CN101502640A - Compound dipeptide pharmaceutical formulations and preparation method thereof - Google Patents
Compound dipeptide pharmaceutical formulations and preparation method thereof Download PDFInfo
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- CN101502640A CN101502640A CNA2009101198979A CN200910119897A CN101502640A CN 101502640 A CN101502640 A CN 101502640A CN A2009101198979 A CNA2009101198979 A CN A2009101198979A CN 200910119897 A CN200910119897 A CN 200910119897A CN 101502640 A CN101502640 A CN 101502640A
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Abstract
The invention relates to a compound dipeptide medicine preparation and a preparation method thereof, belonging to the technical field of medicine. The compound dipeptide medicine preparation mainly consists of glycyl-L-glutamine and glycyl-L-tyrosine with the weight ratio of 100:5 to 100:25. The prepared clinical commonly used effective preparation formulation is liquid injection, freeze-dried powder injection or sterile subpackaging injection. The glycyl-L-glutamine enters the body and is quickly hydrolyzed into glycin and glutamine, thus playing the functions; and the glycyl-L- tyrosine enters the body and is quickly hydrolyzed into glycin and tyrosine, thus playing the functions. The compound dipeptide medicine preparation is a novel amino acid supplementary preparation by intravenous injection.
Description
Technical field:
The present invention relates to a kind of compound dipeptide pharmaceutical formulations and preparation method thereof, belong to medical technical field.This compound preparation is made of by a certain percentage glycyl-L-glutamine and glycyl-L-tyrosine.The present invention relates to prescription ratio of this compound preparation and preparation method thereof.
Background technology:
The thirties in 20th century Robert Elemn observe as the aminoacid of protein hydrolysate form can safety be used for the people, this is march toward parenteral nutrition (Parenteral Nutrition, important first step PN).Total parenteral nutrition (Total Parenteral Nutrition, TPN) be that nineteen sixty-eight Dudric at first reports, promptly supply the complete nutrients matter of needed by human body through vein, comprise fat milk, aminoacid, glucose, vitamin, electrolyte and trace element, make the patient who can not per os ingests be able to long term survival, this is a significant achievement on the modern nutrition treatment.All in lysis oral nutrient can not or insufficient and need the patient of nutritional support to be indication, mainly contain and 1. can't normally ingest from gastrointestinal tract; 2. the digestive tract peace and quiet of need having a rest; 3. hypermetabolism patient; 4. cooperate other treatment.
Aminoacid is the foundation stone of TPN, and its effect is to keep cellularity, produces digestive enzyme, hormone and plasma protein.When selecting amino acid preparation, the total nitrogen that needs considered amino acid liquid to be provided must fully satisfy the needs of body.Must contain 8 kinds of essential amino acids and 2 kinds of semi-dispensable amino acids in the mixed liquor, the amount between the various essential amino acids should meet internationally recognized pattern, should provide multiple non essential amino acid in the preparation simultaneously.The compound amino acid solution should contain each seed amino acid in the in-vivo tissue, and close with human amino acid's ratio as far as possible on prescription, is referred to as " balance aminoacids solution ".
Do not contain glutamine and tyrosine in the tradition TPN nutritional solution, but this two seed amino acid has many important physical functions: the phagocytosis and the lymphocytic propagation of cell function that some are important such as proteinic synthetic, cell, all must rely on competent glutamine, glutamine still is the main matter of intestinal mucosa cells energy supply, so glutamine is counted as the conditionality essential amino acids; Tyrosine is neonate and liver failure patient's essential amino acids, also is the essential amino acids of patients with chronic renal failure.Because aspects such as the dissolubility of glutamine and tyrosine and stability have limited the two and have used clinically.
Glycyl-L-glutamine enters and is hydrolyzed to glycine and glutamine rapidly in the body and plays a role, and glycyl-L-tyrosine enters and is hydrolyzed to glycine and tyrosine rapidly in the body and plays a role.Glycyl-L-glutamine and glycyl-L-tyrosine are soluble in water, and stable in properties in heating disinfection and long term storage process, these characteristics have determined them to can be used as novel vein amino acid supplementation preparation.
Summary of the invention:
The object of the present invention is to provide a kind of preparation method of compound dipeptide pharmaceutical formulations.
