CN1864693A - A glycerin and fructose injection and preparation method thereof - Google Patents
A glycerin and fructose injection and preparation method thereof Download PDFInfo
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- CN1864693A CN1864693A CN 200510070626 CN200510070626A CN1864693A CN 1864693 A CN1864693 A CN 1864693A CN 200510070626 CN200510070626 CN 200510070626 CN 200510070626 A CN200510070626 A CN 200510070626A CN 1864693 A CN1864693 A CN 1864693A
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Abstract
The present invention relates to one kind of glycerine-fructose injection and its preparation process. The injection in 250 liters consists of glycerine fructose in 25 kg, fructose in 12.5 kg, sodium chloride in 2.25 kg and water for injection for the rest, and may be compounded into 1000 bottles of transfused solution of 250 ml each or 500 bottles of transfused solution of 500 ml each. The present invention also provides the preparation process of the injection.
Description
Technical field:
The present invention relates to a kind of pharmaceutical preparation, particularly containing glycerol and fructose is the compound medicine injection of main active.
Background technology:
It is the modal disease of neurosurgery that cranium is pressed height, be to use mannitol to treat for a long time clinically always, respond well, but it has many side effect such as rebound phenomenon, electrolyte disturbance, renal function injury, use the glycerol blood pressure lowering from U.S. Virno in 1961, fail extensively to promote because of it has the haemolysis side effect.Compatibility agent research to glycerol since the eighties has obtained great success, adds fructose and can reduce its haemolysis side effect in glycerol.Therefore be widely used in clinical.
Glycerin and fructose injection is to ooze injection by the height that Glycerin Fructose is made, and oozes the pharmacological action of dehydration by height, in order to illness such as injury of head, cerebral thrombosis, intracranial hemorrhage.This product can be eliminated cerebral edema, reduces intracranial pressure, makes patient's comatose state clear-headed early, alleviates and disables, it can see through blood brain barrier and enter cerebral tissue, is oxidized to phosphorylation substrate, is unique origin of heat in the cerebral tissue, can improve cerebral circulation, the cerebral blood flow increasing amount increases the brain zmount of oxygen consumption.
Glycerin and fructose injection produces direct pharmacological action by the high osmosis dehydration, eliminates cerebral edema, reduces intracranial pressure.Glycerin and fructose injection can increase adenosine triphosphate, phosphate creatine produce power to the cerebral ischemia patient, and metabolism has the improvement effect to brain.Glycerin and fructose injection not only makes intracranial pressure descend, and cerebral blood flow increases, and the secondary perfusion pressure raises, and has also reduced blood capillary edema on every side, has alleviated the mechanicalness compressing.Glycerin and fructose injection enters tricarboxylic acid cycle with the carbohydrate metabolism system, and major part is oxidized to CO
2And H
2Behind the O, discharge by respiratory tract, minute quantity is discharged from urine.
Glycerin and fructose injection has few and electrolyte balance disturbed few characteristics to renal function injury, makes it more be suitable for the patient who is used in chronic high cranium pressure, renal insufficiency or needs the long period dehydration.
Existing glycerin and fructose injection, its prescription is unreasonable, and production technology falls behind, stability is bad, and we have carried out the formulation and technology screening to glycerin and fructose injection on the basis of existing technology, obtained new prescription, improved technology, stability is improved greatly.
Summary of the invention:
The invention provides a kind of new glycerin and fructose injection prescription, the concrete composition and the content of this prescription are as follows:
Glycerol 25kg
Fructose 12.5kg
Sodium chloride 2.25kg
Water for injection is an amount of
Full dose 250L
More than prescription can prepare 1000 bottles of the infusion preparations of 250ml, can prepare 500 bottles of the infusion preparations of 500ml.
