CN102698248A - Medicine composition prepared from alanyl glutamine and compound amino acid by utilizing spray drying method - Google Patents
Medicine composition prepared from alanyl glutamine and compound amino acid by utilizing spray drying method Download PDFInfo
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- CN102698248A CN102698248A CN2012102080675A CN201210208067A CN102698248A CN 102698248 A CN102698248 A CN 102698248A CN 2012102080675 A CN2012102080675 A CN 2012102080675A CN 201210208067 A CN201210208067 A CN 201210208067A CN 102698248 A CN102698248 A CN 102698248A
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Abstract
The invention relates to a medicine composition prepared from alanyl glutamine sterile powder for injection and a compound amino acid injection by utilizing a spray drying method, especially a composition application package. The composition application package comprises the alanyl glutamine sterile powder for injection, water for injection and the compound amino acid injection. By the composition application package, the requirement of clinical medication is greatly met, the purchasing and the dispensation of medication units are also greatly facilitated, and the cost is saved. The composition application package is prepared just before use, is of great benefit to the stability of every independent medicine, and can be used for increasing the clinical application quality and the bioavailability of medicines. The medicine composition has the benefit that the liver injury is obviously reduced.
Description
Technical field
The present invention relates to the pharmaceutical composition of a kind of alanyl glutamine and amino acid; Be specifically related to a kind of Combination application packing of injection alanyl glutamine sterilized powder and Amino Acid Compound Injection of spray drying method for preparation, belong to medical technical field.
Background technology
(L-Glutamine is an essential amino acid in a kind of body Gln) to L-glutaminate, also is the maximum aminoacid of people's in-vivo content, has important function at protein, nucleic acid in synthesizing.The content of Gln in blood plasma up to 0.8 ~ 0.9 mM/liter, account for 20% of free amino acid total amount.Gln is the energy source of metabolically active cells such as intestinal epithelial cell, renal cells and immunologically competent cell; The nitrogenous source vehicle that is considered to body is transported nitrogenous source between each tissue in vivo, and critical functions such as noxious substance such as ammonia are removed in performance.
Alanyl glutamine discharges L-glutaminate through the dipeptidase effect in vivo rapid the decomposition, supplies with the synthetic or energy expenditure use of body material, and its bioavailability height does not have summation.
The injection alanyl glutamine is the aseptic freeze-dried powder of alanyl glutamine, is white or off-white color sterilized powder, is a kind of parenteral nutrition medicine, for the patient who accepts parenteral nutrition provides glutamine.Alanyl glutamine is by the development of German Fresenius company, and import in 1999 is claimed glutamine dipeptide again to China.
Alanyl glutamine generally is with compatible Freamine or contains amino acid whose transfusion and dissolve by 0.2g/ml and be called a volume before infusion, then with the carrier solution infusion.1 volume alanyl glutamine should mix (for example: the 20g/100ml alanyl glutamine should add 500ml carrier solution at least) with the carrier solution of at least 5 volumes.Dosage is decided according to catabolic degree and amino acid whose requirement.Supplying with amino acid whose maximal dose every day for parenteral nutrition is the 2g/kg body weight, and alanine and the glutamine amount supplied with through alanyl glutamine should count.The amount of amino acid of supplying with through alanyl glutamine should not surpass 20% of whole aminoacid quantity delivereds.
At present; It all is respectively from different manufacturer's buyings by medication unit that domestic compatibility about injection alanyl glutamine and Amino Acid Compound Injection is used; Compatibility arrives together during clinical practice; Because the difference of manufacturer causes the widely different of drug quality, compatibility is used and has been had a strong impact on final drug quality, has further influenced patient's treatment like this.
Patent documentation CN201223558Y discloses the double-chamber transfusion bag of a kind of splendid attire amino acid injection and alanyl glutamine injection, but alanyl glutamine exists with the form of solution, places unstablely for a long time, can produce degraded.People such as Zhou Xin research points out that alanyl glutamine adds Amino Acid Compound Injection and causes hepatic injury, and this also is the extensive use that is unfavorable for alanyl glutamine and aminoacid combination.
In order to overcome the insoluble technical problem that the combination of alanyl glutamine and amino acid exists in the prior art, the inventor has proposed a kind of new alanyl glutamine and the pharmaceutical composition and the application packages thereof of amino acid.
Summary of the invention
One of the object of the invention provides a kind of new alanyl glutamine and the pharmaceutical composition of amino acid, comprises the injection alanyl glutamine sterilized powder and the Amino Acid Compound Injection of spray drying method for preparation.
