CN103860592A - Preparation method of inverted sugar electrolyte injection - Google Patents
Preparation method of inverted sugar electrolyte injection Download PDFInfo
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- CN103860592A CN103860592A CN201210552899.9A CN201210552899A CN103860592A CN 103860592 A CN103860592 A CN 103860592A CN 201210552899 A CN201210552899 A CN 201210552899A CN 103860592 A CN103860592 A CN 103860592A
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Abstract
The invention provides a preparation method of an inverted sugar electrolyte injection. The inverted sugar electrolyte injection comprises the components according to 1000 ml: 25/50 g of glucose, 25/50 g of fructose, 1.17 g of sodium chloride, 1.86 g of potassium chloride, 2.80 g of sodium lactate, 0.86 g of sodium dihydrogen phosphate, 0.61 g of magnesium chloride, 0.52 g of sodium hydrogen sulfite, and 0.50 g of hydrochloric acid. In a concentrated mixing stage of the preparation process of the inverted sugar electrolyte injection, a concentrated mixing tank freezing water (0-7 DEG C) circulation way is adopted, and a prepared liquid is cooled to 50-55 DEG C; after sterilization, the product is cooled by freezing water (0-7 DEG C) in a sterilization cabinet, the temperature is dropped to 55-60 DEG C, the sterilization cabinet is started, and then the product is taken out so as to reduce the heat dissipation time of the product. Through improving the preparation method, the 5-hydroxymethylfurfural content in the inverted sugar electrolyte injection is effectively reduced to less than 0.25, the drug quality is improved, untoward effects of patients with medication are reduced, and the medication security is increased. The method is simple, is suitable for industrialized production, and has greater application value.
Description
Technical field
The present invention relates to pharmaceutical preparation, be specifically related to a kind of preparation method of inverted sugar electrolytes injection.
Background technology
Inverted sugar electrolytes injection is clinical in filling body fluid, electrolyte and heat energy, acts on hypoalimentation or a large amount of body fluid loss that a variety of causes causes, and this Nulomoline is glucose, fructose etc.Clinically, in the time that patient cannot per os ingests and obtains nutrition, total intravenous nutrition (total parental nutrition, TPN) just becomes the rely essential means of long term survival of patient.Inverted sugar electrolytes injection indication comprise all in lysis oral nutrient can not or patient insufficient and nutritional support, as: (1) cannot normally ingest from gastrointestinal tract: gastrointestinal fistula; Patient and the peri-operation periods thereof such as the esophageal carcinoma, gastric cancer, colorectal cancer, cancer of pancreas, hepatocarcinoma, intestinal obstruction; Short bowel syndrome.(2) the digestive tract peace and quiet of need to having a rest: acute critical pancreatitis; Traumatic pancreas fistula; Massive hemorrhage of gastrointestinal tract; Clone disease; Ulcerative colitis.(3) hypermetabolism patient: large-area burns, severe trauma, severe infections (as acute peritonitis) etc.(4) coordinate other treatment: cancer chemotherapy and radiation period; Nutritional support when hepatic and kidney function obstacle treatment.
5 hydroxymethyl furfural be monosaccharide (glucose, fructose etc.) under the condition such as high temperature, weak acid, dewater produce aldehyde compound.5 hydroxymethyl furfural can react with some functional group of protein, and what make cell has silk to split to be suppressed and to present cytotoxicity, can cause the infringement of human body striped muscle and internal organs.On the other hand, 5 hydroxymethyl furfural less stable, can further be decomposed into levulic acid and formic acid or polymerization, 5 hydroxymethyl furfural itself is colourless, its polymer is coloring matter, cause injection variable color, the color and luster depth is directly proportional to the growing amount of 5 hydroxymethyl furfural, therefore 5 hydroxymethyl furfural amount can refer to the degree of decomposition of monosaccharide in product.
Inverted sugar electrolytes injection contains glucose and fructose, in the time preparing inverted sugar electrolytes injection, preparation liquid under 70 ℃ of (according to the requirement of GMP, water for injection temperature is greater than 70 ℃) above water for injection conditions, easily causes the rising of 5 hydroxymethyl furfural content for a long time; After sterilizing finishes, product drops to room temperature from 115 ℃ of sterilising temps, time that need to be longer, and under hot conditions, glucose and fructose easily dewater to produce to decompose and produce 5 hydroxymethyl furfural.Dense join stage of the present invention in inverted sugar electrolytes injection preparation process, take dense preparing tank chilled water (0 ~ 7 ℃) circulation, preparation liquid is cooled to 50 ~ 55 ℃; After sterilizing finishes, in sterilizing cabinet, adopt chilled water (0 ~ 7 ℃) to lower the temperature to product, cool the temperature to 55 ~ 60 ℃, open sterilizing cabinet, take out product, to have reduced the product heat radiation time.By preparation technology's optimization, effectively reduce 5 hydroxymethyl furfural content in inverted sugar electrolytes injection, improve drug quality, reduce the untoward reaction of patient's medication, improve drug safety.The inventive method is simple, is suitable for suitability for industrialized production, has larger using value.
