CN101284014A - Inverted sugar electrolytes injection and preparation technique thereof - Google Patents
Inverted sugar electrolytes injection and preparation technique thereof Download PDFInfo
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- CN101284014A CN101284014A CNA2007100392915A CN200710039291A CN101284014A CN 101284014 A CN101284014 A CN 101284014A CN A2007100392915 A CNA2007100392915 A CN A2007100392915A CN 200710039291 A CN200710039291 A CN 200710039291A CN 101284014 A CN101284014 A CN 101284014A
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Abstract
The invention discloses an invert sugar and electrolytes injection, containing the following components of: glucose, fructose, sodium chloride, potassium chloride, sodium lactate, disodium hydrogen phosphate, magnesium chloride and water for injection. The product is an intravenous hyperalimentation injection capable of providing body multiple electrolytes, glucose and fructose at the same time, supplementing body fluids, maintaining balance of water and electrolytes, and providing energy.
Description
Technical field:
The present invention relates to pharmaceutical preparation, be specifically related to inverted sugar electrolytes injection and preparation method thereof.
Background technology:
The effect of inverted sugar electrolytes injection is to replenish body fluid, electrolyte and heat energy, is used for hypoalimentation or a large amount of body fluid that a variety of causes causes and loses, and this Nulomoline is glucose, fructose etc.Clinically, when patient can't per os ingests and when obtaining nutrition, (total parental nutrition TPN) just becomes the rely essential means of long term survival of patient to total intravenous nutrition.The inverted sugar electrolytes injection indication comprise all in lysis oral nutrient can not or insufficient and need the patient of nutritional support, as: (1) can't normally ingest from gastrointestinal tract: gastrointestinal fistula; Patient and 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 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) cooperate other treatment: cancer chemotherapy and radiation period; Nutritional support during the hepatic and kidney function obstacle treatment.This series products of Shi Yonging mainly is the preparation of Nulomoline or Nulomoline and sodium chloride composition in the market, clinical use is complicated, the back dilution is dissolved into wherein to need medical personnel to calculate the preparation that contains sodium, potassium, magnesium, phosphorus respectively accurately, so just cause the chance of repeatedly secondary pollution easily, and can produce the consequence of dosage inaccuracy, medicine waste.
Summary of the invention:
Technical problem to be solved by this invention is to overcome above-mentioned weak point, the injection of research design electrolyte and Nulomoline combination.
The invention provides a kind of inverted sugar electrolytes injection, this injection has the composition of following weight proportion: in 1000ml:
Glucose 25～50g
Fructose 25～50g
Sodium chloride 0.73～1.46g
Potassium chloride 0.93! 1.86g
Sodium lactate 1.40～2.80g
Sodium dihydrogen phosphate 0.375～0.75g
Magnesium chloride 0.143～0.286g
Add the injection water to 1000ml
The effect of each composition is as follows in the present invention's prescription:
The effect of each composition of table 1 in prescription
Hydrochloric acid is not counted in prescription, but in the preparation, generates sodium chloride, counts sodium chloride total amount in the prescription.
Another object of the present invention has provided the preparation technology of inverted sugar electrolytes injection, and this technology comprises the following steps:
(1) dense joining
Get sodium chloride, sodium sulfite, single water glucose, fructose, potassium chloride, magnesium chloride hexahydrate, sodium dihydrogen phosphate and sodium lactate mix, add concentrated hydrochloric acid approximately after, add water for injection (70 ℃) dissolving of 1/3～1/2 formula ratio, pump into dense preparing tank, add the water of 1/3 formula ratio again;
(2) depyrogenation
The amount of pressing 0.15%W/V adds needle-use activated carbon, circulation 30min, fine straining carbon removal;
(3) dilution
Concentrated wiring liquid is pumped into Agitation Tank, add injection and be diluted with water to formula ratio, circulation 30min, 0.22 μ m fine straining;
(4) fill
Fine straining liquid is filled into multi-layer co-extrusion infusion with in the soft bag, the 500ml/ bag behind clarity test;
(5) sterilization
After the fill, put 115 ℃, sterilization 30min promptly gets product.
The present invention makes the total intravenous nutrition injection with electrolyte and the common prescription of Nulomoline, can reach and replenish body body fluid simultaneously for body provides multiple electrolyte and glucose and fructose, keeps fluid and electrolyte balance, and the purpose of energy is provided.