One of the object of the invention provides a kind of injection alanyl glutamine sterilized powder of spray drying method for preparation and the Combination application of Amino Acid Compound Injection to pack, and comprises injection alanyl glutamine sterilized powder and Amino Acid Compound Injection.
Further; Also can comprise injection alanyl glutamine sterilized powder, water for injection and Amino Acid Compound Injection in this assembly packaging; The quality influence that has caused by the mass discrepancy of producing when having avoided that compatibility is used together like this; Improved the safety that the patient uses greatly,, practiced thrift cost simultaneously to the buying of medication unit with make up a prescription very big convenience also is provided.
Combination application packing provided by the invention, usage is added the Amino Acid Compound Injection mix homogeneously for earlier injection alanyl glutamine sterilized powder being dissolved with water for injection earlier fully, and intravenous drip gets final product.
The present invention provides a kind of pharmaceutical composition that contains alanyl glutamine and amino acid; Wherein alanyl glutamine is the injection alanyl glutamine sterilized powder of spray drying method for preparation, and amino acid is compatible Freamine or contains amino acid whose transfusion.
As the present invention's one preferred embodiment, packing specification of the present invention is injection alanyl glutamine sterilized powder 10-20g, water for injection, Amino Acid Compound Injection 50-1000ml.
Injection alanyl glutamine provided by the invention is the sterilized powder of white or off-white color.Its preparation method is:
(1) in ten thousand grades of clean area proportioning room, alanyl glutamine is added the dissolving of injection water, be made into about 20% solution; The medicinal carbon that adds dosing amount about 0.3% (w/v); Stirring and adsorbing 30 minutes, coarse filtration is taken off charcoal, again through 0.22 μ m microporous filter membrane fine straining; The filtrating spray drying gets the alanyl glutamine sterilized powder.
(2) at hundred grades of clean areas, the control relative humidity is lower than about 45%, carries out aseptic subpackagedly with automatic packer, jumps a queue, and rolls lid.
The sterilized water for injection of water for injection provided by the invention for making by the injection production technology.Its preparation method is: get fresh water for injection fill, seal, sterilization promptly gets.
Amino Acid Compound Injection provided by the invention is 18 kinds of sterile water solutions that crystalline amino acid is formulated, and concrete component comprises tyrosine 0.11-0.35g, alanine 1.88-6.20g, leucine 3.79-12.50g; Proline 1.0-3.3g, isoleucine 1.7-5.6g, glycine 3.24-10.70g, phenylalanine 2.83-9.35g; Tryptophan 0.39-1.30g, valine 1.36-4.50g, methionine 1.06-3.50g, Aspartic Acid 1.15-3.80g; Cysteine 0.44-1.00g, glutamic acid 1.97-6.50g, arginase 12 .63-7.90g, histidine 2-6g; Lysine hydrochloride 3.33-12.40g, threonine 1.97-6.50g, serine 0.67-2.20g, disodium edetate 0.1-0.2g; Sodium sulfite 1-2g, sorbitol 20-40g, water for injection 1000ml.
The method for preparing of the Amino Acid Compound Injection that the present invention adopted is:
(1) about 60% water for injection of getting about full dose boils and adds an amount of sorbitol and make dissolving, adds about 0.15% (g/ml) active carbon again and boils 20 minutes, returns 20 minutes after-filtration of filter decolouring and goes into rare filling of joining.
(2) filter feeds nitrogen after going into sorbitol liquid immediately in the dilute preparing tank; 0.15 (g/ml) active carbon of using that adds simultaneously about full dose 40% in addition again boils 20 minutes pretreated water for injection of absorption and the merging of sorbitol liquid, opens when cooling water makes amalgamation liquid be cooled to 60 ℃ to begin to feed intake.
(3) earlier the disodium edetate of an amount of mix homogeneously and the stabilizing agent of sodium sulfite are divided into halves; A copy of it stabilizing agent is dropped in the amalgamation liquid; By above-mentioned prescription order each aminoacid is dropped into one by one then and make dissolving; Should control temperature during to tryptophan and can drop into below 50 ℃ about, aminoacid feeds intake and finishes, and adds another part stabilizing agent and cystine.
(4) slowly add to regulate pH value 5.8-6.2 with about 10% caustic lye of soda, add adding to the full amount of water for injection, add 0.15% (g/ml) active carbon and stir decolouring 20 minutes, circulating filtration 30 minutes.