Prior art inverted sugar electrolytes injection formula:
Preparation:
(1) dense joining
Get sodium chloride, sodium sulfite, glucose, fructose, potassium chloride, magnesium chloride, potassium dihydrogen phosphate and lactic acid and mix, add after hydrochloric acid, add the water for injection of 70 ℃ of left and right of approximately 1/2 formula ratio to dissolve, pump into dense preparing tank, make concentrated wiring liquid;
(2) depyrogenation
Add needle-use activated carbon by the amount of concentrated wiring liquid 0.05～0.15%, circulation 20～30min, 0.22 μ m fine straining carbon removal;
(3) rare joining
Concentrated wiring liquid is pumped into Agitation Tank, inject and be diluted with water to formula ratio, circulation 15～30min, 0.22 μ m fine straining;
(4) fill
Fine straining liquid, after clarity test, is filled into multi-layer co-extrusion infusion with in soft bag, 500ml/ bag;
(5) sterilizing
After fill, adopt 115 ℃, sterilizing 30min or 121 ℃, the sterilizing of sterilizing 15min condition, makes inverted sugar electrolytes injection after completing sterilizing.
Adopt the inverted sugar electrolytes injection prepared of prior art, join the stage dense, medicinal liquid at the temperature in 70 ℃ of left and right, easily causes glucose and fructose dehydration to produce to decompose and produces 5 hydroxymethyl furfural always, increases 5 hydroxymethyl furfural content in injection; At sterilization phase, after sterilizing, not to the sample processing of lowering the temperature, cause sterilizing after product heat radiation slower, in inverted sugar electrolytes injection, 5 methyl furfural content increases.
Summary of the invention
Technical problem to be solved by this invention is to reduce 5 hydroxymethyl furfural content in inverted sugar electrolytes injection, research design inverted sugar electrolytes injection and preparation method thereof.
The invention provides a kind of preparation method of inverted sugar electrolytes injection.
Formula:
Preparation method comprises the following steps:
(1) dense joining
In dense preparing tank, add the water for injection of approximately 1/2 formula ratio, the glucose, fructose, sodium chloride, potassium chloride, magnesium chloride, sodium lactate, sodium dihydrogen phosphate, sodium sulfite and the hydrochloric acid that add respectively water for injection to dissolve, in process for preparation, open chilled water (0 ~ 7 ℃) cooling always, concentrated wiring liquid is cooled to 50 ~ 55 ℃.
(2) depyrogenation
Add needle-use activated carbon by the amount of concentrated wiring liquid 0.05～0.15%, circulation 20～30min, 0.22 μ m fine straining carbon removal;
(3) rare joining
Concentrated wiring liquid is pumped into Agitation Tank, inject and be diluted with water to formula ratio, circulation 15～30min, 0.22 μ m fine straining;
(4) fill
Fine straining liquid, after clarity test, is filled into multi-layer co-extrusion infusion with in soft bag, 500ml/ bag;
(5) sterilizing
After fill, adopt 115 ℃, sterilizing 30min or 121 ℃, sterilizing 15min condition, carries out the sterilizing of superheated water spray, and after finishing, product adopts 0～7 ℃ of chilled water to lower the temperature, and cools the temperature to 55 ~ 60 ℃, opens sterilizing cabinet, takes out product and get final product.
Dense join stage of the present invention in inverted sugar electrolytes injection preparation process, the mode of taking dense preparing tank chilled water (0 ~ 7 ℃) to circulate, is cooled to 50 ~ 55 ℃ by preparation liquid; After sterilizing, in sterilizing cabinet, adopt chilled water (0 ~ 7 ℃) to lower the temperature to product, cool the temperature to 55 ~ 60 ℃, open sterilizing cabinet, take out product, to have reduced the product heat radiation time.By the improvement of preparation method, effectively reduce 5 hydroxymethyl furfural content in inverted sugar electrolytes injection and be less than 0.25, improve drug quality, reduce the untoward reaction of patient's medication, improve drug safety.The inventive method is simple, is suitable for suitability for industrialized production, has larger using value.
