CN102755348B - Carbohydrate and electrolyte injection and preparation method thereof - Google Patents
Carbohydrate and electrolyte injection and preparation method thereof Download PDFInfo
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- CN102755348B CN102755348B CN 201210264635 CN201210264635A CN102755348B CN 102755348 B CN102755348 B CN 102755348B CN 201210264635 CN201210264635 CN 201210264635 CN 201210264635 A CN201210264635 A CN 201210264635A CN 102755348 B CN102755348 B CN 102755348B
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Abstract
The invention provides a carbohydrate and electrolyte injection which comprises the following components by weight part: 30 parts of glucose, 15 parts of fructose, 7.5 parts of xylitol, 0.73 part of sodium chloride, 0.41 part of sodium acetate, 0.185 part of calcium chloride, 0.255 part of magnesium chloride, 0.87 part of dipotassium phosphate, 0.0007 part of zinc sulfate, 0.21 part of sodium bisulfite and 250 parts of water for injection; and the PH value is 5.1-5.5. The injection is low in cost and wide in applicable range. The invention also provides a preparation method of the carbohydrate and electrolyte injection. The preparation method comprises the steps of dissolving carbohydrate and electrolyte (as raw and auxiliary materials), absorbing, decarbonizing, adjusting the pH, and sterilizing to obtain the carbohydrate and electrolyte injection. According to the preparation method, the process is simple, the method is suitable for industrial production, the problems that samples turn yellow after the sterilization, and white substances are separated out can be avoided by increasing the dissolving temperature to be 75 DEG C-85 DEG C and adjusting the pH of the solution, so thatthe carbohydrate and electrolyte injection is stable.
Description
Technical field
The invention belongs to medical technical field, particularly a kind of mixed sugar electrolyte injection and preparation method thereof.
Background technology
Reach average of operation periods under various pathogenic bacteria invasion and attack, human body not only needs to keep the skin wet and electrolyte, and needs to replenish the nutrition thermal source based on saccharic, has therefore developed numerous nutrition infusion preparations.Because glucose wide material sources, cheap, therefore the sugared electrolyte injection of domestic clinical use at present is mainly Dextrose and Sodium Chloride Inj., yet it replenishes all very dull at energy supplement and electrolyte, can't satisfy clinical demand.Simultaneously, for the diabetes patient, because diabetes patient's impaired glucose tolerance, the metabolism load is big behind the injectable dextrose monohydrate, can't effectively utilize glucose.In addition, only use glucose as substrate, the injection back may produce the diabetes sample and change aspect liver enzyme activity, even use insulin, the also remaining inhibition that glucose-6-phosphate dehydrogenase (G6PD) is arranged.
Can be used for clinical transfusion has at present had bigger development with saccharide, as glucose, the fructose of monosaccharide, and the maltose of disaccharides, the glycerol of triose alcohols, and the xylitol of pentose alcohols, the sorbitol of hexose alcohols.Mixed sugar has characteristics such as metabolism is complete, energy supply is high, blood glucose fluctuation is little, insulin dependency is less as energy matter, Kai Fa mixed sugar electrolyte injection is applicable to the patient's that anti-sugar such as diabetes, postoperative, burn and bacteremia are low energy, moisture and electrolytical replenishing based on this, more and more comes into one's own.
CN101947240 discloses a kind of preparation method of mixed sugar electrolyte composition injection, and this preparation method is by being dissolved in mixed sugar and electrolyte in the water for injection under 50 ℃, transfer pH to 4.5-7.0 after, use pin with charcoal absorption, take off charcoal, namely.This method is because solution temperature is low, and especially when pH is higher, sample can flavescence after sterilization, and has a small amount of whiteness and separate out the mixed sugar electrolyte injection instability for preparing.
Summary of the invention
Goal of the invention: first purpose of the present invention provides a kind of mixed sugar electrolyte injection.
Second purpose of the present invention provides the preparation method of above-mentioned mixed sugar electrolyte injection.
Technical scheme: the invention provides a kind of mixed sugar electrolyte injection, the component that comprises following weight portion: 30 parts of glucoses, 15 parts in fructose, 7.5 parts of xylitol, 0.73 part in sodium chloride, 0.41 part of sodium acetate, 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate, 0.0007 part in zinc sulfate, 0.21 part of sodium sulfite, 250 parts of waters for injection; PH is 5.1-5.5.
