CN101156842A - Pharmaceutical preparation containing arginine glutamic acid - Google Patents
Pharmaceutical preparation containing arginine glutamic acid Download PDFInfo
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- CN101156842A CN101156842A CNA2007101753889A CN200710175388A CN101156842A CN 101156842 A CN101156842 A CN 101156842A CN A2007101753889 A CNA2007101753889 A CN A2007101753889A CN 200710175388 A CN200710175388 A CN 200710175388A CN 101156842 A CN101156842 A CN 101156842A
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Abstract
The invention relates to the medicament preparation of arginine glutamic acid and the preparation method and the application thereof. Through long-term experimental study, the personnel of the invention develops the medicament preparation of the arginine glutamic acid, the preparation takes the arginine glutamic acid as raw material medicine, which prepares the preparation with proper medicinal auxiliary material. The operating process of the medicament preparation of the invention is simple, the environmental pollution is small, and the invention is suitable for the production of a great industry. A pharmacological test shows that the medicament preparation of arginine glutamic acid has a very obvious pharmacological function on the aspect of the remedy of the hyperammonemia caused by acute liver disease and chronic liver disease such as hepatocirrhosis, fatty liver and hepatitis.
Description
Technical field
The invention belongs to medical pharmaceutical field, be specifically related to a kind of preparation method and application thereof of arginine glutamic acid pharmaceutical preparation.
Background technology
Liver is the organ of human body maximum, have with various nutrients synthesize, function such as storage, metabolism, detoxifcation.Human liver function grievous injury can cause ammonia metabolism disorder in the body, causes hyperammonemia state in the body, and the human body vitals are produced infringement, as causing hepatic injury and hepatic encephalopathy etc.Hepatic injury comprises chemical liver injury, mechanicalness hepatic injury and hepatitis etc.Clinically cause therapy for hepatic encephalopathy generally to adopt to hepatic injury regulating diet, adjust aminogram, keep comprehensive therapeutic plan such as soda acid electrolyte balance.At present domestic for selection of clinical to fall the blood ammonia medicine considerably less, mainly contain Kaglutam, sodium glutamate, three kinds of medicines of arginine hydrochloride.But because the characteristic of product itself, three kinds of medicines generally need be united use and just can be obtained and fall the blood ammonia effect preferably, and its clinical practice has many restrictions, and must do blood gas analysis and mensuration potassium, sodium content during the medication.So loaded down with trivial details medication operation is very unfavorable for emergency treatment; Brought a large amount of potassium ions, sodium ion and chloride ion into during again because of medication, very easily caused patient's cylinder electrolyte unbalance, and potassium ion has tangible stimulation to blood vessel, during medication patient often pain is unbearably.Due to illness people's hyperammonemia state is the most dangerous symptom, directly influence patient's existence and prognosis and recover, so in the hepatic encephalopathy treatment, the selection and the application of falling the blood ammonia medicine is very crucial.
Arginine and glutamic acid are water-soluble, and 5 ℃ add down absolute methanols, carry out repeatedly recrystallization to get Ginamate, and 60 ℃ of vacuum dryings prepare the Ginamate finished product (referring to United States Patent (USP): US2851482) then.
Arginine and glutamic acid effect combination can be removed the hyperammonemia state quickly and effectively, and the treatment hyperammonemia avoids producing serious organ injury.The arginine glutamic acid medicine can resolve into arginine and glutamic acid in vein input body, wherein arginine participates in ornithine cycle in human body, promotes the formation of carbamide, makes the ammonia that produces in the human body, is transformed into nontoxic carbamide through ornithine cycle, by discharging in the urine; Glutamic acid can be combined into nontoxic glutamine with too much ammonia in the blood, the latter kidney through the effect of glutamine enzyme with aminolysis from, discharge by urine.
Though arginine and glutamic acid are the human body non essential amino acid, all have extremely important physiological function.Arginine can be used as the nutritional support agent.Glutamic acid metabolism in vivo loses amino easily, with keto acid generation transfer reaction, can synthesize other aminoacid.Glutamic acid is absorbed in vivo, can be used as nutritional supplement.
In addition, arginine can promote the healing effect of wound, can promote the synthetic of collagen tissue, repairs wound.Arginine can also reduce the rate of transform of tumor, improves Survival Time and the survival rate of animal.Glutamic acid has the excitatory transmitter effect, and can produce the irritability influence to cortical neuron is to improve and keep the essential aminoacid of brain function.
