CN1582912A - L-onithine and L-aspartic acid composition - Google Patents
L-onithine and L-aspartic acid composition Download PDFInfo
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- CN1582912A CN1582912A CN 200410013274 CN200410013274A CN1582912A CN 1582912 A CN1582912 A CN 1582912A CN 200410013274 CN200410013274 CN 200410013274 CN 200410013274 A CN200410013274 A CN 200410013274A CN 1582912 A CN1582912 A CN 1582912A
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- aspartic acid
- ornithine
- aseptic
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- injection
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- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
A powder injection for preventing and treating hepatitis, the hyperammonemia caused by hepatitis, the disease in central nerve system caused by hepatism and the diseases caused by deficiency of L-ornithin or L-aminosuccinic acid is prepared from L-ornithin and L-aminosuccinic acid or the L-ornithin-L-aminosuccinic acid salt through dissolving in water, filtering and freeze drying.
Description
Technical field
The compositions that the present invention relates to contain L-ornithine and L-Aspartic Acid or contain L-ornithine-L-Aspartic Acid, particularly a kind of injectable sterile powder compositions, i.e. injection freeze-dried product or Injectable sterile packing product.
Background technology
Though L-ornithine-L-Aspartic Acid injection has good therapeutical effect to hepatitis, hepatic coma, but because the structure of the L-ornithine in the compositions, free L-ornithine solid is relatively more unstable at normal temperatures, and is easily more oxidized than salifiable L-ornithine in aqueous solution; L-ornithine-L-Aspartic Acid injection is seen photolysis easily, produces the impurity of no therapeutical effect, may cause human body untoward reaction and medicine irritation, influences this product quality, shortens the effect duration of medicine simultaneously.
Summary of the invention
The objective of the invention is at when treating diseases related, there is certain defective in L-ornithine-L-Aspartic Acid injection in clinical use, but propose a kind of compositions of hyoscine, compositions is injection freeze-dried product or the Injectable sterile packing product that contains L-ornithine and L-Aspartic Acid or contain L-ornithine-L-Aspartic Acid.
New compositions products obtained therefrom quality involved in the present invention is loose, and adding behind the water rapidly, dissolving recovers the original characteristic of medicinal liquid; Can guarantee the steady quality of medicine, can avoid medicine Yin Gaowen, illumination and decompose rottenly, help the long term store of medicine.
In the described compositions of the present invention, contain the L-ornithine of 10 ~ 90% (weight), the L-Aspartic Acid of 90 ~ 10% (weight).
Compositions has certain physiologically active, compositions is used to prevent or treat body L-ornithine and/or L-Aspartic Acid and lacks and cause hyperammonemia due to diseases related, prevention or treatment hepatitis, the hepatitis, is specially adapted to the releasing and the hepatic coma of central nervous system's symptom of causing because of liver disease.
In order to realize purpose of the present invention, the present invention by the following technical solutions:
Getting L-ornithine, L-Aspartic Acid respectively adds the injection water and dissolves in right amount; Or get the L-ornithine respectively, the L-Aspartic Acid places sterile chamber, add water for injection and dissolve the back in right amount and mix; Or get L-ornithine L-aspartate and place sterile chamber, add water for injection and dissolve in right amount; Make into 10 ~ 50% solution, add or do not add an amount of pharmaceutic adjuvant, then in regulator solution pH to 6.0 ~ 7.0 scopes, 0.001% ~ 0.5% active carbon that adds the solution amount of preparation then stirs 15 ~ 30min, filters, handle according to the acceptable crystallization process of pharmaceutics, spray drying method or freeze-drying method, be prepared into acceptable injection freeze-dried product of pharmacy or Injectable sterile packing product.
The type of service of the compositions of L-ornithine-L-Aspartic Acid is: L-ornithine and L-Aspartic Acid or L-ornithine-L-aspartate do not add or add pharmaceutic adjuvant as pharmaceutically acceptable dosage forms such as compositions that pharmaceutic adjuvants such as isotonic agent, antioxidant, filler are made such as injection freeze-dried product or Injectable sterile packing products.
This compositions is divided and is used (1 ~ 6 time) for several times according to concrete conditions such as the symptom of the type of age, body weight, disease, disease and degree every day.
The advantage of this compositions is: health is not had significant side effects and untoward reaction, and production technology is simple, and is free from environmental pollution, can be applicable to medical industry production.