The specific embodiment:
Example 1
1. fill a prescription (in 1000ml)
Glucose 50g
Fructose 50g
Sodium chloride 1.46g
Potassium chloride 1.86g
Sodium lactate 2.80g
Sodium dihydrogen phosphate 0.75g
Magnesium chloride 0.286g
Add the injection water to 1000ml
2. preparation technology's (press 400L amount)
(1) dense joining
Take by weighing sodium chloride 468g, sodium sulfite 208g, other amplifies 400 times by recipe quantity and feeds intake: single water glucose 22kg, fructose 20kg, potassium chloride 744g, magnesium chloride hexahydrate 244g, sodium dihydrogen phosphate 300g, sodium lactate (40.7%) 2.752kg, add the about 197g of concentrated hydrochloric acid, add an amount of 70 ℃ water for injection dissolving, pump into dense preparing tank, add water to 160L.
(2) depyrogenation
Amount by 0.15% (W/V) adds needle-use activated carbon 240g, circulation 30min, fine straining carbon removal.
(3) dilution
Concentrated wiring liquid is pumped into Agitation Tank, add injection and be diluted with water to 400L, circulation 30min, 0.22 μ m fine straining.
(4) fill
Fine straining liquid is filled into multi-layer co-extrusion infusion with in the soft bag, the 500ml/ bag behind clarity test.
(5) sterilization
After the fill, put 115 ℃, sterilization 30min.
Example 2
Main constituent formula ratio (g)
Glucose 50g
Fructose 50g
Sodium chloride 1.46g
Potassium chloride 1.86g
Magnesium chloride 0.286g
Sodium lactate 2.80g
Sodium dihydrogen phosphate 0.75g
PH value: 4.42.Wherein the sign content of Nulomoline, phosphate, chlorine is respectively: 99.59%, 99.02%, 100.54%.
Example 3
Prescription (pressing the 1000ml amount)
Main constituent recipe quantity (g)
Glucose 20kg
Fructose 20kg
Sodium chloride 584g
Potassium chloride 744g
Magnesium chloride 114.1g
Sodium lactate 1.12kg
Sodium dihydrogen phosphate 300g
Step: take by weighing each component by inventory, add the dissolving of an amount of 70 ℃ water for injection, pump into dense preparing tank, add water to 160L (total amount 40%).0.15% (W/V) by amount of liquid adds needle-use activated carbon 240g, circulation 30min, absorption pyrogen, coarse filtration carbon removal.Concentrated wiring liquid is pumped into Agitation Tank, add injection and be diluted with water to 400L, circulation 30min, 0.22 μ m fine straining.Fine straining liquid is filled into multi-layer co-extrusion infusion with in the soft bag, the 500ml/ bag behind clarity test.Put 115 ℃, sterilization 30min.Get inverted sugar electrolytes injection.
Through checking: appearance luster is little yellow clear liquid; PH value is 4.36; Inspections such as minimum fill, clarity, particulate matter, aseptic, pyrogen, 5-hydroxymethylfurfural all meet the requirements; Content of beary metal is less than 5/1000000ths; The content of each electrolyte and Nulomoline is: chlorine 96.47%, phosphate 96.45%, lactate 96.35%, sodium 97.36%, potassium 101.92%, magnesium 101.07%, Nulomoline 95.77%.All meet the requirement of quality standard.
Claims (3)
1, a kind of inverted sugar electrolytes injection is characterized in that it is made up of the component of following weight proportion:
Glucose 25～50g
Fructose 25～50g
Sodium chloride 0.73～1.46g
Potassium chloride 0.93～1.86g
Sodium lactate 1.40～2.80g
Sodium dihydrogen phosphate 0.375～0.75g
Magnesium chloride 0.143～0.286g
Add the injection water to 1000ml.
2, a kind of inverted sugar electrolytes injection is characterized in that it is made up of the component of following weight proportion:
Glucose 50g
Fructose 50g
Sodium chloride 1.46g
Potassium chloride 1.86g
Sodium lactate 2.80g
Sodium dihydrogen phosphate 0.75g
Magnesium chloride 0.286g
Add the injection water to 1000ml.
