CN105055388A - Potassium magnesium aspartate injection and preparation method thereof - Google Patents
Potassium magnesium aspartate injection and preparation method thereof Download PDFInfo
- Publication number
- CN105055388A CN105055388A CN201510490443.8A CN201510490443A CN105055388A CN 105055388 A CN105055388 A CN 105055388A CN 201510490443 A CN201510490443 A CN 201510490443A CN 105055388 A CN105055388 A CN 105055388A
- Authority
- CN
- China
- Prior art keywords
- injection
- aspartate
- potassium
- magnesium aspartate
- preparation
- 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
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention belongs to the field of medicine and particularly relates to a potassium magnesium aspartate injection and a preparation method thereof. The injection comprises raw and auxiliary materials in parts by weight as follows: 400-500 parts of potassium aspartate, 350-450 parts of magnesium aspartate and 10,000 parts of water for injection. The potassium magnesium aspartate injection overcomes the defect about batch charging for reaction of aspartate with sylvite (potassium hydroxide) and magnesium oxide and solves the problems about raw material dissolution in a storage process simultaneously. The invention further provides a preparation method of the potassium magnesium aspartate injection. The preparation method comprises the following steps: the water for injection accounting for 2/3 of the total volume of a prepared medical solution is added, and magnesium aspartate is added and stirred until magnesium aspartate is dissolved; potassium aspartate is added and stirred until potassium aspartate is dissolved; activated carbon is weighed and added to the solution, and the mixture is stirred for 15 min; the water for injection is added to the total volume, and uniform stirring is performed; filtered medical solution is subjected to heat-preservation storage at the temperature of 25-40 DEG C; the filtered medical solution is encapsulated in a glass ampule, and an intermediate product after encapsulation is subjected to sterilization and leak detection; the process is simple and easy to implement.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of potassium magnesium aspartate and glucose injection and preparation method thereof.
Background technology
Motassium magnessium aspartate is saccharide, salt and acid-base balance regulating, and for the arrhythmia that hypokalemia, low potassium and digitalism cause, viral hepatitis, liver cirrhosis closes the treatment of hepatic encephalopathy.
The production technology that motassium magnessium aspartate compound preparation many employings Aspartic Acid and potassium salt (as potassium hydroxide) and magnesium oxide feed intake, this production technology easily produces quality problems and produces safety risks and affect clinical application effect in actual production, as inaccurate in fed intake, quality heterogeneity between different batches, introduce a large amount of impurity etc., especially for injection, this feeding mode cannot remove the impurity that raw material is introduced, and the clinical practice unsafe factor of increase may bring more serious consequence.Existing technological means, in the process stored, also there is the shortcoming that raw material is separated out in potassium magnesium aspartate and glucose injection.
Summary of the invention
The object of this invention is to provide a kind of potassium magnesium aspartate and glucose injection, solve and adopt Aspartic Acid and potassium salt (potassium hydroxide) and magnesium oxide to react the deficiency fed intake, also solve the problem that storage process Raw is separated out simultaneously; The present invention also provides its preparation method.
Potassium magnesium aspartate and glucose injection of the present invention, comprises the supplementary material of following parts by weight:
Aspartic acid 400-500 part
Magnesium Aminosuccinate 350-450 part
Water for injection 10000 parts.
Wherein:
Aspartic acid and Magnesium Aminosuccinate are all its laevoisomers.
The present invention is raw materials used except water for injection, only includes aspartic acid and Magnesium Aminosuccinate, not containing pH adjusting agent, preferably uses charcoal treatment, to remove impurity wherein.The preferably charcoal treatment of every 10000 weight portion potassium magnesium aspartate and glucose injection 2.5-7.5 weight portions.
