CN1351866A - Levo-potassium magnesium aspartate freeze drying powder injection and preparing method - Google Patents
Levo-potassium magnesium aspartate freeze drying powder injection and preparing method Download PDFInfo
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- CN1351866A CN1351866A CN 01133483 CN01133483A CN1351866A CN 1351866 A CN1351866 A CN 1351866A CN 01133483 CN01133483 CN 01133483 CN 01133483 A CN01133483 A CN 01133483A CN 1351866 A CN1351866 A CN 1351866A
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Abstract
A levo-potassium magnesium aspartate freeze-dried powder injection consists of levo-potassium aspartate, levo-magnesium aspartate, freeze-dried power supporting agent and pH regulator. it is a kind of electrolyte extender, contains no crystal water, and has pH value of 5-11.5, large dosage, physical stability not affected by temperature and no pollution. It has wide application range, and is suitable for intravenously guttae to treat arrhythmia caused by various causes, chronic alcoholism fremitus, myocardiopathy as diabetes complication, etc. and application in heart operation. It is also suitable for acute and chronic hepatitis, intrahepatic cholestasis, and diseases of respiratory system, nerve system and metabolic system.
Description
Technical field:
The invention belongs to electrolyte complementary medical, particularly a kind of levo-potassium magnesium aspartate freeze drying powder injection also relates to the preparation method of this injection simultaneously.
Background technology:
Levo-potassium magnesium aspartate is the more stronger medicine of Physiology and biochemistry effect, be applicable to the ARR treatment that a variety of causes causes, in recent years this product purposes is clinically widened to some extent, as be applied to that chronic alcoholism is trembled, diabetes merge cardiomyopathy etc. treatment and the application in operation on heart.The dosage form of clinical practice at present is an aqueous injection, and inconvenience is in use arranged more: 1. need take out to use liquid in practical operation, preparation very easily infects pyrogen and polluted bacteria more; 2. in actual clinical, various disease conditions requires to reduce the patient infusion amount, and can't solve with liquid drugs injection; 3. in cold season, particularly in the north and the transportation of extremely frigid zones and storage all have inconvenience; 4. liquid preparation breakage very easily causes cross-contamination to packing and inner packing; 5. range of application is narrower.
Summary of the invention:
The object of the present invention is to provide a kind of heavy dose, do not contain water of crystallization, physical stability is temperature influence not, and is pollution-free, applied range, and be convenient to operation, transportation, storage, be suitable for the levo-potassium magnesium aspartate freeze drying powder injection of large-scale production.
Another object of the present invention is to provide a kind of preparation method of this injection.
The object of the present invention is achieved like this: the present invention forms and to comprise left-handed-aspartic acid, left-handed-Magnesium Aminosuccinate, freeze-dried powder proppant and pH value regulator, and parts by weight are:
Left-handed-0.1～10 part of aspartic acid
Left-handed-0.1～10 part of Magnesium Aminosuccinate
The pH regulator agent is an amount of
0.5～1.5 part of lyophilized powder proppant
The present invention is not for containing the lyophilized injectable powder of water of crystallization; pH value is between 5～11.5; optimum pH is between 6.2～7.8; its purposes widen for: be applicable to various acute, chronic hepatitis, intrahepatic cholestasis, respiratory system, nervous system (to protecting neuron from acute) and metabolic disease, can supply the intravenous drip administration.Wherein left-handed-aspartic acid can be selected its anhydride or crystalline hydrate, also can be to be obtained when the preparation injection by left-handed-Aspartic Acid and potassium hydroxide or potassium carbonate.Left-handed-Magnesium Aminosuccinate can be selected its anhydride or crystalline hydrate, also can be to be obtained when preparing injection by left-handed-Aspartic Acid and magnesium hydroxide, magnesium oxide, magnesium carbonate.Levo-potassium magnesium aspartate lyophilized powder proppant is the water solublity proppant, and is soluble in water, dissolves rapidly when this preparation is used, and is convenient to clinical use, is selected from mannitol, glucose, NaCl, dextran, sucrose, lactose, gelatin hydrolysate.The pH value regulator is a water solublity, during with 250ml0.9% sodium chloride, 10% or 5% this preparation of glucose injection dilution agent, make pH value in the scope that body can bear, be selected from diethanolamine, monoethanolamine, diisopropylamine, diisopropanolamine (DIPA), triethanolamine, 1,2-hexamethylene diamine, natrium carbonicum calcinatum, sal soda, monohydrated sodium carbonate, isopropanolamine, monoethanolamine, sodium hydroxide, sodium citrate, sodium hexametaphosphate, Polymeric sodium metaphosphate., sodium bicarbonate, sodium hydrogen phosphate.
