CN100450476C - Electrolyte complementary medical combination for injection - Google Patents
Electrolyte complementary medical combination for injection Download PDFInfo
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- CN100450476C CN100450476C CNB2007100802479A CN200710080247A CN100450476C CN 100450476 C CN100450476 C CN 100450476C CN B2007100802479 A CNB2007100802479 A CN B2007100802479A CN 200710080247 A CN200710080247 A CN 200710080247A CN 100450476 C CN100450476 C CN 100450476C
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Abstract
The electrolyte replenishing medicine composition for injection contains potassium aspartate and magnesium aspartate in the weight ratio of 1 to 1 as effective components, mannitol as freeze drying excipient and pH regulator, with the ratio between total weight of potassium aspartate and magnesium aspartate and the weight of mannitol being 10 to 7.
Description
Technical field
The present invention relates to electrolyte complementary medical, particularly a kind of aspartic acid and Magnesium Aminosuccinate are 1: 1 the injection powder injection composition and the preparation method and the purposes of said composition by anhydride calculated mass ratio.
Background technology
Motassium magnessium aspartate is the mixture of Aspartic Acid potassium salt and magnesium salt, is electrolyte complementary medical.Magnesium and potassium are intracellular important cationes, are playing the part of important role in plurality of enzymes reaction and muscle contraction process, the scale effect myocardial contractility of the inside and outside potassium ion of cell, calcium ion, sodium ion, magnesium ion concentration.Aspartic Acid is the precursor of oxaloacetic acid in the body, plays an important role in tricarboxylic acid cycle.Simultaneously, Aspartic Acid is also participated in ornithine cycle, promotes the metabolism of ammonia and carbon dioxide, makes it to generate carbamide, the content of ammonia and carbon dioxide in the reduction blood.Aspartic Acid and cell have very strong affinity, can be used as the carrier that potassium, magnesium ion enter cell, and potassium ion is returned in the cell, promote cell depolarization and cellular metabolism, keep its normal function.Magnesium ion is to generate glycogen and the indispensable material of energy-rich phosphate ester, can strengthen the therapeutical effect of Aspartic Acid potassium salt.At present motassium magnessium aspartate being widely used clinically comprises that mainly the cardiovascular diseases accompanies low potassium hypomagnesemia, arrhythmia, long-pending disease of the stasis of blood and icteric virus hepatitis in the trimester of pregnancy liver, and concurrent low potassium hypomagnesemia etc. in the operation.
The motassium magnessium aspartate dosage form of clinical practice at present mostly is aqueous injection, causes secondary pollution when clinical use easily, and exists breakage easily and transportation to store the problem of inconvenience.The part bibliographical information said preparation is prepared into the injection freeze-dried powder will be of value to clinical practice, for example publication number is to disclose with Aspartic Acid, magnesium oxide and potassium hydroxide respectively in the patent application of CN 1468603A and CN1830431A to be raw material, to prepare the method for motassium magnessium aspartate injection freeze-dried powder behind the quantitative response salify in solution.Said method employing direct reaction salify in solution prepares motassium magnessium aspartate, because not through preparing the subtractive processes such as recrystallization of aspartic acid, Aspartic Acid magnesium raw material, cause prepared freeze-dried powder ubiquity potassium, magnesium ion content inaccurate, ratio is inharmonious, and difference is big between criticizing and criticizing; And impurity content height, poor solubility, zest are strong, poor stability, and problem such as clarity disqualification rate height.At the problems referred to above, publication number is that to adopt aspartic acid and Magnesium Aminosuccinate in the patent application of CN 1351866A be raw material, prepares potassium magnesium aspartate freeze dried powder injection with freeze-dried powder proppant and pH regulator agent.
