CN1485043A - Adetphos sodium chloride injection and its preparation method - Google Patents
Adetphos sodium chloride injection and its preparation method Download PDFInfo
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- CN1485043A CN1485043A CNA031422543A CN03142254A CN1485043A CN 1485043 A CN1485043 A CN 1485043A CN A031422543 A CNA031422543 A CN A031422543A CN 03142254 A CN03142254 A CN 03142254A CN 1485043 A CN1485043 A CN 1485043A
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- adenosine triphosphate
- disodium salt
- sodium chloride
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- triphosphate disodium
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Abstract
An adetphos injecting liquid for intravenous injection and its preparation method. The medical carriers include buffering agents such as phosphate, carbonate, acetate and citrate solution, as well as water for injecting. The another object of the invention is the preparation method of the adetphos injecting liquid. It comprises preparing a concentrated solution of the stabilizing agent, preparing a concentrated adetphos solution, preparing a concentrated solution of buffering agents, preparing injecting liquid of adetphos and sodium chloride. The adetphos injecting liquid is stable, avoid cross infection, and improve the clinical application of adetphos.
Description
Technical field
The present invention relates to a kind of medicine injection, become especially adenosine triphosphate disodium salt sodium chloride injection.
Background technology
Adenosine triphosphate disodium salt is a kind of coenzyme, and the effect that improves organism metabolism is arranged, and participates in the metabolism of body fat, protein, sugar, nucleic acid and nucleotide.Be again the main source of energy i (in vivo) simultaneously, when absorption in the body, secretion, muscle contraction and carry out biochemical synthetic reaction etc. when needing energy, adenosine triphosphate promptly resolves into adenosine diphosphate (ADP) and phosphate, gives off energy simultaneously.Animal experiment proof this product can suppress the slow flow of calcium ions of long response time fiber, blocks or delays forward conduction in the atrioventricular nodal reentry approach, heavy dose of forward direction and the antidromic conduction that also may block or delay bypass; Also have the vagal effect of of short duration strong enhancing in addition, thereby can stop the arrhythmia that atrioventricular nodal reentry and bypass foldback mechanism cause.The auxiliary treatment (heart failure, myocarditis, myocardial infarction, cerebral arteriosclerosis, coronary atherosclerosis etc. also are used for hepatitis, acute grey myelitis, progressive myatrophy etc.) that is used for progressive myatrophy, apoplexy sequela, cardiac insufficiency, myocardosis and hepatitis etc.Adenosine triphosphate disodium salt raw material and injection record in the 6th of Ministry of Health of the People's Republic of China.Belong to national essential drugs.The existing market supply have only aqueous injection, dosage form is more single, muscle or intravenous injection.Because the liquid of getting before the intravenous injection mixes, and has brought some shortcomings, not only formality is loaded down with trivial details, and be subjected to the pollution of environment, apparatus easily, user produces infusion reaction, as have a fever, feel sick, feel cold, tachycardia or slow excessively etc., can jeopardize patient's life in the time of seriously.
Summary of the invention
The objective of the invention is to overcome above-mentioned shortcoming, development contains the adenosine triphosphate disodium salt of aforementioned stable agent and annotates infusion products, and another object of the present invention is annotated the preparation method of transfusion for this kind of development.
Technical scheme of the present invention is: tribiofosfor injection of the present invention is by forming as pharmaceutical carriers such as the adenosine triphosphate disodium salt of active component and stabilizing agent, buffer agents, and wherein adenosine triphosphate disodium salt and pharmaceutical carrier are formed with adenosine triphosphate disodium salt that contains 0.01-1.0% and the arbitrary proportion that contains the medicinal stabilizing agent of 0.01-50.0% (weight).Pharmaceutical carrier in the tribiofosfor injection of the present invention has buffer agent such as phosphate, carbonate, acetate, citrate etc., also has water for injection.Can not contain or contain simultaneously in the tribiofosfor injection of the present invention one or more etc. buffer agent.