Arginine and glutamic acid are the aminoacid to the human body beneficial, have the effect of hepatoprotective, can recover impaired liver function, strengthen the human body immunity.
Summary of the invention
Research worker of the present invention is developed a kind of arginine glutamic acid pharmaceutical preparation through long term test research, and said preparation as crude drug, combines Ginamate and makes preparation with the pharmaceutic adjuvant that suits.Pharmaceutical preparation operating procedure of the present invention is simple, and environmental pollution is little, is fit to big commercial production, the bioavailability height, and animal test results shows that arginine glutamic acid pharmaceutical preparation has the pharmacological action of significantly falling blood ammonia.
The object of the present invention is to provide a kind of operating procedure simple, environmental pollution is little, is fit to big commercial production, the injection arginine glutamic acid pharmaceutical preparation that bioavailability is high.
What the object of the present invention is to provide a kind ofly has the arginine glutamic acid pharmaceutical preparation of obviously falling blood ammonia.
The present invention also aims to provide a kind of preparation method of arginine glutamic acid pharmaceutical preparation.
The present invention is achieved by the following scheme:
One, preparation technology
1. the present invention's weight portion proportioning of writing out a prescription is:
Arginine: glutamic acid=1: 0.2-5;
2. process recipes:
Get the recipe quantity arginine and be dissolved in the water that 1-5 doubly measures, stir adding glutamic acid under the room temperature, dissolving is filtered, and filtrate decompression concentrates, and obtains the arginine glutamic acid compositions;
A. arginine glutamic acid freeze-dried powder
1. the arginine glutamic acid compositions is joined 1-5 weight portion lyophilizing pharmaceutical excipient, stir, be dissolved in 1-10 again and doubly measure in the water for injection, make dissolving, with pH regulator agent regulator solution pH value 6.0-8.0, add 0.1-2% (W/V) active carbon, under the room temperature, stir decolouring 10-60min, filter, filtrate is again through filtering with microporous membrane degerming, packing, freezing, vacuum drying, tamponade, gland, the freeze-dried powder finished product;
2. the arginine glutamic acid compositions is added to 1-10 and doubly measures water for injection, stir and make dissolving, make solution A; 1-5 weight portion lyophilizing pharmaceutical excipient is added 1-3 doubly measure water for injection, stir and make dissolving, make solution B; A, B two solution are mixed, with pH regulator agent regulator solution pH value 6.0-8.0, add 0.1-2% (W/V) active carbon, stirring under the room temperature, decolouring 10-60min add sterile water for injection, filter, filtrate is again through the filtering with microporous membrane degerming, packing, freezing, vacuum drying, tamponade, gland, the freeze-dried powder finished product;
3. the arginine glutamic acid compositions is added to 1-10 and doubly measures water for injection, stirring makes dissolving, with pH regulator agent regulator solution pH value 6.0-8.0, add 0.1-2% (W/V) active carbon, the 10-60min that stirs under the room temperature, decolours filters, filtrate is again through the filtering with microporous membrane degerming, packing, freezing, vacuum drying, tamponade, gland, the freeze-dried powder finished product;
B. arginine glutamic acid aseptic powder injection preparation
1. under aseptic condition, the arginine glutamic acid compositions is added to 1-10 doubly measures water for injection, stirring and dissolving under the room temperature with pH regulator agent regulator solution pH value 6.0-8.0, is filtered, filtrate is spray drying under aseptic condition, refining obtain aseptic drug powder, then with prepared sterilized powder under aseptic condition, quantitative, aseptic subpackaged, get aseptic powder injection preparation finished product;
2. under aseptic condition, the arginine glutamic acid compositions is added to 1-5 doubly measures water for injection, stirring and dissolving under the 60-90 ℃ of temperature, with pH regulator agent regulator solution pH value 6.0-8.0, to filter, filtrate was left standstill 12-48 hour, crystallization is cooled off, separated out to room temperature, collect crystallization, vacuum drying is pulverized, packing, tamponade, gland gets aseptic powder injection preparation finished product;
C. arginine glutamic acid granule
With the pharmaceutic adjuvant mix homogeneously of arginine glutamic acid compositions and 1-5 weight portion, granulate, drying, granulate is made the granule finished product;
D. arginine glutamic acid powder
With the arginine glutamic acid compositions pulverize, sieve, mix homogeneously, divided dose is made the powder finished product.