The specific embodiment
Example 1:
Formula (in 1000ml):
Preparation method (pressing 400L amount):
(1) dense joining
Take sodium chloride 468g, sodium sulfite 208g, other amplify 400 times by formula ratio and feed intake: glucose 22kg, fructose 20kg, potassium chloride 744g, magnesium chloride hexahydrate 244g, sodium dihydrogen phosphate 300g, sodium lactate (40.7%) 2.752kg, add the about 197kg of concentrated hydrochloric acid, add the water for injection of 70 ℃ of 100L to dissolve, pump into dense preparing tank, add water to 160L; Dense joining opens dense preparing tank chilled water (0～7 ℃) in process and will prepare liquid circulation temperature lowering to 54 ℃;
(2) depyrogenation
By 0.15%(W/V) amount add needle-use activated carbon 240g, circulation 30min, fine straining carbon removal;
(3) rare joining
Concentrated wiring liquid is pumped into Agitation Tank, inject and be diluted with water to 400L, circulation 15～30min, 0.22 μ m fine straining;
(4) fill
Fine straining liquid, after clarity test, is filled into multi-layer co-extrusion infusion with in soft bag, 500ml/ bag;
(5) sterilizing
After fill, adopt 115 ℃, sterilizing 30min, carries out the sterilizing of superheated water spray, after finishing, in sterilizing cabinet, adopts 0～7 ℃ of spray of chilled water to lower the temperature to product, cools the temperature to 57 ℃, opens sterilizing cabinet, takes out product.
Product checks the 5 hydroxymethyl furfural in inverted sugar electrolytes injection according to State Food and Drug Administration's standard (YBH21112005), get test sample 1ml, put in 50ml measuring bottle, be diluted with water to scale, shake up, according to light splitting light photometry (two appendix IV A of Chinese Pharmacopoeia version in 2010), measure trap at 284nm wavelength place, should be not more than 0.25.
5 hydroxymethyl furfural check result: 0.14.
Example 2:
(1) dense joining opens dense preparing tank chilled water (0～7 ℃) in process and will prepare liquid circulation temperature lowering to 55 ℃;
(2) after sterilizing, in sterilizing cabinet, adopt 0～7 ℃ of spray of chilled water to lower the temperature to product, cool the temperature to 60 ℃, open sterilizing cabinet, take out product.
Detection method is the same.
5 hydroxymethyl furfural check result: 0.15.
Example 3:
(1) dense joining opens dense preparing tank chilled water (0～7 ℃) in process and will prepare liquid circulation temperature lowering to 52 ℃;
(2) after sterilizing, in sterilizing cabinet, adopt chilled water (0 ~ 7 ℃) to lower the temperature to product, cool the temperature to 55 ℃, open sterilizing cabinet, take out product.
According to State Food and Drug Administration's standard (YBH128702008), the 5 hydroxymethyl furfural in inverted sugar electrolytes injection is checked, get test sample 2ml, put in 50ml measuring bottle, be diluted with water to scale, shake up, according to light splitting light photometry (two appendix IV A of Chinese Pharmacopoeia version in 2010), measure trap at 284nm wavelength place, should be not more than 0.25.
5 hydroxymethyl furfural check result: 0.13.
Embodiment 4
In preparation method of the present invention to concentrated wiring liquid temperature screening test
1. instrument and equipment
1.1 equipment
| Device name | Model specification | Heap(ed) capacity or production capacity |
| Dense preparing tank | FR-2000 | 2000L |
| Dilute preparing tank | FR-4000 | 4000L |
| Transfusion bag-making loading sealing machine | FFS794/S | 3000 bags/time |
| Superheated water fountain sterilizing cabinet | SWS15.12.108/2F | 10000 bags/time |
1.2 instrument
UV-2550 type ultraviolet-uisible spectrophotometer (SHIMADZU)
2. detection method
Stipulate according to state food and drug administration's standard (YBH21112005): get test sample 1ml, put in 50ml measuring bottle, be diluted with water to scale, shake up, according to spectrophotography (two appendix IV A of Chinese Pharmacopoeia version in 2010), measure trap at 284nm wavelength place, should be not more than 0.25.
