CN102370640A - Compound amino acid preparation for hemodialysis and hemodialysis preparation containing same - Google Patents

Compound amino acid preparation for hemodialysis and hemodialysis preparation containing same Download PDF

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Publication number
CN102370640A
CN102370640A CN201010255751XA CN201010255751A CN102370640A CN 102370640 A CN102370640 A CN 102370640A CN 201010255751X A CN201010255751X A CN 201010255751XA CN 201010255751 A CN201010255751 A CN 201010255751A CN 102370640 A CN102370640 A CN 102370640A
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hemodialysis
preparation
amino acid
acid
isoleucine
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CN201010255751XA
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俞黎黎
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Hainan Wanzhou Green Pharmaceutical Co., Ltd.
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俞黎黎
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Abstract

The invention relates to a compound amino acid preparation for hemodialysis and a hemodialysis preparation containing the same. The invention provides a preparation for modulating disorder of plasma aminogram of hemodialysis patients by using a plurality of essential amino acids and semi-essential amino acids, specifically relates to a solid powder form or liquid bicarbonate hemodialysis preparation used for treating nephrosis and containing compound amino acids, and especially to a hemodialysis preparation containing L-leucine, L-isoleucine, L-valine, L-threonine, L-phenylalanine, L-methionine, L-tryptophan, L-lysine, L-histidine, L-arginine and a pH conditioning agent (e.g., acetic acid, citric acid, malic acid, lactic acid and hydrochloric acid) and a preparation method thereof. The hemodialysis preparation further contains sodium chloride, potassium chloride, calcium chloride, magnesium chloride and sodium bicarbonate, and can also include glucose. Compared to conventional bicarbonate hemodialysis preparations, the preparation provided in the invention has the advantages of partly modulating disorder of plasma aminogram of hemodialysis patients and reducing side effects in hemodialysis treatment.

