CN1468603A - Preparation method of potassium magnesium aspartate for injection - Google Patents
Preparation method of potassium magnesium aspartate for injection Download PDFInfo
- Publication number
- CN1468603A CN1468603A CNA021326185A CN02132618A CN1468603A CN 1468603 A CN1468603 A CN 1468603A CN A021326185 A CNA021326185 A CN A021326185A CN 02132618 A CN02132618 A CN 02132618A CN 1468603 A CN1468603 A CN 1468603A
- Authority
- CN
- China
- Prior art keywords
- injection
- potassium
- preparation
- aspartic acid
- excipient
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000007924 injection Substances 0.000 title claims abstract description 9
- 238000002347 injection Methods 0.000 title claims abstract description 9
- LVBRFZFUCKKGDJ-HJWRJIQTSA-J magnesium;dipotassium;(2s)-2-aminobutanedioate;hydron Chemical compound [Mg+2].[K+].[K+].OC(=O)[C@@H](N)CC([O-])=O.OC(=O)[C@@H](N)CC([O-])=O.[O-]C(=O)[C@@H](N)CC(O)=O.[O-]C(=O)[C@@H](N)CC(O)=O LVBRFZFUCKKGDJ-HJWRJIQTSA-J 0.000 title claims abstract description 7
- 229940111263 potassium magnesium aspartate Drugs 0.000 title claims abstract description 7
- 238000002360 preparation method Methods 0.000 title claims description 8
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 claims abstract description 15
- BWHMMNNQKKPAPP-UHFFFAOYSA-L potassium carbonate Chemical compound [K+].[K+].[O-]C([O-])=O BWHMMNNQKKPAPP-UHFFFAOYSA-L 0.000 claims abstract description 14
- CKLJMWTZIZZHCS-REOHCLBHSA-N L-aspartic acid Chemical compound OC(=O)[C@@H](N)CC(O)=O CKLJMWTZIZZHCS-REOHCLBHSA-N 0.000 claims abstract description 8
- 235000003704 aspartic acid Nutrition 0.000 claims abstract description 7
- OQFSQFPPLPISGP-UHFFFAOYSA-N beta-carboxyaspartic acid Natural products OC(=O)C(N)C(C(O)=O)C(O)=O OQFSQFPPLPISGP-UHFFFAOYSA-N 0.000 claims abstract description 7
- 239000000395 magnesium oxide Substances 0.000 claims abstract description 7
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 claims abstract description 7
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 claims abstract description 7
- 229910000027 potassium carbonate Inorganic materials 0.000 claims abstract description 7
- 238000010438 heat treatment Methods 0.000 claims abstract description 6
- 238000001914 filtration Methods 0.000 claims abstract description 4
- 238000004108 freeze drying Methods 0.000 claims abstract 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 5
- 239000008227 sterile water for injection Substances 0.000 claims description 5
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 3
- 229930195725 Mannitol Natural products 0.000 claims description 3
- 239000000594 mannitol Substances 0.000 claims description 3
- 235000010355 mannitol Nutrition 0.000 claims description 3
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims description 2
- 230000000295 complement effect Effects 0.000 claims description 2
- 239000003792 electrolyte Substances 0.000 claims description 2
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims 2
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims 1
- 229920002307 Dextran Polymers 0.000 claims 1
- 108010010803 Gelatin Proteins 0.000 claims 1
- 239000004471 Glycine Substances 0.000 claims 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-PHYPRBDBSA-N alpha-D-galactose Chemical compound OC[C@H]1O[C@H](O)[C@H](O)[C@@H](O)[C@H]1O WQZGKKKJIJFFOK-PHYPRBDBSA-N 0.000 claims 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims 1
- 229930182830 galactose Natural products 0.000 claims 1
- 229920000159 gelatin Polymers 0.000 claims 1
- 239000008273 gelatin Substances 0.000 claims 1
- 235000019322 gelatine Nutrition 0.000 claims 1
- 235000011852 gelatine desserts Nutrition 0.000 claims 1
- 210000004907 gland Anatomy 0.000 claims 1
- 239000008103 glucose Substances 0.000 claims 1
- 239000000413 hydrolysate Substances 0.000 claims 1
- FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 claims 1
- 239000008101 lactose Substances 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 239000002994 raw material Substances 0.000 claims 1
- 238000000034 method Methods 0.000 abstract description 2
- 208000024172 Cardiovascular disease Diseases 0.000 abstract 1
- 230000002194 synthesizing effect Effects 0.000 abstract 1
- 229940090044 injection Drugs 0.000 description 6
- 238000012856 packing Methods 0.000 description 6
- 239000000706 filtrate Substances 0.000 description 4
- 238000007689 inspection Methods 0.000 description 4
