CN1197623C - Sparagin injection using xylitol as isosmotic adjusting agent - Google Patents
Sparagin injection using xylitol as isosmotic adjusting agent Download PDFInfo
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- CN1197623C CN1197623C CNB031310672A CN03131067A CN1197623C CN 1197623 C CN1197623 C CN 1197623C CN B031310672 A CNB031310672 A CN B031310672A CN 03131067 A CN03131067 A CN 03131067A CN 1197623 C CN1197623 C CN 1197623C
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Abstract
The present invention relates to kalium magnesium aspartate injection with xylitol as an isosmotic regulating agent. 1.70g of aspartate, 0.14g of magnesium oxide, 0.328g of potassium hydroxide and 12.5g of xylitol are contained in a kalium magnesium aspartate solution per 250 ml, and the rest is the water for injection. The utilization rate of the kalium magnesium aspartate is effectively improved, and simultaneously, the present invention has the advantages of convenient clinical use, reduction of iatrogenic pollution, etc.
Description
Technical field
The present invention relates to a kind of motassium magnessium aspartate transfusion, relate in particular to a kind of motassium magnessium aspartate transfusion of making isoosmotic adjusting agent with xylitol.
Background technology
We know that infusion medicine must have isoosmotic adjusting agent.What generally use at present is to regulate to wait with sodium chloride or glucose as carrier to ooze, but the instillation sodium salt can reduce the effect of potassium during the vein kalium replenishment, so the osmotic pressure regulator that motassium magnessium aspartate is infused should not be selected sodium chloride for use; And the hydroxyl amino reaction can take place in Aspartic Acid and glucose compatibility in the aspartic acid magnesium injection liquid, i.e. prunus mume (sieb.) sieb.et zucc. rad (Maillard) reaction influence the utilization of Aspartic Acid, quickens the decomposition of glucose, so also should not select for use glucose to do osmotic pressure regulator.Existing in addition aspartic acid magnesium injection liquid is a small-volume injection, must be diluted in quiet use in the infusion solutions during clinical practice, exists clinical application inconvenience and easily causes shortcoming such as iatrogenic pollution.
Summary of the invention
The object of the present invention is to provide a kind of motassium magnessium aspartate transfusion of making isoosmotic adjusting agent with xylitol.
Each component of the present invention and content are: contain Aspartic Acid 1.70g in per 250 milliliters of aspartic acid magnesium solutions, and magnesium oxide 0.14g, potassium hydroxide 0.328g, xylitol 12.5g, all the other are water for injection, concrete preparation process is as follows:
250 liters of aspartic acid magnesium solutions of desire preparation, need elder generation in Agitation Tank, to add 50 liters water for injection, take by weighing Aspartic Acid 1.70kg, magnesium oxide 0.14kg puts into Agitation Tank, stirred 30 minutes, and added potassium hydroxide 0.328kg, stirring is dissolved raw material fully, add xylitol 12.5kg, stirring and dissolving;
In solution, add the medicinal charcoal that accounts for liquor capacity 0.1%, stir after 30 minutes, with titanium filter stick filtering decarbonization;
In Agitation Tank, add water for injection to 80% of overall solution volume, promptly reach 200 liters, stir, measure the pH value and the material content of medicinal liquid, mend and add to the full amount of water for injection 250 liters;
Medicinal liquid adopts 0.22 μ m filter element filtering qualified to clarity, canned then;
Adopted the water-bath type pressure sterilizing 20 minutes, finished product is carried out clarity test after, packing, warehouse-in.
Xylitol is the polyhydric alcohol of pentose, be glycometabolic intermediate in the body, participate in the recirculation of glucuronic acid, metabolism is not subjected to the influence of insulin in vivo, does not promptly need too many insulin can enter in the cell, directly infiltrates tissue and participates in metabolism, almost all be used as body in vivo the energy is provided, the Developmental and Metabolic Disorder that simultaneously can also correct protein, fat and steroid can promote liver glycogen to generate, and has the ketoplastic effect of powerful inhibition.