3. EXPERIMENTAL DESIGN and result
Concentrated wiring liquid is set to different temperatures scope: 1. 70～80 ℃ 2. 60～70 ℃ 3. 50～60 ℃ 4. 40～50 ℃, in each temperature range, sampling detects, and record measured value and the preparation time (puts into after dense preparing tank with water for injection, opening freezing water for cooling is the time started, being cooled to temperature required is the termination time, weighing and charging time counted in the preparation time, and 70～80 ℃ of temperature ranges are not opened freezing water for cooling system, were conventional weighing and charging time).
Prepare respectively three batches of preparation liquid (in batches: 500L), the impact with research preparation liquid temp on 5 hydroxymethyl furfural (5-HMF), its result is as follows:
Do not open chilled water system when medicinal liquid is lowered the temperature, it is 0.0067 that 5-HMF measures meansigma methods; Open chilled water system, when preparation liquid temp is reduced within the scope of 50～60 ℃, it is 0.0043 that 5-HMF measures meansigma methods, and when preparation liquid temp is reduced within the scope of 40～50 ℃, it is 0.0043 that 5-HMF measures meansigma methods.
Open dense preparing tank chilled water system, complete while feeding intake, preparation liquid temp has been reduced within the scope of 50～60 ℃ (three batches of concentrated wiring liquid temperature are respectively: 55 ℃, 53 ℃, 55 ℃), does not increase the preparation time.
As can be seen here, open dense preparing tank chilled water system while being cooled within the scope of 50～60 ℃ to medicinal liquid, can obviously reduce preparation liquid 5-HMF content, also can not extend the preparation time and cause extending manufacture cycle.Therefore the dense phase characteristic of joining of the present invention is: with chilled water (0 ~ 7 ℃), medicinal liquid is lowered the temperature, concentrated wiring liquid temperature is down to 50 ~ 55 ℃.
Embodiment 5
In preparation method of the present invention to sterilization phase temperature screening test
1. instrument and equipment
1.1 equipment
| Device name | Model specification | Heap(ed) capacity or production capacity |
| Superheated water fountain sterilizing cabinet | SWS15.12.108/2F | 10000 bags/time |
1.2 instrument
UV-2550 type ultraviolet-uisible spectrophotometer (SHIMADZU).
2. detection method
Stipulate according to state food and drug administration's standard (YBH21112005): get test sample 1ml, put in 50ml measuring bottle, be diluted with water to scale, shake up, according to spectrophotography (two appendix IV A of Chinese Pharmacopoeia version in 2010), measure trap at 284nm wavelength place, should be not more than 0.25.
3. EXPERIMENTAL DESIGN and result
EXPERIMENTAL DESIGN scheme:
Condition 1: do not lower the temperature after sterilizing finishes, go out sterilizing cabinet, measure after being cooled to room temperature.
Condition 2: after sterilizing finishes, product is down to 80～90 ℃, goes out sterilizing cabinet, measure after being cooled to room temperature.
Condition 3: after sterilizing finishes, product is down to 70～80 ℃, goes out sterilizing cabinet, measure after being cooled to room temperature.
Condition 4: after sterilizing finishes, product is down to 65～70 ℃, goes out sterilizing cabinet, measure after being cooled to room temperature.
Condition 5: after sterilizing finishes, product is down to 60～65 ℃, goes out sterilizing cabinet, measure after being cooled to room temperature.
Condition 6: after sterilizing finishes, product is down to 55～60 ℃, goes out sterilizing cabinet, measure after being cooled to room temperature.
Condition 7: after sterilizing finishes, product is down to 50～55 ℃, goes out sterilizing cabinet, measure after being cooled to room temperature.
Condition 8: after sterilizing finishes, product is down to 45～50 ℃, goes out sterilizing cabinet, measure after being cooled to room temperature.
Adopt above four conditions to carry out sterilizing to same batch of inverted sugar electrolytes injection, do three batches of parallel tests and study as a comparison.After investigating sterilizing, product goes out the impact of sterilizing cabinet temperature on 5 hydroxymethyl furfural (5-HMF) content.Result is as follows:
Can be found out by result, after sterilizing, whether product is carried out to chilled water (0～7 ℃) cooling, 5 hydroxymethyl furfural content be had to the impact of significance.
After sterilizing, adopt cooling water that product temperature is down within the scope of 55～60 ℃, can well control below 5 hydroxymethyl furfural content to 0.16, then continue product to lower the temperature, 5 hydroxymethyl furfural content declines not obvious.
Sterilization phase of the present invention is characterised in that:
After sterilizing, in sterilizing cabinet, adopt chilled water (0 ~ 7 ℃) to lower the temperature to product, product temperature is down to 55 ~ 60 ℃.