The preparation technology that the present invention also provides the present invention to fill a prescription injection, the concrete steps of this technology are as follows:
A. get 50L water for injection, add glycerol, fructose and the sodium chloride of recipe quantity, stir and make its dissolving;
B. (w/v, injection-use activated carbon 50g) fully stir, and are heated to about 70 ℃, stir 30 minutes, and coarse filtration is taken off charcoal while hot by volume to add 0.1% again; Put and be chilled to room temperature;
C. add water for injection to nearly full dose, regulate pH value, measure the pH value and the content of solution, make between the pH value control 4.0～5.0;
D. filter repeatedly with 0.22 μ m microporous filter membrane, clarify to solution;
E. filtrate in the water white infusion bottle of 250ml, adds mylar by every bottle of 250ml fill, jumps a queue Zha Lvgai;
F. in 115 ℃ of pressure sterilizings 30 minutes;
G. press the quality standard check;
H. the product that is up to the standards is packed, and promptly gets the glycerin and fructose injection finished product.(1000 bottles or 500 bottles)
Wherein regulate pH value and make between the pH value control 4.0～5.0, use acid or alkaline matter as the pH value regulator, as sodium hydroxide, hydrochloric acid etc., preferred pH value is 4.5.
The method of quality control that the present invention also provides the present invention to fill a prescription injection, this method comprises following content:
Character is checked, differentiates, and the pH value inspection, the 5 hydroxymethyl furfural inspection, the heavy metal inspection, arsenic salt is checked, particulate matter inspection, pyrogen test, steps such as assay.
Differentiate that wherein item comprises: air-generating reaction, chromogenic reaction, sodium salt reaction, chloride reaction, high performance liquid chromatography etc.Should be up to specification or consistent with reference substance.Check that item comprises: clarity test, content uniformity inspection, pH value inspection, 5 hydroxymethyl furfural, heavy metal, pyrogen test, sterility test, arsenic salt, particulate matter etc.Should be up to specification.Differentiate and assay with the HPLC chromatography.Carry out the preparation Destructive Test Study simultaneously, comprise acid degradation test, alkaline degradation test, oxidation failure test.The HPLC chromatogram of main degradation product shows that glycerin and fructose injection is stable under acid, alkali condition; But the oxidation failure test shows that catabolite is arranged, and oxidation product can well separate with main composition.
Method of quality control concrete steps of the present invention are as follows: and (following with the fill a prescription infusion preparation of injection finished product 250ml of the present invention, or the infusion preparation of 500ml is called this product)
[character] this product is colourless clear liquid; It is little sweet to distinguish the flavor of, little salty.
[discriminating]
(1) gets this product 1ml, add potassium acid sulfate 0.5g, heat, the pungent odor of acrylic aldehyde promptly takes place.
(2) get this product 10ml, add resorcinol 0.1g and hydrochloric acid 1ml, heating is 3 minutes in water-bath, should show red.
(3) under the assay item in the chromatogram of gained, each chromatographic peak of test sample is consistent with the retention time of reference substance respective peaks.
(4) this product shows sodium salt and muriatic identification (two appendix III of Chinese Pharmacopoeia version in 2000).
[inspection]
PH value should be 3.0～6.0 (two appendix VI of Chinese Pharmacopoeia version in 2000 H).
5 hydroxymethyl furfural is got this product 5.0ml, adds water 20.0ml, shakes up, and according to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2000 A), measures at the wavelength place of 284nm, and trap must not be greater than 0.80.
Heavy metal is got this product 10ml, adds acetate buffer (pH3.5) 2ml and makes into 25ml in right amount with water, checks to contain (two appendix VIII of Chinese Pharmacopoeia version in 2000 H, first method) heavy metal and must not cross 2/1000000ths. five in accordance with the law.
Arsenic salt is got this product 4ml, adds hydrochloric acid 5ml and water 19ml, checks that in accordance with the law (two appendix VIII of Chinese Pharmacopoeia version in 2000 J, first method) should (0.00005%) up to specification.
Particulate matter is got 1 bottle of this product, checks (two appendix IX of Chinese Pharmacopoeia version in 2000 C) in accordance with the law, should be up to specification.