There are not nitro or ketone group on the xylitol structure, mailland reaction in glucose and the aminoacid compatibility can not take place, and the body utilization rate of xylitol is better than similar sorbitol, the consumption of saving the amino nitrogen amount is the twice of glucose, guarantee amino acid whose effective utilization, be particularly useful for hepatopathy and diabetes patient.
The present invention has effectively improved the utilization rate of motassium magnessium aspartate, have simultaneously clinical easy to use, reduce advantage such as iatrogenic pollution.
The specific embodiment
Below the present invention is further specified:
Each component of the present invention and content are: contain Aspartic Acid 1.70kg in per 250 liters of aspartic acid magnesium solutions, and magnesium oxide 0.14kg, potassium hydroxide 0.328kg, xylitol 12.5kg, all the other are water for injection.
The door winter meets the Chinese Pharmacopoeia standard by acid in the raw material that uses, xylitol (injection) meets the national drug standards, magnesium oxide is all formulated the injection inner quality standard on the basis of Chinese Pharmacopoeia, potassium hydroxide is domestic still not to have medicinal standard, has formulated the inner quality standard (as following table) of potassium hydroxide according to the BP2000 version:
| The supplementary material title | The place of production | Standard |
| Aspartic Acid | Tianjin aminoacid company | Chinese Pharmacopoeia version in 2000 |
| Magnesium oxide | Xingtai metallurgical magnesium industry company limited | The injection inner quality standard |
| Potassium hydroxide | The Hubei University chemical plant | The BP2000 version |
| Xylitol | Yucheng, Shandong Feitian pharmaceutcal corporation, Ltd | National drug standards WS-10001-(HD-0497)-2000 |
Concrete preparation process is as follows:
250 liters of aspartic acid magnesium solutions of desire preparation, need elder generation in Agitation Tank, to add 50 liters water for injection, take by weighing Aspartic Acid 1.70kg, magnesium oxide 0.14kg puts into Agitation Tank, stirred 30 minutes, and added potassium hydroxide 0.328kg, stirring is dissolved raw material fully, add xylitol 12.5kg, stirring and dissolving;
In solution, add the medicinal charcoal that accounts for liquor capacity 0.1%, stir after 30 minutes, with titanium filter stick filtering decarbonization;
In Agitation Tank, add water for injection to 80% of overall solution volume, promptly reach 200 liters, stir, measure the pH value and the material content of medicinal liquid, mend and add to the full amount of water for injection 250 liters;
Medicinal liquid adopts 0.22 μ m filter element filtering qualified to clarity, preferentially selects non-PVC copolymerized compound membrane soft bag packing then for use, also can use soft bag of PVC or glass bottle packaging, can press 50～1000 milliliters capacity packing as required;
Adopted 121 ℃ of pressure sterilizings of water-bath type sterilization cabinet 20 minutes, finished product is carried out clarity test after, packing, warehouse-in.
For verifying effect of the present invention, also carry out following experiment:
(1) preliminary experiment takes by weighing Aspartic Acid, magnesium oxide, the potassium hydroxide of recipe quantity, adds in the water of recipe quantity, and stirring raw material can be water-soluble, adds xylitol in the medicinal liquid, stirs very fast dissolving, and the medicinal liquid pH value is about 6.5.After medicinal liquid adopted 0.45 μ m micro-pore-film filtration, clarity was fine.