In the disclosed freeze-dried composition of prior art CN 1351866A, the prescription of compositions also exists unsatisfactory and needs further improved place.For lyophilized formulations, there are problems such as energy consumption is big, cost height in its preparation process, how to optimize preparation prescription and preparation technology, improve the formability and the quality of lyophilized formulations under the prerequisite that cuts down the consumption of energy, the pain and the adverse reaction rate that reduce in the clinical use are the major issues of preparation freeze-dried powder injection.And present disclosed pharmaceutical composition can not satisfy instructions for use.
Summary of the invention
The purpose of this invention is to provide that a kind of preparation cost is low, stable in properties, motassium magnessium aspartate injection powder injection composition that formability is good and its production and use.
In the process of experimentation, by screening to each supplementary material component in the drug prescription, aspects such as the selection of usage ratio are object as a comparison, to the preparation cost of preparation in freeze dried process, the formability of preparation, aspects such as untoward reaction situation in quality and the clinical use are as evaluation index, the unexpected discovery: the application's pharmaceutical composition is in freeze dried process, time and the energy consumption of comparing freeze-drying process with other prescription obviously reduce, the formability and the quality of preparation further improve, reach best solid dispersion effect, no pain and untoward reaction phenomenon in clinical use.This result exceeds those skilled in the art to expect.
Therefore, the objective of the invention is to big at the energy consumption that exists in the motassium magnessium aspartate injection powder pin preparation process, cost is high, the product shaping difference and batch with criticize between the quality instability, and problems such as pain that exists in the clinical use and adverse reaction rate height, provide that a kind of preparation cost is low, stable in properties, solid dispersion is effective, formability good, the motassium magnessium aspartate injection powder injection composition that adverse reaction rate is low, and the preparation method of said composition.To solve the problems of the technologies described above.The invention provides a kind of electrolyte complementary medical combination of injection, it is characterized in that: containing aspartic acid and Magnesium Aminosuccinate is that raw material, mannitol are freeze-dried excipient and pH regulator agent, wherein aspartic acid and Magnesium Aminosuccinate are 1: 1 by the mass ratio that anhydride calculates, and aspartic acid and Magnesium Aminosuccinate are 10: 7 in the weight sum of anhydride calculating and the ratio of mannitol.
Aspartic acid and Magnesium Aminosuccinate can be anhydride or crystalline hydrate in the compositions, and being preferably aspartic acid is semihydrate, and Magnesium Aminosuccinate is tetrahydrate or dihydrate.
Compositions of the present invention, can be used as electrolyte complementary medical, be used for the arrhythmia that hypokalemia, digitalism cause, the auxiliary treatment of myocarditis sequela, chronic cardiac insufficiency and coronary heart disease etc., and the interior stasis of blood of trimester of pregnancy liver is amassed low potassium hypomagnesemia concurrent in disease and icteric virus hepatitis and the operation etc.
The present composition can be by the conventional preparation method preparation of pharmaceutics, and carry out lyophilization by following method for optimizing then: (1) plate temperature is provided with-48 ℃, the goods cartonning, and the product temperature control is incubated 2 hours to-45 ℃; (2) the condenser refrigeration is opened vacuum pump to-50 ℃, and the drying baker evacuation reaches-15pa; (3) heating flaggy, follow procedure heats up: rise to 0 ℃ with 15 ℃/hour, rise to 12 ℃ with 0.7 ℃/hour again, rise to 30 ℃ with 9 ℃/hour, 20 ℃/hour rise to 50 ℃, treat after the product temperature rise to 45 ℃ insulation 5 hours, lower the temperature 1 hour naturally; (4) vacuum tamponade in the case, the air inlet outlet rolls mouth with the plastic-aluminum composite cover.
The specific embodiment
Specify the present invention below with reference to embodiment, embodiments of the invention only are used to technical scheme of the present invention is described, and non-limiting essence of the present invention.