Among the present invention, preferred sodium sulfite is as antioxidant, and its quality and described mixed sugar electrolyte injection volume ratio are (0.08-0.20): 100; Preferably, be 0.084:100.
Among the present invention, optimization citric acid is as the pH regulator agent, and its consumption is to make the pH value of whole solution system reach 5.1-5.5.
The present invention also provides the preparation method of above-mentioned mixed sugar electrolyte injection, comprises the steps:
(1) with glucose, fructose, xylitol and electrolyte supplementary material, add in 75-85 ℃ the water for injection of amount of preparation 90%, stirring is dissolved it fully, gets mixed solution;
(2) add needle-use activated carbon in above-mentioned mixed solution, the quality of described active carbon and the volume ratio of mixed solution are 0.05g:100ml, 55-65 ℃ insulated and stirred 10-20 minute, the decarburization of solution filtered while hot;
(3) add water for injection to full dose, use the pH regulator agent to transfer pH to 5.1-5.5;
(4) with the above-mentioned solution of microporous filter membrane fine straining of 0.45 μ m;
(5) packing, sterilization, namely.
A kind of preferred as mixed sugar electrolyte injection liquid and preparation method thereof of the present invention, in the step (1), described electrolyte supplementary material comprises sodium chloride, sodium acetate, calcium chloride, magnesium chloride, dipotassium hydrogen phosphate, zinc sulfate, sodium sulfite.
Further preferred as mixed sugar electrolyte injection liquid and preparation method thereof of the present invention, the said components weight portion is respectively: 30 parts of glucoses, 15 parts in fructose, 7.5 parts of xylitol, 0.73 part in sodium chloride, 0.41 part of sodium acetate, 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate, 0.0007 part in zinc sulfate, 0.21 part of sodium sulfite, 250 parts of waters for injection.
Another kind as mixed sugar electrolyte injection liquid and preparation method thereof of the present invention is preferred, and in the step (1), the temperature of described water for injection is 80 ℃.
Another kind as mixed sugar electrolyte injection liquid and preparation method thereof of the present invention is preferred, and in the step (3), described pH regulator agent is citric acid.
Another kind as mixed sugar electrolyte injection liquid and preparation method thereof of the present invention is preferred, and in the step (5), sterilising temp is 115 ℃, and sterilization time is 30 minutes.
Beneficial effect: electrolyte injection provided by the invention is with low cost, applied widely, mixed sugar has characteristics such as metabolism is complete, energy supply is high, blood glucose fluctuation is little, insulin dependency is less as energy matter in this injection, all can use for the low patient's of anti-sugar such as diabetes, postoperative, burn and bacteremia energy, moisture and electrolytical replenishing.Wherein, glucose can provide energy, and fructose and xylitol have and can not be subjected to advantages such as glucokinase and the kinase whose adjusting of hexose by cell membrane, metabolism in non-insulin-dependent ground, can provide human body existence required energy simultaneously; Adopt xylitol and glucose to share the inhibition that can effectively prevent glucose-6-phosphate dehydrogenase (G6PD), so this mixed sugar electrolyte injection is specially adapted to the patient of metabolism obstacles of blood glucose.
Simple, the suitable suitability for industrialized production of the preparation method technology of the mixed sugar injection that provides of the present invention, by improving solution temperature to 75-85 degree centigrade, and the pH of regulator solution has effectively avoided the problem that sample flavescence, adularescent material are separated out after the sterilization, thereby make that the mixed sugar electrolyte injection is more stable, the injection of this method preparation pH no change after different condition is handled, hydroxymethyl furfural content changes less.
The specific embodiment
Embodiment 1
The mixed sugar electrolyte injection, it is as follows to write out a prescription:
30 parts of glucoses, 15 parts in fructose, 7.5 parts of xylitol, 0.73 part in sodium chloride, 0.41 part of sodium acetate, 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate, 0.0007 part in zinc sulfate, 0.21 part of sodium sulfite, 250 parts of waters for injection; PH is 5.1.