- ISYHFARMUCCYDZ-DKWTVANSSA-N (2s)-2-aminobutanedioic acid;magnesium Chemical compound [Mg].OC(=O)[C@@H](N)CC(O)=O ISYHFARMUCCYDZ-DKWTVANSSA-N 0.000 description 3
- JGSARLDLIJGVTE-UHFFFAOYSA-N 3,3-dimethyl-7-oxo-6-[(2-phenylacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid Chemical compound O=C1N2C(C(O)=O)C(C)(C)SC2C1NC(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-UHFFFAOYSA-N 0.000 description 3
- 239000011521 glass Substances 0.000 description 3
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 2
- 229910052799 carbon Inorganic materials 0.000 description 2
- 238000006243 chemical reaction Methods 0.000 description 2
- 238000005261 decarburization Methods 0.000 description 2
- 238000001035 drying Methods 0.000 description 2
- 238000013467 fragmentation Methods 0.000 description 2
- 238000006062 fragmentation reaction Methods 0.000 description 2
- 239000012982 microporous membrane Substances 0.000 description 2
- 239000000047 product Substances 0.000 description 2
- 238000009287 sand filtration Methods 0.000 description 2
- 230000001954 sterilising effect Effects 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- 238000005406 washing Methods 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 239000008215 water for injection Substances 0.000 description 2
- 238000005303 weighing Methods 0.000 description 2
- 201000006306 Cor pulmonale Diseases 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
- 206010053159 Organ failure Diseases 0.000 description 1
- 208000004186 Pulmonary Heart Disease Diseases 0.000 description 1
- 206010000891 acute myocardial infarction Diseases 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
- 229940009098 aspartate Drugs 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229940093181 glucose injection Drugs 0.000 description 1
- 239000012669 liquid formulation Substances 0.000 description 1
- 238000005096 rolling process Methods 0.000 description 1
- 239000008354 sodium chloride injection Substances 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention mainly relates to a method for preparing potassium magnesium aspartate for injection by heating, synthesizing, decoloring, filtering, freeze-drying and the like with aspartic acid, potassium carbonate, potassium hydroxide, magnesium oxide and the like, wherein the potassium magnesium aspartate is widely applied to treating cardiovascular diseases.
Description
The present invention relates to the preparation method of potassium magnesium aspartate for injection
The aspartic acid magnesium injection has a wide range of applications clinically as electrolyte complementary medical.Arrhythmia, heart failure, the concurrent organ failure of pulmonary heart disease, hypertension, acute myocardial infarction etc. there is better curative effect.Because the aspartic acid magnesium injection is a sterile liquid formulations, makes inner packing with the glass ampoule of 10ml and two kinds of specifications of 20ml, as easy as rolling off a log fragmentation in the transportation, transportation inconvenience; On the other hand, less stable variable color appears, in the aspartic acid magnesium injection storage process.
The present invention makes the block of loose drying with motassium magnessium aspartate, has improved stability of drug, as inner packing, is not easy fragmentation with cillin bottle in the transportation, has made things convenient for transportation.
The potassium magnesium aspartate for injection made from the present invention is convenient transportation not only, and good stability can use dissolvings such as glucose injection, sodium chloride injection for clinical use very easily.
Now preparation method of the present invention is described in down:
Prescription:
Aspartic Acid 800-1900g
Potassium carbonate 0-500g
Potassium hydroxide 0-450g
Magnesium oxide 80-180g
Excipient 200-800g
Sterilized water for injection adds to 2000-8000ml
Making 1000-3000 props up
The step of preparation is:
1. take by weighing Aspartic Acid, magnesium oxide, potassium hydroxide, the potassium carbonate of recipe quantity respectively, add an amount of sterilized water for injection, heating, after stirring makes abundant reaction, add the 0.01-0.5% active carbon and be heated to 50-80 ℃ of decolouring 20-40 minute, filter decarburization, filtrate adds excipient and is stirred to moltenly entirely, is settled to full dose with water for injection.
