CN102697775A - Compound amino acid drug composition - Google Patents
Compound amino acid drug composition Download PDFInfo
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- CN102697775A CN102697775A CN2012101975974A CN201210197597A CN102697775A CN 102697775 A CN102697775 A CN 102697775A CN 2012101975974 A CN2012101975974 A CN 2012101975974A CN 201210197597 A CN201210197597 A CN 201210197597A CN 102697775 A CN102697775 A CN 102697775A
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Abstract
The invention discloses a compound amino acid drug composition which is characterized by comprising 1.15g aspartate, 1.97g glutamic acid, 0.11g tyrosine, 1.7g isoleucine, 3.79g leucine, 1.36g valine, 2.83g phenylalanine, 0.39g tryptophan, 0.44g cysteine hydrochloride, 2.46g histidine hydrochloride, 2.89g arginine hydrochloride, 3.33g lysine hydrochloride, 1.97g threonine, 1.06g methionine, 3.24g glycine, 1.88g alanine, 1.0g proline, 0.67g serine, 50g xylitol, 0.5g sodium bisulfite and 1000ml water for injection.
Description
Technical field
The present invention relates to the medicament preparation field, be specifically related to a kind of amino acid pharmaceutical composition.
Background technology
Amino Acid Compound Injection except that parenteral nutrition, has good treatment and auxiliary treatment effect and already generally use to numerous disease through expert's checking.But common amino acid transfusion for a long time is clinical exist always infusion pain, toleration poor, detest shortcoming such as notes, fail well fundamentally to solve.(18AA-V) is a kind of amino acid transfusion that xylitol provides the non-albumen energy that contains to the Amino Acid Compound Injection of our development, and it has overcome amino acid transfusion long-standing two big side effect: venous stimulation, pain and patient tolerability are poor during instillation; Use continuously and the notes phenomenon occurs detesting.Simultaneously, these article as the heat supply energy, can form " sugar--alcohol " coexistence in vivo with xylitol; Improved energy utilization ratio; Xylitol provides in donor in the process of energy as non-reducing sugar, can not resemble to be changed into fat by savings the glucose and cause obesity.Therefore the nutritional support treatment that these article are specially adapted to pregnant and lying-in women, blood glucose, blood fat is too high, fat and avoid the sugared patient of limit such as fat.
Hausmam Amin 20 adopts central vein and peripheral intravenous injection, severe trauma, and patients such as the surgical patient under the stress state such as capital operation, fasting, the applying high density Hausmam Amin 20 cooperates various nutrition to carry out the central vein injection.And great amount of conventional is used; Like non-fasting patient, the bad patient of gastrointestinal absorption; Muscle power deposit before the operation; The patient of postoperative recovery patient, patient the old and the weak, pregnant and lying-in women, rehabilitation after being ill uses peripheral intravenous injection, and the grade that it is good that prescription should be selected population of China tolerance is oozed balance Amino Acid Compound Injection (18AA-V).
A large amount of in the market sugarfree foods, be exactly non-reducing sugars such as xylitol be the food of energy.Because xylitol can promote liver glycogen synthetic, transaminase lowering improves liver function, the generation of prevention fatty liver.Can treatment B-mode delay property, chronic hepatitis and liver cirrhosis.Therefore, amino acid (18AA--V) is highly suitable for that the abnormal liver function patient is amino acid whose to be replenished.Before normal person, fatigue and tired crowd, diabetes patient, pregnant and lying-in women, the operation and patient, the obesity of surgery recovery phase patient, hyperlipidemia and Cardiovascular abnormality and can be directly when avoiding fat patient and need replenish aminoacid with amino acid (18AA-V).
Summary of the invention
Main purpose of the present invention is to provide a kind of amino acid pharmaceutical composition.