Another object of the present invention provides the preparation method of above-mentioned tribiofosfor injection, this method comprises the following steps: 1, prepares the stabilizing agent concentrated wiring liquid: get the water for injection that stabilizing agent adds 10% times of amount of full dose, stirring and dissolving, adding 0.3% active carbon boiled 30 minutes, through sand filtration rod filtering decarbonization, get concentrated wiring liquid.2, preparation adenosine triphosphate disodium salt concentrated wiring liquid: get the stabilizing agent concentrated wiring liquid, add adenosine triphosphate disodium salt, stir and make dissolving, get the adenosine triphosphate disodium salt concentrated wiring liquid.3, preparation buffer agent concentrated wiring liquid: get the water for injection that buffer agent adds 20% times of amount of full dose, stirring and dissolving gets the buffer agent concentrated wiring liquid.4, preparation adenosine triphosphate disodium salt sodium chloride injection: get above-mentioned buffer agent concentrated wiring liquid and adenosine triphosphate disodium salt concentrated wiring liquid and merge, add to the full amount of water for injection again, add 0.02% active carbon, stir evenly, insulation was placed 30 minutes, filter, measure intermediate content, pH value, through 0.45 μ m filtering with microporous membrane, fill is in infusion bottle or transfusion bag, through the routine sterilization, lamp inspection makes the adenosine triphosphate disodium salt sodium chloride injection after the quality inspection.
The invention has the advantages that: adenosine triphosphate disodium salt sodium chloride injection good stability of the present invention, reduced the dilution in the existing medicining condition, avoid cross infection, and improve the clinical practice level and the safety of adenosine triphosphate disodium salt, also be convenient to patient and use.
The survey report that is used for the adenosine triphosphate disodium salt sodium chloride injection that method of the present invention makes is as follows:
The name of an article: adenosine triphosphate disodium salt sodium chloride injection
Character: this product is colourless or almost colourless clear liquid
Differentiate: be positive reaction
PH value: 8.0-9.5
Adenosine triphosphate disodium salt content is labelled amount %: 〉=80.0%
Related substance:＜15.0%
Other: meet requirement under the injection item
Sterility test: qualified
Pyrogen testing: qualified
Adenosine triphosphate sodium chloride injection hemolytic test report of the present invention is as follows:
Sample: adenosine triphosphate disodium salt sodium chloride injection
Preparation unit: Liu Xiaoqing
Detect unit: pharmacology teaching and research room of Chinese Medical Sciences University
One, test objective:
When investigating the intravenous drip of adenosine triphosphate disodium salt sodium chloride injection, whether cause the body hemolytic reaction.
Two, animal:
Experimental rabbit, body weight 2.2kg, Chinese Medical Sciences University's second clinical experiment zoopery animal center provides, the quality certification number: No. 021, distant real kinoplaszm word.
Three, method:
Get 1 of experimental rabbit, from the about 10ml of heart extracting blood, put in the beaker, stir with bamboo let and remove fibrin, then blood is moved in the graduated centrifuge tube, add normal saline 5-10ml, behind the mixing centrifugal 5 minutes (2000-2500r/ branch), remove supernatant, it is centrifugal to add the normal saline mixing again, wash 3-4 time repeatedly, be water white transparency to supernatant and can be used for test.The gained erythrocyte is diluted to 2% suspension with normal saline, standby.
Get 7 in test tube, numbering is arranged on the test tube rack, add 2% red cell suspension and normal saline successively by table 1 proportional quantity, each pipe is shaken up gently, behind the mixing, in 37 ℃ of calorstats, place half an hour, 1～No. 5 pipe adds not commensurability test sample respectively, and the 6th pipe only adds normal saline and makes blank usefulness, and the 7th only manages adding distil water makes positive control, behind the mixing, put in 37 ℃ of calorstats.Beginning was observed once every 15 minutes, observed once every 1 hour after 1 hour.Observed 4 hours, and observed solution and haemolysis or coacervation whether occur.
Four, result:
Test sample adenosine triphosphate disodium salt sodium chloride injection hemolytic test feminine gender.Chinese Medical Sciences University's second clinical experiment zoopery animal center provides, the quality certification number: No. 021, distant real kinoplaszm word.
