is injected first, and then the soluble amino acid is injected after it dis...

Examples

Embodiment 1

[0313] Embodiment 1: the preparation of compound amino acid injection

[0314] Arginine Hydrochloride 2.89g

[0315] Histidine Hydrochloride 2.46g

[0316] Leucine 3.79g

[0317] Isoleucine 1.70g

[0318] Lysine Hydrochloride 3.33g

[0319] Phenylalanine 2.83g

[0320] Threonine 1.97g

[0321] Valine 1.36g

[0322] Methionine 1.06g

[0323] Tryptophan 0.39g

[0324] Glycine 3.24g

[0325] Alanine 1.88g

[0326] Proline 1.00g

[0327] Tyrosine 0.11g

[0328] Serine 0.67g

[0329] Cysteine ​​Hydrochloride 0.44g

[0330] Aspartic Acid 1.15g

[0331] Glutamic acid 1.97g

[0332] Sodium bisulfite 0.50g

[0333] Xylitol 50.0g

[0334] Appropriate amount of water for injection

[0335] Full volume 1000ml;

[0336] Weigh each raw and auxiliary material according to the formula amount, wherein tryptophan is fed at 110% of the marked amount, and the rest is fed at 100% of the marked amount; water for injection is added to the liquid preparation tank to 80% of the tota...

Embodiment 2

[0337] Embodiment 2: the preparation of compound amino acid injection

[0338] Arginine Hydrochloride 2.65g

[0339] Histidine Hydrochloride 3.64g

[0340] Leucine 4.28g

[0341] Isoleucine 1.2g

[0342] Lysine Hydrochloride 2.84g

[0343] Phenylalanine 3.63g

[0344] Threonine 2.87g

[0345] Valine 0.82g

[0346] Methionine 0.65g

[0347] Tryptophan 0.52g

[0348] Glycine 3.84g

[0349] Alanine 1.25g

[0350] Proline 0.7g

[0351] Tyrosine 0.14g

[0352] Serine 0.86g

[0353] Cysteine ​​Hydrochloride 0.35g

[0354] Aspartic acid 0.83g

[0355] Glutamic acid 2.65g

[0356] Sodium bisulfite 0.7g

[0357] Xylitol 45.0g

[0358] Appropriate amount of water for injection

[0359] Full volume 1000ml;

[0360] Weigh each raw and auxiliary material according to the formula amount, wherein tryptophan is fed with 105% of the marked amount, and the rest is fed with 100% of the marked amount; add water for injection to 70% of the total amount prepared in the liquid pre...

Embodiment 3

[0361] Embodiment 3: the preparation of compound amino acid injection

[0362] Arginine Hydrochloride 3.46g

[0363] Histidine Hydrochloride 1.54g

[0364] Leucine 3.52g

[0365] Isoleucine 2.6g

[0366] Lysine hydrochloride 4.26g

[0367] Phenylalanine 2.25g

[0368] Threonine 1.34g

[0369] Valine 1.84g

[0370] Methionine 1.45g

[0371] Tryptophan 0.28g

[0372] Glycine 2.54g

[0373] Alanine 2.75g

[0374] Proline 1.4g

[0375] Tyrosine 0.08g

[0376] Serine 0.45g

[0377] Cysteine ​​Hydrochloride 0.52g

[0378] Aspartic Acid 1.48g

[0379] Glutamic acid 1.23g

[0380] Sodium bisulfite 0.35g

[0381] Xylitol 56.0g

[0382] Appropriate amount of water for injection

[0383] Full volume 1000ml;

[0384] Weigh each raw and auxiliary material according to the formula quantity, wherein tryptophan is fed with 115% of the marked amount, and the rest is fed with 100% of the marked amount; add water for injection to 85% of the total amount prepared in the liquid pr...

technical field

[0001] The invention relates to an injection and a preparation method and a detection method thereof, in particular to a compound amino acid injection and a preparation method and a detection method thereof. Background technique

[0002] Compound Amino Acid Injection (18AA) is an amino acid infusion. Under the condition of sufficient energy supply, it participates in the synthesis and metabolism of protein, obtains positive nitrogen balance, and generates enzymes, hormones, antibodies and structural proteins, promotes tissue healing and restores normal physiological functions It is mainly suitable for patients with protein deficiency of total parenteral nutrition and severe protein loss caused by various reasons such as surgery and burns.