Concrete technical scheme of the present invention is as follows:
The invention provides a kind of preparation method of compound dipeptide pharmaceutical formulations, wherein compound dipeptide is made of by a certain percentage glycyl-L-glutamine and glycyl-L-tyrosine, and the part by weight scope is that 100:5 is to 100:25.Glycyl-L-glutamine and glycyl-L-tyrosine injection preparation are: it is an amount of to get two kinds of dipeptides, adding the injection water, to make the concentration that contains glycyl-L-glutamine be 2.0% to 40%, and the concentration of glycyl-L-tyrosine is 0.2% to 4.0% solution.Wherein pH value is adjusted into selectable items: adjusting range is 3.0～7.0, and the reagent of using is citric acid, hydrochloric acid, sodium citrate, sodium hydroxide, sodium dihydrogen phosphate, sodium hydrogen phosphate, potassium dihydrogen phosphate or dipotassium hydrogen phosphate etc.The pharmaceutic adjuvant of wherein using also is selectable items: can be disodiumedetate, citric acid, sodium citrate, sodium hydroxide, sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate, vitamin C, mannitol, dextran, lactose or glucose, ethanol, hydrochloric acid, sodium chloride, Polyethylene Glycol, glycerol etc.
Glycyl-L-glutamine and glycyl-L-tyrosine powder pin (aseptic subpackaged) preparation method are: in hundred grades of toilets, with glycyl-L-glutamine and glycyl-L-tyrosine aseptic powder by a certain percentage mix homogeneously (proportion 100:5 is to 100:25.), packing is promptly.
Glycyl-L-glutamine and glycyl-L-tyrosine freeze-dried powder preparation method are: glycyl-L-glutamine and glycyl-L-tyrosine are added the dissolving of injection water, making the concentration that contains glycyl-L-glutamine is 2.0% to 40.0%, the concentration of glycyl-L-tyrosine is 0.2% to 4.0% solution, the medicinal carbon that adds 0.1% (g/v), stir absorption in 5～120 minutes, decarbonization filtering; After crossing 0.45 μ m and 0.22 μ m microporous filter membrane fine straining, be sub-packed in the lyophilizing pallet, the medicinal liquid liquid level must not be crossed 1～5cm, with goods obtained by freeze drying sterile powder injection.
The specific embodiment
Line by following examples, the bright foregoing of the other side is described in further detail, but this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following embodiment, all technology of implementing based on foregoing of the present invention all belong to scope of the present invention.
The preparation of embodiment 1, glycyl-L-glutamine and glycyl-L-tyrosine powder pin (aseptic subpackaged): get 15.135Kg glycyl-L-glutamine aseptic powder and 1.725Kg glycyl-L-tyrosine aseptic powder, mix homogeneously under the environment of hundred grades of toilets, divide then to be filled in the cillin bottle, every contains glycyl L-glutaminate aseptic powder 15.135g and glycyl-L-tyrosine aseptic powder 1.725g.
The preparation of embodiment 2, glycyl-L-glutamine and glycyl-L-tyrosine freeze-dried powder: 15.135Kg glycyl-L-glutamine and 1.725Kg glycyl-L-tyrosine are added the dissolving of injection water, be mixed with 15% solution, the medicinal carbon that adds 0.1% (g/v), stir absorption in 20 minutes, decarbonization filtering; After crossing 0.45 μ m and 0.22 μ m microporous filter membrane fine straining, be sub-packed in the lyophilizing pallet, the medicinal liquid liquid level must not be crossed 3cm, and goods are got sterilized powder through lyophilization.Get above-mentioned sterilized powder branch and be filled in the cillin bottle, every contains glycyl-L-glutamine aseptic powder 15.135g and glycyl-L-tyrosine aseptic powder 1.725g.
The preparation of embodiment 3, glycyl-L-glutamine and glycyl-L-tyrosine injection:
Take by weighing 15.135Kg glycyl-L-glutamine and 1.725Kg glycyl-L-tyrosine respectively and add the dissolving of injection water, be mixed with 33.72% solution, the medicinal carbon that adds 0.1% (g/v), stir absorption in 20 minutes, decarbonization filtering, survey pH value, regulate pH value between 5.0～6.0, benefit adds to the full amount of water for injection; After crossing 0.45 μ m and 0.22 μ m microporous filter membrane fine straining, lamp inspection, respectively fill to the 50ml vial, tamponade, 115 ℃ of pressure sterilizing 30min; Lamp inspection; Product inspection, the packing warehouse-in, getting specification is the two peptide injections of 50ml:16.86g.
The preparation of embodiment 4, glycyl-L-glutamine and glycyl-L-tyrosine injection:
Take by weighing 15.135Kg glycyl-L-glutamine and 1.725Kg glycyl-L-tyrosine respectively and add the dissolving of injection water, be mixed with 16.86% solution, the medicinal carbon that adds 0.1% (g/v), stir absorption in 20 minutes, decarbonization filtering, survey pH value, regulate pH value between 5.0～6.0, benefit adds to the full amount of water for injection; After crossing 0.45 μ m and 0.22 μ m microporous filter membrane fine straining, lamp inspection, respectively fill to the 100ml vial, tamponade, 115 ℃ of pressure sterilizing 30min; Lamp inspection; Product inspection, the packing warehouse-in, getting specification is the two peptide injections of 100ml:16.86g.