The specific embodiment
Embodiment 1: injection freeze-dried product preparation method 1
Get L-ornithine L-Aspartic Acid 200g respectively and add injection water 500ml and make dissolving, add active carbon 1g, stir decolouring 30min, filter, add water for injection, be sub-packed in the sterilization cillin bottle by every bottle of 12.5ml to 1000ml, behind the frozen drying, sterile packaged is promptly made freeze-dried product.
Embodiment 2: injection freeze-dried product preparation method 2
Getting L-ornithine 100g, L-Aspartic Acid 100g respectively adds injection water 500ml and makes dissolving, add active carbon 1g, stir decolouring 30min, filter, add water for injection to 1000ml, be sub-packed in the sterilization cillin bottle, behind the frozen drying by every bottle of 2.5ml, sterile packaged is promptly made freeze-dried product.
Embodiment 3: sterilization or sterile solution crystallization process refining and aseptic drug powder or Injectable sterile packing product preparation method 1
Get L-ornithine 100g, L-Aspartic Acid 100g respectively, add injection water 500ml dissolving, add active carbon 1g, stir decolouring 30min, filter, concentrate by decompression method, crystallization obtains required medical solid, and the solid of gained pulverized under aseptic condition, sieve, make aseptic raw material.Then with prepared powder under aseptic condition, be sub-packed in the sterilization container, sterile packaged, promptly.
Embodiment 4: sterilization or sterile solution crystallization process refining and aseptic drug powder or Injectable sterile packing product preparation method 2
Get L-ornithine 100g respectively, sodium sulfite 5g adds injection water 250ml dissolving, other gets L-Aspartic Acid 90g, adds injection water 250ml dissolving, mixes above two kinds of solution, with 1mol/L hydrochloric acid conditioning solution pH to 6.5, add active carbon 1g then, stir decolouring 30min, filter, concentrate by decompression method, crystallization obtains required medical solid, and the solid of gained is pulverized under aseptic condition, sieve, make aseptic raw material.Then, be sub-packed in the sterilization cillin bottle by every bottle of 2.5g, aseptic packaging, promptly.
Embodiment 5: spray drying method refining and aseptic drug powder or Injectable sterile packing product preparation method 1
Get L-ornithine 75g, L-Aspartic Acid 75g respectively, add injection water 500ml and make dissolving, add active carbon 1g then, stir decolouring 30min, filter, under aseptic condition, obtain aseptic drug powder with spray drying method is refining, then with prepared powder under aseptic condition, be sub-packed in the sterilization container, sterile packaged, promptly.
Embodiment 6: spray drying method refining and aseptic drug powder or Injectable sterile packing product preparation method 2
Get L-ornithine L-Aspartic Acid 150g, add injection water 500ml and make dissolving, add active carbon 1g then, stir decolouring 30min, filter, under aseptic condition, obtain aseptic drug powder with spray drying method is refining, then with prepared powder under aseptic condition, be sub-packed in the cillin bottle of sterilizing by every bottle of 5g, sterile packaged, promptly.
Embodiment 7: stability test
Requirement according to two appendix pages or leaves of Pharmacopoeia of the People's Republic of China version in 2000 XIX C medicine stability test guideline, carry out study on the stability with L-ornithine-L-Aspartic Acid injection with by the injectable sterile powder sample of embodiment 1 preparation: sample thief is put into surface plate respectively, be placed on 40 ℃ respectively, under 60 ℃ and illumination (4500LX) condition, 5, sampling in 10 days, measure outward appearance and related substance, experimental result shows that L-ornithine-L-Aspartic Acid injection begins variable color in illumination and high temperature after 2 days, 5,10 days outward appearances are by the colourless light brown that becomes, and the thin layer chromatography inspection of related substance has impurity to produce; And L-ornithine-5,10 days outward appearance no changes of L-Aspartic Acid injectable sterile powder still are the white loose powder, and the thin layer chromatography of related substance checks that free from admixture produces.Test explanation injectable powder stability of the present invention is better than with the kind injection.
Claims (6)
1. L-ornithine-L-Aspartic Acid compositions is characterized by the injectable sterile powder that contains L-ornithine and L-Aspartic Acid or L-ornithine-L-Aspartic Acid.
