CN103071145A - N(2)-L-alanyl-L-glutamine/compound amino acid injection (18AA-V) pharmaceutical composite preparation - Google Patents
N(2)-L-alanyl-L-glutamine/compound amino acid injection (18AA-V) pharmaceutical composite preparation Download PDFInfo
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- CN103071145A CN103071145A CN2011103266395A CN201110326639A CN103071145A CN 103071145 A CN103071145 A CN 103071145A CN 2011103266395 A CN2011103266395 A CN 2011103266395A CN 201110326639 A CN201110326639 A CN 201110326639A CN 103071145 A CN103071145 A CN 103071145A
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Abstract
The invention relates to the technical field of medicines and discloses an N(2)-L-alanyl-L-glutamine/compound amino acid injection (18AA-V) pharmaceutical composite preparation which is prepared by mixing N(2)-L-alanyl-L-glutamine and compound amino acid injection (18AA-V). The pharmaceutical composite preparation has the advantages of definite components, stable quality, high bioavailability, less adverse reactions and the like and has a good application prospect in clinical practice.
Description
Technical field
The present invention relates to medical technical field, related in particular to a kind of N (2)-Ala-Gln/Amino Acid Compound Injection (18AA-V) medicine composition.
Background technology
N (2)-Ala-Gln is an ingredient of parenteral nutrition, have the positive nitrogen balance of promotion, the anabolic effect of regulating muscle albumen, can prevent that the small intestinal mucosa permeability that causes because of long-term parenteral from strengthening and atrophy, the third improving immunocompetence and prevent bacteremic generation.N (2)-Ala-Gln can be decomposed into alanine and glu famine in vivo, can replenish glutamine via the parenteral nutrition transfusion.
Because N (2)-Ala-Gln has the effect that promotes positive nitrogen balance, and its solution is hyperosmotic solution, the transfusion Cmax should not surpass 3.5%, as fail correctly to grasp its using method, the serious adverse reactions such as Dehydration that nitrogen loss, vascular stimulation and vitals will occur cause N (2)-Ala-Gln can not reach clinical requirement.
Summary of the invention
The purpose of this invention is to provide that a kind of stability is high, composition is definite, bioavailability is high, untoward reaction is few, can effectively promote the N (2) of positive nitrogen balance-Ala-Gln/Amino Acid Compound Injection (18AA-V) medicine composition.
In order to solve the problems of the technologies described above, the present invention is solved by following technical proposals:
N (2)-Ala-Gln/Amino Acid Compound Injection (18AA-V) medicine composition is characterized in that: described medicine composition is combined by N (2)-Ala-Gln solution and Amino Acid Compound Injection (18AA-V).
As preferably, the liquor capacity of described N (2)-Ala-Gln and Amino Acid Compound Injection (18AA-V) is than being 1:5.
As preferably, described medicine composition is that every gram N (2)-Ala-Gln dissolves with the 5ml sterilized water for injection, then is dissolved in the Amino Acid Compound Injection (18AA-V) of 5 times of volumes and the mixed liquor that forms.
The present invention has significant technique effect: N (2)-Ala-Gln good water solubility owing to having adopted above technical scheme, and bioavailability is higher, and the scope of application is wider.In clinical use, N (2)-Ala-Gln must compatible Freamine Ⅲ or is contained amino acid whose transfusion and mix mutually, and Cmax should not surpass 3.5%.Therefore, in clinical use procedure, there are a lot of inconvenience and risk.The present invention is by the drug regimen of injection N (2)-Ala-Gln and Amino Acid Compound Injection (18AA-V), efficiently solve in the compatibility process and the untoward reaction that incompatibility and excessive concentration etc. cause may occur, amino acid has the homergy that promotes human body protein simultaneously, but absorption and the metabolism of Effective Raise N (2)-Ala-Gln.Show by development test: this medicine composition has the advantages such as composition is definite, steady quality, bioavailability is high, untoward reaction is few, has a good application prospect in clinical use procedure.
The specific embodiment
Below in conjunction with embodiment the present invention is described in further detail:
Embodiment 1
N (2)-Ala-Gln/Amino Acid Compound Injection (18AA-V) medicine composition is to be made by the component of following weight portion:
Injection N (2)-Ala-Gln 10g;
Sterilized water for injection 50ml;
Amino Acid Compound Injection (18AA-V) 250ml:8.06g (total amino acids) and 12.5 g xylitol.
Embodiment 2
N (2)-Ala-Gln/Amino Acid Compound Injection (18AA-V) medicine composition is to be made by the component of following weight portion:
Injection N (2)-Ala-Gln 20g;
Sterilized water for injection 100ml;
Amino Acid Compound Injection (18AA-V) 500ml:16.12g (total amino acids) and 25 g xylitol.
Quality research is investigated
The sample that makes among above two embodiment is carried out quality testing, and the sample that makes more than inciting somebody to action respectively carried out influence factor's test in 5--10 days in placement under 40 ℃ of high temperature, illumination 4500Lx ± 500Lx condition, the results are shown in Table 1; Under 40 ℃ of high temperature, relative humidity 75% ± 5% condition, carried out accelerated test 6 months, the results are shown in Table 2; Long term test is 24 months under 25 ℃ of high temperature, relative humidity 60% ± 10% condition, detects the variation of every quality index, and data result sees Table 3.