The preparation method of described potassium magnesium aspartate and glucose injection: comprise the following steps:
(1) get the water for injection of institute's vehicle cumulative volume 2/3, add Magnesium Aminosuccinate, be stirred to dissolving;
(2) add aspartic acid again, be stirred to dissolving;
(3) add active carbon, stir;
(4) add remaining water for injection, stir evenly;
(5) filter;
(6) the medicinal liquid insulation after filtration is stored;
(7) again medicine liquid irrigation is enclosed in ampoule bottle;
(8) the intermediate products after embedding are carried out sterilizing and leak detection;
(9) lamp inspection, packaging.
The dissolubility of Magnesium Aminosuccinate in water is less, and select appropriate process parameter very important to the dissolving accelerating motassium magnessium aspartate, the preferred technological parameter of the present invention is as follows:
Mixing speed in step (1) and step (2) is 10-180rpm, preferred 100rmp.The temperature 50-90 degree Celsius of the water for injection in step (1) and step (4), preferably 70 degrees Celsius.Mixing time in step (3) is 5-30min; In step (3), the ratio of active carbon and water for injection gross weight is 2.5-7.5:10000.
Step is filtered in (5): the microporous filter membrane decarburization first using 0.45um, and the microporous filter membrane then through 0.22um carries out aseptic filtration.
The temperature that insulation in step (6) stores is 25-40 degree Celsius.
In step (7), ampoule bottle is glass ampule or the plastic ampoule bottle of below 20ml.
In described step (8), sterilising temp is 100-121 degree Celsius, and sterilization time is 8-30min.
The present invention compared with prior art, has following beneficial effect:
The invention solves and adopt Aspartic Acid and potassium salt (potassium hydroxide) and magnesium oxide to react the deficiency fed intake, also solve the problem that storage process Raw is separated out simultaneously; Separate out without winter propylhomoserin potassium magnesium in pouring process.
Detailed description of the invention
Below in conjunction with embodiment, the present invention will be further described.
Embodiment 1-5
Add the water for injection of institute's vehicle cumulative volume 2/3, add Magnesium Aminosuccinate 400g, be stirred to dissolving.Add aspartic acid 450g, be stirred to dissolving.Take active carbon 5g, join in above-mentioned solution, stir 15min.Inject water to 10000ml, stir evenly.Medicinal liquid after filtering is stored in 25-40 DEG C of insulation.Medicine liquid irrigation after filtering is enclosed in glass ampule.Intermediate products after embedding are carried out sterilizing (121 DEG C of 15min) and leak detection.
Add Magnesium Aminosuccinate in embodiment 1-5 and all dissolve required time in table 1 with the mixing speed and Magnesium Aminosuccinate adding aspartic acid.
Table 1 embodiment 1-5 mixing speed and Magnesium Aminosuccinate all dissolve required time
Data as can be seen from table 1, preferred technological parameter is: mixing speed 100rpm, water for injection temperature 70 C.
Embodiment 6-10
Add the water for injection of 70 DEG C of institute's vehicle cumulative volume 2/3, add Magnesium Aminosuccinate 400g, under 100rpm, stir 15min.Add aspartic acid 450g, be stirred to dissolving.Take the active carbon of embodiment amount, join in above-mentioned solution, stir.Inject water to 10000ml, stir evenly.Medicinal liquid after filtering is stored in 25-40 DEG C of insulation.Medicine liquid irrigation after filtering is enclosed in glass ampoule bottles.Intermediate products after embedding are carried out sterilizing (121 DEG C of 15min) and leak detection.
In embodiment 6-10, activated carbon dosage and time are in table 2.