Pyrogen is got this product, checks (two appendix IX of Chinese Pharmacopoeia version in 2000 D) in accordance with the law, and dosage is slowly injected 10ml by the every 1kg of rabbit body weight, should be up to specification.
Other should meet every regulation relevant under the injection item (two appendix I of Chinese Pharmacopoeia version in 2000 B).
[assay]
Measure according to high performance liquid chromatography (two appendix V of Chinese Pharmacopoeia version in 2000 D).
Chromatographic condition and system suitability test are filler with sulfonic acid type polystyrene and divinylbenzene copolymer cation exchange resin H type, and column temperature is 50 ℃, is mobile phase with the 0.04mol/L phosphoric acid solution, and the detection wavelength is 200nm.Number of theoretical plate calculates by sodium chloride should be not less than 3500, and the separating degree of sodium chloride peak, fructose peak, glycerol peak and internal standard substance mass peak all should meet the requirements.
The preparation of inner mark solution gets 1, and 2-propylene glycol 15ml is diluted to 100ml with mobile phase, shakes up, promptly.
It is an amount of that algoscopy is got chloride, fructose and glycerol reference substance, the accurate title, decide, add water and make the solution that contains 9mg, 50mg, 100mg among every 1ml respectively, precision measures this solution 5ml and inner mark solution 10ml puts in the 100ml measuring bottle, add mobile phase and be diluted to scale, shake up, get 20 μ l and inject chromatograph of liquid, the record chromatogram; It is an amount of that other gets this product, measures with method.Press internal standard method with calculated by peak area, promptly.
The present invention's injection of filling a prescription has been carried out the test of medicine stability research, proved that medicine of the present invention is more stable than prior art, technology is more advanced.
Test as follows:
One, sample source
The glycerin and fructose injection test sample (lot number: 20020901,20020902,20020903), for Sichuan Kelun Large Pharmaceutical Factory Co. Ltd provides.To produce lot number (200102021) by Tianjin aminoacid company in the same old way.
Two, content of the test and method
1. accelerated test
Sample thief is an amount of, intends the listing packing, places 6 months in 40 ℃ ± 2 ℃ calorstat, respectively at the 0th, 1,2,3 and sampling in 6 months, detects.
2. long term test
Sample thief is an amount of, intends the listing packing, places 36 months in 25 ℃ ± 2 ℃ calorstat, respectively at the 0th, 3,6,9,12,18,24 and sampling in 36 months, detects.
Three, inspection item and method
Press pertinent regulations in the stability of drug products test direction principle (two appendix XIX of Chinese Pharmacopoeia version in 2000 C), detect this product respectively and test the situation of change of the character of front and back, clarity, pH value, 5 hydroxymethyl furfural, content indexs such as (glycerol, fructose, sodium chloride), and predict its effect duration.
Four, result of the test and conclusion
1. accelerated test result
Through three batch samples are tested, this product is under simulation listing terms of packing, placed 6 months under 40 ℃ ± 2 ℃ conditions of relative temperature, its character, clarity, pH value, 5 hydroxymethyl furfural, content every indexs such as (glycerol, fructose, sodium chloride) all do not take place obviously to change before and after the test.Illustrate that sample is stable under this terms of packing.Result of the test sees Table 1.
2. long-term test results
Through three batch samples are tested, three batch samples are under simulation listing terms of packing, place JIUYUE under the approaching actual storage requirement of 25 ℃ of relative humiditys 60%, temperature, its character, clarity, pH value, 5 hydroxymethyl furfural, content every indexs such as (glycerol, fructose, sodium chloride) all take place obviously to change.Illustrate that the packing sample is stable under this condition.Result of the test sees Table 2.
3. conclusion
Investigate through above accelerated test and long term test, the result proves that this product is stable.