Take by weighing glucose, fructose, xylitol, sodium chloride, sodium acetate, calcium chloride, magnesium chloride, dipotassium hydrogen phosphate, zinc sulfate, sodium sulfite by above-mentioned recipe quantity, add 85 ℃ of waters for injection by 90% of amount of preparation, be stirred to dissolving fully.In above-mentioned solution, add needle-use activated carbon, the quality of described active carbon and the volume ratio of mixed solution are 0.05g:100ml, under 55-65 ℃ of heating condition, constantly stirred 15 minutes the decarburization of solution filtered while hot, the water for injection of adding amount of preparation 10%, regulate pH to 5.1, with the above-mentioned solution of microporous filter membrane fine straining of 0.45 μ m, fill, the plug bottle, roll lid, 115 ℃ of pressure sterilizings 30 minutes.
Embodiment 2
The mixed sugar electrolyte injection, it is as follows to write out a prescription:
30 parts of glucoses, 15 parts in fructose, 7.5 parts of xylitol, 0.73 part in sodium chloride, 0.41 part of sodium acetate, 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate, 0.0007 part in zinc sulfate, 0.21 part of sodium sulfite, 250 parts of waters for injection; PH is 5.5.
Take by weighing glucose, fructose, xylitol, sodium chloride, sodium acetate, calcium chloride, magnesium chloride, dipotassium hydrogen phosphate, zinc sulfate, sodium sulfite by above-mentioned recipe quantity, add 75 ℃ of waters for injection by 90% of amount of preparation, be stirred to dissolving fully.In above-mentioned solution, add needle-use activated carbon, the quality of described active carbon and the volume ratio of mixed solution are 0.05g:100ml, under 55-65 ℃ of heating condition, constantly stirred 20 minutes the decarburization of solution filtered while hot, the water for injection of adding amount of preparation 10%, regulate pH to 5.5, with the above-mentioned solution of microporous filter membrane fine straining of 0.45 μ m, fill, the plug bottle, roll lid, 115 ℃ of pressure sterilizings 30 minutes.
Embodiment 3
The mixed sugar electrolyte injection, it is as follows to write out a prescription:
30 parts of glucoses, 15 parts in fructose, 7.5 parts of xylitol, 0.73 part in sodium chloride, 0.41 part of sodium acetate, 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate, 0.0007 part in zinc sulfate, 0.21 part of sodium sulfite, 250 parts of waters for injection; PH is 5.3.
Take by weighing glucose, fructose, xylitol, sodium chloride, sodium acetate, calcium chloride, magnesium chloride, dipotassium hydrogen phosphate, zinc sulfate, sodium sulfite by above-mentioned recipe quantity, add 80 ℃ of waters for injection by 90% of amount of preparation, be stirred to dissolving fully.In above-mentioned solution, add needle-use activated carbon, the quality of described active carbon and the volume ratio of mixed solution are 0.05g:100ml, under 55-65 ℃ of heating condition, constantly stirred 10 minutes the decarburization of solution filtered while hot, the water for injection of adding amount of preparation 10%, regulate pH to 5.3, with the above-mentioned solution of microporous filter membrane fine straining of 0.45 μ m, fill, the plug bottle, roll lid, 115 ℃ of pressure sterilizings 30 minutes.
Embodiment 4
Adopt existing method to prepare the mixed sugar electrolyte injection.
The mixed sugar electrolyte injection, it is as follows to write out a prescription:
30 parts of glucoses, 15 parts in fructose, 7.5 parts of xylitol, 0.73 part in sodium chloride, 0.41 part of sodium acetate, 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate, 0.0007 part in zinc sulfate, 0.21 part of sodium sulfite, 250 parts of waters for injection; PH is 6.5.
Take by weighing glucose, fructose, xylitol, sodium chloride, sodium acetate, calcium chloride, magnesium chloride, dipotassium hydrogen phosphate, zinc sulfate, sodium sulfite by above-mentioned recipe quantity, add 50 ℃ of waters for injection by 90% of amount of preparation, be stirred to dissolving fully.In above-mentioned solution, add needle-use activated carbon, the quality of described active carbon and the volume ratio of mixed solution are 0.05g:100ml, under 55-65 ℃ of heating condition, constantly stirred 10 minutes the decarburization of solution filtered while hot, the water for injection of adding amount of preparation 10%, regulate pH to 6.5, with the above-mentioned solution of microporous filter membrane fine straining of 0.45 μ m, fill, the plug bottle, roll lid, 115 ℃ of pressure sterilizings 30 minutes.