(5) filter to visible foreign matters qualified after, fill is sealed, the sterilization, promptly get.
The purpose of this invention is to provide a kind of method for preparing Amino Acid Compound Injection, step is: above-mentioned various amino acid sequences are added, and pH value is regulated in dissolving, carbon absorption, and fill is sealed, sterilization.
The purpose of this invention is to provide a kind of method of spray drying method for preparation injection alanyl glutamine sterilized powder, step is: alanyl glutamine is dissolved in water, and carbon absorption, decarburization, fine straining, spray drying, aseptic subpackaged, jump a queue, roll lid.
The present invention also provides a kind of injection alanyl glutamine sterilized powder of spray drying method for preparation and the Combination application of Amino Acid Compound Injection to be packaged in the application in the preparation treatment amino acids nutritional supplementation medicine; It is normal to have the metabolism of the human body protein of promotion; Correct negative nitrogen balance; Replenish protein, the effect of accelerating wound.
Alanyl glutamine and amino acid make up extensive use in the prior art; But both exist with liquid form; Particularly the injection of alanyl glutamine duration of storage more be easy to generate decomposition, so after remix uses, produce the side effect that is difficult to expect.
Even more serious ground; People such as Zhou Xin research points out that alanyl glutamine adds Amino Acid Compound Injection and causes hepatic injury; Through studying for a long period of time of inventor, produce basic reason that liver decreases and also be quality owing to the injection of the injection of alanyl glutamine and amino acid and change and cause.
Pharmaceutical composition of the present invention dissolves injection alanyl glutamine sterilized powder earlier during use with water for injection, again with compatible Freamine or contain amino acid whose transfusion and mix intravenous drip.
Therefore; Because the dissolubility of partial amino-acid is relatively poor; The Amino Acid Compound Injection incompatibility is processed aseptic powder injection; The inventor has produced the alanyl glutamine injection that degraded will take place more easily and has processed the independent preservation of sterilized powder, and the comparative test through hereinafter has proved that product of the present invention has the side effect that unforeseeable reduction liver decreases.
The applicant has disclosed the injection alanyl glutamine sterilized powder that makes the preparation of a kind of lyophilization in its priority document 201110267409.6 and the Combination application of Amino Acid Compound Injection is packed; In follow-up research; The applicant finds to use the injection alanyl glutamine sterilized powder of spray drying method for preparation and the Combination application packing of Amino Acid Compound Injection to have better stability and curative effect, and the reason that experiment is inferred is the time weak point that spray drying method needs, and the time that active component exists under liquid state is short; Help the raising of stability greatly; And the spray drying method for preparation process is simple, and the time that needs is short, has practiced thrift cost; The sterilized powder particle diameter of spray drying method for preparation is bigger, good fluidity, packing more easily; The sample dissolution of simultaneous spray drying method preparation is fast, and curative effect is rapid-action.
Benefit of the present invention:
(1) Combination application packing of the present invention greatly facilitates the needs of clinical application.
(2) Combination application of the present invention packing has been practiced thrift cost to the buying of medication unit with make up a prescription very big convenience also is provided.
(3) Combination application of the present invention packing is existing with joining at present, and the stability of each drug alone is of great benefit to, and can improve the clinical practice quality and the bioavailability of medicine.
(4) combination of the present invention has the benefit that reduces hepatic injury significantly.
The specific embodiment
Embodiment 1The preparation of assembly packaging medicine
Combination: injection alanyl glutamine sterilized powder 10g, water for injection 50ml and Amino Acid Compound Injection 250ml
The preparation process:
1, the preparation of injection alanyl glutamine
(1) in ten thousand grades of clean area proportioning room, the 1000g alanyl glutamine is added injection water 5000ml dissolving, be made into about 20% solution; The medicinal carbon that adds 15g; Stirring and adsorbing 30 minutes, coarse filtration is taken off charcoal, again through 0.22 μ m microporous filter membrane fine straining; The filtrating spray drying gets the alanyl glutamine sterilized powder.
(2) hundred grades of clean areas, under hundred grades of conditions, the control relative humidity is lower than 45%, carries out aseptic subpackagedly with automatic packer, and the 10g/ bottle is jumped a queue, and rolls lid.
2, the preparation of water for injection
Get fresh water for injection fill, 10ml/ props up, and seals, and 121 ℃ of pressure sterilizings 20 minutes promptly get.