The invention is not restricted to above-described embodiment.
Claims (12)
1, a kind of compound dipeptide pharmaceutical formulations is characterized in that being made up of glycyl-L-glutamine and two kinds of dipeptides of glycyl-L-tyrosine.
2, compound dipeptide pharmaceutical formulations according to claim 1, the weight ratio that it is characterized in that contained glycyl-L-glutamine and glycyl-L-tyrosine is 100:5 to 100:25.
3, the compositions of a kind of glycyl-L-glutamine as claimed in claim 2 and glycyl-L-tyrosine is characterized in that and can make arbitrary acceptable forms clinically with acceptable accessories.
4, arbitrary acceptable forms clinically as claimed in claim 3 is an injection.
5, injection as claimed in claim 4 can be an injection, or makes by aseptic subpackaged or lyophilizing.
6, injection as claimed in claim 5 comprises 50ML, 100ML, 250ML and 500ML specification.
7, injection as claimed in claim 6, wherein the concentration of glycyl-L-glutamine is 2.0% to 40.0%, the concentration of glycyl-L-tyrosine is 0.2% to 4.0%.
8, injection as claimed in claim 7 is characterized in that the compound dipeptide of aforementioned proportion is formed with the water for injection configuration under the condition of sterile working; Add medicinal carbon then, stirring and adsorbing, decarbonization filtering, behind 0.45 μ m and 0.22 μ m microporous filter membrane fine straining, fill, tamponade; Lamp inspection; Make the transfusion finished product.
9, injection as claimed in claim 7 is characterized in that the compound dipeptide of aforementioned proportion is formed with the water for injection configuration; Add medicinal carbon then, stirring and adsorbing, decarbonization filtering, behind 0.45 μ m and 0.22 μ m microporous filter membrane fine straining, fill, tamponade, pressure sterilizing; Lamp inspection; Make the transfusion finished product.
10, injection as claimed in claim 7 is characterized in that the compound dipeptide of aforementioned proportion is added water for injection, adds the proper quantity of medicinal auxiliary material configuration again and form; Add medicinal carbon then, stirring and adsorbing, decarbonization filtering, behind 0.45 μ m and 0.22 μ m microporous filter membrane fine straining, fill, tamponade, pressure sterilizing; Lamp inspection; Make the transfusion finished product; This finished product can also be adjusted the solution pH value between 3 to 7 in preparation process.
11, injection as claimed in claim 10 is characterized in that used adjuvant can be but is not limited to disodiumedetate, citric acid, sodium citrate, sodium hydroxide, sodium sulfite, sodium sulfite, sodium pyrosulfite, sodium thiosulfate, vitamin C, mannitol, dextran, lactose or glucose, ethanol, hydrochloric acid, sodium chloride, Polyethylene Glycol, glycerol etc.; The reagent that the adjustment pH value is used can be but be not limited to citric acid, hydrochloric acid, sodium citrate, sodium hydroxide, sodium dihydrogen phosphate or sodium hydrogen phosphate, potassium dihydrogen phosphate or dipotassium hydrogen phosphate.
12, injection as claimed in claim 10 is characterized in that dense joining or rare joining or the protection of fill operation inflated with nitrogen.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2009101198979A CN101502640A (en) | 2009-03-23 | 2009-03-23 | Compound dipeptide pharmaceutical formulations and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2009101198979A CN101502640A (en) | 2009-03-23 | 2009-03-23 | Compound dipeptide pharmaceutical formulations and preparation method thereof |
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| CN101502640A true CN101502640A (en) | 2009-08-12 |
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| CNA2009101198979A Pending CN101502640A (en) | 2009-03-23 | 2009-03-23 | Compound dipeptide pharmaceutical formulations and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2812316C2 (en) * | 2018-01-23 | 2024-01-29 | Сэйнда Фармасьютикал Гуанчжоу Корпорейшн | Ophthalmological pharmaceutical composition and methods of its preparation and use |
-
2009
- 2009-03-23 CN CNA2009101198979A patent/CN101502640A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2812316C2 (en) * | 2018-01-23 | 2024-01-29 | Сэйнда Фармасьютикал Гуанчжоу Корпорейшн | Ophthalmological pharmaceutical composition and methods of its preparation and use |
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Open date: 20090812 |