Table 1 accelerated tests result
| Lot number | Moon time | Appearance character | The clarity of solution | PH | 5 hydroxymethyl furfural | Glycerol | Content % fructose | Sodium chloride | Related substance |
| 020901 020902 | 0 1 2 3 6 0 1 | Colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid | Up to specification up to specification up to specification | 4.20 4.21 4.24 4.21 4.20 4.22 4.23 | 0.062 0.060 0.063 0.063 0.062 0.064 0.065 | 99.66 98.93 99.31 98.31 99.28 99.88 98.94 | 99.80 99.00 99.24 98.27 99.54 98.43 96.68 | 98.00 97.51 97.87 97.90 98.45 97.09 97.84 | ＜1％ ＜1％ ＜1％ ＜1％ ＜1％ ＜1％ ＜1％ |
| 020903 | 2 3 6 0 1 2 3 6 | Colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid | Up to specification | 4.20 4.19 4.19 4.18 4.19 4.19 4.22 4.21 | 0.062 0.062 0.063 0.060 0.068 0.065 0.061 0.061 | 99.43 99.22 99.74 99.93 99.11 99.44 99.82 98.77 | 98.87 98.25 99.83 99.12 98.71 98.69 99.43 98.74 | 97.99 96.87 99.64 97.35 96.28 97.85 97.86 98.92 | ＜1％ ＜1％ ＜1％ ＜1％ ＜1％ ＜1％ ＜1％ ＜1％ |
Table 2 long-term experiment result
| Lot number | Moon time | Appearance character | The clarity of solution | PH | 5 hydroxymethyl furfural | Glycerol | Content % fructose | Sodium chloride | Related substance |
| 020901 020902 020903 | 0 3 6 9 0 3 6 9 0 3 6 | Colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid colourless clear liquid | Up to specification up to specification up to specification | 4.20 4.20 4.20 4.20 4.22 4.18 4.22 4.21 4.18 4.19 4.18 | 0.062 0.061 0.064 0.060 0.064 0.062 0.062 0.060 0.060 0.062 0.060 | 99.66 98.84 98.90 97.95 99.88 99.29 99.00 97.98 99.93 98.91 99.11 | 99.80 98.72 98.63 98.94 98.43 98.85 98.04 99.21 99.12 98.80 97.95 | 98.00 98.31 96.78 100.20 97.09 97.82 98.04 100.68 97.35 97.73 97.95 | ＜1％ ＜1％ ＜1％ ＜1％ ＜1％ ＜1％ ＜1％ ＜1％ ＜1％ ＜1％ ＜1％ |
| 9 | Colourless clear liquid | Up to specification | 4.20 | 0.062 | 99.27 | 98.90 | 96.53 | ＜1％ |
The invention has the advantages that, add sodium chloride 2.25kg in the prescription, make to wait and ooze better effects if, have the effect of stabilizing solution simultaneously, in the formulation preparation process, regulate pH value in addition, the solution pH value is controlled between 4.0～5.0; Like this can stabilizing solution, prolong storage period.
The specific embodiment:
Further specify the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1
One, prescription research (1000 bottles)
Glycerol 25kg
Fructose 12.5kg
Sodium chloride 2.25kg
Water for injection is an amount of
Full dose 250L
Two. preparation technology's (1000 bottles)
A. get 50L water for injection, add glycerol, fructose and the sodium chloride of recipe quantity, stir and make its dissolving;
B. (w/v, injection-use activated carbon 50g) fully stir, and are heated to about 70 ℃, stir 30 minutes, and coarse filtration is taken off charcoal while hot by volume to add 0.1% again; Put and be chilled to room temperature;
C. add water for injection to nearly full dose, measure the pH value and the content of solution, make between the pH value control 4.0～5.0;
D. filter repeatedly with 0.22 μ m microporous filter membrane, clarify to solution;
E. filtrate in the water white infusion bottle of 250ml, adds mylar by every bottle of 250ml fill, jumps a queue Zha Lvgai;
F. in 115 ℃ of pressure sterilizings 30 minutes;
G. press the quality standard check;
H. the product that is up to the standards is packed, and promptly gets the glycerin and fructose injection finished product.