Description

Hemodialysis is used preparation with compound amino acid supplement and the hemodialysis that contains amino acid
Technical field
The present invention relates to the amino acid that a kind of hemodialysis is used, be exactly specifically the kidney patient in hemodialysis with each seed amino acid as the hemodialysis of nutritional supplementation with preparation and preparation method thereof.
Background technology
As everyone knows; The impairment of renal function can increase the underfed chance of occurrence of nephrotic; When many evidence acute renal failures and chronic renal failure, protein and amino acid metabolism are unusual, show as the interior amino acid levels of blood plasma amino acid levels and cell and occur unusual.Relevant 1. loss of appetite of its reason with multiple factor, vomiting, diarrhoea, long-term low protein diet makes and must reduce by aminoacid.2. the nonessential ability of amino acid of RE descends, and causes nonessential aminoacid to raise.3. renal failure and hemodialysis patients often merge VitB 6Shortage, cause the concentration of branched-chain amino acid such as leucine, isoleucine, valine to reduce, again because the amino acid molecular amount is less; Very easily removed by hemodialysis; Many clinical researches prove, each hemodialysis, and the patient will lose the aminoacid of 5-8g; Wherein essential amino acids is reduced to 16.85 ± 4.09mg% after the dialysis by preceding the 22.4 ± 3.3mg% of dialysis, thereby causes the more tangible disorder of amino acid metabolism of uremic patient.
Summary of the invention
For above-mentioned reasons, the present invention has added multiple to very important essential amino acids of kidney patient and semi-dispensable amino acid in original traditional dialysis preparation.Can regulate the amino acid whose balance of hemodialysis process effectively, improve in the hemodialysis or patient's ill symptoms behind the hemodialysis.
In order to achieve the above object; The present invention proposes a kind of contain amino acid, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium bicarbonate, stabilizing agent or pH regulator agent (can be acetic acid, lactic acid, malic acid, citric acid, hydrochloric acid etc.); Preparation is used in the hemodialysis that also can comprise the Fructus Vitis viniferae composition; Provided by the inventionly contain the amino acid hemodialysis and use preparation; Can be to contain the amino acid hemodialysis of above-mentioned electrolyte ingredient with powderous preparations and liquid preparation, also can be not above-mentioned four kinds of products that contain the hemodialysis of electrolyte ingredient with amino acid powderous preparations and liquid preparation.
The objective of the invention is to realize through following technical scheme.
Preparation is used in amino acid hemodialysis provided by the invention, is solid-state powderous preparations and liquid preparation, and main component does; L-leucine, L-isoleucine, L-valine, L-methionine, L-phenylalanine, L-lysine, L-threonine, L-tryptophan, L-histidine, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium bicarbonate, PH regulator (like malic acid, citric acid, lactic acid, acetic acid, hydrochloric acid etc.) also can comprise glucose and L-arginine.Dissolve at the clinical liquid that should be prepared into following concentration when carrying out hemodialysis; L-leucine 5-15mg/L, L-isoleucine 3-12mg/L, L-valine 3-12mg/L, L-methionine 6-18mg/L, L-phenylalanine 7-22mg/L, L-lysine 3-12mg/L, L-threonine 2-9mg/L, L-tryptophan 1-5mg/L, L-histidine 2-16mg/L, L-arginine 0-20mg/L, Na +130-145mmol/L, K +0-4mmol/L, Ca 2+1-3mmol/L, Mg 2+0.25-1.0mmol/L, Cl -90-120mmol/L, HCO -25-40mmol/L, pH regulator agent 1-10mmol/L, glucose 0-5g/L
Each composition preferred concentration of the present invention does; L-leucine 11.43mg/L, L-isoleucine 8.3mg/L, L-valine 8.52mg/L, L-methionine 12.5mg/L, L-phenylalanine 14.5mg/L, L-lysine 8.8mg/L, L-threonine 5.2mg/L, L-tryptophan 3.6mg/L, L-histidine 6.23mg/L, L-arginine 0 or 10.4mg/L, Na +138mmol/L, K +2mmol/L, Ca 2+1.5mmol/L, Mg 2+0.5mmol/L, Cl -110mmol/L, HCO -35mmol/L, pH regulator agent 2mmol/L, glucose 0.2g/L
The invention provides a kind of hemodialysis with the compound amino acid supplement and contain the solid powder product preparation method of the hemodialysis of amino acid with preparation; The raw material of being selected for use in the present invention prescription through sieving, is sealed up for safekeeping after the mixing in packing container, during application with the water for dialysis dissolving and be diluted to above-mentioned concentration.
The invention provides a kind of hemodialysis with the compound amino acid supplement and contain the method for preparing of the hemodialysis of amino acid with the fluid product of preparation; With raw material of selecting for use in the present invention's prescription and purified water combination, through dissolving, filter the back embedding in packing container, be diluted to above-mentioned concentration with dialysis water during application.
The present invention compares with the similar preparation of prior art and has the following advantages