The pharmaceutical excipient of freeze-dried powder of the present invention is a kind of in mannitol, glucose, dextran, sucrose, lactose, polyvinylpyrrolidone, the sorbitol.
The pH regulator agent of freeze-dried powder of the present invention, sterile powder injection is acid regulator, alkaline conditioner.
The acidic ph modifier of freeze-dried powder of the present invention, sterile powder injection is a kind of in citric acid, citric acid, the acetic acid.
The alkaline pH regulator of freeze-dried powder of the present invention, sterile powder injection is a kind of in sodium hydroxide, sodium dihydrogen phosphate, sodium hydrogen phosphate, sodium acetate, sodium citrate, sodium bicarbonate, the sodium carbonate.
The needle-use activated carbon of freeze-dried powder of the present invention, sterile powder injection is a kind of in 767 type injection-use activated carbons, 732 type injection-use activated carbons, the ZC-1 type injection-use activated carbon.
Injection arginine glutamic acid preparation of the present invention also can be used for intravenous injection and intramuscular injection.
The pharmaceutic adjuvant of granule of the present invention is any one in starch, lactose, Icing Sugar, dextrin, the microcrystalline Cellulose.
Two, pharmacological testing
Reagent: arginine glutamic acid pharmaceutical preparation of the present invention (, providing) by Beijing HeWeiKang Pharmaceutical Technology Co., Ltd's laboratory by preparation technology's preparation of the present invention; Sodium glutamate (Xinan Pharmaceutical Co., Ltd.), Kaglutam (Zizhu Pharmaceutical Co., Ltd., Beijing), aspartate for injection ornithine (Wuhan Qirui Pharmaceuticals Co., Ltd.) (positive control medicine, commercially available product).
1. the blood ammonia effect falls in arginine glutamic acid
Test animal: 50 of bull mices, body weight is 270～320g, is divided into five groups of blank groups, model group, arginine glutamic acid freeze-dried powder group, arginine glutamic acid liquid drugs injection group, aspartic acid ornithine group.Give mice by intraperitoneal injection 80g/L NH4Cl 0.01L/kg respectively, make hepatic encephalopathy ammonia intoxication model, wherein blank group injecting normal saline.After 30 minutes by vein respectively normal saline solution (dosage is 10mmol/kg), arginine glutamic acid liquid drugs injection injection (dosage is 10mmol/kg), the normal saline solution (dosage is 10mmol/kg) of aspartic acid ornithine of injecting normal saline, normal saline, arginine glutamic acid lyophilized powder, extract blood sample after 1 hour, seal up for safekeeping immediately in-5 ℃ brine ice, and it is centrifugal down at-5 ℃, get the stillness of night, analyze its result following (in the bracket is the experimental animal number) with enzyme process:
The result of the test of blood ammonia falls in table 1 intravenous injection arginine glutamic acid
| Group | The blank group | Model group | Smart glutamic acid powder pin group | Smart glutamic acid liquid drugs injection group | The aspartic acid ornithine group |
| Ammonia concentration (umol/L) | 45±9(5) | 135±12(10) | 65±4(10) | 75±4(10) | 98±8(10) |
2. arginine glutamic acid prevention hyperammonemia effect
Experimental animal is 40 of bull mices, and body weight is 240～285g, is divided into four groups, is respectively: blank group, Ammoniom-Acetate (model) group, arginine glutamic acid aseptic powder injection group, sodium glutamate group.Except that the blank group, all feeding dosage is the Ammoniom-Acetate of 40mmol/kg/d, cause the ammonia intoxication model, wherein arginine glutamic acid aseptic powder injection group and sodium glutamate group also respectively intramuscular injection dosage be arginine glutamic acid, the sodium glutamate of 40mmol/kg/d, continuously feeding extracts blood sample more respectively after 3 days, seals up for safekeeping immediately in-5 ℃ brine ice, and it is centrifugal down at-5 ℃, get the stillness of night, analyze, its result following (in the bracket is the experimental animal number) with enzyme process:
The result of the test of blood ammonia falls in table 2 arginine glutamic acid aseptic powder injection
| Group | The blank group | Model group | Smart glutamic acid aseptic powder injection group | The sodium glutamate group |
| Ammonia concentration (umol/L) | 55±8(5) | 125±10(10) | 67±9(10) | 110±8(10) |
Above-mentioned evidence, arginine glutamic acid and ammonia effect are removed ammonia in the blood thereby reach, the purpose of prevention and inhibition hyperammonemia.