Embodiment 2
One, prescription research (500 bottles)
Glycerol 25kg
Fructose 12.5kg
Sodium chloride 2.25kg
Water for injection is an amount of
Full dose 250L
Two. preparation technology's (500 bottles)
A. get 50L water for injection, add glycerol, fructose and the sodium chloride of recipe quantity, stir and make its dissolving;
B. (w/v, injection-use activated carbon 50g) fully stir, and are heated to about 70 ℃, stir 30 minutes, and coarse filtration is taken off charcoal while hot by volume to add 0.1% again; Put and be chilled to room temperature;
C. add water for injection to nearly full dose, measure the pH value and the content of solution, make between the pH value control 4.0～5.0;
D. filter repeatedly with 0.22 μ m microporous filter membrane, clarify to solution;
E. filtrate in the water white infusion bottle of 250ml, adds mylar by every bottle of 250ml fill, jumps a queue Zha Lvgai;
F. in 115 ℃ of pressure sterilizings 30 minutes;
G. press the quality standard check;
H. the product that is up to the standards is packed, and promptly gets the glycerin and fructose injection finished product.
Claims (10)
1, a kind of injection is characterized in that, contains two kinds of active component of glycerol and fructose, also contains solvent for injection.
2, the injection of claim 1 also contains sodium chloride.
3, the injection of claim 2 is characterized in that, described solvent for injection is a water for injection.
4, the injection of claim 3 is characterized in that, each set of dispense is such as following
Glycerol 25kg
Fructose 12.5kg
Sodium chloride 2.25kg
Water for injection is an amount of
Full dose 250L
1000 bottles in the preparation that this proportioning can be made into 250ml maybe can prepare 500 bottles in the preparation of 500ml.
5, the preparation method of the injection of claim 4 is characterized in that, the process following steps:
A. get 50L water for injection, add glycerol, fructose and the sodium chloride of recipe quantity, stir and make its dissolving;
B. the injection-use activated carbon that adds 50g fully stirs, and is heated to about 70oC, stirs 30 minutes, and coarse filtration is taken off charcoal while hot; Put and be chilled to room temperature;
C. add water for injection to nearly full dose, regulate pH value, measure the pH value and the content of solution, make between the pH value control 4.0～5.0;
D. filter repeatedly with 0.22 μ m microporous filter membrane, clarify to solution;
E. filtrate in the water white infusion bottle of 250ml, adds mylar by every bottle of 250ml fill, jumps a queue Zha Lvgai;
F. in 115 ℃ of pressure sterilizings 30 minutes;
G. press the quality standard check;
H. the product that is up to the standards is packed, promptly.
6, the preparation method of claim 5 is characterized in that, uses the pH value regulator to regulate pH value to 4.5.
7, the preparation method of claim 6 is characterized in that, described pH value regulator is sodium hydroxide or hydrochloric acid.
8, the method for quality control of the injection of claim 4 is characterized in that, this method may further comprise the steps: the character inspection, differentiate, pH value is checked, the 5 hydroxymethyl furfural inspection, and the heavy metal inspection, arsenic salt is checked, particulate matter is checked, pyrogen test, assay.
9, the method for quality control of claim 8 is characterized in that, described discriminating comprises: air-generating reaction, chromogenic reaction, sodium salt reaction, chloride reaction, high performance liquid chromatography.