Activated carbon dosage and time in table 2 embodiment 6-10
| Project | Embodiment 6 | Embodiment 7 | Embodiment 8 | Embodiment 9 | Embodiment 10 |
| Activated carbon dosage | 2.5g | 5g | 7.5g | 5g | 5g |
| Mixing time | 15min | 15min | 15min | 5min | 30min |
| Pyrogen | Qualified | Qualified | Qualified | Qualified | Qualified |
| The labelled amount of aspartic acid | 99.8％ | 99.5％ | 99.2％ | 99.7％ | 99.2％ |
| The labelled amount of Magnesium Aminosuccinate | 99.7％ | 99.6％ | 99.4％ | 99.8％ | 99.1％ |
Adding active carbon in the production process of injection, its objective is the effect in order to adsorb pyrogen and decolouring, if consumption may not have the effect of depyrogenation and decolouring very little, if consumption too much, the absorption of medicine can be caused.The active carbon of the present embodiment different amounts has prepared potassium magnesium aspartate and glucose injection, and have detected the labelled amount of pyrogen and aspartic acid and Magnesium Aminosuccinate according to State Bureau quality standard YBH11372006.As can be seen from the data of table 2, preferred activated carbon dosage is: 5g, and mixing time is 15min.
Embodiment 11-13
Add the water for injection of 70 DEG C of institute's vehicle cumulative volume 2/3, add Magnesium Aminosuccinate 400g, under 100rpm, stir 10min.Add aspartic acid 450g, be stirred to dissolving.Take active carbon 5g, and join in above-mentioned solution, stir.Inject water to 10000ml, stir evenly.Deposit at different temperatures for the ease of medicinal liquid, by liquid medicine filling in 10ml glass ampule, at each temperature, deposit 200.
Solution storage temperature in embodiment 11-13 pouring process and time are in table 3.
As can be seen from the data of table 3, in pouring process, the storage temperature of aspartic acid magnesium solution is 25-40 DEG C, and preferred storage temperature is 30 DEG C.
Solution storage temperature in table 3 embodiment 11-13 pouring process and time
| Project | Embodiment 11 | Embodiment 12 | Embodiment 13 |
| Storage temperature | 5℃ | 25℃ | 40℃ |
| Resting period | 12 hours | 12 hours | 12 hours |
| Phenomenon | Indivedual ampoule has crystallization | Nodeless mesh is separated out | Nodeless mesh is separated out |
Embodiment 14-16
Add the water for injection of institute's vehicle cumulative volume 2/3, add Magnesium Aminosuccinate 400g, be stirred to dissolving.Add aspartic acid 450g, be stirred to dissolving.Take active carbon 5g, and join in above-mentioned solution, stir 15min.Inject water to 10000ml, stir evenly.Medicinal liquid after filtering is stored in 25-40 DEG C of insulation.Medicine liquid irrigation after filtering is enclosed in glass ampoule bottles.Intermediate products after embedding are carried out sterilizing and leak detection.
Check according to the sample of relevant regulations to embodiment 14-16 in state food drug surveilance office standard YBH11372006 and the Sanitation Ministry medicine standard two (six) potassium magnesium aspartate and glucose injection quality standard, the sterilising conditions of embodiment 14-16 is in table 4, and under the different sterilising conditions of embodiment 14-16, the testing result of potassium magnesium aspartate and glucose injection is in table 5.
The sterilising conditions of table 4 embodiment 14-16
| Project | Embodiment 14 | Embodiment 15 | Embodiment 16 |
| Sterilising temp | 100℃ | 115℃ | 121℃ |
| Sterilization time | 30min | 30min | 15min |
The testing result of potassium magnesium aspartate and glucose injection under the different sterilising conditions of table 5 embodiment 14-16
Data as can be seen from table 5, before and after sterilizing the pH of aspartic acid magnesium solution and the content of main component basically identical, the injection stable in properties adopting the preparation method that the present invention relates to prepare is described, solves and adopt Aspartic Acid and potassium salt (potassium hydroxide) and magnesium oxide to react the deficiency fed intake.Preferred sterilising conditions is 121 DEG C of 15min.
Also carried out steriling test according to the relevant regulations of 2010 editions Chinese Pharmacopoeias to the sample of embodiment 14-16, result all conforms with the regulations simultaneously.
