CN101120917A - Compound amino acid injection composition suitable for kidney disease patient - Google Patents
Compound amino acid injection composition suitable for kidney disease patient Download PDFInfo
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- CN101120917A CN101120917A CNA2007100239258A CN200710023925A CN101120917A CN 101120917 A CN101120917 A CN 101120917A CN A2007100239258 A CNA2007100239258 A CN A2007100239258A CN 200710023925 A CN200710023925 A CN 200710023925A CN 101120917 A CN101120917 A CN 101120917A
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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. The present invention also contains non essential amino acid with insufficient quantity or incapable of production in the body for kidney disease. The compound amino acid injection is prepared under strict control of aerobic environment, which makes the product in accordance with quality requirements without any antioxidant. The production is applicable in the patients with kidney 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
The invention discloses a kind of compound amino acid injection composition that contains 15 seed amino acids and preparation method thereof, the prescription of this compound amino acid injection composition is applicable to the nephrotic.
Background technology
Acute renal failure is to cause that by a variety of causes the renal excretion function sharply goes down, serious disorderly clinical syndrome appears in organismic internal environment.During acute renal failure, body is in stress state, and catabolism is greater than anabolism.Renal function sharply descends, and the vivotoxin savings causes each system's poisoning symptom of whole body.Wherein symptom of digestive tract occurs the earliest, and loss of appetite, nausea,vomiting,diarrhea etc. make and take in the nutrition minimizing every day, more stimulate body consumption self deposit, employ protein, fatty energy supply.By the acute renal failure due to septicemia, the severe trauma, belong to the high de-agglomeration type.Catabolism is extremely vigorous, and muscle protein is degraded in a large number, and causing nitrogen to be detained obviously increases, and blood urea nitrogen raise and can reach 7.14～35.7mmol/L every day, and the serum creatinine increase reaches 176.8 μ mol/L.The high de-agglomeration metabolism has more increased the weight of renal failure.Acute renal failure patient is in the high de-agglomeration metabolism state on the one hand, one side nutrition Deficiency of Intake, so malnutrition is the one of the main reasons that causes the acute renal failure death.
The caused metabolic alterations of chronic renal failure is similar to acute renal failure, but with the progress of the course of disease, carrying out property of metabolism disorder increases the weight of, and nutrient imbalance is serious, influences prognosis.Protein and disorder of amino acid catabolism all appear in patients with chronic renal failure, are in the negative nitrogen balance state for a long time, and blood plasma total protein, serum albumin, transferrins, immunoglobulin level all descend.Disorder of amino acid metabolism makes that aminoacid is in balance-loss state in the blood plasma, and blood plasma essential amino acids ratio reduces and part non essential amino acid ratio is higher.
Hemodialysis itself also can cause amino acid whose losing.Ultrafiltration, dialysate flow and aminoacid infusion velocity when the permeability of amino acid whose removing and filter membrane, dialysis are relevant.Blood purification treatment during acute renal failure, every day, about 4～7g aminoacid was eliminated.Patients with chronic renal failure is carried out conventional low discharge dialyser when dialysing, and has the free amino acid of 6～8g (on an empty stomach) or 8～10g (after the meal) to be lost in the dialysis solution approximately, with advancing to have the polypeptide of 2～3g or also being eliminated in conjunction with aminoacid at every turn; When using the high flow capacity dialyser to carry out hemodialysis, the removing of free amino acid increases to some extent, and average out to 9.3 ± 2.7g when abdomen is saturating, as carries out CAPD, has every day the free amino acid of 2.0～3.5g to be eliminated from blood approximately.