Table 1 N (2)-Ala-Gln/Amino Acid Compound Injection (18AA-V) medicine composition influence factor result of the test is as follows:
Table 2 N (2)-Ala-Gln/Amino Acid Compound Injection (18AA-V) medicine composition carried out accelerated test 6 months under 40 ℃ of high temperature, relative humidity 75% ± 5% condition, result of the test is as follows:
Table 3 N (2)-Ala-Gln/Amino Acid Compound Injection (18AA-V) medicine composition long term test 24 months under 25 ℃ of high temperature, relative humidity 60% ± 10% condition, result of the test is as follows:
Can be found out by above data result, the N that the present invention makes (2)-Ala-Gln/Amino Acid Compound Injection (18AA-V) medicine composition sample quality meets the requirements, and influence factor 10 days, after accelerated test June and long-term 24 months every quality index without significant change, all conform to quality requirements, illustrated the present invention's preparation N (2)-Ala-Gln/Amino Acid Compound Injection (18AA-V) medicine composition sample quality stability is fine.
In a word, the above only is preferred embodiment of the present invention, and all equalizations of doing according to the present patent application claim change and modify, and all should belong to the covering scope of patent of the present invention.
Claims (3)
1.N (2)-and Ala-Gln/Amino Acid Compound Injection (18AA-V) medicine composition, it is characterized in that: described medicine composition is mixed by N (2)-Ala-Gln solution and Amino Acid Compound Injection (18AA-V).
2. N according to claim 1 (2)-Ala-Gln/Amino Acid Compound Injection (18AA-V) medicine composition is characterized in that: the solution mixed volume of described N (2)-Ala-Gln and Amino Acid Compound Injection (18AA-V) is than being 1:5.
3. described N (2)-Ala-Gln/Amino Acid Compound Injection (18AA-V) medicine composition according to claim 1-2, it is characterized in that: described medicine composition is that every gram N (2)-Ala-Gln dissolves with the 5ml sterilized water for injection, then is dissolved in the Amino Acid Compound Injection (18AA-V) of 5 times of volumes and the mixed liquor that forms.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110326639.5A CN103071145B (en) | 2011-10-25 | 2011-10-25 | N(2)-L-alanyl-L-glutamine/compound amino acid injection (18AA-V) pharmaceutical composite preparation |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110326639.5A CN103071145B (en) | 2011-10-25 | 2011-10-25 | N(2)-L-alanyl-L-glutamine/compound amino acid injection (18AA-V) pharmaceutical composite preparation |
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| CN103071145A true CN103071145A (en) | 2013-05-01 |
| CN103071145B CN103071145B (en) | 2014-06-25 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108721596A (en) * | 2018-06-29 | 2018-11-02 | 复旦大学附属中山医院 | A kind of compound amino acid vitamin injection and its application |
| 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 |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN201223558Y (en) * | 2008-06-12 | 2009-04-22 | 山东鲁抗辰欣药业有限公司 | Double-chamber transfusion bag containing amino acid injection and alanyl-glutamine injection |
| CN102429902A (en) * | 2011-09-09 | 2012-05-02 | 海南灵康制药有限公司 | Pharmaceutical composition of alanyl glutamine and compound amino acid |
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2011
- 2011-10-25 CN CN201110326639.5A patent/CN103071145B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN201223558Y (en) * | 2008-06-12 | 2009-04-22 | 山东鲁抗辰欣药业有限公司 | Double-chamber transfusion bag containing amino acid injection and alanyl-glutamine injection |
| CN102429902A (en) * | 2011-09-09 | 2012-05-02 | 海南灵康制药有限公司 | Pharmaceutical composition of alanyl glutamine and compound amino acid |
Non-Patent Citations (1)
| Title |
|---|
| 缪明永等: "肠外营养中氨基酸制剂的发展", 《2010广州国际肿瘤营养与支持治疗研讨会、外科代谢与营养支持学习班、结直肠肿瘤循证治疗学习班论文汇编》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108721596A (en) * | 2018-06-29 | 2018-11-02 | 复旦大学附属中山医院 | A kind of compound amino acid vitamin injection and its application |
| 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 |
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| CN103071145B (en) | 2014-06-25 |
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Effective date of registration: 20200413 Address after: 310000 room 1301 and 1401, building B, No. 3, Weiye Road, Binjiang District, Hangzhou City, Zhejiang Province Patentee after: ZHEJIANG CHANGDIAN PHARMACEUTICAL Co.,Ltd. Address before: Hangzhou City, Zhejiang Province, Binjiang District Jiangnan Road 310000 No. 3688 Topchoice Plaza building seven floor trendsetter Department Patentee before: HANGZHOU CHANGDIAN MEDICAL TECHNOLOGY Co.,Ltd. |
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Denomination of invention: N (2) - L-alanyl-L-glutamine / compound amino acid injection (18aa-v) drug combination Effective date of registration: 20210325 Granted publication date: 20140625 Pledgee: China Minsheng Banking Corp Hangzhou branch Pledgor: ZHEJIANG CHANGDIAN PHARMACEUTICAL Co.,Ltd. Registration number: Y2021330000241 |
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