3, a kind of preparation technology of inverted sugar electrolytes injection as claimed in claim 1 or 2 is characterized in that this technology comprises the following steps:
(1) dense joining
Getting sodium chloride, sodium sulfite, single water glucose, fructose, potassium chloride, magnesium chloride hexahydrate, sodium dihydrogen phosphate and sodium lactate mixes, after adding concentrated hydrochloric acid, add the water for injection of 1/3～1/2 formula ratio, 70 ℃ of dissolvings, pump into dense preparing tank, add the water for injection of 1/3 formula ratio again;
(2) depyrogenation
The amount of pressing 0.15%W/V adds needle-use activated carbon, circulation 30min, fine straining carbon removal;
(3) dilution
Concentrated wiring liquid is pumped into Agitation Tank, add injection and be diluted with water to formula ratio, circulation 30min, 0.22 μ m fine straining;
(4) fill
Fine straining liquid is filled into multi-layer co-extrusion infusion with in the soft bag, the 500ml/ bag behind clarity test;
(5) sterilization
After the fill, put 115 ℃, sterilization 30min promptly gets product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007100392915A CN101284014A (en) | 2007-04-10 | 2007-04-10 | Inverted sugar electrolytes injection and preparation technique thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2007100392915A CN101284014A (en) | 2007-04-10 | 2007-04-10 | Inverted sugar electrolytes injection and preparation technique thereof |
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| CN101284014A true CN101284014A (en) | 2008-10-15 |
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Cited By (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102379882A (en) * | 2011-03-10 | 2012-03-21 | 海南美好西林生物制药有限公司 | Invert sugar and injection medicinal preparation prepared from same |
| CN102657678A (en) * | 2012-05-02 | 2012-09-12 | 四川科伦药业股份有限公司 | Composition of potassium chloride and glucose and preparation method for composition |
| CN102949413A (en) * | 2012-06-08 | 2013-03-06 | 辽宁海思科制药有限公司 | Method for preparing invert sugar and electrolytes injection |
| CN103301152A (en) * | 2012-03-13 | 2013-09-18 | 扬子江药业集团上海海尼药业有限公司 | Inverted sugar electrolyte injection and preparation method thereof |
| CN103520192A (en) * | 2013-10-25 | 2014-01-22 | 海南通用康力制药有限公司 | Invert sugar freeze-dried powder preparation for injection and preparation method thereof |
| CN103860592A (en) * | 2012-12-18 | 2014-06-18 | 扬子江药业集团上海海尼药业有限公司 | Preparation method of inverted sugar electrolyte injection |
| 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 |
| CN102824364B (en) * | 2012-08-15 | 2017-12-01 | 湖北凤凰白云山药业有限公司 | A kind of oral liquid of anti-dehydrating and its application |
| 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 |
-
2007
- 2007-04-10 CN CNA2007100392915A patent/CN101284014A/en active Pending
Cited By (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102379882A (en) * | 2011-03-10 | 2012-03-21 | 海南美好西林生物制药有限公司 | Invert sugar and injection medicinal preparation prepared from same |
| CN103301152A (en) * | 2012-03-13 | 2013-09-18 | 扬子江药业集团上海海尼药业有限公司 | Inverted sugar electrolyte injection and preparation method thereof |
| CN102657678A (en) * | 2012-05-02 | 2012-09-12 | 四川科伦药业股份有限公司 | Composition of potassium chloride and glucose and preparation method for composition |
| CN102949413A (en) * | 2012-06-08 | 2013-03-06 | 辽宁海思科制药有限公司 | Method for preparing invert sugar and electrolytes injection |
| CN102949413B (en) * | 2012-06-08 | 2014-12-03 | 辽宁海思科制药有限公司 | Method for preparing invert sugar and electrolytes injection |
| CN102824364B (en) * | 2012-08-15 | 2017-12-01 | 湖北凤凰白云山药业有限公司 | A kind of oral liquid of anti-dehydrating and its application |
| CN103860592A (en) * | 2012-12-18 | 2014-06-18 | 扬子江药业集团上海海尼药业有限公司 | Preparation method of inverted sugar electrolyte injection |
| CN103860592B (en) * | 2012-12-18 | 2016-01-13 | 扬子江药业集团上海海尼药业有限公司 | A kind of preparation method of inverted sugar electrolytes injection |
| CN103520192A (en) * | 2013-10-25 | 2014-01-22 | 海南通用康力制药有限公司 | Invert sugar freeze-dried powder preparation for injection and preparation method thereof |
| CN103520192B (en) * | 2013-10-25 | 2015-06-10 | 海南通用康力制药有限公司 | preparation method of invert sugar freeze-dried powder preparation for injection |
| 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 |
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Open date: 20081015 |