1. preparation provided by the invention and traditional hemodialysis with preparation relatively have the disorderly effect of obvious suppression blood plasma aminogram, can prevent the nephrotic blood plasma is amino acid whose when carrying out dialysis treatment to lose, and can improve the nutritional status of dialysis patient.In clinical respectively with the hemodialysis of the present invention preparation with preparation and traditional hemodialysis preparation, through the concentration of essential amino acids in the amino-acid analyzer mensuration blood plasma.Relatively the concentration results of essential amino acids is following in the patient's blood plasma of dialysis front and back:
(umol/L)
Aminoacid Key health people Before the dialysis After the tradition dialysis After the present invention's dialysis
The L-isoleucine 89.6±15.4 86.3±39.6 63.4±33.8 81.4±17.6
The L-leucine 159.7±56.5 137.7±60.5 115.5±45.1 152.7±29.1
The L-threonine 620.0±110.3 548.4±130.3 430.9±113.3 532.2±105.3
The L-valine 232.5±47.5 227.5±108.8 108.8±61.8 152.3±43.3
The L-phenylalanine 78.1±13.4 140.9±47.2 96.4±26.4 88.3±23.0
The L-methionine 35.9±8.0 35.9±8.0 25.5±9.9 29.9±5.7
Continuous table (umol/L)
L-lysine 187.5±66.5 177.7±67.2 110.3±35.0 133.6±27.8
The L-histidine 147.2±25.5 126.8±44.3 76.0±30.4 101.6±12.9
The L-arginine 109.5±22.4 95.1±39.9 49.1±20.7 73.7±25.3
2. clinical effectiveness is definite.Have a headache in the hemodialysis, cardiopalmus, uncomfortable in chest and side effect incidence rates such as hypertension or hypotension all obviously reduce.
The specific embodiment
Embodiment 1.
Press the row weight portion respectively and get following various amino acid starting material; L-leucine 12.9g, L-isoleucine 9.3g, L-lysine 10g, L-methionine 14.14g, L-phenylalanine 16.15g, L-valine 9.3g, L-threonine 5.8g, L-tryptophan 3.8g, L-histidine 6.4g, L-arginine 11.6g; Mix homogeneously after sieving is packaged in the container.
Instance 2.
Press the row weight portion respectively and get following various amino acid starting material; L-leucine 12.9g, L-isoleucine 9.3g, L-lysine 10g, L-methionine 14.1g, L-phenylalanine 16.1g, L-valine 9.6gL-threonine 5.8g, L-tryptophan 3.8g, L-histidine 6.4g, L-arginine 11.6g; Place purified water to dissolve; Neutral with pH regulator agent acid adjustment basicity to closely; After the aseptic filtration with the concentrated solution fill in container, seal after charging into nitrogen.
Instance 3.
Press the row weight portion and get following various amino acid starting material; L-leucine 14.6g, L-isoleucine 10.6g, L-lysine 11.3g, L-methionine 16g, L-phenylalanine 18.2g, L-valine 10.9g/, L-threonine 6.6g, L-tryptophan 4.3g, L-histidine 7.3g; Mix homogeneously after sieving respectively is packaged in the container.
Instance 4.
Press the row weight portion and get following various amino acid starting material; L-leucine 12.9g, L-isoleucine 9.3g, L-lysine 10g, L-methionine 14.1g, L-phenylalanine 16.1g, L-valine 9.6g, L-threonine 5.8g, L-tryptophan 3.8g, L-histidine 6.4g, L-arginine 11.6g; And sodium chloride, potassium chloride, calcium chloride, magnesium chloride, the pH regulator agent of recipe quantity, also can comprise glucose; Mix homogeneously after sieving respectively is packaged in the container.
After sieving, the sodium bicarbonate that other gets recipe quantity is packaged in the container.
Instance 5.
Press the row weight portion and get following various amino acid starting material; L-leucine 14.6g, L-isoleucine 10.6g, L-lysine 11.3g, L-methionine 16g, L-phenylalanine 18.2g, L-valine 10.9g, L-threonine 6.6g, L-tryptophan 4.3g, L-histidine 7.3g; And sodium chloride, potassium chloride, calcium chloride, magnesium chloride, the pH regulator agent of recipe quantity, also can comprise glucose; Mix homogeneously after sieving respectively is packaged in the container.
Other gets and is packaged in the container after the recipe quantity sodium bicarbonate sieves.
Instance 6
Press the row weight portion and get following various amino acid starting material; L-leucine 12.9g, L-isoleucine 9.3g, L-lysine 10g, L-methionine 14.1g, L-phenylalanine 16.1g, L-valine 9.6g, L-threonine 5.8g, L-tryptophan 3.8g, L-histidine 6.4g, L-arginine 11.6g; And sodium chloride, potassium chloride, calcium chloride, magnesium chloride, the pH regulator agent of recipe quantity, also can comprise glucose; Be dissolved in the purified water, embedding is in container after filtering.
The sodium bicarbonate that other gets recipe quantity is dissolved in the purified water, and embedding is in container after filtering.
Instance 7
Press the row weight portion and get following various amino acid starting material; L-leucine 14.6g, L-isoleucine 10.6g, L-lysine 11.3g, L-methionine 16g, L-phenylalanine 18.2g, L-valine 10.9g, L-threonine 6.6g, L-tryptophan 4.3g, L-histidine 7.3g; And sodium chloride, potassium chloride, calcium chloride, magnesium chloride, the pH regulator agent of recipe quantity, also can comprise glucose; Be dissolved in the purified water, embedding is in container after filtering.
Other gets the recipe quantity sodium bicarbonate and is dissolved in the purified water, and embedding is in container after filtering.