Embodiment 1
Prescription:
Aspartic acid 500g
Magnesium Aminosuccinate 500g
Mannitol 500g
0.2mol/L potassium hydroxide is an amount of
Water for injection 4L
Preparation technology:
Indoor in the sterile working, take by weighing aspartic acid, Magnesium Aminosuccinate and mannitol by recipe quantity, add successively in the water for injection of recipe quantity 75%, be heated to about 60 ℃, and stirring makes dissolving; The active carbon that adds amount of preparation 0.5% (g/ml), 60 ℃ of insulated and stirred 30min, mixed cellulose ester microporous membrane coarse filtration with 1.2 μ m, with low amounts of water (be about recipe quantity 5%) detergent active charcoal layer, regulate pH to 5.6～6.2 (, generally need not regulate) as long as press recipe quantity input crude drug with the potassium hydroxide solution of 0.2mol/L, supply water for injection to full dose, the mixed cellulose ester microporous membrane fine straining of reuse 0.22 μ m is measured solution content, determines accurate loading amount.Detect color, clarity, pH value, the clarity of semi-finished product sterile solution.Get the about 4ml of above-mentioned fine straining liquid after qualified and be sub-packed in the control cillin bottle of 15ml, carry out lyophilization as follows: setting-4g ℃ of (1) plate temperature, the goods cartonning, the product temperature control is incubated 2 hours to-45 ℃; (2) the condenser refrigeration is opened vacuum pump to-50 ℃, and the drying baker evacuation reaches-15pa; (3) heating flaggy, follow procedure heats up: rise to 0 ℃ with 15 ℃/hour, rise to 12 ℃ with 0.7 ℃/hour again, rise to 30 ℃ with 9 ℃/hour, 20 ℃/hour rise to 50 ℃, treat after the product temperature rise to 45 ℃ insulation 5 hours, lower the temperature 1 hour naturally; (4) vacuum tamponade in the case, the air inlet outlet rolls mouth with the plastic-aluminum composite cover.
Embodiment 2
Prescription:
Aspartic acid 500g
Magnesium Aminosuccinate 500g
Mannitol 700g
0.2mol/L potassium hydroxide is an amount of
Water for injection 4L
Preparation technology: with embodiment 1 preparation technology.
Embodiment 3
Prescription:
Aspartic acid 500g
Magnesium Aminosuccinate 500g
Mannitol 900g
0.2mol/L potassium hydroxide is an amount of
Water for injection 5L
Preparation technology: with embodiment 1 preparation technology.
Embodiment 4
Prescription:
Aspartic acid 500g
Magnesium Aminosuccinate 500g
Mannitol 1100g
0.2mol/L potassium hydroxide is an amount of
Water for injection 5L
Preparation technology: with embodiment 1 preparation technology.
Embodiment 5
Prescription:
Aspartic acid 1000g
Magnesium Aminosuccinate 1000g
Mannitol 1400g
0.2mol/L potassium hydroxide is an amount of
Water for injection 10L
Preparation technology:
Indoor in the sterile working, take by weighing aspartic acid, Magnesium Aminosuccinate and mannitol by recipe quantity, add successively in the water for injection of recipe quantity 75%, be heated to about 60 ℃, and stirring makes dissolving; The active carbon that adds amount of preparation 0.5% (g/ml), 60 ℃ of insulated and stirred 30min, mixed cellulose ester microporous membrane coarse filtration with 1.2 μ m, with low amounts of water (be about recipe quantity 5%) detergent active charcoal layer, regulate pH to 5.6～6.2 (, generally need not regulate) as long as press recipe quantity input crude drug with the potassium hydroxide solution of 0.2mol/L, supply water for injection to full dose, the mixed cellulose ester microporous membrane fine straining of reuse 0.22 μ m is measured solution content, determines accurate loading amount.Detect color, clarity, pH value, the clarity of semi-finished product sterile solution.Get the about 10ml of above-mentioned fine straining liquid after qualified and be sub-packed in the control cillin bottle of 20ml, carry out lyophilization by the method among embodiment 1 preparation technology.