In order to investigate the influence factor of the crystal precipitation affecting potassium magnesium aspartate and glucose injection, deposited under different conditions by the sample in embodiment 14-16, concrete outcome is in table 6:
The shelf test at different temperatures of table 6 potassium magnesium aspartate and glucose injection
Data as can be seen from table 6, storage temperature reduces, the probability that potassium magnesium aspartate and glucose injection crystal is separated out increases, therefore in design process of the present invention, the storage temperature of aspartic acid magnesium solution before fill is defined as 25-40 degree Celsius, and object is to prevent motassium magnessium aspartate from separating out in pouring process.Data from table 6 it can also be seen that, through the potassium magnesium aspartate and glucose injection that high-temperature process is crossed, then when being kept at lower temperature, the probability that crystal is separated out greatly reduces, therefore, necessary heat treatment process is also one of measure of potassium magnesium aspartate and glucose injection crystal precipitation.
Claims (10)
1. a potassium magnesium aspartate and glucose injection, is characterized in that: the supplementary material comprising following parts by weight:
Aspartic acid 400-500 part
Magnesium Aminosuccinate 350-450 part
Water for injection 10000 parts.
2. potassium magnesium aspartate and glucose injection according to claim 1, is characterized in that: aspartic acid and Magnesium Aminosuccinate are all its laevoisomers.
3. potassium magnesium aspartate and glucose injection according to claim 1, is characterized in that: the charcoal treatment of every 10000 weight portion potassium magnesium aspartate and glucose injection 2.5-7.5 weight portions, to remove impurity wherein.
4. a preparation method for the arbitrary described potassium magnesium aspartate and glucose injection of claim 1-3, is characterized in that: comprise the following steps:
(1) get the water for injection of institute's vehicle cumulative volume 2/3, add Magnesium Aminosuccinate, be stirred to dissolving;
(2) add aspartic acid again, be stirred to dissolving;
(3) add active carbon, stir;
(4) add remaining water for injection, stir evenly;
(5) filter;
(6) the medicinal liquid insulation after filtration is stored;
(7) again medicine liquid irrigation is enclosed in ampoule bottle;
(8) the intermediate products after embedding are carried out sterilizing and leak detection;
(9) lamp inspection, packaging.
5. the preparation method of potassium magnesium aspartate and glucose injection according to claim 4, is characterized in that: the mixing speed in step (1) and step (2) is 10-180rpm, and the mixing time in step (3) is 5-30min; The temperature 50-90 degree Celsius of the water for injection in step (1) and step (4).
6. the preparation method of potassium magnesium aspartate and glucose injection according to claim 4, is characterized in that: in step (3), the ratio of active carbon and water for injection gross weight is 2.5-7.5:10000.
7. the preparation method of potassium magnesium aspartate and glucose injection according to claim 4, is characterized in that: step is filtered in (5): the microporous filter membrane decarburization first using 0.45um, and the microporous filter membrane then through 0.22um carries out aseptic filtration.
8. the preparation method of potassium magnesium aspartate and glucose injection according to claim 4, is characterized in that: the temperature that the insulation in step (6) stores is 25-40 degree Celsius.
9. the preparation method of potassium magnesium aspartate and glucose injection according to claim 4, is characterized in that: in step (7), ampoule bottle is glass ampule or the plastic ampoule bottle of below 20ml.