2. the described compositions of claim 1, according to the acceptable method of pharmaceutics, by crystallization process aseptic or the sterilization solvent, refining and aseptic drug powder, and packing and getting under aseptic condition.
3. the described compositions of claim 1, according to the acceptable method of pharmaceutics, by aseptic spray drying method, refining and aseptic drug powder, and packing and getting under aseptic condition.
4. the described compositions of claim 1, according to the acceptable method of pharmaceutics, by aseptic freeze-drying, the freeze-dried product that makes.
5. the described compositions of claim 1 contains the L-ornithine of 10 ~ 90% (weight), the L-Aspartic Acid of 90 ~ 10% (weight).
6. the compositions of claim 1, be used to prevent or treat body L-ornithine, the L-Aspartic Acid lacks and cause hyperammonemia due to diseases related, prevention or treatment hepatitis, the hepatitis, is specially adapted to the releasing and the hepatic coma of central nervous system's symptom of causing because of liver disease.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410013274 CN1582912A (en) | 2004-06-10 | 2004-06-10 | L-onithine and L-aspartic acid composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410013274 CN1582912A (en) | 2004-06-10 | 2004-06-10 | L-onithine and L-aspartic acid composition |
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| Publication Number | Publication Date |
|---|---|
| CN1582912A true CN1582912A (en) | 2005-02-23 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN 200410013274 Pending CN1582912A (en) | 2004-06-10 | 2004-06-10 | L-onithine and L-aspartic acid composition |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005120488A1 (en) * | 2004-06-10 | 2005-12-22 | Sara Sarig | Aspartic acid for the regeneration of bone matter |
| CN101987094A (en) * | 2009-08-07 | 2011-03-23 | 上海秀新臣邦医药科技有限公司 | Ornithine aspartate injection and preparation method thereof |
| US10596136B2 (en) | 2018-06-20 | 2020-03-24 | Axcella Health Inc. | Compositions and methods for the treatment of fat infiltration in muscle |
| US10660870B2 (en) | 2017-08-14 | 2020-05-26 | Axcella Health Inc. | Compositions and methods for the treatment of liver diseases and disorders associated with one or both of hyperammonemia or muscle wasting |
| US11129804B2 (en) | 2016-12-19 | 2021-09-28 | Axcella Health Inc. | Amino acid compositions and methods for the treatment of liver diseases |
-
2004
- 2004-06-10 CN CN 200410013274 patent/CN1582912A/en active Pending
Cited By (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005120488A1 (en) * | 2004-06-10 | 2005-12-22 | Sara Sarig | Aspartic acid for the regeneration of bone matter |
| CN101987094A (en) * | 2009-08-07 | 2011-03-23 | 上海秀新臣邦医药科技有限公司 | Ornithine aspartate injection and preparation method thereof |
| CN101987094B (en) * | 2009-08-07 | 2013-02-20 | 上海秀新臣邦医药科技有限公司 | Ornithine aspartate injection and preparation method thereof |
| US11129804B2 (en) | 2016-12-19 | 2021-09-28 | Axcella Health Inc. | Amino acid compositions and methods for the treatment of liver diseases |
| US11602511B2 (en) | 2016-12-19 | 2023-03-14 | Axcella Health Inc. | Amino acid compositions and methods for the treatment of liver diseases |
| US10660870B2 (en) | 2017-08-14 | 2020-05-26 | Axcella Health Inc. | Compositions and methods for the treatment of liver diseases and disorders associated with one or both of hyperammonemia or muscle wasting |
| US10682325B2 (en) | 2017-08-14 | 2020-06-16 | Axcella Health Inc. | Compositions and methods for the treatment of liver diseases and disorders associated with one or both of hyperammonemia or muscle wasting |
| US11571404B2 (en) | 2017-08-14 | 2023-02-07 | Axcella Health Inc. | Compositions and methods for the treatment of liver diseases and disorders associated with one or both of hyperammonemia or muscle wasting |
| US10596136B2 (en) | 2018-06-20 | 2020-03-24 | Axcella Health Inc. | Compositions and methods for the treatment of fat infiltration in muscle |
| US10973793B2 (en) | 2018-06-20 | 2021-04-13 | Axcella Health Inc. | Compositions and methods for the treatment of fat infiltration in muscle |
| US11833127B2 (en) | 2018-06-20 | 2023-12-05 | Axcella Health Inc. | Compositions and methods for the treatment of fat infiltration in muscle |
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