Therefore, because the nephrotic causes Deficiency of Intake because disease itself influences on the one hand, as the anorexia that uremic toxins causes, some protopathy such as diabetes, lupus erythematosus and medicine etc. further go down patient's appetite, cause Deficiency of Intake; Secondary disease such as infection, pericarditis, heart failure and hormone therapy etc. can make patient more weak, have further limited the absorption of food; Dialysis itself can cause that nutrient substance loses in addition.Nearly all studies show that, the patient who no matter dialyses and still dialyse, the protein of normal various degrees～heat shortage property malnutrition.Wherein 1/3rd is light to the moderate malnutrition, and 6%～8% is severe malnutrition.Malnutrition mainly shows as the decline of many anthroposomatology indexs, as the decline of relative body weight, skinfold, all footpaths of upper arm or area, overall nitrogen; Total water and extracellular water increase; Multiple plasma protein concentration descends; Growthretardation; Amino acid metabolism unusual.
Malnutrition again to the nephrotic more after very adverse influence is arranged.Many discovering, in maintenance hemodialysis and the saturating patient of chronic abdomen, patient's nutriture and its sickness rate and case fatality rate are closely related.Lowie etc. find that in 13000 routine maintenance hemodialysis patients being carried out the retrospective study in 1 year by a definite date the serum albumin level is an important factor of prediction patient case fatality rate height.Other discovers, patient's sickness rate and case fatality rate and low albumen absorption, low serum albumin, low blood urea nitrogen and creatinine, low cholesterol, hypokalemia are closely related.Certainly, except that albumin, These parameters is too high also can to increase case fatality rate.
Nutrition treatment helps the recovery of renal function during acute renal failure.In the acute renal failure of acute tubular necrosis, the synthetic increase of the protein in the proximal tubule epithelial cell, nucleic acid and phospholipid, the acceleration of cell growth all needs certain nutrition as assurance, comprises the aminoacid that some are special.Willmore in 1969 and Dudrick at first reported and used the TPN treatment acute renal failure that contains hypertonic glucose and essential amino acids liquid, and indexs such as patient body weight, serum albumin are improved, and uremia's sx is used and obtained positive nitrogen balance after 5 days.Other has report use in conjunction essential amino acids and glucose and list to make comparisons with glucose, finds that the former descends by the easier serum creatinine that makes.
The nutrition treatment of chronic renal failure can delay the progress of renal failure, keeps good nutritional status, alleviates uremia's toxic reaction and metabolism disorder.
The domestic nephrotic's of being exclusively used in amino acid injection is at present: Amino Acid Compound Injection (9AA), former name are kidney peace injection.Comprise 8 kinds of essential amino acids and histidine in the prescription, be used for acute and the parenteral alimentation support chronic renal insufficiency patient; Severe renal nonfunction that major operation, wound or pyemia cause and acute and chronic renal failure.This product has numerous manufacturer production such as Guangzhou emigrant light, Cologne, Hunan and favorable to the people pharmaceutical factory, and clinical practice has certain curative effect.Its prescription is dependent on nephrotic's disorder of amino acid metabolism and shows the essential amino acids lowering of concentration, and discovers that histidine becomes essential amino acids when renal insufficiency.
Form from prescription, the prescription design of Amino Acid Compound Injection (9AA) has certain reasonability but irrational one side is also arranged.Reasonability embodies and to be that this prescription considered the low characteristics of essential amino acids content in such patient's body, and irrational one side has been to ignore fully the demand of such patient to non essential amino acid.In the renal insufficiency patient, some non essential amino acid such as arginine can become the condition essential amino acids, and a lot of non essential amino acid not only have the important physical function, also be the essential raw material of protein synthesis, therefore comprise a certain proportion of non essential amino acid in the prescription and be necessary.
Taken all factors into consideration the demand of patient in the prescription of the present invention to essential amino acids and non essential amino acid, not only comprised essential amino acids, and comprise under the kidney disease situation and can not synthesize in vivo or the insufficient non essential amino acid of synthetic quantity that essential amino acids and non essential amino acid ratio are 60%: 40%.For preventing the cysteine oxidation, select comparatively stable acetylcysteine in the prescription for use.Therapeutical effect of the present invention comprises the whole generation of thanking to product the last reign of a dynasty of minimizing nitrogen; The nutriture of correcting calcium, disorders of phosphorus metabolism and improving patient, just both intravital amino acid contents of balance patient supplements the nutrients again.