Test explanation is compared with existing preparation method, and the present invention has following effect:
1. dense the joining the stage in inverted sugar electrolytes injection preparation process, take dense preparing tank chilled water (0 ~ 7 ℃) circulation, preparation liquid is cooled to 50 ~ 55 ℃, can well control 5 hydroxymethyl furfural content.
2. after sterilizing, in sterilizing cabinet, adopt chilled water (0 ~ 7 ℃) to lower the temperature to product, cool the temperature to 55 ~ 60 ℃, open sterilizing cabinet, take out product, to have reduced the product heat radiation time.
Claims (1)
1. a preparation method for inverted sugar electrolytes injection, is characterized in that,
Formula: inverted sugar electrolytes injection is in 1000ml:
Preparation method comprises the following steps:
(1) dense joining
In dense preparing tank, add the water for injection of approximately 1/2 formula ratio, the glucose, fructose, sodium chloride, potassium chloride, magnesium chloride, sodium lactate, sodium dihydrogen phosphate, sodium sulfite and the hydrochloric acid that add respectively water for injection to dissolve, in process for preparation, 0 ~ 7 ℃ of cooling of a direct-open tank interlayer chilled water, is cooled to 50 ~ 55 ℃ by concentrated wiring liquid;
(2) depyrogenation
Add needle-use activated carbon by the amount of concentrated wiring liquid 0.05～0.15%, circulation 20～30min, 0.22 μ m fine straining carbon removal;
(3) rare joining
Concentrated wiring liquid is pumped into Agitation Tank, inject and be diluted with water to formula ratio, circulation 15～30min, 0.22 μ m fine straining;
(4) fill
Fine straining liquid, after clarity test, is filled into multi-layer co-extrusion infusion with in soft bag, 500ml/ bag;
(5) sterilizing
After fill, adopt 115 ℃, sterilizing 30min or 121 ℃, sterilizing 15min, carries out the sterilizing of superheated water spray, after finishing, adopts 0～7 ℃ of chilled water to lower the temperature to product, cools the temperature to 55 ~ 60 ℃, opens sterilizing cabinet, takes out product and get final product.
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| CN201210552899.9A CN103860592B (en) | 2012-12-18 | 2012-12-18 | A kind of preparation method of inverted sugar electrolytes injection |
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| CN201210552899.9A CN103860592B (en) | 2012-12-18 | 2012-12-18 | A kind of preparation method of inverted sugar electrolytes injection |
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| CN103860592A true CN103860592A (en) | 2014-06-18 |
| CN103860592B CN103860592B (en) | 2016-01-13 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104013643A (en) * | 2014-06-26 | 2014-09-03 | 扬子江药业集团上海海尼药业有限公司 | Compound electrolyte invert sugar injection liquid |
| 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 |
| CN109010362A (en) * | 2018-10-09 | 2018-12-18 | 济南康和医药科技有限公司 | A kind of children's compound electrolyte glucose injection and preparation method thereof |
| CN109498649A (en) * | 2018-12-10 | 2019-03-22 | 南京恩泰医药科技有限公司 | A kind of sodium potassium magnesium calcium glucose injection and preparation method |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101284014A (en) * | 2007-04-10 | 2008-10-15 | 扬子江药业集团上海海尼药业有限公司 | Inverted sugar electrolytes injection and preparation technique thereof |
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2012
- 2012-12-18 CN CN201210552899.9A patent/CN103860592B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101284014A (en) * | 2007-04-10 | 2008-10-15 | 扬子江药业集团上海海尼药业有限公司 | Inverted sugar electrolytes injection and preparation technique thereof |
Non-Patent Citations (1)
| Title |
|---|
| 王亚平: "必须降低蜂蜜中羟甲基糠醛含量", 《蜂蜜杂志》, 30 June 1985 (1985-06-30), pages 18 - 19 * |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104013643A (en) * | 2014-06-26 | 2014-09-03 | 扬子江药业集团上海海尼药业有限公司 | Compound electrolyte invert sugar injection liquid |
| 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 |
| CN109010362A (en) * | 2018-10-09 | 2018-12-18 | 济南康和医药科技有限公司 | A kind of children's compound electrolyte glucose injection and preparation method thereof |
| CN109498649A (en) * | 2018-12-10 | 2019-03-22 | 南京恩泰医药科技有限公司 | A kind of sodium potassium magnesium calcium glucose injection and preparation method |
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|---|---|
| CN103860592B (en) | 2016-01-13 |
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