Claims (6)

1. amino acid is used in hemodialysis; It is characterized in that forming, when clinical practice, should be prepared into following concentration: L-leucine 5-15mg/L, L-isoleucine 3-12mg/L, L-lysine 3-12mg/L, L-methionine 6-18mg/L, L-phenylalanine 7-22mg/L, L-valine 3-12mg/L, L-threonine 2-9mg/L, L-tryptophan 1-5mg/L, L-histidine 2-10mg/L, L-arginine 0-20mg/L by following several seed amino acids
2. preparation is used in the hemodialysis that contains amino acid; It is characterized in that by following several seed amino acids and sodium chloride; Potassium chloride, calcium chloride, magnesium chloride; Sodium bicarbonate; The pH regulator agent is formed, and also can comprise glucose, when clinical practice, should be prepared into following concentration: L-leucine 5-15mg/L, L-isoleucine 3-12mg/L, L-lysine 3-12mg/L, L-methionine 6-18mg/L, L-phenylalanine 7-22mg/L, L-valine 3-12mg/L, L-threonine 2-9mg/L, L-tryptophan 1-5mg/L, L-histidine 2-10mg/L, L-arginine 0-20mg/L, Na+130-145mmol/L, K +0-4mmol/L, Ca 2+1-3mmol/L, Mg 2+0.25-1.0mmol/L, Cl -90-120mmol/L, HCO -25-40mmol/L, pH regulator agent 1-10mmol/L, glucose 0-5g/L
3. use the compound amino acid supplement according to the hemodialysis of claim 1, each constituent concentration is when clinical practice: L-leucine 11.43mg/L, L-isoleucine 8.3mg/L, L-lysine 8.83mg/L, L-methionine 12.5mg/L, L-phenylalanine 14.55mg/L, L-valine 8.52mg/L, L-threonine 5.2mg/L, L-tryptophan 3.6mg/L, L-histidine 6.23mg/L, L-arginine 0-10.39mg/L, pH regulator agent 1-4mmg/L, glucose 0.2g/L
4. use preparation according to the amino acid hemodialysis that contains of claim 1.2, the various compositions of said preparation should be prepared into following concentration when clinical clinical practice: L-leucine 11.43mg/L, L-isoleucine 8.3mg/L, L-lysine 8.83mg/L, L-methionine 12.5mg/L, L-phenylalanine 14.55mg/L, L-valine 8.52mg/L, L-threonine 5.2mg/L, L-tryptophan 3.6mg/L, L-histidine 6.23mg/L, L-arginine 0-10.39mg, Na +138mmol/L, K +2.0mmol/L, Ca 2+1.5mmol/L, Mg 2+0.5mmol/L, Cl -110mmol/L, HCO -35mmol/L, pH regulator agent 1-4mmol/L, glucose 0.2g/L
5. the hemodialysis of using amino acid according to the hemodialysis of claim 1-4 and containing amino acid uses the pH regulator agent described in the composition of preparation to be: acetic acid (or glacial acetic acid) citric acid, malic acid, lactic acid or hydrochloric acid, can use separately also can work in coordination mixes and uses.
6. it also can be the liquid condition preparation as the powder of solid state that preparation is used in the hemodialysis of using amino acid according to claim 1-5 hemodialysis and containing amino acid.
CN201010255751XA 2010-08-18 2010-08-18 Compound amino acid preparation for hemodialysis and hemodialysis preparation containing same Pending CN102370640A (en)

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CN103638526A (en) * 2013-12-12 2014-03-19 河北紫薇山制药有限责任公司 Preparation for purifying blood as well as preparation method and application thereof
CN104586884A (en) * 2015-01-09 2015-05-06 李淑秀 Novel hemodialysis concentrate
CN106176730A (en) * 2015-05-05 2016-12-07 刘力 The amino acid whose medical composition and its use of 9AA containing chiral photo-isomerisation compound
CN106511339A (en) * 2015-09-09 2017-03-22 华仁药业股份有限公司 Dual-chamber bag amino acid peritoneal dialysis solution and preparation method thereof
CN107456462A (en) * 2016-06-02 2017-12-12 山东威高药业股份有限公司 Amino acid haemodialysis concentrate
AU2017300740B2 (en) * 2016-07-22 2023-05-11 Fresenius Medical Care Deutschland Gmbh HD acid concentrate with amino acids

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103638526A (en) * 2013-12-12 2014-03-19 河北紫薇山制药有限责任公司 Preparation for purifying blood as well as preparation method and application thereof
CN104586884A (en) * 2015-01-09 2015-05-06 李淑秀 Novel hemodialysis concentrate
CN106176730A (en) * 2015-05-05 2016-12-07 刘力 The amino acid whose medical composition and its use of 9AA containing chiral photo-isomerisation compound
CN106511339A (en) * 2015-09-09 2017-03-22 华仁药业股份有限公司 Dual-chamber bag amino acid peritoneal dialysis solution and preparation method thereof
CN106511339B (en) * 2015-09-09 2020-01-21 华仁药业股份有限公司 Double-chamber bag amino acid peritoneal dialysis solution and preparation method thereof
CN107456462A (en) * 2016-06-02 2017-12-12 山东威高药业股份有限公司 Amino acid haemodialysis concentrate
AU2017300740B2 (en) * 2016-07-22 2023-05-11 Fresenius Medical Care Deutschland Gmbh HD acid concentrate with amino acids

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