3. arginine glutamic acid is to CCl
4The effect of inductive hyperammonemia
40 of Wistar male white rats, body weight 200～250g is divided into four groups, is respectively blank group, model group, arginine glutamic acid freeze-dried powder group and aspartic acid ornithine group.Rat oral gavage 20%CCl is given in the experiment beginning once a day
4Paraffin solution 5ml/kg, continuous 2 days, behind rat fasting 12 h, excise 2/3 liver, set up rat HE animal model.The blank group is correspondingly irritated the normal saline of stomach equal volume simultaneously, parallel sham-operation (cut open the belly but do not cut liver).Postoperative blank group, model group injecting normal saline are injected the normal saline solution (dosage is 10mmol/kg) of arginine glutamic acid, the normal saline solution (dosage is 10mmol/kg) of aspartic acid ornithine respectively for other two groups.Under etherization rat heart was taken a blood sample in the 8th day in experiment, get the hepatic tissue specimen.Getting 1ml places the apyrogeneity calparine pipe to survey blood ammonia (BA) with full-automatic blood ammonia analyser rapidly; Get the 2ml whole blood, analyze alanine aminotransferase (ALT), total bilirubin (TBil), blood urea nitrogen (BUN) with full-automatic biochemical after the separated plasma.Result of the test sees Table 3.
Table 3 injection arginine glutamic acid is to CCl
4The influence of inductive hyperammonemia
| Group | n | ALT(IU/L) | TBil(IU/L) | BUN(mmol/L) | BA(mg/L) |
| The blank group | 10 | 59±14.4 | 9.8±4.7 | 5.2±1.3 | 1.0±0.4 |
| Model group | 10 | 1339.4±302.4 | 73.4±19.2 | 8.2±7.3 | 5.3±2.5 |
| The arginine glutamic acid group | 10 | 60.1±23.2 | 10.2±5.3 | 5.8±5.4 | 1.2±2.9 |
| Aspartic acid ornithine | 10 | 79.4±22.6 | 15.6±4.7 | 7.0±2.3 | 2.7±8.2 |
Three, preparation embodiment
Embodiment 1
The arginine of 17.4g and the glutamic acid of 14.7g are added the 32.1g lactose, be dissolved in the 300ml water for injection, stir, sodium citrate regulator solution pH value is 7.0, adds 0.1% (W/V) 732 type injection-use activated carbons, stir decolouring 10-60min under the room temperature, filter, filtrate is again through filtering with microporous membrane degerming, packing, freezing, vacuum drying, tamponade, gland, the freeze-dried powder finished product.
Embodiment 2
The arginine of 8.7g and the glutamic acid of 14.7g are dissolved in the 120ml water for injection, stir, make solution A; The 46.8g lactose is dissolved in the 100ml water for injection, stirs and make dissolving, make solution B; A, B two solution are mixed, and the pH value of sodium carbonate regulating solution is 7.0, adds 0.1% (W/V) 732 type injection-use activated carbons, stir decolouring 10-60min under the room temperature, filter, filtrate is again through the filtering with microporous membrane degerming, packing, freezing, vacuum drying, tamponade, gland, the freeze-dried powder finished product.
Embodiment 3
Arginine and the 7.3g glutamic acid of 17.4g are added to 90ml water for injection, stir and make dissolving, make solution A, 49.0g mannitol is added 150ml water for injection, mix, the pH value of citric acid regulator solution is 7.0, adds 0.2% (W/V) 732 type injection-use activated carbons, stir decolouring 10-60min under the room temperature, filter, filtrate is again through filtering with microporous membrane degerming, packing, freezing, vacuum drying, tamponade, gland, the freeze-dried powder finished product.