The table test sample is to erythrocytic influence
Annotate: "+" expression haemolysis; Haemolysis and red blood cell condensation do not appear in "-" expression.
Five, conclusion:
Above results suggest: test sample hemolytic test feminine gender, so can think that adenosine triphosphate disodium salt sodium chloride injection hemolytic test is qualified.
Adenosine triphosphate disodium salt sodium chloride injection sensitivity test of the present invention is reported as follows:
Sample: adenosine triphosphate disodium salt sodium chloride injection
Preparation unit: Liu Xiaoqing
Detect unit: pharmacology teaching and research room of Chinese Medical Sciences University
One, test objective:
When investigating the intravenous drip of adenosine triphosphate disodium salt sodium chloride injection, whether can cause the body anaphylaxis.
Two, animal:
Healthy guinea pig, male and female half and half, body weight 250-300g, Chinese Medical Sciences University's second clinical experiment zoopery animal center provides, the quality certification number: No. 021, distant real kinoplaszm word.
Three, method
Get 16 of healthy guinea pigs, be divided into 2 groups at random, A at the 1st, 3,5 day lumbar injection test sample 0.5ml/ only organizes, and the B group lumbar injection 5% fresh Ovum Gallus domesticus album normal saline solution 0.5ml/ same period only makes animal allergy.A, B are divided into 2 groups respectively for two groups more then, and A1 organizes in injecting back 14 days first, and 2ml/ only attacks observation by the intravenous injection test sample, and the A2 group is then injected in first and attacked with method in back 21 days.B1,2 groups also only attack respectively at corresponding intravenous injection in period 5% fresh Ovum Gallus domesticus album normal saline solution 2ml/, and close observation injection back animal has or not anaphylaxiss such as grabbing nose, perpendicular hair, dyspnea, spasm, shock, death.
Four, result
The test sample tribiofosfor injection does not have obvious anaphylaxis to Cavia porcellus, and positive reference substance 5% fresh Ovum Gallus domesticus album normal saline solution then causes the Cavia porcellus severe allergic reaction.
The table test sample is to the anaphylaxis of Cavia porcellus
The group Mus is counted 14 days irritated the 21st day allergy of priming dose aggressive agent flow control
(only) order of reaction order of reaction
Only 0 grade 0 grade of test sample 8 a 0.5ml/ 2ml/
Only 4 grades 4 grades of 5% new fresh hen egg 8 0.5ml/ 2ml/
Clear normal saline solution
Five, conclusion
Above results suggest, test sample fails to cause obvious anaphylaxis to Cavia porcellus, so can think that adenosine triphosphate disodium salt sodium chloride injection hypersensitive test is qualified.
Adenosine triphosphate disodium salt sodium chloride injection local irritation test report of the present invention is as follows:
Sample: adenosine triphosphate disodium salt sodium chloride injection
Preparation unit: Liu Xiaoqing
Detect unit: pharmacology teaching and research room of Chinese Medical Sciences University
One, test objective:
When investigating the intravenous drip of adenosine triphosphate disodium salt sodium chloride injection, whether can cause blood vessel irritation.
Two, animal:
Experimental rabbit, male and female half and half, body weight 2.0-2.5kg, Chinese Medical Sciences University's second clinical experiment zoopery animal center provides, the quality certification number: No. 021, distant real kinoplaszm word.
Three, test method
Get 6 of healthy experimental rabbits, fix 1 hour after, at its left auricular vein with a certain amount of test sample of 4# scalp acupuncture intravenous drip (by the conversion of clinical application amount, 1ml/ branch), for three days on end, every day 1 time; Auris dextra gives equivalent 5% glucose injection with same procedure.The close observation vein has or not expansion, spasm and part to have or not phenomenons such as hyperemia, edema.Observing venous simultaneously, hard of hearing corresponding site does not have or insufficiency of blood pipe place difference subcutaneous injection test sample and normal saline solution in the left and right sides, and diameter about 0.5cm in skin mound observes the skin mound and has or not hyperemia, edema and extinction time.After last administration finishes, cut one section away from the about 2cm in needle point the place ahead place blood vessel rapidly, fix with 10% formalin be, conventional embedding, stained, microscopically is observed and is had or not pathological change.