Embodiment 6
Prescription:
Aspartic Acid 850g
Magnesium oxide 163.7g
Potassium hydroxide 70g
Mannitol 700g
0.2mol/L potassium hydroxide is an amount of
Water for injection 5L
Preparation technology:
Indoor in the sterile working, claim Aspartic Acid, potassium hydroxide, magnesium oxide and mannitol by recipe quantity, add the water for injection of recipe quantity 60%, be heated to about 60 ℃, and stirring makes dissolving; The active carbon that adds amount of preparation 0.5% (W/V), 60 ℃ of insulated and stirred 30min, film coarse filtration with 1.2 μ m, with low amounts of water (be about recipe quantity 5%) detergent active charcoal layer, potassium hydroxide with 0.1mol/L is regulated pH to 5.0～7.0, supplies water for injection to full dose, the microporous filter membrane fine straining of reuse 0.22 μ m, measure solution content, determine accurate loading amount.Detect color, clarity, pH value, the clarity of semi-finished product sterile solution.Get the about 5ml of above-mentioned fine straining liquid after qualified and be sub-packed in the control cillin bottle of 15ml, carry out lyophilization by the method among embodiment 1 preparation technology.
Embodiment 7
Prescription:
Aspartic Acid 1700g
Magnesium oxide 327.4g
Potassium hydroxide 140g
Mannitol 1400g
0.2mol/L potassium hydroxide is an amount of
Water for injection 10L
Preparation technology:
Indoor in the sterile working, claim Aspartic Acid, potassium hydroxide, magnesium oxide and mannitol by recipe quantity, add the water for injection of recipe quantity 60%, be heated to about 60 ℃, and stirring makes dissolving; The active carbon that adds amount of preparation 0.5% (W/V), 60 ℃ of insulated and stirred 30min, film coarse filtration with 1.2 μ m, with low amounts of water (be about recipe quantity 5%) detergent active charcoal layer, potassium hydroxide with 0.1mol/L is regulated pH to 5.0～7.0, supplies water for injection to full dose, the microporous filter membrane fine straining of reuse 0.22 μ m, measure solution content, determine accurate loading amount.Detect color, clarity, pH value, the clarity of semi-finished product sterile solution.Get the about 10ml of above-mentioned fine straining liquid after qualified and be sub-packed in the control cillin bottle of 20ml, carry out lyophilization by the method among embodiment 1 preparation technology.
Embodiment 8
Prescription:
Aspartic acid 3000g
Magnesium Aminosuccinate 3000g
Glucose 200g
Sodium hydrogen phosphate is an amount of
Water for injection 15L
Preparation technology:
Get the aspartic acid of recipe quantity by CN 1351866A embodiment 2, Magnesium Aminosuccinate and glucose add injection water 1500ml, stir, and add 40% disodium phosphate soln accent pH 5～11.5, and make whole dissolvings, add 0.1% needle-use activated carbon, 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 ℃, and in 7 hours, temperature rises to 60 ℃ by-10 ℃ again, continue to keep vacuum 3 hours, take out, add plug, jewelling cover finished product.
Embodiment 9
By indexs such as vein irritating after preparation time, sample appearance, solubility, moisture, clarity, heavy metal and the patient's medication of freeze-dry process and adverse reaction rates the foregoing description is compared, the results are shown in Table 1.The inspection method of each index is as follows:
Freeze-drying time: the total time of the required freeze-dry process of each sample preparation.
Appearance character: under each embodiment item, randomly draw 10 bottles respectively in the sample, observe appearance character.
Solubility: under each embodiment item, randomly draw 10 bottles respectively in the sample, remove aluminium lid, inject water for injection 10ml by plug, jolting, the time that the observation sample dissolving is required, calculating mean value with syringe.
Moisture: under each embodiment item, randomly draw 10 bottles respectively in the sample, get the content mixing after, take by weighing powder 0.1g, 3ml makes solvent with Methanamide, slight fever makes dissolving, be cooled to room temperature after, measure according to aquametry (two appendix VIII of Chinese Pharmacopoeia version in 2005 M).