Embodiment 4
34.7g arginine and 29.4g glutamic acid are added to 65ml water for injection, stirring makes dissolving, the pH value of sodium citrate regulator solution is 7.0,0.1% (W/V) 767 type injection active carbons, and 10-60min stirs under the room temperature, decolours, add sterile water for injection, filter, filtrate is again through filtering with microporous membrane degerming, packing, freezing, vacuum drying, tamponade, gland, the freeze-dried powder finished product.
Embodiment 5
17.4g arginine and 73.5g glutamic acid are added to 455ml water for injection, stir and make dissolving, make solution A; 90.9g lyophilizing pharmaceutical excipient is added 91ml water for injection, stir and make dissolving, make solution B; A, B two solution are mixed, sodium hydrogen phosphate regulator solution pH value 6.0, add 0.2% (W/V) 767 type injection-use activated carbons, stirring under the room temperature, decolouring 10-60min add sterile water for injection, filter, filtrate is again through the filtering with microporous membrane degerming, packing, freezing, vacuum drying, tamponade, gland, the freeze-dried powder finished product.
Embodiment 6
17.4g arginine and 14.7g glutamic acid are added the 32.1g dextran, stir, add 160ml water for injection again, stirring makes dissolving, the pH value of sodium acetate regulator solution is 7.0, adds 0.2% (W/V) ZC-1 type injection-use activated carbon, and 10-60min stirs under the room temperature, decolours, add sterile water for injection, filter, filtrate is again through filtering with microporous membrane degerming, packing, freezing, vacuum drying, tamponade, gland, the freeze-dried powder finished product.
Embodiment 7
87g arginine and 14.7g glutamic acid are added 102g mannitol, stir, add 205ml water for injection again, stirring makes dissolving, the pH value of citric acid regulating solution is 8.0, adds 0.1% (W/V) ZC-1 type injection-use activated carbon, and 10-60min stirs under the room temperature, decolours, add sterile water for injection, filter, filtrate is again through filtering with microporous membrane degerming, packing, freezing, vacuum drying, tamponade, gland, the freeze-dried powder finished product.
Embodiment 8
17.4g arginine and 29.4g glutamic acid are added to 375ml water for injection, stirring makes dissolving, the pH value of manganese hydrogen sodium regulating solution is 6.0,0.2% (W/V) 767 type injection active carbons, and 10-60min stirs under the room temperature, decolours, add sterile water for injection, filter, filtrate is again through filtering with microporous membrane degerming, packing, freezing, vacuum drying, tamponade, gland, the freeze-dried powder finished product.
Embodiment 9
Under aseptic condition, 17.4g arginine, 14.7g glutamic acid are added to 100ml water for injection, stirring under the room temperature and making dissolving, the pH value of manganese hydrogen sodium regulating solution is 7.0, filters, filtrate is spray drying under aseptic condition, refining obtain aseptic drug powder, then with prepared sterilized powder under aseptic condition, quantitative, aseptic subpackaged, get aseptic powder injection preparation finished product.
Embodiment 10
Under aseptic condition, 17.4g arginine, 29.4g glutamic acid are added to 188ml water for injection, heated and stirred makes dissolving under the 60-90 ℃ of temperature, and the pH value of sodium dihydrogen phosphate regulator solution is 7.0, filters, filtrate is spray drying under aseptic condition, refining obtain aseptic drug powder, then with prepared sterilized powder under aseptic condition, quantitative, aseptic subpackaged, get aseptic powder injection preparation finished product.
Embodiment 11
Under aseptic condition, 17.4g arginine, 73.5g glutamic acid are added to 727ml water for injection, heated and stirred makes dissolving under the 60-90 ℃ of temperature, and the pH value of sodium hydrate regulator solution is 7.0, filters, filtrate is spray drying under aseptic condition, refining obtain aseptic drug powder, then with prepared sterilized powder under aseptic condition, quantitative, aseptic subpackaged, get aseptic powder injection preparation finished product.
Embodiment 12
Under aseptic condition, 17.4g arginine, 14.7g glutamic acid are added to 32.1ml water for injection, stirring and dissolving under the 60-90 ℃ of temperature, the pH value of sodium citrate regulator solution is 7.0, filters, and filtrate was left standstill 12-48 hour, crystallization is cooled off, separated out to room temperature, collect crystallization, vacuum drying is pulverized, packing, tamponade, gland gets aseptic powder injection preparation finished product.