Summary of the invention
The objective of the invention is Amino Acid Compound Injection (15AA～2) compositions at a kind of nephrotic of being applicable to of patients design of renal insufficiency,
According to technical scheme provided by the invention, contain following substances in every 1000ml compositions:
Component content
L-isoleucine 4.08 grams～6.12 grams
L-leucine 8.24 grams～12.36 grams
L-lysine acetate 8.008 grams～12.012 grams
L-methionine 2.24 grams～3.36 grams
Acetylcysteine 0.4 gram～0.6 gram
L-phenylalanine-3,4-quinone .04 gram～4.56 grams
L-threonine 3.84 grams～5.76 grams
L-tryptophan 1.52 grams～2.28 grams
L-valine 4.96 grams～7.44 grams
L-arginine 3.92 grams～5.88 grams
L-histidine 3.44 grams～5.16 grams
Glycine 2.56 grams～3.84 grams
L-alanine 5.04 grams～7.56 grams
L-proline 3 .44 gram～5.16 grams
L-serine 3.6 grams～5.4 grams
L MALIC ACID 1.2 grams～1.8 grams
Surplus is a water for injection.
Described amino acid injection also contains an amount of glacial acetic acid in order to regulate medicinal liquid pH value to 5～7.
In compositions, do not contain any antioxidant.
The preparation method of the above-mentioned nephrotic's of being applicable to compound amino acid injection composition comprises:
With all production equipments of water for injection drip washing, amino acid starting material is used through the 0.22 filtering nitrogen protection in μ m aperture in the whole process of production;
Load weighted amino acid starting material is dropped in the preparing tank; Preparing tank is evacuated to vacuum reaches more than 80%, inflated with nitrogen is to malleation behind the evacuation;
Contain following compositions (containing in every 1000ml compositions) in the amino acid starting material:
Component content
L-isoleucine 4.08 grams～6.12
L-leucine 8.24 grams～12.36 grams
L-lysine acetate 8.008 grams～12.012 grams
L-methionine 2.24 grams～3.36 grams
Acetylcysteine 0.4 gram～0.6 gram
L-phenylalanine-3,4-quinone .04 gram～4.56 grams
L-threonine 3.84 grams～5.76 grams
L-tryptophan 1.52 grams～2.28 grams
L-valine 4.96 grams～7.44 grams
L-arginine 3.92 grams～5.88 grams
L-histidine 3.44 grams～5.16 grams
Glycine 2.56 grams～3.84 grams
L-alanine 5.04 grams～7.56 grams
L-proline 3 .44 gram～5.16 grams
L-serine 3.6 grams～5.4 grams
L MALIC ACID 1.2 grams～1.8 grams
Under nitrogen protection, in preparing tank, add water for injection 780～820 grams, regulate nitrogen flow to gauge pressure 0.1bar, turn on agitator makes material dissolution;
Add glacial acetic acid 1～3 gram under the strong agitation.This glacial acetic acid is in advance with 10～30 gram water for injection dilutions;
After amino acid starting material all dissolves, add water for injection to medicinal liquid gross weight 1020 grams.Sampling detects the medicinal liquid pH value, and regulates pH value to 5～7 of compositions on request;
The Freamine for preparing in automatic filling machine pours into washed vial, and is evacuated to more than 80% in front filter is transferred to the fill jar immediately, fills nitrogen, through the corking machine tamponade; Again by the automatic capping machine gland;
By setup program with the Freamine behind the gland 121 ± 1 ℃ of sterilizations, the F0 value is 9～18 minutes;
Freamine after the sterilization is after lamp inspection is qualified, and labeling is packed in the carton, the finished product warehouse-in.