PH value: under each embodiment item, randomly draw 10 bottles respectively in the sample, remove aluminium lid, add water and make the solution that contains anhydrous aspartic acid 0.1g among every 1ml approximately, check according to pH value algoscopy (two appendix VI of Chinese Pharmacopoeia version in 2000 H).
Clarity: under each embodiment item, randomly draw 5 bottles respectively in the sample, remove aluminium lid, inject water for injection 10ml dissolving by plug, shake up, according to " clarity test detailed rules and regulations and criterion " method inspection with syringe.
Particulate matter: under each embodiment item, randomly draw 5 bottles respectively in the sample, remove aluminium lid, inject water for injection 10ml dissolving by plug, shake up, check according to particulate matter inspection technique (two appendix IX of Chinese Pharmacopoeia version in 2005 C) with syringe.
Heavy metal: under each embodiment item, randomly draw 10 bottles respectively in the sample, get the content mixing after, take by weighing powder 1.0g, add water 20ml dissolving, add acetate buffer (pH3.5) 2ml, add water to 25ml again, check (two appendix VIII of Chinese Pharmacopoeia version in 2005 J, first method) in accordance with the law.
Vein irritating and untoward reaction: intravenous drip, adds slowly intravenous drip among the 5% glucose injection 250ml, once a day at one time 1～2 bottle (being equivalent to aspartic acid 1g).Observe vein irritating and untoward reaction.
Conclusion:
Adopt penetrating with aspartic acid magnesium powder pin and can effectively shortening the freeze-dry process time of the present invention's preparation, reduce energy consumption, reduce cost.Prepared product has good surface appearance character and solubility; Moisture is lower; The pH value scope is narrower; Indexs such as clarity, particulate matter, heavy metal are better than other embodiment; No pain and untoward reaction phenomenon in the clinical use.Illustrate that the present invention reaches best solid dispersion effect, can improve the quality of product, reduce adverse reaction rate.In multiple batches of trial-manufacturing process in enormous quantities, further find, adopt the potassium magnesium aspartate for injection powder pin pH value of the present invention's preparation stable, potassium/magnesium proportions constant, related substance is few, the product that has fully guaranteed safe and effective.
The present composition and freeze-dry process, the time that both solved in the motassium magnessium aspartate injection powder pin preparation process is long, the energy consumption height, the problem that cost is high is beneficial to commercial production; Can further improve the formability and the quality of product again, reach best solid dispersion effect, reduce the adverse reaction rate in the clinical use, have good social benefit and economic benefit.
Claims (8)
1, the additional injection powder medicine administered by injection compositions of a kind of electrolysis matter, it is characterized in that: contain active component aspartic acid and Magnesium Aminosuccinate, and freeze-dried excipient mannitol, pH regulator agent, wherein aspartic acid and Magnesium Aminosuccinate are 1: 1 by the mass ratio that anhydride calculates, and aspartic acid and Magnesium Aminosuccinate are 10: 7 by the weight sum of anhydride calculating and the weight ratio of mannitol.
2, compositions as claimed in claim 1, wherein aspartic acid is anhydride or crystalline hydrate.
3, compositions as claimed in claim 2, wherein aspartic acid is a semihydrate.
4, compositions as claimed in claim 1, wherein Magnesium Aminosuccinate is anhydride or crystalline hydrate.
5, compositions as claimed in claim 4, wherein Magnesium Aminosuccinate is a tetrahydrate.
6, compositions as claimed in claim 4, wherein Magnesium Aminosuccinate is a dihydrate.
7, each pharmaceutical composition of claim 1-6 is used to prepare the adjuvant therapy medicaments of arrhythmia, myocarditis sequela, chronic cardiac insufficiency and coronary heart disease that treatment hypokalemia, digitalism cause, and the purposes of concurrent low potassium hypomagnesemia medicine in the long-pending disease of the stasis of blood, icteric virus hepatitis and the operation in the treatment trimester of pregnancy liver.