Before using, the present invention joins in 250ml 0.9% sodium chloride injection, 5%, 10% glucose injection, 20% formula mannitol injection liquid, compound sodium chloride injection, the low molecular dextran injection, with the intravenous drip administration.
The preparation method of levo-potassium magnesium aspartate freeze drying powder injection provided by the invention is: gets the left-handed-aspartic acid of recipe quantity, left-handed-Magnesium Aminosuccinate and adds the dissolving of injection water, and standby with pH value regulator adjust pH to proper range; Proppant adds the water for injection stirring and dissolving, and mixes with levo-potassium magnesium aspartate solution, adds 0.1～0.5% pin activated carbon, filters de-carbon, degerming, fill; At first pre-freeze is incubated 1～4 hour to-55～-40 ℃, and the beginning evacuation in 15～30 hours, rises to temperature-10～-5 ℃, and reuse 4～7 hours rises to 20～60 ℃ with temperature, continues to keep vacuum 3～10 hours, gland.
The present invention is that for not containing the lyophilized injectable powder of water of crystallization, pH value is between 5～11.5 with the injectable sterile powder of lyophilization principle preparation compared with prior art.Possesses following advantage: 1. be convenient to operation, be suitable for large-scale production; 2. reduce number of operations, solved preparation simultaneously by the chance of pyrogen contamination; 3. accurate controlled quentity controlled variable has reduced the input quantity of patient's liquid, and many disease kinds that require amount of liquid clinically (as heart failure etc.) are obtained medical treatment, and reduces patient's burden, has 4. solved the cross-contamination chance of damaged back product; 5. reduced volume and weight, reduced the cost of transportation of each process of operation widely, and be easy to transportation with the dosage finished product; 6. the transportation and the storage problem in the north and extremely frigid zones winter have been solved.7. applied range, except that be applicable to that arrhythmia, the chronic alcoholism that a variety of causes causes trembled, diabetes merge cardiomyopathy etc. the treatment and the application in operation on heart, also be applicable to the frontier of various acute, chronic hepatitis, intrahepatic cholestasis, respiratory system, nervous system and metabolic disease, can supply the intravenous drip administration.
The specific embodiment:
Be described in further detail the present invention below by embodiment.
Embodiment 1
(1) preparation prescription:
Left-handed-Aspartic Acid 3400g
Potassium hydroxide 65.4g
Magnesium oxide 27.8g
Mannitol 100.0g
Sodium hydroxide is an amount of
Water for injection 15000ml
Prepare 1000 bottles
(2) preparation technology: get recipe quantity left-handed-Aspartic Acid, potassium hydroxide, magnesium oxide add injection water 1500ml, stirs, and add 40% sodium hydroxide solution and transfer pH5～11.5, makes whole dissolvings; Mannitol adds injection water 200ml, stirs and makes its dissolving; Two liquid mixing are added 0.1% pin activated carbon, and stirring at room 20min filters de-carbon, after the microporous filter membrane degerming, add sterile water for injection to 15000ml, behind the mensuration content, fill, every bottle of about 15ml, pre-freeze is incubated 3 hours to-50 ℃, the beginning lyophilizing, in 30 hours, temperature rises to-10 ℃ by-50 ℃, in 7 hours, temperature rises to 60 ℃ by-10 ℃ again, continues to keep vacuum 3 hours, take out, add plug, jewelling cover finished product.
Embodiment 2
(1) preparation prescription:
Left-handed-aspartic acid 3000g
Left-handed-Magnesium Aminosuccinate 3000g
Glucose 200.0g
Sodium hydrogen phosphate is an amount of
Water for injection 15000ml
Prepare 1000 bottles
(2) preparation technology: get recipe quantity left-handed-aspartic acid, left-handed-Magnesium Aminosuccinate and glucose add injection water 1500ml, stir, and add 40% disodium phosphate soln accent pH5～11.5, make whole dissolvings, add 0.1% pin activated carbon, stirring at room 20min, filter de-carbon,, add sterile water for injection to 15000ml after the microporous filter membrane degerming, after measuring content, fill, every bottle of about 15ml, pre-freeze is to-50 ℃, be incubated 3 hours, the beginning lyophilizing, in 30 hours, temperature rises to-10 ℃ by-50 ℃, again in 7 hours, temperature rises to 60 ℃ by-10 ℃, continues to keep vacuum 3 hours, takes out, add plug, jewelling cover finished product.