The technical solution adopted for the present invention to solve the technical problems is:
The amino acid pharmaceutical composition comprises: Aspartic Acid 1.15g, glutamic acid 1.97g, tyrosine 0.11g, isoleucine 1.7g, leucine 3.79g, valine 1.36g, phenylalanine 2.83g, tryptophan 0.39g, cysteine hydrochloride 0.44g, histidine monohydrochloride 2.46g, arginine hydrochloride 2.89g, lysine hydrochloride 3.33g, threonine 1.97g, methionine 1.06g, glycine 3.24g, alanine 1.88g, proline 1.0g, serine 0.67g, xylitol 50g, sodium sulfite 0.5g and water for injection 1000ml.Amino acid preparation of drug combination method comprises: (1) is formulated in and feeds nitrogen in the dense preparing tank, and injects about 750,000 m1 waters for injection; About 70 ℃-90 ℃ of water temperature adds xylitol simultaneously, stirred 5 minutes, to dissolving mixing fully; Under logical nitrogen condition, add sodium sulfite, make dissolving fully; Drop into Aspartic Acid, glutamic acid, tyrosine, isoleucine, leucine, valine, phenylalanine more successively; Stirring makes dissolving fully, is slowly adding other aminoacid outside demineralizing acid cysteine, the tryptophan respectively under the cooling condition then, stirs to make dissolving fully.Add active carbon 0.01%-0.03% (W/V), stir 20min, backflow 15min.Take off charcoal through titanium rod filter; Concentrated wiring liquid is filtered to dilute preparing tank (dilute preparing tank should feed nitrogen in advance) through the titanium rod, adds, fluid temperature is reduced to about 45 ℃ into proper amount of water for injection; Add cysteine hydrochloride, tryptophan (with the dissolving earlier of a small amount of water for injection), after-teeming is penetrated water to amount of preparation.Regulate pH value to 5.5～6.5 with sodium hydroxide or hydrochloric acid, stir 15min, backflow 20min filters back fill (notes: join in the process rare, requirement is controlled at fluid temperature about 45 ℃, can fill) through 1 μ m, 0.45 μ m, 0.22 μ m folder filter.(2) inflated with nitrogen rolls lid, sterilizes 30 minutes for 115 ℃.The sample thief check is up to the standards, labeling, packing, warehouse-in.
Preferably, said acidity regulator is hydrochloric acid solution or sodium hydroxide solution.
Preferably, regulate pH to 5.5～6.5 with hydrochloric acid solution or sodium hydroxide solution.
Preferably, the specification of said Amino Acid Compound Injection (18AA-V) is 250ml:8.06g (total amino acids) and 12.5g xylitol.
Preferably, the temperature of said water for injection is 80 ℃.
Preferably, after sodium hydroxide solution adjusting pH to 5.5-6.5, extremely clear and bright with 0.22 micron filtering with microporous membrane.
Description of drawings
Below in conjunction with accompanying drawing and embodiment the present invention is further specified.
Fig. 1 is the amino acid preparation of pharmaceutical compositions process chart of the embodiment of the invention.
The specific embodiment
Below in conjunction with accompanying drawing and specific embodiment amino acid pharmaceutical composition of the present invention is done further to describe.
The amino acid pharmaceutical composition that provides in the present embodiment is write out a prescription as follows:
In the present embodiment, the specification of preferred Amino Acid Compound Injection (18AA-V) is 250ml:8.06g (total amino acids) and 12.5g xylitol.
The pH value test of Amino Acid Compound Injection (18AA-V).Table one is the test situation of different pH value.
Table one
According to the injection that supplies intravenous drip to use, general pH should be controlled between the 3.0-8.5, intends being controlled at 5.5-7.0 through advance copy article pH value, and Amino Acid Compound Injection (18AA-V) is stable in this scope.The adjusting of pH value can use dilute hydrochloric acid and sodium hydroxide solution to regulate.
The supplementary material quality standard of present embodiment: all supplementary materials of Amino Acid Compound Injection (18AA-V) all meet national drug standards regulation.
Pharmacology, toxicity and internal metabolism situation also are provided in the present embodiment: 1, aminoacid
1. these article essential amino acids meets the Vuj-N formula proportion, and non essential amino acid meets Albumin's pattern.The ratio of these article essential amino acids and non essential amino acid is 1.04: 1, and every seed amino acid is prone to be used for the synthetic of human body protein effectively, and its bioavailability is high.
2. the contained xylitol of these article can get into the cell interior of no insulin, and the formation of tool inhibition ketoboidies, practices thrift protein, improves rate of ultilization of amino acid, and promotes the effect that hepatic glycogen is accumulated, and carbohydrate metabolism is had no adverse effect, and does not see to cause the metabolic complication.
3. carry out toxicity test with Mus, its rat LD50＞20ml/kg, mice LD50＞40ml/kg, the safety range of these article is bigger.
4. amino acid transfusion is supplied with under the competent situation at energy, can get into histiocyte, participates in proteinic anabolism, obtains positive nitrogen balance, and generates enzyme, hormone, antibody, structural protein, promotes organization healing, obtains normal physiological function.
Amino Acid Compound Injection can provide complete, equilibrated 18 kinds of essential and non essential amino acid, comprises tyrosine and cystine, in order to satisfy the needs of body synthetic protein, improves nitrogen balance.Amino acid transfusion is supplied with under the competent situation at energy, can get into histiocyte, participates in proteinic anabolism, promotes organization healing, recovers normal physiological function.
2, xylitol
These article ability additional heat is improved carbohydrate metabolism.Metabolism does not rely on the participation of insulin in vivo, directly permeate through cell membranes involved in sugar metabolism and do not increase blood sugar concentration, and its sweet taste and quantity of heat production and glucose are similar, and in addition, these article still have the ketoplastic effect of inhibition, can make blood plasma fatty acid generation minimizing.