8, a kind of method for preparing each pharmaceutical composition of claim 1-6, it is characterized in that carry out lyophilization then as follows: (1) plate temperature is provided with-48 ℃, the goods cartonning by each composition weight proportioning preparation lyophilizing solution of compositions, the product temperature control is incubated 2 hours to-45 ℃; (2) the condenser refrigeration is opened vacuum pump to-50 ℃, and the drying baker evacuation reaches-15pa; (3) heating flaggy, follow procedure heats up: rise to 0 ℃ with 15 ℃/hour, rise to 12 ℃ with 0.7 ℃/hour again, rise to 30 ℃ with 9 ℃/hour, 20 ℃/hour rise to 50 ℃, treat after the product temperature rise to 45 ℃ insulation 5 hours, lower the temperature 1 hour naturally; (4) vacuum tamponade in the case, the air inlet outlet rolls mouth with the plastic-aluminum composite cover.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2007100802479A CN100450476C (en) | 2007-02-15 | 2007-02-15 | Electrolyte complementary medical combination for injection |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2007100802479A CN100450476C (en) | 2007-02-15 | 2007-02-15 | Electrolyte complementary medical combination for injection |
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| Publication Number | Publication Date |
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| CN101032477A CN101032477A (en) | 2007-09-12 |
| CN100450476C true CN100450476C (en) | 2009-01-14 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2007100802479A Active CN100450476C (en) | 2007-02-15 | 2007-02-15 | Electrolyte complementary medical combination for injection |
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Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| 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 |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1351866A (en) * | 2001-11-22 | 2002-06-05 | 于航 | Levo-potassium magnesium aspartate freeze drying powder injection and preparing method |
| CN1351867A (en) * | 2001-11-22 | 2002-06-05 | 于航 | Levo-potasisum magnesium asparate infusion injection and preparing method |
| CN1468603A (en) * | 2002-07-18 | 2004-01-21 | 挺 赵 | Prepn of potassium magnesium aspartate for injection |
| CN1830431A (en) * | 2005-03-08 | 2006-09-13 | 巴里莫尔制药（通化）有限公司 | Preparation method of potassium magnesium aspartate freeze dried powder injection |
| CN1879611A (en) * | 2005-06-19 | 2006-12-20 | 青岛众智医药科技有限公司 | A lyophilized powder injection of potassium magnesium aspartate and preparation method thereof |
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2007
- 2007-02-15 CN CNB2007100802479A patent/CN100450476C/en active Active
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1351866A (en) * | 2001-11-22 | 2002-06-05 | 于航 | Levo-potassium magnesium aspartate freeze drying powder injection and preparing method |
| CN1351867A (en) * | 2001-11-22 | 2002-06-05 | 于航 | Levo-potasisum magnesium asparate infusion injection and preparing method |
| CN1468603A (en) * | 2002-07-18 | 2004-01-21 | 挺 赵 | Prepn of potassium magnesium aspartate for injection |
| CN1830431A (en) * | 2005-03-08 | 2006-09-13 | 巴里莫尔制药（通化）有限公司 | Preparation method of potassium magnesium aspartate freeze dried powder injection |
| CN1879611A (en) * | 2005-06-19 | 2006-12-20 | 青岛众智医药科技有限公司 | A lyophilized powder injection of potassium magnesium aspartate and preparation method thereof |
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| TR01 | Transfer of patent right | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20170329 Address after: 851400 Tibet economic and Technological Development Zone, Lhasa City incubator Park No. 1 factory floor, the south side of the contraction seam (201) room Patentee after: Tibet Zhong Kang Pharmaceutical Co., Ltd. Address before: 851400 Lhasa economic and Technological Development Zone, Tibet incubator plant floor, the two floor of the contraction of the South 201-1 room, Patentee before: Tibet Xingkang pharmaceutical Limited by Share Ltd |