Embodiment 5
With above 4 batches of mixed sugar electrolyte injections of preparing respectively at preparation back, 60 ℃ place after 5 days, 60 ℃ place after 10 days, illumination after 5 days, illumination after 10 days etc. different condition handle and detect, the results are shown in Table 1.The result shows, the mixed sugar electrolyte injection presentation quality that this method prepares is good, color and luster is clear and bright, hydroxymethyl furfural content changes little, and the injection that the method that adopts comparative example 4 prepares is yellow green after the sterilization, after different condition is handled, yellow green has the trend that increases the weight of, and hydroxymethyl furfural content changes greatly.
Table 1 is the testing result that mixed sugar electrolyte injection different condition is handled
Claims (4)
1. the preparation method of a mixed sugar electrolyte injection, described mixed sugar electrolyte injection is made by the component of following weight portion: 30 parts of glucoses, 15 parts in fructose, 7.5 parts of xylitol, 0.73 part in sodium chloride, 0.41 part of sodium acetate, 0.185 part in calcium chloride, 0.255 part in magnesium chloride, 0.87 part of dipotassium hydrogen phosphate, 0.0007 part in zinc sulfate, 0.21 part of sodium sulfite, 250 parts of waters for injection; It is characterized in that: comprise the steps:
(1) with glucose, fructose, xylitol and electrolyte supplementary material, add in 75-85 ℃ the water for injection of amount of preparation 90%, stirring is dissolved it fully, gets mixed solution;
(2) add needle-use activated carbon in above-mentioned mixed solution, the quality of described active carbon and the volume ratio of mixed solution are 0.05g:100ml, 55-65 ℃ insulated and stirred 10-20 minute, the solution filtered while hot is taken off charcoal;
(3) add water for injection to full dose, use the pH regulator agent to transfer pH to 5.1-5.5;
(4) with the above-mentioned solution of microporous filter membrane fine straining of 0.45 μ m;
(5) packing, sterilization, namely.
2. the preparation method of a kind of mixed sugar electrolyte injection according to claim 1, it is characterized in that: in the step (1), the temperature of described water for injection is 80 ℃.
3. the preparation method of a kind of mixed sugar electrolyte injection according to claim 1, it is characterized in that: in the step (3), described pH regulator agent is citric acid.
4. the preparation method of a kind of mixed sugar electrolyte injection according to claim 1, it is characterized in that: in the step (5), sterilising temp is 115 ℃, and sterilization time is 30 minutes.
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Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN103989705B (en) * | 2014-05-05 | 2017-01-18 | 肖义军 | Sugar electrolyte injection liquid and preparation method thereof |
| CN105497061B (en) * | 2015-12-24 | 2019-01-08 | 长沙利星医药科技开发有限公司 | A kind of electrolyte injection and preparation method thereof without glucose |
| CN108113998A (en) * | 2016-11-28 | 2018-06-05 | 华仁药业股份有限公司 | A kind of preparation method of parenteral solution |
| CN108969475A (en) * | 2018-08-13 | 2018-12-11 | 岳景春 | Application and low deuterium subset injection of the low deuterium subset in injection |
| CN109833330B (en) * | 2019-04-15 | 2021-04-30 | 河南利欣制药股份有限公司 | Production process of glucose sodium chloride injection |
| CN112603888A (en) * | 2020-12-30 | 2021-04-06 | 中国大冢制药有限公司 | Preparation method of mixed sugar electrolyte injection and prepared mixed sugar electrolyte injection |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101947240A (en) * | 2010-09-13 | 2011-01-19 | 海南本创医药科技有限公司 | Mixed sugar electrolyte drug composite injection |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101947240A (en) * | 2010-09-13 | 2011-01-19 | 海南本创医药科技有限公司 | Mixed sugar electrolyte drug composite injection |
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