Above-described embodiment, the present invention specific embodiment a kind of more preferably just, common variation that those skilled in the art carries out in technical scheme scope of the present invention and replacement all should be included in protection scope of the present invention.
Claims (4)
1. amino acid pharmaceutical composition; Comprise: Aspartic Acid 1.15g, glutamic acid 1.97g, tyrosine 0.11g, isoleucine 1.7g, leucine 3.79g, valine 1.36g, phenylalanine 2.83g, tryptophan 0.39g, cysteine hydrochloride 0.44g, histidine monohydrochloride 2.46g, arginine hydrochloride 2.89g, lysine hydrochloride 3.33g, threonine 1.97g, methionine 1.06g, glycine 3.24g, alanine 1.88g, proline 1.0g, serine 0.67g, xylitol 50g, sodium sulfite 0.5g and water for injection 1000ml; It is characterized in that: (1) is formulated in and feeds nitrogen in the dense preparing tank; And inject about 750,000 ml waters for injection, about 80 ℃ of water temperature adds xylitol simultaneously, stirred 5 minutes; To dissolving mixing fully; Under logical nitrogen condition, add sodium sulfite, make dissolving fully; Drop into Aspartic Acid, glutamic acid, tyrosine, isoleucine, leucine, valine, phenylalanine more successively; Stirring makes dissolving fully, is slowly adding other aminoacid outside demineralizing acid cysteine, the tryptophan respectively under the cooling condition then, stirs to make dissolving fully.Add active carbon 0.02% (W/V), stir 20min, backflow 15min.Take off charcoal through titanium rod filter, concentrated wiring liquid is filtered to dilute preparing tank through the titanium rod, add into proper amount of water for injection, fluid temperature is reduced to about 45 ℃, add cysteine hydrochloride, tryptophan, after-teeming is penetrated water to amount of preparation.Regulate pH value to 5.5～6.5 with sodium hydroxide or hydrochloric acid, stir 15min, backflow 20min, fill after 1 μ m, 0.45 μ m, 0.22 μ m folder filter filter; 2) inflated with nitrogen rolls lid, sterilizes sample survey 30 minutes for 115 ℃; Be up to the standards labeling, packing, warehouse-in.
2. the amino acid pharmaceutical composition of stating according to claim 1 is characterized in that, regulates acid with sodium hydroxide solution or hydrochloric acid solution.
3. the amino acid pharmaceutical composition of stating according to claim 1 is characterized in that, regulates pH to 5.5～6.5 with sodium hydroxide solution or hydrochloric acid solution.
4. the amino acid pharmaceutical composition of stating according to claim 1 is characterized in that, the temperature of said water for injection is 80 ℃.
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| CN2012101975974A CN102697775A (en) | 2012-06-15 | 2012-06-15 | Compound amino acid drug composition |
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| CN2012101975974A CN102697775A (en) | 2012-06-15 | 2012-06-15 | Compound amino acid drug composition |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106083220A (en) * | 2016-06-13 | 2016-11-09 | 湖北航天杜勒制药有限公司 | A kind of big tree nutritional solution compositing acid solution and processing technology thereof |
| WO2021203606A1 (en) * | 2020-04-08 | 2021-10-14 | 河北科星药业有限公司 | Preparation method for compound amino acid injection for livestock |
| WO2021203605A1 (en) * | 2020-04-08 | 2021-10-14 | 河北科星药业有限公司 | Compound amino acid injection for livestock and preparation method therefor |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101439036A (en) * | 2008-12-22 | 2009-05-27 | 郑飞雄 | Pharmaceutical composition containing 18 kinds of amino acid |
| CN102440989A (en) * | 2010-10-13 | 2012-05-09 | 四川科伦药物研究有限公司 | Compound amino acid injecta, and preparation method and detection method thereof |
-
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- 2012-06-15 CN CN2012101975974A patent/CN102697775A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101439036A (en) * | 2008-12-22 | 2009-05-27 | 郑飞雄 | Pharmaceutical composition containing 18 kinds of amino acid |
| CN102440989A (en) * | 2010-10-13 | 2012-05-09 | 四川科伦药物研究有限公司 | Compound amino acid injecta, and preparation method and detection method thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106083220A (en) * | 2016-06-13 | 2016-11-09 | 湖北航天杜勒制药有限公司 | A kind of big tree nutritional solution compositing acid solution and processing technology thereof |
| WO2021203606A1 (en) * | 2020-04-08 | 2021-10-14 | 河北科星药业有限公司 | Preparation method for compound amino acid injection for livestock |
| WO2021203605A1 (en) * | 2020-04-08 | 2021-10-14 | 河北科星药业有限公司 | Compound amino acid injection for livestock and preparation method therefor |
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Application publication date: 20121003 |