Embodiment 3
(1) preparation prescription:
Left-handed-Aspartic Acid 8500g
Potassium carbonate 288.8g
Magnesium oxide 69.6g
Dextran-40 200.0g
Isopropanolamine is an amount of
Water for injection 15000ml
Prepare 1000 bottles
(2) preparation technology: with embodiment 1.
Embodiment 4
(1) preparation prescription:
Left-handed-Aspartic Acid 1700g
Potassium hydroxide 32.7g
Magnesium oxide 13.9g
Dextran-20 400.0g
Sodium carbonate is an amount of
Water for injection 15000ml
Prepare 1000 bottles of (2) preparation technologies: with embodiment 1.
Embodiment 5 (1) preparation prescriptions:
Left-handed-aspartic acid 1/2H
2O 2500g
Left-handed-Magnesium Aminosuccinate 4H
2O 2500g
Gelatin hydrolysate 400.0g
Ammonium carbonate is an amount of
Water for injection 15000ml
Prepare 1000 bottles of (2) preparation technologies: with embodiment 2.
Claims (11)
1, a kind of levo-potassium magnesium aspartate freeze drying powder injection is characterized in that: its composition comprises left-handed-aspartic acid, left-handed-Magnesium Aminosuccinate, freeze-dried powder proppant and pH regulator agent, and parts by weight are:
Left-handed-0.1～10 part of aspartic acid
Left-handed-0.1～10 part of Magnesium Aminosuccinate
The pH regulator agent is an amount of
0.05～1.5 part of lyophilized powder proppant
2, levo-potassium magnesium aspartate freeze drying powder injection according to claim 1 is characterized in that: this injection is not for containing the lyophilized injectable powder of water of crystallization.
3, levo-potassium magnesium aspartate freeze drying powder injection according to claim 1 is characterized in that: this injection also is applicable to various acute, chronic hepatitis, intrahepatic cholestasis, respiratory system, nervous system and metabolic disease, can supply the intravenous drip administration.
4, the preparation method of levo-potassium magnesium aspartate freeze drying powder injection according to claim 2, it is characterized in that: get recipe quantity left-handed-aspartic acid, left-handed-Magnesium Aminosuccinate adds the water for injection stirring and dissolving, with pH regulator agent adjust pH to proper range; Proppant adds the water for injection stirring and dissolving; Above-mentioned two liquid are mixed, add the pin activated carbon of 0.1～0.3% (W/V), filter de-carbon, degerming, after-teeming are penetrated water to capacity, fill; At first pre-freeze is incubated 1～4 hour to-55～-40 ℃, and the beginning evacuation in 15～30 hours, rises to temperature-10～-5 ℃, and reuse 4～7 hours rises to 20～60 ℃ with temperature, continues to keep vacuum 3～10 hours, gland.
5, levo-potassium magnesium aspartate freeze drying powder injection according to claim 2, it is characterized in that: join before the use in 250ml 0.9% sodium chloride injection, 5%, 10% glucose injection, 20% formula mannitol injection liquid, compound sodium chloride injection, the low molecular dextran injection, with the intravenous drip administration.
6, according to claim 1 or 4 described levo-potassium magnesium aspartate freeze drying powder injection and preparation methoies, it is characterized in that: its pH value is between 5～11.5.
7, according to claim 1 or 4 described levo-potassium magnesium aspartate freeze drying powder injection and preparation methoies, it is characterized in that: described lyophilized powder proppant is the water solublity proppant, is selected from mannitol, glucose, NaCl, dextran, sucrose, lactose, gelatin hydrolysate.
8, according to claim 1 or 4 described levo-potassium magnesium aspartate freeze drying powder injection and preparation methoies, it is characterized in that: described pH value regulator is a water solublity, be selected from diethanolamine, monoethanolamine, diisopropylamine, diisopropanolamine (DIPA), triethanolamine, 1, the 2-hexamethylene diamine, natrium carbonicum calcinatum, sal soda, monohydrated sodium carbonate, isopropanolamine, monoethanolamine, sodium hydroxide, potassium hydroxide, sodium citrate, potassium citrate, the D-sodium potassium tartrate tetrahydrate, potassium metaphosphate, Kurrol's salt, Polymeric sodium metaphosphate., sodium bicarbonate, potassium bicarbonate, ammonium carbonate, sodium hydrogen phosphate, dipotassium hydrogen phosphate.
9, according to claim 1 or 4 described levo-potassium magnesium aspartate freeze drying powder injection and preparation methoies, it is characterized in that: described left-handed-aspartic acid is anhydride or crystalline hydrate and obtained when preparing injection by left-handed-Aspartic Acid and potassium hydroxide or potassium carbonate.
10, according to claim 1 or 4 described levo-potassium magnesium aspartate freeze drying powder injection and preparation methoies, it is characterized in that: described left-handed-Magnesium Aminosuccinate is anhydride or crystalline hydrate and obtained when preparing injection by left-handed-Aspartic Acid and magnesium hydroxide, magnesium oxide, magnesium carbonate.
11, levo-potassium magnesium aspartate freeze drying powder injection according to claim 6 and preparation method is characterized in that: its optimum pH is between 6.2～7.8.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 01133483 CN1351866A (en) | 2001-11-22 | 2001-11-22 | Levo-potassium magnesium aspartate freeze drying powder injection and preparing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 01133483 CN1351866A (en) | 2001-11-22 | 2001-11-22 | Levo-potassium magnesium aspartate freeze drying powder injection and preparing method |
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| CN1351866A true CN1351866A (en) | 2002-06-05 |
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| CN 01133483 Pending CN1351866A (en) | 2001-11-22 | 2001-11-22 | Levo-potassium magnesium aspartate freeze drying powder injection and preparing method |
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Cited By (8)
| 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 |
| CN102670645A (en) * | 2012-05-29 | 2012-09-19 | 海南卫康制药(潜山)有限公司 | Potassium magnesium aspartate lyophilized powder composition for injection and preparation method of potassium magnesium aspartate lyophilized powder composition |
| CN102875402A (en) * | 2012-10-30 | 2013-01-16 | 宜兴市前成生物有限公司 | Method for preparing magnesium L-aspartate |
| CN104352452A (en) * | 2014-10-09 | 2015-02-18 | 海南通用康力制药有限公司 | Potassium magnesium aspartate freeze-dried powder for injection and preparation method of potassium magnesium aspartate freeze-dried powder |
| CN107303279A (en) * | 2016-04-21 | 2017-10-31 | 辽宁药联制药有限公司 | A kind of aspartate for injection potassium freeze-dried powder and preparation method thereof |
| CN108969493A (en) * | 2018-09-06 | 2018-12-11 | 海南通用康力制药有限公司 | A kind of potassium magnesium aspartate for injection is freeze-dried and its manufacturing method |
| CN109053478A (en) * | 2018-08-22 | 2018-12-21 | 上海青平药业有限公司 | A kind of preparation method of potassium L-aspartate magnesium salts |
| CN114732825A (en) * | 2022-03-14 | 2022-07-12 | 山东德信拓达生物科技研究院有限公司 | Cardiac anti-stress product for livestock and poultry and preparation method thereof |
-
2001
- 2001-11-22 CN CN 01133483 patent/CN1351866A/en active Pending
Cited By (8)
| 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 |
| CN102670645A (en) * | 2012-05-29 | 2012-09-19 | 海南卫康制药(潜山)有限公司 | Potassium magnesium aspartate lyophilized powder composition for injection and preparation method of potassium magnesium aspartate lyophilized powder composition |
| CN102875402A (en) * | 2012-10-30 | 2013-01-16 | 宜兴市前成生物有限公司 | Method for preparing magnesium L-aspartate |
| CN104352452A (en) * | 2014-10-09 | 2015-02-18 | 海南通用康力制药有限公司 | Potassium magnesium aspartate freeze-dried powder for injection and preparation method of potassium magnesium aspartate freeze-dried powder |
| CN107303279A (en) * | 2016-04-21 | 2017-10-31 | 辽宁药联制药有限公司 | A kind of aspartate for injection potassium freeze-dried powder and preparation method thereof |
| CN109053478A (en) * | 2018-08-22 | 2018-12-21 | 上海青平药业有限公司 | A kind of preparation method of potassium L-aspartate magnesium salts |
| CN108969493A (en) * | 2018-09-06 | 2018-12-11 | 海南通用康力制药有限公司 | A kind of potassium magnesium aspartate for injection is freeze-dried and its manufacturing method |
| CN114732825A (en) * | 2022-03-14 | 2022-07-12 | 山东德信拓达生物科技研究院有限公司 | Cardiac anti-stress product for livestock and poultry and preparation method thereof |
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