The invention has the beneficial effects as follows:
Prescription of the present invention has been taken all factors into consideration the demand of nephrotic to essential amino acids and non essential amino acid, and the essential amino acids of its higher proportion helps to recover essential amino acids level in the body, and helps correcting negative nitrogen balance in nephrotic's body; And certain non essential amino acid becomes the essential raw material of patient's protein synthesis as the condition essential amino acids.This product can improve these patients' nutriture, corrects intravital aminoacid imbalance state, had both reduced the patient uremic risk takes place, and satisfies the demand that patient utilizes the aminoacid synthetic protein again.
The specific embodiment
Embodiment one:
According to each amino acid starting material of following table weighing:
Component content
L-isoleucine 4.08 grams
L-leucine 8.24 grams
L-lysine acetate 8.008 grams
L-methionine 2.24 grams
Acetylcysteine 0.4 gram
L-phenylalanine-3,4-quinone .04 gram
L-threonine 3.84 grams
L-tryptophan 1.52 grams
L-valine 4.96 grams
L-arginine 3.92 grams
L-histidine 3.44 grams
Glycine 2.56 grams
L-alanine 5.04 grams
L-proline 3 .44 gram
L-serine 3.6 grams
L MALIC ACID 1.2 grams
With all production equipments of water for injection drip washing, product will be used through the 0.22 filtering nitrogen protection in μ m aperture in the whole process of production.
Load weighted amino acid starting material is dropped in the preparing tank.Preparing tank is evacuated to vacuum reaches more than 80%, inflated with nitrogen is to malleation behind the evacuation.
Under nitrogen protection, in preparing tank, add water for injection 780～820 grams, regulate nitrogen flow to gauge pressure 0.1bar, turn on agitator makes material dissolution;
Add glacial acetic acid 1～3 gram under the strong agitation.This glacial acetic acid is in advance with 10～30 gram water for injection dilutions;
After amino acid starting material all dissolves, add water for injection to medicinal liquid gross weight 1020 grams.Sampling detects the medicinal liquid pH value, and regulates pH value to 5～7 of compositions on request;
The Freamine for preparing in automatic filling machine pours into washed vial, and is evacuated to more than 80% in front filter is transferred to the fill jar immediately, fills nitrogen, and product is through the corking machine tamponade.The product that presses plug is by the automatic capping machine gland.
By setup program with product 121 ± 1 ℃ of sterilizations, the F0 value is 9～18 minutes.
Product after the sterilization is after lamp inspection is qualified, and labeling is packed in the carton, the finished product warehouse-in.
Embodiment two:
According to each amino acid starting material of following table weighing:
Composition weight
L-isoleucine 5.10 grams
L-leucine 10.30 grams
L-lysine acetate 10.01 grams
L-methionine 2.80 grams
Acetylcysteine 0.50 gram
L-phenylalanine-3,4-quinone .80 gram
L-threonine 4.80 grams
L-tryptophan 1.90 grams
L-valine 6.20 grams
L-arginine 4.90 grams
L-histidine 4.30 grams
Glycine 3.20 grams
L-alanine 6.30 grams
L-proline-4 .30 gram
L-serine 4.50 grams
L MALIC ACID 1.50 grams
With all production equipments of water for injection drip washing, product will be used through the 0.22 filtering nitrogen protection in μ m aperture in the whole process of production.
Load weighted amino acid starting material is dropped in the preparing tank.Preparing tank is evacuated to vacuum reaches more than 80%, inflated with nitrogen is to malleation behind the evacuation.
Under nitrogen protection, in preparing tank, add water for injection 780～820 grams, regulate nitrogen flow to gauge pressure 0.1bar, turn on agitator makes material dissolution;
Add glacial acetic acid 1～3 gram under the strong agitation.This glacial acetic acid is in advance with 10～30 gram water for injection dilutions;
After amino acid starting material all dissolves, add water for injection to medicinal liquid gross weight 1020 grams.Sampling detects the medicinal liquid pH value, and regulates pH value to 5～7 of compositions on request;
The Freamine for preparing in automatic filling machine pours into washed vial, and is evacuated to more than 80% in front filter is transferred to the fill jar immediately, fills nitrogen, and product is through the corking machine tamponade.The product that presses plug is by the automatic capping machine gland.