10, the method for quality control of claim 9 is characterized in that,
Step is as follows:
[character] this product is colourless clear liquid; It is little sweet to distinguish the flavor of, little salty;
[discriminating]
(1) gets this product 1ml, add potassium acid sulfate 0.5g, heat, the pungent odor of acrylic aldehyde promptly takes place;
(2) get this product 10ml, add resorcinol 0.1g and hydrochloric acid 1ml, heating is 3 minutes in water-bath, should show red;
(3) under the assay item in the chromatogram of gained, each chromatographic peak of test sample is consistent with the retention time of reference substance respective peaks;
(4) this product shows sodium salt and muriatic identification (two appendix III of Chinese Pharmacopoeia version in 2000);
[inspection]
PH value should be 3.0～6.0 (two appendix VI of Chinese Pharmacopoeia version in 2000 H);
5 hydroxymethyl furfural is got this product 5.0ml, adds water 20.0ml, shakes up, and according to spectrophotography (two appendix IV of Chinese Pharmacopoeia version in 2000 A), measures at the wavelength place of 284nm, and trap must not be greater than 0.80;
Heavy metal is got this product 10ml, adds acetate buffer (pH3.5) 2ml and makes into 25ml in right amount with water, checks to contain (two appendix VIII of Chinese Pharmacopoeia version in 2000 H, first method) heavy metal and must not cross 2/1000000ths. five in accordance with the law;
Arsenic salt is got this product 4ml, adds hydrochloric acid 5ml and water 19ml, checks that in accordance with the law (two appendix VIII of Chinese Pharmacopoeia version in 2000 J, first method) should (0.00005%) up to specification;
Particulate matter is got 1 bottle of this product, checks (two appendix IX of Chinese Pharmacopoeia version in 2000 C) in accordance with the law, should be up to specification;
Pyrogen is got this product, checks (two appendix IX of Chinese Pharmacopoeia version in 2000 D) in accordance with the law, and dosage is slowly injected 10ml by the every 1kg of rabbit body weight, should be up to specification;
Other should meet every regulation relevant under the injection item (two appendix IB of Chinese Pharmacopoeia version in 2000);
[assay]
Measure according to high performance liquid chromatography (two appendix V of Chinese Pharmacopoeia version in 2000 D);
Chromatographic condition and system suitability test are filler with sulfonic acid type polystyrene and divinylbenzene copolymer cation exchange resin H type, and column temperature is 50 ℃, is mobile phase with the 0.04mol/L phosphoric acid solution, and the detection wavelength is 200nm.Number of theoretical plate calculates by sodium chloride should be not less than 3500, and the separating degree of sodium chloride peak, fructose peak, glycerol peak and internal standard substance mass peak all should meet the requirements;
The preparation of inner mark solution gets 1, and 2-propylene glycol 15ml is diluted to 100ml with mobile phase, shakes up, promptly;
It is an amount of that algoscopy is got chloride, fructose and glycerol reference substance, the accurate title, decide, add water and make the solution that contains 9mg, 50mg, 100mg among every 1ml respectively, precision measures this solution 5ml and inner mark solution 10ml puts in the 100ml measuring bottle, add mobile phase and be diluted to scale, shake up, get 20 μ l and inject chromatograph of liquid, the record chromatogram; It is an amount of that other gets this product, measures with method.Press internal standard method with calculated by peak area, promptly;
Wherein said this product is the injection finished product that claim 4 prescription is made.
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| CN101836997A (en) * | 2010-05-20 | 2010-09-22 | 西安万隆制药有限责任公司 | Glycerol/fructose composite and preparation method thereof |
| CN102440949A (en) * | 2010-10-09 | 2012-05-09 | 江苏正大丰海制药有限公司 | Preparation method of fructose injection |
| CN102440949B (en) * | 2010-10-09 | 2013-06-05 | 江苏正大丰海制药有限公司 | Preparation method of fructose injection |
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| CN103083230B (en) * | 2013-01-18 | 2014-07-30 | 安徽丰原药业股份有限公司 | Fructose-containing injection and preparation method thereof |
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| CN104622895A (en) * | 2015-01-20 | 2015-05-20 | 石家庄四药有限公司 | Preparation method of glycerin fructose sodium chloride injection packaged in double-chamber bag |
| CN108158982A (en) * | 2017-11-16 | 2018-06-15 | 佛山双鹤药业有限责任公司 | Mannitol sodium chloride injection and production technology |
| CN109464389A (en) * | 2018-12-27 | 2019-03-15 | 四川太平洋药业有限责任公司 | A kind of glycerin and fructose injection production technology |
| CN113030359A (en) * | 2021-01-28 | 2021-06-25 | 成都第一制药有限公司 | Detection method for various index components in motherwort injection and quality control method of motherwort injection |
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