2. with after the filter just of sintered glass funnel or sand filtration rod, with the degerming of 0.22um filtering with microporous membrane, after the filtrate quality inspection is qualified embedding immediately in the cillin bottle of washing and sterilizing, the freeze dryer of packing into.
3. goods are reduced to-20～45 ℃ from room temperature, use 2-5 hour approximately, kept 2-5 hour below-20～45 ℃, evacuation treats that goods case vacuum reaches 5-20pa subsequently, and subliming by heating is to products temperature 30-50 ℃, time spent 25-35 hour approximately, under 30-50 ℃ of temperature dry 2-6 hour, whole dry run finished the time spent and is about 36-51 hour, tamponade, Zha Gai, after quality inspection is qualified, packing, warehouse-in.Promptly.
Embodiment
Aspartic Acid 1700g
Potassium carbonate 403g
Magnesium oxide 139.3g
Mannitol 600g
Sterilized water for injection adds to 6000ml
Make 1000
Preparation:
Take by weighing Aspartic Acid, magnesium oxide, the potassium carbonate of recipe quantity respectively, add an amount of sterilized water for injection, heating, stirring makes abundant reaction, adds 0.04% active carbon and is heated to 70 ℃ of decolourings 20 minutes, filters decarburization, filtrate is stirred to molten entirely with mannitol, be settled to full dose with water for injection.After the filter just of sintered glass funnel or sand filtration rod, with the degerming of 0.22um filtering with microporous membrane, after the filtrate quality inspection is qualified embedding immediately in the cillin bottle of washing and sterilizing, the freeze dryer of packing into.Goods are reduced to-40 ℃ from room temperature, use 3 hours approximately, kept 3 hours below-40 ℃, evacuation treats that goods case vacuum reaches 5-20pa subsequently, and subliming by heating is to 40 ℃ of products temperatures, about 35 hours times spent, drying is 4 hours under 40 ℃ of temperature, and the whole dry run end time spent is about 45 hours, tamponade, Zha Gai, after quality inspection is qualified, packing, warehouse-in.Promptly.
Claims (3)
1. the preparation method of an electrolyte complementary medical potassium magnesium aspartate for injection, it is characterized in that with Aspartic Acid, potassium hydroxide, potassium carbonate, magnesium oxide be raw material, add an amount of excipient, make through steps such as heating, synthetic, dissolving, decolouring, filtration, fill, lyophilization, glands.
2. preparation method according to claim 1, the prescription of wherein said each component is:
Aspartic Acid 400-900g
Potassium carbonate 0-300g
Potassium hydroxide 0-250g
Magnesium oxide 20-80g
Excipient 100-500g
Sterilized water for injection adds to 1000-6000ml
Making 1000-3000 props up
3. prescription according to claim 2 is characterized in that excipient can be mannitol, dextran, lactose, galactose, glucose, gelatin hydrolysate and glycine etc., also can be above several mixture.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA021326185A CN1468603A (en) | 2002-07-18 | 2002-07-18 | Preparation method of potassium magnesium aspartate for injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA021326185A CN1468603A (en) | 2002-07-18 | 2002-07-18 | Preparation method of potassium magnesium aspartate for injection |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1468603A true CN1468603A (en) | 2004-01-21 |
Family
ID=34145252
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA021326185A Pending CN1468603A (en) | 2002-07-18 | 2002-07-18 | Preparation method of potassium magnesium aspartate for injection |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1468603A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100450476C (en) * | 2007-02-15 | 2009-01-14 | 北京京卫信康医药科技发展有限公司 | Electrolyte complementary medical combination for injection |
| CN113209032A (en) * | 2021-05-26 | 2021-08-06 | 海南通用康力制药有限公司 | Potassium magnesium aspartate freeze-dried powder injection for injection and preparation method thereof |
-
2002
- 2002-07-18 CN CNA021326185A patent/CN1468603A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100450476C (en) * | 2007-02-15 | 2009-01-14 | 北京京卫信康医药科技发展有限公司 | Electrolyte complementary medical combination for injection |
| CN113209032A (en) * | 2021-05-26 | 2021-08-06 | 海南通用康力制药有限公司 | Potassium magnesium aspartate freeze-dried powder injection for injection and preparation method thereof |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |