CN1439629A - Laevo potassium aspartate material and preparation therefrom and preparing method thereof - Google Patents
Laevo potassium aspartate material and preparation therefrom and preparing method thereof Download PDFInfo
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- CN1439629A CN1439629A CN 03111212 CN03111212A CN1439629A CN 1439629 A CN1439629 A CN 1439629A CN 03111212 CN03111212 CN 03111212 CN 03111212 A CN03111212 A CN 03111212A CN 1439629 A CN1439629 A CN 1439629A
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Abstract
A medicine in the form of injection, perfusion, tablet, capsule, or oral liquid for preventing and treating hypokalemia, early heartbeat and arrhythmia is prepared from levo-aminosuccinic acid (1-10 wt. portions), potassium salt (1-12) and auxiliary (0-100). Its advantages are sure curative effect, high stability and no pollution.
Description
Technical field:
The invention belongs to electrolyte complementary medical, particularly a kind of left-handed-raw material of aspartic acid and utilize the made liquid drugs injection of this raw material, freeze-dried powder, transfusion, tablet, capsule, oral liquid and preparation method thereof.
Background technology:
There is more multiple benefit potassium medicine to be used for prevention and treatment potassium deficiency disease in the market, but owing to the potassium amount that can enter cell is less, thereby curative effect is not obvious.The benefit potassium medicine that has is subjected to the influence of light, heat, oxygen, water bigger, and unstable properties is not easy to operation, transportation and storage.
Summary of the invention:
In view of the deficiency that above-mentioned prior art exists, the purpose of this invention is to provide a kind of to stable performances such as light, heat, oxygen, water, pollution-free, be convenient to operate, transport and store and the left-handed-aspartic acid raw material of higher curative effect arranged and utilize made preparation of this raw material and preparation method treating various potassium deficiency diseases.
The object of the present invention is achieved like this:
Left-handed-the aspartic acid raw material: be made up of left-handed-Aspartic Acid and sylvite, its parts by weight are: left-handed-Aspartic Acid 1-10 part; Sylvite 1-12 part.
The preparation method of left-handed-aspartic acid raw material is: the sylvite of getting recipe quantity adds in the retort, dissolve with suitable quantity of water, add amount of methanol or ethanol again, left-handed-the Aspartic Acid that adds recipe quantity more lentamente, the limit edged stirs, transfer PH8 with left-handed-Aspartic Acid or sylvite, emitting solution filters, filtrate adds in the retort again, cooling slowly adds methyl alcohol or ethanol again and stirs, add in case of necessity a spot of left-handed-aspartic acid, from solution, be settled out loose white crystalline left-handed-aspartic acid, promptly through centrifugation, oven dry.
Preparation: be made up of left-handed-aspartic acid and auxiliary material, its parts by weight are: left-handed-aspartic acid 0.1-10 part; Auxiliary material 0-100 part.
Preparation comprises liquid drugs injection, freeze-dried powder, transfusion, oral liquid, tablet and capsule, wherein the preparation method of liquid drugs injection is: left-handed-aspartic acid, the adding proper amount of water for injection stirring and dissolving of getting recipe quantity, transfer pH to 5～9 scopes, add the needle-use activated carbon of 0.01～0.5% (W/V), filter, benefit adds to the full amount of water for injection, can, sealing by fusing, sterilization, the lamp inspection, packing is promptly;
The preparation method of freeze-dried powder is: left-handed-aspartic acid and the lyophilized powder balustrade of getting recipe quantity add water for injection, stirring makes dissolving, transfer PH to 5～9 scopes with the PH conditioning agent, the pin activated carbon that adds 0.01% ~ 0.5% (W/V), filter de-carbon, degerming, after-teeming is penetrated water to capacity and is crossed the 0.2um millipore filtration, behind the mensuration content, and can; At first pre-freeze be incubated 1-5 hour to-50 ℃-35 ℃, vacuumizes, in 15-30 hour, temperature is risen to-10--3 ℃ rose 15-50 ℃ at 2-10 hour with temperature again, continues 3-10 hour gland of maintenance, promptly;
The preparation method of transfusion is: left-handed-aspartic acid, the adding proper amount of water for injection stirring and dissolving of getting recipe quantity, transfer pH to 5～9 scopes, other gets osmotic pressure regulator and adds the water for injection dissolving, and above-mentioned two kinds of solution are mixed, and adds the needle-use activated carbon of 0.01～0.5% (W/V), filter, benefit adds to the full amount of water for injection, can, sterilization, the lamp inspection, packing is promptly;
The preparation method of oral liquid is: left-handed-aspartic acid and an amount of sanitas of getting recipe quantity, adding an amount of distilled water dissolves, filters, transfer pH to 2～11 scopes, mend distilled water again to full dose, filtration, can, gland, sterilization, lamp inspection, packing are promptly;
The preparation method of tablet is:: the left-handed-aspartic acid and the appropriate amount of auxiliary materials of getting recipe quantity are mixed pulverizing, mixing granulation, oven dry, whole grain, measure content, are played sheet, dressing, packing.
Capsular preparation method is:: the left-handed-aspartic acid and the appropriate amount of auxiliary materials of getting recipe quantity are mixed pulverizing (granulation, oven dry, whole grain), are measured content, filled capsules, polishing, packing promptly.
The invention has the advantages that stable formulation such as raw material that left-handed-aspartic acid is provided and the liquid drugs injection made from this raw material, freeze-dried powder, transfusion, oral liquid, tablet, capsule, make things convenient for patient's medication of different states.Left-handed-aspartic acid is the stronger medicine of Physiology and biochemistry effect, can prevent and treat because the potassium deficiency disease that a variety of causes causes, and then keep the metabolism of cell, keep the function of nerve, muscle, experiment shows uses multiple benefit potassium medicine respectively, the potassium amount that left-handed-aspartic acid enters cell is maximum, thereby curative effect is obvious.
Be described in further detail the present invention below by embodiment:
Embodiment 1
(1) left-handed-aspartic acid raw material prescription: left-handed-Aspartic Acid 1331 grams, potassium hydroxide 560 grams; Make left-handed-aspartic acid raw material 1712 grams.
(2) feedstock production technology: the potassium hydroxide of getting recipe quantity adds in the retort, dissolve with suitable quantity of water, the methyl alcohol or the ethanol that add 3kg again, left-handed-the Aspartic Acid that adds recipe quantity more lentamente, the limit edged stirs, transfer PH8 with left-handed-Aspartic Acid or potassium hydroxide, emitting solution filters, filtrate adds in the retort again, cooling slowly adds methyl alcohol or ethanol again and stirs, add in case of necessity a spot of left-handed-aspartic acid, from solution, be settled out loose white crystalline left-handed-aspartic acid, promptly through centrifugation, oven dry.
Embodiment 2
(1) aqueous injection prescription: left-handed-aspartic acid 1712 grams, water for injection adds to 10000 milliliters, makes 1000.
(2) preparation technology of aqueous injection: get left-handed-aspartic acid, the adding proper amount of water for injection stirring and dissolving of recipe quantity, transfer pH to 6.8, add the needle-use activated carbon of 0.01～0.5% (W/V), filter, benefit adds to the full amount of water for injection, check, can, sealing by fusing, sterilization, the lamp inspection, packing is promptly.
Embodiment 3
(1) lyophilized injectable powder prescription: left-handed-aspartic acid 1712 grams, N.F,USP MANNITOL 210 grams, water for injection adds to 5000 milliliters, makes 1000.
(2) preparation technology of lyophilized injectable powder: get recipe quantity left-handed-aspartic acid and N.F,USP MANNITOL adds the water for injection stirring and dissolving, transfer PH6.8, add solution amount 0.1% pin activated carbon, stirring at room 15min, filter after-teeming and penetrate water, cross the little also filter membrane of 0.2um, behind the mensuration content to 3000ml, can in glass tube vial, every 3ml.The sample that can is good is inserted in the freeze drier, reduces temperature earlier to-45 ℃, is incubated 2 hours, vacuumizes after the heat, and by about 2 ℃ of/hour intensifications, after temperature reaches-5 ℃, is warming up to 25 ℃ by 5 ℃/hour, is incubated 2 hours, adds plug, Zha Gai, quality inspection, vanning.
Embodiment 4
(1) infusion preparation prescription: left-handed-aspartic acid 1712 grams, glucose 2500 grams, water for injection adds to 250000 milliliters, makes 1000 bottles.
(2) preparation technology of infusion preparation: left-handed-aspartic acid, the adding proper amount of water for injection stirring and dissolving of getting recipe quantity, transfer pH to 5～9 scopes, other gets osmotic pressure regulator and adds the water for injection dissolving, and above-mentioned two kinds of solution are mixed, and adds the needle-use activated carbon of 0.01～0.5% (W/V), filter, benefit adds to the full amount of water for injection, can, sterilization, the lamp inspection, packing promptly.
Embodiment 5
(1) oral liquid formulations prescription: left-handed-aspartic acid 1712 grams, Sorbic Acid 120 grams, distilled water adds to 10000 milliliters, makes 1000.
(2) preparation technology of oral liquid formulations: get left-handed-aspartic acid, the sanitas of recipe quantity, add an amount of distilled water and dissolve, filter, transfer pH to 2～11 scopes, mend distilled water again to full dose, filtration, can, sterilization, lamp inspection, packing are promptly.
Embodiment 6
(1) prescription of tablet: left-handed-aspartic acid 300 grams, starch 350 grams are made 1000.
(2) preparation technology of tablet: left-handed-aspartic acid 300 grams and starch 350 grams of getting recipe quantity mix pulverizing, carry out mixing granulation, oven dry, whole grain, play sheet, dressing, packing with appropriate amount of starch slurry and alcohol.
Embodiment 7
(1) prescription of capsule preparations: left-handed-aspartic acid 300 grams, Microcrystalline Cellulose 10 grams, starch 90 grams are made 1000.
(2) preparation technology of capsule preparations: left-handed-aspartic acid, Microcrystalline Cellulose and the appropriate amount of starch of getting recipe quantity are mixed pulverizing, again with disintegrating agent, be mixed, the capsule of packing into No. 1, the packing get final product.
Claims (10)
1, a kind of left-handed-aspartic acid, it is characterized in that it is made by the raw material of following parts by weight, left-handed-Aspartic Acid 1-10 part; Sylvite 1-12 part.
2, a kind of left-handed according to claim 1-preparation method of aspartic acid, it is characterized in that the sylvite of getting recipe quantity adds in the retort, dissolve with suitable quantity of water, add amount of methanol or ethanol again, left-handed-the Aspartic Acid that adds recipe quantity more lentamente, the limit edged stirs, transfer PH8 with left-handed-Aspartic Acid or sylvite, emit solution and filter, filtrate adds in the retort again, cooling, slowly add methyl alcohol or ethanol and stirring again, add in case of necessity a spot of left-handed-aspartic acid, from solution, be settled out loose white crystalline left-handed-aspartic acid, through centrifugation, oven dry promptly.
3, as left-handed-aspartic acid as described in claim 1 and 2, it is characterized in that described sylvite is potassium hydroxide, salt of wormwood, saleratus.
4, a kind of utilize claim 1 described left-handed-the made preparation of aspartic acid raw material, it is characterized in that it is made by the raw material of following parts by weight, left-handed-aspartic acid 0.1-10 part; Auxiliary material 0-100 part; Described preparation is liquid drugs injection, freeze-dried powder, transfusion, tablet, capsule, oral liquid.
5, as claimed in claim 4 left-handed-aspartic acid liquid drugs injection preparation method, it is characterized in that: left-handed-aspartic acid, the adding proper amount of water for injection stirring and dissolving of getting recipe quantity, transfer pH to 5～9 scopes, add the needle-use activated carbon of 0.01～0.5% (W/V), filter, benefit adds to the full amount of water for injection, can, sealing by fusing, sterilization, the lamp inspection, packing promptly.
6, as claimed in claim 4 left-handed-aspartic acid freeze-dried powder preparation method, it is characterized in that: left-handed-aspartic acid and the lyophilized powder balustrade of getting recipe quantity add water for injection, stirring makes dissolving, transfer PH to 5～9 scopes with the PH conditioning agent, the pin activated carbon that adds 0.01% ~ 0.5% (W/V) filters de-carbon, degerming, and after-teeming is penetrated water to capacity and crossed the 0.2um millipore filtration, after measuring content, can; At first pre-freeze be incubated 1-5 hour to-50 ℃-35 ℃, vacuumizes, in 15-30 hour, temperature is risen to-10--3 ℃ rose 15-50 ℃ at 2-10 hour with temperature again, continues 3-10 hour gland of maintenance, promptly.
7, as claimed in claim 4 left-handed-aspartic acid transfusion preparation method, it is characterized in that: get left-handed-aspartic acid, the adding proper amount of water for injection stirring and dissolving of recipe quantity, transfer pH to 5～9 scopes, other gets osmotic pressure regulator and adds the water for injection dissolving, above-mentioned two kinds of solution are mixed, the needle-use activated carbon that adds 0.01～0.5% (W/V) filters, and benefit adds to the full amount of water for injection, can, sterilization, the lamp inspection, packing is promptly.
8, as claimed in claim 4 left-handed-the aspartic acid method for preparing tablet thereof, it is characterized in that: get the left-handed-aspartic acid of recipe quantity and auxiliary material mixing pulverizing, mixing granulation, oven dry, whole grain, measure content, play sheet, dressing, packing; Auxiliary material is selected from starch, dextrin, Icing Sugar, lactose, N.F,USP MANNITOL, calcium sulfate, weighting agents such as Microcrystalline Cellulose, calcium sulfate, secondary calcium phosphate, lime carbonate, light magnesium oxide, absorption agents such as Aluminium Hydroxide, water, wetting agents such as ethanol, HPMC, dextrin, polyvidone, starch slurry, syrup, tackiness agent such as Mierocrystalline cellulose and derivative thereof, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, starch and derivative thereof, disintegrating agents such as croscarmellose sodium, fossil meal, stearic acid, calcium stearate, lubricants such as Magnesium Stearate, fossil meal, derivatived cellulose, polyoxyethylene glycol, polyvidone, coating materials such as crylic acid resin, fat, beeswax, methylcellulose gum, slow control agent auxiliary material such as polyvidone and other pharmacy acceptable auxiliary.
9, as claimed in claim 4 left-handed-the aspartic acid oral liquor, it is characterized in that: oral liquid consists of left-handed-aspartic acid, sanitas, pH regulator agent; Get the left-handed-aspartic acid and an amount of sanitas of recipe quantity, add an amount of distilled water and dissolve, filter, transfer pH to 2～11 scopes, mend distilled water again to full dose, filtration, can, gland, sterilization, lamp inspection, packing are promptly.
10, as claimed in claim 4 left-handed-the aspartic acid capsule preparation method thereof, it is characterized in that: get that the left-handed-aspartic acid of recipe quantity and appropriate amount of auxiliary materials are mixed pulverizing, granulation, oven dry, whole grain, measured content, encapsulated, polishing, packing promptly; The capsule auxiliary material is selected from weighting agents such as starch, dextrin, Icing Sugar, lactose, N.F,USP MANNITOL, calcium sulfate, Microcrystalline Cellulose, absorption agents such as calcium sulfate, secondary calcium phosphate, lime carbonate, light magnesium oxide, Aluminium Hydroxide, wetting agent such as water, ethanol, tackiness agents such as HPMC, dextrin, polyvidone, starch slurry, syrup, Mierocrystalline cellulose and derivative thereof, low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, starch and disintegrating agents such as derivative, croscarmellose sodium thereof.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03111212 CN1439629A (en) | 2003-03-21 | 2003-03-21 | Laevo potassium aspartate material and preparation therefrom and preparing method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 03111212 CN1439629A (en) | 2003-03-21 | 2003-03-21 | Laevo potassium aspartate material and preparation therefrom and preparing method thereof |
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| CN1439629A true CN1439629A (en) | 2003-09-03 |
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Cited By (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103130669A (en) * | 2013-02-28 | 2013-06-05 | 大同长兴制药有限责任公司 | Potassium aspartate preparation method |
| CN103655461A (en) * | 2012-09-24 | 2014-03-26 | 沈阳药联科技创新有限公司 | Method for preparing potassium aspartate injection |
| CN103664668A (en) * | 2012-09-24 | 2014-03-26 | 沈阳药联科技创新有限公司 | Preparation method of potassium aspartate crude drug |
| CN104069082A (en) * | 2013-03-25 | 2014-10-01 | 辽宁药联制药有限公司 | Potassium aspartate tablet and preparation method thereof |
| CN105708791A (en) * | 2014-12-04 | 2016-06-29 | 辽宁药联制药有限公司 | Method for treating severe hypokalemia through micro-pump injection of high-concentration potassium aspartate via central venous catherization |
| CN106137950A (en) * | 2015-04-03 | 2016-11-23 | 西藏卫信康医药股份有限公司 | Potassium aspartate pharmaceutical composition and preparation method |
| CN107432870A (en) * | 2016-05-25 | 2017-12-05 | 辽宁药联制药有限公司 | A kind of aspartic acid capsule and preparation method thereof |
| CN108261403A (en) * | 2017-01-04 | 2018-07-10 | 辽宁药联制药有限公司 | A kind of aspartic acid pellet tablet and preparation method thereof |
| CN110464706A (en) * | 2019-07-19 | 2019-11-19 | 济南康和医药科技有限公司 | A kind of preparation method of potassium aspartate injection |
| CN111302964A (en) * | 2018-12-11 | 2020-06-19 | 赵紫岭 | Novel stable crystal of potassium L-aspartate and preparation method thereof |
-
2003
- 2003-03-21 CN CN 03111212 patent/CN1439629A/en active Pending
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103655461A (en) * | 2012-09-24 | 2014-03-26 | 沈阳药联科技创新有限公司 | Method for preparing potassium aspartate injection |
| CN103664668A (en) * | 2012-09-24 | 2014-03-26 | 沈阳药联科技创新有限公司 | Preparation method of potassium aspartate crude drug |
| CN103130669A (en) * | 2013-02-28 | 2013-06-05 | 大同长兴制药有限责任公司 | Potassium aspartate preparation method |
| CN103130669B (en) * | 2013-02-28 | 2014-10-15 | 山西国润制药有限公司 | Potassium aspartate preparation method |
| CN104069082A (en) * | 2013-03-25 | 2014-10-01 | 辽宁药联制药有限公司 | Potassium aspartate tablet and preparation method thereof |
| CN104069082B (en) * | 2013-03-25 | 2017-12-05 | 辽宁药联制药有限公司 | A kind of aspartic acid piece and preparation method thereof |
| CN105708791A (en) * | 2014-12-04 | 2016-06-29 | 辽宁药联制药有限公司 | Method for treating severe hypokalemia through micro-pump injection of high-concentration potassium aspartate via central venous catherization |
| CN106137950A (en) * | 2015-04-03 | 2016-11-23 | 西藏卫信康医药股份有限公司 | Potassium aspartate pharmaceutical composition and preparation method |
| CN107432870A (en) * | 2016-05-25 | 2017-12-05 | 辽宁药联制药有限公司 | A kind of aspartic acid capsule and preparation method thereof |
| CN108261403A (en) * | 2017-01-04 | 2018-07-10 | 辽宁药联制药有限公司 | A kind of aspartic acid pellet tablet and preparation method thereof |
| CN111302964A (en) * | 2018-12-11 | 2020-06-19 | 赵紫岭 | Novel stable crystal of potassium L-aspartate and preparation method thereof |
| CN110464706A (en) * | 2019-07-19 | 2019-11-19 | 济南康和医药科技有限公司 | A kind of preparation method of potassium aspartate injection |
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