10. the preparation method of potassium magnesium aspartate and glucose injection according to claim 4, is characterized in that: in described step (8), sterilising temp is 100-121 degree Celsius, and sterilization time is 8-30min.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510490443.8A CN105055388A (en) | 2015-08-11 | 2015-08-11 | Potassium magnesium aspartate injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510490443.8A CN105055388A (en) | 2015-08-11 | 2015-08-11 | Potassium magnesium aspartate injection and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN105055388A true CN105055388A (en) | 2015-11-18 |
Family
ID=54485073
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201510490443.8A Pending CN105055388A (en) | 2015-08-11 | 2015-08-11 | Potassium magnesium aspartate injection and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN105055388A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN110731967A (en) * | 2019-12-03 | 2020-01-31 | 海南顿斯医药科技有限公司 | potassium magnesium aspartate composition and application thereof |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0202106A3 (en) * | 1985-05-13 | 1987-10-14 | George H. Clark | A beverage and method of making a beverage for the replacement of body fluids and electrolytes |
| CN1351867A (en) * | 2001-11-22 | 2002-06-05 | 于航 | Levo-potasisum magnesium asparate infusion injection and preparing method |
| CN103110616A (en) * | 2013-03-14 | 2013-05-22 | 山西普德药业股份有限公司 | Potassium magnesium aspartate freeze-dried powder preparation for injection and preparation method of preparation |
| CN103536623A (en) * | 2013-10-15 | 2014-01-29 | 海南卫康制药(潜山)有限公司 | Potassium magnesium aspartate composition freeze-dried powder for injection |
| 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 |
-
2015
- 2015-08-11 CN CN201510490443.8A patent/CN105055388A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0202106A3 (en) * | 1985-05-13 | 1987-10-14 | George H. Clark | A beverage and method of making a beverage for the replacement of body fluids and electrolytes |
| CN1351867A (en) * | 2001-11-22 | 2002-06-05 | 于航 | Levo-potasisum magnesium asparate infusion injection and preparing method |
| CN103110616A (en) * | 2013-03-14 | 2013-05-22 | 山西普德药业股份有限公司 | Potassium magnesium aspartate freeze-dried powder preparation for injection and preparation method of preparation |
| CN103536623A (en) * | 2013-10-15 | 2014-01-29 | 海南卫康制药(潜山)有限公司 | Potassium magnesium aspartate composition freeze-dried powder for injection |
| 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 |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN110731967A (en) * | 2019-12-03 | 2020-01-31 | 海南顿斯医药科技有限公司 | potassium magnesium aspartate composition and application thereof |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN103768091B (en) | Sodium bicarbonate injection and its preparation method | |
| CN105055388A (en) | Potassium magnesium aspartate injection and preparation method thereof | |
| CN103550143A (en) | Preparation method of levetiracetam injection | |
| CN103989630B (en) | Moxifloxacin hydrochloride injection and preparation method thereof | |
| CN103479522A (en) | Method for preparing levofloxacin hydrochloride sodium chloride injection | |
| CN102600070B (en) | Meglumine adenosine cyclophosphate composition injection and preparation method thereof | |
| CN103191431B (en) | Coenzyme Q10 sodium chloride injection uneasy to crystallize and preparation method thereof | |
| CN103371969A (en) | Metaraminol bitartrate injection and preparation technology thereof | |
| CN112618496A (en) | Preparation method of azithromycin freeze-dried powder injection for injection | |
| CN105640876B (en) | A kind of preparation process of moxifloxacin hydrochloride injection | |
| CN102144963B (en) | Citicoline sodium glucose injecta and preparation process thereof | |
| CN110538144A (en) | Ornidazole injection and S-ornidazole injection | |
| CN103110616B (en) | Potassium magnesium aspartate freeze-dried powder preparation for injection and preparation method of preparation | |
| CN103371967A (en) | Furosemide injection and preparation process thereof | |
| CN103239392B (en) | Ornidazole injection preparation and preparation method thereof | |
| CN105476954B (en) | A kind of lomefloxacin hydrochloride injection and preparation method | |
| CN107789324A (en) | A kind of injection De Lasha star meglumines and preparation method thereof | |
| CN103520122B (en) | Preparation method for Bumetanide freeze-dried powder preparation for injection | |
| CN112022802A (en) | Method for preparing linezolid injection | |
| CN102871961B (en) | Injection containing tirofiban | |
| CN104288099A (en) | Ibuprofen injection | |
| CN106420599A (en) | Preparation method of citric acid caffeine injection | |
| CN105055307A (en) | Meglumine adenosine cyclophosphate injection and preparation method thereof | |
| CN104224707A (en) | Granisetron hydrochloride glucose injection and preparation method thereof | |
| WO2017114214A1 (en) | Composition, applications thereof, and stabilizer comprising composition |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20151118 |
|
| RJ01 | Rejection of invention patent application after publication |