3, the preparation of Amino Acid Compound Injection
(1) gets 60L water for injection and boil and add sorbitol 2000g and make dissolving, add the 90g active carbon again and boiled 20 minutes, return 20 minutes after-filtration of filter decolouring and go into rare filling of joining.
(2) filter feeds nitrogen after going into sorbitol liquid immediately in the dilute preparing tank, adds other 40L simultaneously again and begins to feed intake through boiling 20 minutes pretreated water for injection of absorption and the merging of sorbitol liquid with the 60g active carbon, opening when cooling water makes amalgamation liquid be cooled to 60 ℃.
(3) earlier with the disodium edetate 10g of mix homogeneously and the sodium sulfite 200g part that is divided into two, a copy of it is dropped in the amalgamation liquid, then in order with tyrosine 0.11g, alanine 1.88g; Leucine 3.79g, proline 1.0g, isoleucine 1.7g, glycine 3.24g; Phenylalanine 2.83g, tryptophan 0.39g, valine 1.36g, methionine 1.06g; Aspartic Acid 1.15g, cysteine 0.44g, glutamic acid 1.97g, arginase 12 .63g; Histidine 2g, lysine hydrochloride 3.33g, threonine 1.97g, serine 0.67g; Drop into one by one and make dissolving, should control temperature during to tryptophan and can drop into below 50 ℃, aminoacid feeds intake and finishes, and adds another part stabilizing agent and cystine.
(4) slowly add to regulate pH value 6.0 with 10% caustic lye of soda, add adding to the full amount of water for injection, add the 150g active carbon and stir decolouring 20 minutes, circulating filtration 30 minutes.
(5) filter to visible foreign matters qualified after, fill, the 250ml/ bottle seals, 121 ℃ of pressure sterilizings 20 minutes promptly get.
Embodiment 2The preparation of assembly packaging medicine
Combination: injection alanyl glutamine powder 20g, water for injection 100ml and Amino Acid Compound Injection 500ml
The preparation process:
1, the preparation of injection alanyl glutamine
(1) in ten thousand grades of clean area proportioning room, the 2000g alanyl glutamine is added injection water 10000ml dissolving, be made into about 20% solution; The medicinal carbon that adds 30g; Stirring and adsorbing 30 minutes, coarse filtration is taken off charcoal, again through 0.22 μ m microporous filter membrane fine straining; The filtrating spray drying gets the alanyl glutamine sterilized powder.
(2) hundred grades of clean areas, under hundred grades of conditions, the control relative humidity is lower than 45%, carries out aseptic subpackagedly with automatic packer, and the 20g/ bottle is jumped a queue, and rolls lid.
2, the preparation of water for injection
Get fresh water for injection fill, 20ml/ props up, and seals, and 121 ℃ of pressure sterilizings 20 minutes promptly get.
3, the preparation of Amino Acid Compound Injection
(1) gets 60L water for injection and boil and add sorbitol 4000g and make dissolving, add the 90g active carbon again and boiled 20 minutes, return 20 minutes after-filtration of filter decolouring and go into rare filling of joining.
(2) filter feeds nitrogen after going into sorbitol liquid immediately in the dilute preparing tank, adds other 40L simultaneously again and begins to feed intake through boiling 20 minutes pretreated water for injection of absorption and the merging of sorbitol liquid with the 60g active carbon, opening when cooling water makes amalgamation liquid be cooled to 60 ℃.
(3) earlier with the disodium edetate 20g of mix homogeneously and the sodium sulfite 100g part that is divided into two, a copy of it is dropped in the amalgamation liquid, then in order with tyrosine 0.35g, alanine 6.20g; Leucine 12.50g, proline 3 .3g, isoleucine 5.6g, glycine 10.70g; Phenylalanine 9.35g, tryptophan 1.30g, valine 4.50g, methionine 3.50g; Aspartic Acid 3.80g, cysteine 1.00g, glutamic acid 6.50g, arginine 7.90g; Histidine 6g, lysine hydrochloride 12.40g, threonine 6.50g, serine 2.20g; Drop into one by one and make dissolving, should control temperature during to tryptophan and can drop into below 50 ℃, aminoacid feeds intake and finishes, and adds another part stabilizing agent and cystine.
(4) slowly add to regulate pH value 6.1 with 10% caustic lye of soda, add adding to the full amount of water for injection, add the 150g active carbon and stir decolouring 20 minutes, circulating filtration 30 minutes.