(2) medicinal liquid pH value scope determines
The human plasma pH value is 7.4, and common infusion fluid pH value scope is 3.2～8.5.For determining this product pH value scope, design this product pH value value scope is 5.0～7.0, consider that the solution pH value may influence the stability of medicinal liquid, preparing pH value respectively is 5.0,6.0,7.0 each two batch sample (non-PVC multi-layer co-extruded transfusion thin film packed in flexible pouchy), get respectively that sterilization back sample is put respectively in 60 ℃ of baking ovens, in 4 ℃ of refrigerators, lightness is placement 10 days 4500 ± 500LX sight lamp under, sampling and measuring related substance during respectively at 0 day, 5 days, 10 days, the result is as follows:
| Investigation condition, time | Project | pH5.0 | pH6.0 | pH7.0 | ||||
| 011212-1 | 011212-2 | 011213-1 | 011213-2 | 011214-1 | 011214-2 | |||
| 0 day | Color and luster | Colourless | Colourless | Colourless | Colourless | Colourless | Colourless | |
| pH | 5.04 | 5.06 | 6.02 | 6.01 | 7.02 | 7.03 | ||
| Aspartic Acid content | 98.10％ | 97.87％ | 99.51％ | 99.67％ | 100.1％ | 100.2％ | ||
| Potassium content | 99.34％ | 99.24％ | 98.96％ | 98.86％ | 100.2％ | 100.4％ | ||
| Content of magnesium | 98.45％ | 98.63％ | 99.36％ | 99.54％ | 100.1％ | 100.3％ | ||
| Xylitol content | 100.6％ | 100.7％ | 98.05％ | 98.24％ | 99.66％ | 99.19％ | ||
| Related substance | 0.21％ | 0.31％ | 0.26％ | 0.24％ | 0.24％ | 0.26％ | ||
| 60℃ | 5 days | Color and luster | Colourless | Colourless | Colourless | Colourless | Colourless | Colourless |
| pH | 5.05 | 5.04 | 6.02 | 6.02 | 7.01 | 7.02 | ||
| Aspartic Acid content | 98.18％ | 97.79％ | 99.28％ | 99.67％ | 100.2％ | 99.98％ | ||
| Potassium content | 99.53％ | 99.86％ | 99.43％ | 98.67％ | 100.1％ | 99.29％ | ||
| Content of magnesium | 98.60％ | 98.56％ | 99.47％ | 99.39％ | 100.1％ | 100.2％ | ||
| Xylitol content | 100.4％ | 99.95％ | 98.14％ | 98.24％ | 99.57％ | 99.47％ | ||
| Related substance | 0.52％ | 0.53％ | 0.52％ | 0.51％ | 0.54％ | 0.53％ | ||
| 10 days | Color and luster | Colourless | Colourless | Colourless | Colourless | Colourless | Colourless | |
| pH | 5.04 | 5.05 | 6.03 | 6.02 | 7.04 | 7.02 | ||
| Aspartic Acid content | 97.87％ | 97.71％ | 99.12％ | 99.43％ | 100.1％ | 100.1％ | ||
| Potassium content | 99.10％ | 99.29％ | 99.34％ | 98.48％ | 99.91％ | 99.15％ | ||
| Content of magnesium | 98.38％ | 98.60％ | 99.36％ | 99.65％ | 100.1％ | 100.3％ | ||
| Xylitol content | 100.4％ | 100.1％ | 97.48％ | 98.05％ | 99.76％ | 99.09％ | ||
| Related substance | 0.85％ | 0.92％ | 0.92％ | 0.96％ | 0.87％ | 0.86％ | ||
| 4℃ | 5 days | Color and luster | Colourless | Colourless | Colourless | Colourless | Colourless | Colourless |
| pH | 5.03 | 5.04 | 6.02 | 6.05 | 7.04 | 7.03 | ||
| Aspartic Acid content | 98.02％ | 97.63％ | 99.51％ | 99.59％ | 100.2％ | 100.1％ | ||
| Potassium content | 99.34％ | 99.19％ | 99.10％ | 98.81％ | 99.67％ | 100.1％ | ||
| Content of magnesium | 98.60％ | 98.53％ | 99.50％ | 99.36％ | 99.86％ | 100.2％ | ||
| Xylitol content | 100.5％ | 100.4％ | 98.33％ | 98.62％ | 99.47％ | 99.28％ | ||
| Related substance | 0.31％ | 0.31％ | 0.33％ | 0.30％ | 0.30％ | 0.30％ | ||