By setup program with product 121 ± 1 ℃ of sterilizations, the F0 value is 9～18 minutes.
Product after the sterilization is after lamp inspection is qualified, and labeling is packed in the carton, the finished product warehouse-in.
Embodiment three:
According to each amino acid starting material of following table weighing:
Composition weight
L-isoleucine 6.12 grams
L-leucine 12.36 grams
L-lysine acetate 12.012 grams
L-methionine 3.36 grams
Acetylcysteine 0.6 gram
L-phenylalanine 4.56 grams
L-threonine 5.76 grams
L-tryptophan 2.28 grams
L-valine 7.44 grams
L-arginine 5.88 grams
L-histidine 5.16 grams
Glycine 3.84 grams
L-alanine 7.56 grams
L-proline 5.16 grams
L-serine 5.4 grams
L MALIC ACID 1.8 grams
With all production equipments of water for injection drip washing, product will be used through the 0.22 filtering nitrogen protection in μ m aperture in the whole process of production.
Load weighted amino acid starting material is dropped in the preparing tank.Preparing tank is evacuated to vacuum reaches more than 80%, inflated with nitrogen is to malleation behind the evacuation.
Under nitrogen protection, in preparing tank, add water for injection 780～820 grams, regulate nitrogen flow to gauge pressure 0.1bar, turn on agitator makes material dissolution;
Add glacial acetic acid 1～3 gram under the strong agitation.This glacial acetic acid is in advance with 10～30 gram water for injection dilutions;
After amino acid starting material all dissolves, add water for injection to medicinal liquid gross weight 1020 grams.Sampling detects the medicinal liquid pH value, and regulates pH value to 5～7 of compositions on request;
The Freamine for preparing in automatic filling machine pours into washed vial, and is evacuated to more than 80% in front filter is transferred to the fill jar immediately, fills nitrogen, and product is through the corking machine tamponade.The product that presses plug is by the automatic capping machine gland.
By setup program with product 121 ± 1 ℃ of sterilizations, the F0 value is 9～18 minutes.
Product after the sterilization is after lamp inspection is qualified, and labeling is packed in the carton, the finished product warehouse-in.
Claims (4)
1. a compound amino acid injection composition that is applicable to the nephrotic is characterized in that, contains in every 1000ml compositions:
Component content
L-isoleucine 4.08 grams～6.12 grams
L-leucine 8.24 grams～12.36 grams
L-lysine acetate 8.008 grams～12.012 grams
L-methionine 2.24 grams～3.36 grams
Acetylcysteine 0.4 gram～0.6 gram
L-phenylalanine-3,4-quinone .04 gram～4.56 grams
L-threonine 3.84 grams～5.76 grams
L-tryptophan 1.52 grams～2.28 grams
L-valine 4.96 grams～7.44 grams
L-arginine 3.92 grams～5.88 grams
L-histidine 3.44 grams～5.16 grams
Glycine 2.56 grams～3.84 grams
L-alanine 5.04 grams～7.56 grams
L-proline 3 .44 gram～5.16 grams
L-serine 3.6 grams～5.4 grams
L MALIC ACID 1.2 grams～1.8 grams
All the other are water for injection.
2. be applicable to nephrotic's compound amino acid injection composition according to claim 1, it is characterized in that every 1000ml contains an amount of glacial acetic acid regulates medicinal liquid pH value to 5～7.
3. be applicable to nephrotic's compound amino acid injection composition as claimed in claim 1 or 2, it is characterized in that, do not contain any antioxidant in the recombinant thing.