(5) filter to visible foreign matters qualified after, fill, the 500ml/ bottle seals, 121 ℃ of pressure sterilizings 20 minutes promptly get.
Experimental example 3Stability test
A collection of and the embodiment of the invention 1 preparation sample compares by 201110267409.6 embodiment 1 preparation sample, and 40 ℃ of high temperature, following 6 months of relative humidity 75% ± 5% condition is carried out accelerated test and investigated, and the result sees table 1.
Table 1 stability and measuring of dissolution velocity result
Can know by table 1, the sample of 201110267409.6 embodiment, 1 preparation, dissolution velocity is significantly very slow, and related substance raises when quickening June; And the sample dissolution speed of the embodiment of the invention 1 preparation is very fast, and it is less to quicken after 6 months the related substance variation.Proved absolutely the superiority of the present invention aspect raising stability and dissolution velocity.
Experimental example 4The clinical application test
The be admitted to hospital patient of the pharmaceutical composition that uses alanyl glutamine and amino acid of 30 examples is investigated; One group for using alanyl glutamine injection and Amino Acid Compound Injection (with the isocyatic commercially available prod of the product of embodiments of the invention 1; Shandong Lukang Cisen Pharmaceutical Co., Ltd produces; Lot number 20110701) 10 examples (being called for short combination 1), one group for using injection alanyl glutamine sterilized powder and Amino Acid Compound Injection (product of the embodiment of the invention 1) 10 examples (being called for short combination 2).One group is used the product (combination 3) from 201110267409.6 embodiment 1.Three groups of compositions medicines that use are same lot number, and be after the date of manufacture 6 months service time.Using the course of treatment is 3 days, respectively three groups of patients with hepatic functions is checked that 10 routine patient's average test results are following before and after using:
Table 2 liver function test result
Can find out by above result, 10 routine patient's medications of using combination 1 alanyl glutamine injection and Amino Acid Compound Injection after 3 days liver function occur changing bigger unusually; And using 10 routine patient's each items detection indexs variations of combination 2 injection alanyl glutamine sterilized powders and Amino Acid Compound Injection very little, abnormal phenomena does not appear in liver function, is superior to making up 3 widely.
Liver function recovery is normal after patient's drug withdrawal of combination 1; Explain that combination 1 alanyl glutamine injection and Amino Acid Compound Injection can produce damage to patient's liver function; This is because alanyl glutamine injection in the combination 1 is that the form with solution exists, and alanyl glutamine poor stability in aqueous solution; Be easy to degraded, its catabolite causes hepatocyte impaired; Make up that the aseptic freeze-dried powder of alanyl glutamine exists with solid form in 2 injection alanyl glutamine sterilized powders and the Amino Acid Compound Injection, stablized by contrast a lot, so the abnormal liver function phenomenon do not occur.
Claims (7)
1. pharmaceutical composition that contains alanyl glutamine and amino acid is characterized in that alanyl glutamine is that injection alanyl glutamine sterilized powder, the amino acid of spray drying method for preparation is compatible Freamine or contains amino acid whose transfusion.
2. pharmaceutical composition according to claim 1 is characterized in that wherein can also comprising water for injection, and wherein, packing specification is injection alanyl glutamine 10-20g, water for injection, Amino Acid Compound Injection 50-1000ml.
3. method for preparing Amino Acid Compound Injection is characterized in that step is: each seed amino acid is added in certain sequence, and pH value is regulated in dissolving, carbon absorption, and fill is sealed, sterilization.
4. the method for a spray drying method for preparation injection alanyl glutamine sterilized powder is characterized in that step is: alanyl glutamine is dissolved in water, and carbon absorption, decarburization, fine straining, spray drying, aseptic subpackaged, jump a queue, roll lid.
5. according to 1 described pharmaceutical composition, it is characterized in that this pharmaceutical composition can pack for Combination application.
6. according to the application of each described pharmaceutical composition of claim 1-5 in preparation treatment amino acids nutritional supplementation medicine, it is normal to have a metabolism of the human body protein of promotion, corrects negative nitrogen balance, replenishes protein, the effect of accelerating wound.
7. pharmaceutical composition according to claim 1 dissolves injection alanyl glutamine sterilized powder earlier during use with water for injection, again with compatible Freamine or contain amino acid whose transfusion and mix intravenous drip.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104940195A (en) * | 2015-05-14 | 2015-09-30 | 海南圣欣医药科技有限公司 | Pharmaceutical composition containing alanyl glutamine and compound amino acid |
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