| 10 days | Color and luster | Colourless | Colourless | Colourless | Colourless | Colourless | Colourless | |
| pH | 5.04 | 5.02 | 6.01 | 6.03 | 7.01 | 7.04 | ||
| Aspartic Acid content | 98.02％ | 97.87％ | 99.43％ | 99.75％ | 100.4％ | 100.2％ | ||
| Potassium content | 99.77％ | 99.67％ | 99.34％ | 99.05％ | 100.2％ | 99.86％ | ||
| Content of magnesium | 98.71％ | 98.63％ | 99.58％ | 99.58％ | 99.94％ | 100.2％ | ||
| Xylitol content | 100.2％ | 100.1％ | 98.43％ | 98.52％ | 99.76％ | 99.38％ | ||
| Related substance | 0.31％ | 0.31％ | 0.35％ | 0.37％ | 0.29％ | 0.28％ | ||
| Illumination | 5 days | Color and luster | Colourless | Colourless | Colourless | Colourless | Colourless | Colourless |
| pH | 5.01 | 4.99 | 6.03 | 6.04 | 7.02 | 6.99 | ||
| Aspartic Acid content | 97.55％ | 97.32％ | 99.20％ | 99.59％ | 99.98％ | 100.1％ | ||
| Potassium content | 99.48％ | 99.91％ | 99.24％ | 98.19％ | 99.77％ | 98.62％ | ||
| Content of magnesium | 98.16％ | 98.35％ | 99.10％ | 99.58％ | 100.0％ | 100.3％ | ||
| Xylitol content | 100.3％ | 100.2％ | 98.14％ | 97.86％ | 100.0％ | 99.28％ | ||
| Related substance | 0.63％ | 0.64％ | 0.43％ | 0.44％ | 0.52％ | 0.57％ | ||
| 10 days | Color and luster | Colourless | Colourless | Colourless | Colourless | Colourless | Colourless | |
| pH | 5.04 | 5.03 | 6.02 | 6.03 | 7.02 | 7.02 | ||
| Aspartic Acid content | 97.24％ | 97.71％ | 98.89％ | 99.59％ | 99.67％ | 100.2％ | ||
| Potassium content | 99.00％ | 100.2％ | 99.48％ | 98.43％ | 99.63％ | 98.76％ | ||
| Content of magnesium | 98.24％ | 98.13％ | 99.36％ | 99.07％ | 99.83％ | 100.2％ | ||
| Xylitol content | 99.76％ | 100.3％ | 97.86％ | 98.24％ | 100.1％ | 99.38％ | ||
| Related substance | 1.52％ | 1.54％ | 1.55％ | 1.53％ | 1.54％ | 1.55％ |
As can be seen: the sample of different pH value is investigated 10 days under 60 ℃, 4 ℃, illumination condition, each is investigated index and changes basically identical, and pH value is not obvious to its influence, and pH value generally transfers to about 6.0 in the technology for this reason, standard is controlled at 5.0～7.0, with the pH value near blood.
By the result as can be known: this product is investigated 10 days under 60 ℃ and illumination condition, related substance obviously raises, and prove this product to high temperature, illumination instability, and the prompting sample must lucifuge Liang Chu preservation.
(3) medicinal adsorption experiment
Adopt the dense method of joining in preparation process, the medicinal charcoal that adds usual amounts 0.1% in the concentrated wiring liquid stirs absorption in 30 minutes and filters with decolouring and depyrogenation, and the The effects medicinal charcoal is to the Adsorption Effect of medicinal liquid for this reason.
Method is: at ambient temperature, the Aspartic Acid, magnesium oxide, the potassium hydroxide that take by weighing recipe quantity are put into Agitation Tank, the water for injection that adds recipe quantity 20%, stirring is dissolved raw material fully, add xylitol, stirring and dissolving, 0.1% the medicinal charcoal that adds in the solution, through 30 minutes stirring and adsorbing, at the content that adds charcoal front and back mensuration Aspartic Acid, magnesium, potassium and xylitol.