Embodiment 13
Under aseptic condition, 34.8g arginine, 14.7g glutamic acid are added to 50ml water for injection, stirring and dissolving under the 60-90 ℃ of temperature, the pH value of acetic acid regulator solution is 8.0, filters, and filtrate was left standstill 12-48 hour, crystallization is cooled off, separated out to room temperature, collect crystallization, vacuum drying is pulverized, packing, tamponade, gland gets aseptic powder injection preparation finished product.
Embodiment 14
Under aseptic condition, 87g arginine, 14.7g glutamic acid are added to 203ml water for injection, stirring and dissolving under the 60-90 ℃ of temperature, the pH value of citric acid regulating solution is 8.0, filters, and filtrate was left standstill 12-48 hour, crystallization is cooled off, separated out to room temperature, collect crystallization, vacuum drying is pulverized, packing, tamponade, gland gets aseptic powder injection preparation finished product.
Embodiment 15
Under aseptic condition, 17.4g arginine, 73.5g glutamic acid are added to 542ml water for injection, stirring and dissolving under the 60-90 ℃ of temperature, the pH value of sodium hydrogen phosphate regulator solution is 6.0, filters, and filtrate was left standstill 12-48 hour, crystallization is cooled off, separated out to room temperature, collect crystallization, vacuum drying is pulverized, packing, tamponade, gland gets aseptic powder injection preparation finished product.
Embodiment 16
With 17.4g arginine, 14.7g glutamic acid and 64.2g starch mix homogeneously, granulate, drying, granulate is made the granule finished product.
Embodiment 17
With 34.8g arginine, 14.7g glutamic acid and 49.5g microcrystalline Cellulose mix homogeneously, granulate, drying, granulate is made the granule finished product.
Embodiment 18
With 17.4g arginine, 29.4g glutamic acid and 234g lactose mix homogeneously, granulate, drying, granulate is made the granule finished product.
Embodiment 19
17.4g arginine, 14.7g glutamic acid are ground into fine powder, and the mix homogeneously that sieves is promptly made arginine glutamic acid powder finished product.
Claims (9)
1. arginine glutamic acid pharmaceutical preparation is characterized in that the effective ingredient arginine in this pharmaceutical preparation and the weight proportion of glutamic acid are 1: 0.2-5.
2. arginine glutamic acid pharmaceutical preparation as claimed in claim 1 is characterized in that the preparation method of said preparation is as follows:
1) get the recipe quantity arginine and be dissolved in the water that 1-5 doubly measures, stir adding glutamic acid under the room temperature, dissolving is filtered, and filtrate decompression concentrates, and obtains the arginine glutamic acid compositions;
2) preparation of preparation
A: arginine glutamic acid lyophilized injectable powder
Method for making 1: the arginine glutamic acid compositions is added 1-5 weight portion lyophilizing pharmaceutical excipient, stir, be dissolved in 1-10 and doubly measure in the water for injection, stirring and dissolving, with pH regulator agent regulator solution pH value 6.0-8.0, add 0.1-2% (W/V) active carbon, under the room temperature, stir decolouring 10-60min, filter, filtrate is again through filtering with microporous membrane degerming, packing, freezing, vacuum drying, tamponade, gland, the freeze-dried powder finished product;
Method for making 2: the arginine glutamic acid compositions is added to 1-10 doubly measures water for injection, stir and make dissolving, make solution A; 1-5 weight portion lyophilizing pharmaceutical excipient is added 1-3 doubly measure water for injection, stir and make dissolving, make solution B; A, B two solution are mixed, with pH regulator agent regulator solution pH value 6.0-8.0, add 0.1-2% (W/V) active carbon, stirring under the room temperature, decolouring 10-60min add sterile water for injection, filter, filtrate is again through the filtering with microporous membrane degerming, packing, freezing, vacuum drying, tamponade, gland, the freeze-dried powder finished product;
Method for making 3: the arginine glutamic acid compositions is added to 1-10 doubly measures water for injection, stirring makes dissolving, with pH regulator agent regulator solution pH value 6.0-8.0, add 0.1-2% (W/V) active carbon, the 10-60min that stirs under the room temperature, decolours filters, filtrate is again through the filtering with microporous membrane degerming, packing, freezing, vacuum drying, tamponade, gland, the freeze-dried powder finished product;
B: arginine glutamic acid sterile powder injection
Method for making 1: under aseptic condition, the arginine glutamic acid compositions is added to 1-10 doubly measures water for injection, stirring and dissolving under the room temperature with pH regulator agent regulator solution pH value 6.0-8.0, is filtered, filtrate is spray drying under aseptic condition, refining obtain aseptic drug powder, then with prepared sterilized powder under aseptic condition, quantitative, aseptic subpackaged, get aseptic powder injection preparation finished product;
Method for making 2: under aseptic condition, the arginine glutamic acid compositions is added to 1-5 doubly measures water for injection, stirring and dissolving under the 60-90 ℃ of temperature, with pH regulator agent regulator solution pH value 6.0-8.0, to filter, filtrate was left standstill 12-48 hour, crystallization is cooled off, separated out to room temperature, collect crystallization, vacuum drying is pulverized, packing, tamponade, gland gets aseptic powder injection preparation finished product;
C: arginine glutamic acid granule
With the pharmaceutic adjuvant mix homogeneously of arginine glutamic acid compositions and 1-5 weight portion, granulate, drying, granulate is made the granule finished product;
D: arginine glutamic acid powder
With the arginine glutamic acid compositions pulverize, sieve, mix homogeneously, divided dose is made the powder finished product.