[0003] At present, the production process of compound amino acid injection (18AA) is mostly based on the solubility, and the intolerant amino acid is injected first, and then the soluble amino acid is injected after it dis...

Examples

Embodiment 1

[0313] Embodiment 1: the preparation of compound amino acid injection

[0314] Arginine Hydrochloride 2.89g

[0315] Histidine Hydrochloride 2.46g

[0316] Leucine 3.79g

[0317] Isoleucine 1.70g

[0318] Lysine Hydrochloride 3.33g

[0319] Phenylalanine 2.83g

[0320] Threonine 1.97g

[0321] Valine 1.36g

[0322] Methionine 1.06g

[0323] Tryptophan 0.39g

[0324] Glycine 3.24g

[0325] Alanine 1.88g

[0326] Proline 1.00g

[0327] Tyrosine 0.11g

[0328] Serine 0.67g

[0329] Cysteine ​​Hydrochloride 0.44g

[0330] Aspartic Acid 1.15g

[0331] Glutamic acid 1.97g

[0332] Sodium bisulfite 0.50g

[0333] Xylitol 50.0g

[0334] Appropriate amount of water for injection

[0335] Full volume 1000ml;

[0336] Weigh each raw and auxiliary material according to the formula amount, wherein tryptophan is fed at 110% of the marked amount, and the rest is fed at 100% of the marked amount; water for injection is added to the liquid preparation tank to 80% of the tota...

Embodiment 2

[0337] Embodiment 2: the preparation of compound amino acid injection

[0338] Arginine Hydrochloride 2.65g

[0339] Histidine Hydrochloride 3.64g

[0340] Leucine 4.28g

[0341] Isoleucine 1.2g

[0342] Lysine Hydrochloride 2.84g

[0343] Phenylalanine 3.63g

[0344] Threonine 2.87g

[0345] Valine 0.82g

[0346] Methionine 0.65g

[0347] Tryptophan 0.52g

[0348] Glycine 3.84g

[0349] Alanine 1.25g

[0350] Proline 0.7g

[0351] Tyrosine 0.14g

[0352] Serine 0.86g

[0353] Cysteine ​​Hydrochloride 0.35g

[0354] Aspartic acid 0.83g

[0355] Glutamic acid 2.65g

[0356] Sodium bisulfite 0.7g

[0357] Xylitol 45.0g

[0358] Appropriate amount of water for injection

[0359] Full volume 1000ml;

[0360] Weigh each raw and auxiliary material according to the formula amount, wherein tryptophan is fed with 105% of the marked amount, and the rest is fed with 100% of the marked amount; add water for injection to 70% of the total amount prepared in the liquid pre...

Embodiment 3

[0361] Embodiment 3: the preparation of compound amino acid injection

[0362] Arginine Hydrochloride 3.46g

[0363] Histidine Hydrochloride 1.54g

[0364] Leucine 3.52g

[0365] Isoleucine 2.6g

[0366] Lysine hydrochloride 4.26g

[0367] Phenylalanine 2.25g

[0368] Threonine 1.34g

[0369] Valine 1.84g

[0370] Methionine 1.45g

[0371] Tryptophan 0.28g

[0372] Glycine 2.54g

[0373] Alanine 2.75g

[0374] Proline 1.4g

[0375] Tyrosine 0.08g

[0376] Serine 0.45g

[0377] Cysteine ​​Hydrochloride 0.52g

[0378] Aspartic Acid 1.48g

[0379] Glutamic acid 1.23g

[0380] Sodium bisulfite 0.35g

[0381] Xylitol 56.0g

[0382] Appropriate amount of water for injection

[0383] Full volume 1000ml;

[0384] Weigh each raw and auxiliary material according to the formula quantity, wherein tryptophan is fed with 115% of the marked amount, and the rest is fed with 100% of the marked amount; add water for injection to 85% of the total amount prepared in the liquid pr...

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