Result such as following table:
| Lot number | Add charcoal prodrug liquid hold-up (%) | Add medicinal liquid content (%) behind the charcoal | ||||||
| Aspartic Acid | Magnesium | Potassium | Xylitol | Aspartic Acid | Magnesium | Potassium | Xylitol | |
| 020107-1 | 97.40 | 98.09 | 99.43 | 99.76 | 97.48 | 98.20 | 99.15 | 99.66 |
| 020107-2 | 97.71 | 98.13 | 99.86 | 99.95 | 97.63 | 98.16 | 99.91 | 99.76 |
| 020107-3 | 98.18 | 98.63 | 99.48 | 98.71 | 98.02 | 98.31 | 99.53 | 99.06 |
Can find that medicinal charcoal does not have adsorption to raw material.
Claims (5)
1. do the motassium magnessium aspartate transfusion of isoosmotic adjusting agent with xylitol for one kind, its component and content are: contain Aspartic Acid 1.70g, magnesium oxide 0.14g in per 250 milliliters of aspartic acid magnesium solutions, potassium hydroxide 0.328g, xylitol 12.5g, all the other are water for injection, concrete preparation process is as follows:
250 liters of aspartic acid magnesium solutions of desire preparation, need elder generation in Agitation Tank, to add 50 liters water for injection, take by weighing Aspartic Acid 1.70kg, magnesium oxide 0.14kg puts into Agitation Tank, stirred 30 minutes, and added potassium hydroxide 0.328kg, stirring is dissolved raw material fully, add xylitol 12.5kg, stirring and dissolving;
In solution, add the medicinal charcoal that accounts for liquor capacity 0.1%, stir after 30 minutes, with titanium filter stick filtering decarbonization;
In Agitation Tank, add water for injection to 80% of overall solution volume, promptly reach 200 liters, stir, measure the pH value and the material content of medicinal liquid, mend and add to the full amount of water for injection 250 liters;
Medicinal liquid adopts 0.22 μ m filter element filtering qualified to clarity, canned then;
Adopted the water-bath type pressure sterilizing 20 minutes, finished product is carried out clarity test after, packing, warehouse-in.
2. motassium magnessium aspartate transfusion according to claim 1 is characterized in that: medicinal liquid adopts 0.22 μ m filter element filtering to the qualified back of clarity to pack with non-PVC copolymerized compound membrane soft bag.
3. motassium magnessium aspartate transfusion according to claim 1 is characterized in that: medicinal liquid adopts 0.22 μ m filter element filtering to the qualified back of clarity soft bag of PVC or glass bottle packaging.
4. according to claim 1 or 2 or 3 described motassium magnessium aspartate transfusions, it is characterized in that: the capacity packing that can press 50～1000 milliliters as required.
5. according to claim 1 or 2 or 3 described motassium magnessium aspartate transfusions, it is characterized in that: adopting the temperature of water-bath type sterilization is 121 ℃.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031310672A CN1197623C (en) | 2003-05-15 | 2003-05-15 | Sparagin injection using xylitol as isosmotic adjusting agent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB031310672A CN1197623C (en) | 2003-05-15 | 2003-05-15 | Sparagin injection using xylitol as isosmotic adjusting agent |
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| Publication Number | Publication Date |
|---|---|
| CN1451438A CN1451438A (en) | 2003-10-29 |
| CN1197623C true CN1197623C (en) | 2005-04-20 |
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| Application Number | Title | Priority Date | Filing Date |
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| CNB031310672A Expired - Fee Related CN1197623C (en) | 2003-05-15 | 2003-05-15 | Sparagin injection using xylitol as isosmotic adjusting agent |
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Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108272819A (en) * | 2018-03-16 | 2018-07-13 | 辽宁药联制药有限公司 | A kind of aspartic acid Multiple electrolytes injection and preparation method thereof |
| 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 |
| CN113209032B (en) * | 2021-05-26 | 2023-04-07 | 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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