3. the preparation method of a kind of arginine glutamic acid pharmaceutical preparation as claimed in claim 2, the pharmaceutical excipient that it is characterized in that freeze-dried powder are a kind of in mannitol, glucose, dextran, sucrose, lactose, polyvinylpyrrolidone, the sorbitol.
4. the preparation method of a kind of arginine glutamic acid pharmaceutical preparation as claimed in claim 2, the needle-use activated carbon that it is characterized in that freeze-dried powder, sterile powder injection are a kind of in 767 type injection-use activated carbons, 732 type injection-use activated carbons, the ZC-1 type injection-use activated carbon.
5. a kind of arginine glutamic acid pharmaceutical preparation as claimed in claim 1 is characterized in that described arginine glutamic acid preparation can be used for drug administration by injection.
6. a kind of arginine glutamic acid pharmaceutical preparation as claimed in claim 1 is characterized in that described arginine glutamic acid preparation can be used for oral administration.
7. a kind of arginine glutamic acid pharmaceutical preparation as claimed in claim 1 is characterized in that described arginine glutamic acid preparation can be used for treating the hyperammonemia due to the hepatic injury.
8. a kind of arginine glutamic acid pharmaceutical preparation as claimed in claim 1 is characterized in that described arginine glutamic acid preparation can be used for treating hepatic encephalopathy and other reason causes hyperammonemia.
9. a kind of arginine glutamic acid pharmaceutical preparation as claimed in claim 1 is characterized in that described arginine glutamic acid preparation can be used as nutrition enhancer.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101709042B (en) * | 2009-12-22 | 2012-07-04 | 蚌埠丰原涂山制药有限公司 | Aseptic arginine glutamate and preparation method of powder injection thereof |
| CN103027890A (en) * | 2011-09-29 | 2013-04-10 | 天津市汉康医药生物技术有限公司 | Ibuprofen medicine composition for injection |
| CN112679370A (en) * | 2020-12-30 | 2021-04-20 | 无锡晶海氨基酸股份有限公司 | Preparation method of medicinal arginine glutamic acid |
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2007
- 2007-09-29 CN CNA2007101753889A patent/CN101156842A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101709042B (en) * | 2009-12-22 | 2012-07-04 | 蚌埠丰原涂山制药有限公司 | Aseptic arginine glutamate and preparation method of powder injection thereof |
| CN103027890A (en) * | 2011-09-29 | 2013-04-10 | 天津市汉康医药生物技术有限公司 | Ibuprofen medicine composition for injection |
| CN103027890B (en) * | 2011-09-29 | 2014-06-18 | 天津市汉康医药生物技术有限公司 | Ibuprofen medicine composition for injection |
| CN112679370A (en) * | 2020-12-30 | 2021-04-20 | 无锡晶海氨基酸股份有限公司 | Preparation method of medicinal arginine glutamic acid |
| CN112679370B (en) * | 2020-12-30 | 2023-07-18 | 无锡晶海氨基酸股份有限公司 | Preparation method of medicinal arginine glutamic acid |
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