4. be applicable to the preparation method of nephrotic's compound amino acid injection composition according to claim 1, it is characterized in that,
With all production equipments of water for injection drip washing, amino acid starting material is used through the 0.22 filtering nitrogen protection in μ m aperture in the whole process of production;
Load weighted amino acid starting material is dropped in the preparing tank; Preparing tank is evacuated to vacuum reaches more than 80%, inflated with nitrogen is to malleation behind the evacuation;
Contain following compositions in the amino acid starting material:
Component content
L-isoleucine 4.08 grams～6.12 grams
L-leucine 8.24 grams～12.36 grams
L-lysine acetate 8.008 grams～12.012 grams
L-methionine 2.24 grams～3.36 grams
Acetylcysteine 0.4 gram～0.6 gram
L-phenylalanine-3,4-quinone .04 gram～4.56 grams
L-threonine 3.84 grams～5.76 grams
L-tryptophan 1.52 grams～2.28 grams
L-valine 4.96 grams～7.44 grams
L-arginine 3.92 grams～5.88 grams
L-histidine 3.44 grams～5.16 grams
Glycine 2.56 grams～3.84 grams
L-alanine 5.04 grams～7.56 grams
L-proline 3 .44 gram～5.16 grams
L-serine 3.6 grams～5.4 grams
L MALIC ACID 1.2 grams～1.8 grams
Under nitrogen protection, in preparing tank, add water for injection 780～820 grams, regulate nitrogen flow to gauge pressure 0.1bar, turn on agitator makes material dissolution;
Add glacial acetic acid 1～3 gram under the strong agitation; This glacial acetic acid is in advance with 10～30 gram water for injection dilutions;
After amino acid starting material all dissolves, add water for injection to medicinal liquid gross weight 1020 grams.Sampling detects the medicinal liquid pH value, and regulates pH value to 5～7 of compositions on request;
The Freamine for preparing in automatic filling machine pours into washed vial, and is evacuated to more than 80% in front filter is transferred to the fill jar immediately, fills nitrogen, through the corking machine tamponade; Again by the automatic capping machine gland;
By setup program with the Freamine behind the gland 121 ± 1 ℃ of sterilizations, the F0 value is 9～18 minutes;
Freamine after the sterilization is after lamp inspection is qualified, and labeling is packed in the carton, the finished product warehouse-in.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2007100239258A CN101120917B (en) | 2007-06-29 | 2007-06-29 | Compound amino acid injection composition suitable for kidney disease patient |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2007100239258A CN101120917B (en) | 2007-06-29 | 2007-06-29 | Compound amino acid injection composition suitable for kidney disease patient |
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| CN101120917A true CN101120917A (en) | 2008-02-13 |
| CN101120917B CN101120917B (en) | 2010-06-16 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102988360A (en) * | 2012-12-13 | 2013-03-27 | 天津金耀集团有限公司 | Compound amino acid injection (15HBC) composition |
| 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 |
| CN110507604A (en) * | 2019-08-08 | 2019-11-29 | 武汉久安药业有限公司 | A kind of Amino Acid Compound Injection and preparation method thereof |
| CN111603442A (en) * | 2020-06-04 | 2020-09-01 | 费森尤斯卡比华瑞制药有限公司 | Fat emulsion, compound amino acid and glucose injection and preparation method thereof |
-
2007
- 2007-06-29 CN CN2007100239258A patent/CN101120917B/en active Active
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102988360A (en) * | 2012-12-13 | 2013-03-27 | 天津金耀集团有限公司 | Compound amino acid injection (15HBC) composition |
| 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 |
| CN110507604A (en) * | 2019-08-08 | 2019-11-29 | 武汉久安药业有限公司 | A kind of Amino Acid Compound Injection and preparation method thereof |
| CN111603442A (en) * | 2020-06-04 | 2020-09-01 | 费森尤斯卡比华瑞制药有限公司 | Fat emulsion, compound amino acid and glucose injection and preparation method thereof |
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|---|---|
| CN101120917B (en) | 2010-06-16 |
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Address after: 214092, No. 16, Zhabei Road, Mashan, Binhu District, Jiangsu, Wuxi Patentee after: Fresenius Cabi Huarui Pharmaceutical Co. Ltd. Address before: 214092, No. 16, Zhabei Road, Mashan, Binhu District, Jiangsu, Wuxi Patentee before: Sino-Swed Pharmaceutical Co., Ltd. |
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