Four, result
Perusal Pi Qiu position: skin mound, the corresponding position of left and right sides ear does not all have abnormal changes such as obvious hyperemia, edema; In the intravenous drip process, venectasia, spasm and hyperemia, edema phenomenon all do not appear in each rabbit administration and contrast ear; The pathology microscopy shows: the blood vessel wall structure is clear, and no expansion, hyperemia and erythrocyte spill phenomenon.
Five, conclusion
Above results suggest, test sample does not have obvious irritation to rabbit ear edge vein blood vessel and rabbit ear subcutaneous tissue, so can think that the local excitation of adenosine triphosphate disodium salt sodium chloride injection is up to specification.
Adenosine triphosphate disodium salt sodium chloride injection study on the stability:
According to the requirement of two appendix XIXC of Chinese Pharmacopoeia version in 2000 medicine stability test guideline, infusion solutions quality stability is investigated through 40 ℃ of 6 months (being equivalent to room temperature 2 years) of acceleration and 6 months study on the stability of long-term stable experiment, and the result is as follows:
One, 6 months results of accelerated tests
Adenosine triphosphate
Sampling sodium chloride contains
Lot number character clarity pH value related substance % glycosides disodium contains
Time quantum %
Amount %
0 colourless clear liquid up to specification 8.72＜20 92.76 109.95
1 colourless clear liquid up to specification 8.72＜20 93.17 102.13
020,615 2 colourless clear liquids up to specification 8.72＜20 92.58 102.17
3 colourless clear liquids up to specification 8.72＜20 92.77 99.00
6 colourless clear liquids up to specification 8.72＜20 90.51 101.93
0 colourless clear liquid up to specification 8.72＜20 92.70 110.09
1 colourless clear liquid up to specification 8.72＜20 92.94 102.06
020,616 2 colourless clear liquids up to specification 8.72＜20 92.58 102.11
3 colourless clear liquids up to specification 8.71＜20 92.70 99.13
6 colourless clear liquids up to specification 8.72＜20 90.99 101.82
0 colourless clear liquid up to specification 8.72＜20 92.65 110.14
1 colourless clear liquid up to specification 8.72＜20 92.74 102.13
020,617 2 colourless clear liquids up to specification 8.72＜20 92.68 102.02
3 colourless clear liquids up to specification 8.71＜20 92.80 99.17
6 colourless clear liquids up to specification 8.72＜20 90.85 102.06
Two, 12 months results of long-term experiment
Adenosine triphosphate
Sampling
Sodium chloride contains
Lot number character clarity pH value related substance % glycosides disodium contains
Time quantum %
Amount %
0 colourless clear liquid up to specification 8.72＜20 92.76 109.95
3 colourless clear liquids up to specification 8.72＜20 92.69 101.17
6 colourless clear liquids up to specification 8.72＜20 90.51 101.98
020615
9 colourless clear liquids up to specification 8.72＜20 89.12 102.44
12 colourless clear liquids up to specification 8.71＜20 88.36 101.78
0 colourless clear liquid up to specification 8.72＜20 92.70 110.09
3 colourless clear liquids up to specification 8.72＜20 92.65 101.11
6 colourless clear liquids up to specification 8.72＜20 90.35 102.17
020,616 9 colourless clear liquids up to specification 8.71＜20 89.45 101.89
12 colourless clear liquids up to specification 8.72＜20 88.16 102.09
0 colourless clear liquid up to specification 8.72＜20 92.65 110.14
3 colourless clear liquids up to specification 8.72＜20 92.89 101.17
020,617 6 colourless clear liquids up to specification 8.72＜20 90.49 102.02
9 colourless clear liquids up to specification 8.71＜20 89.02 102.11
12 colourless clear liquids up to specification 8.71＜20 88.46 102.04
Conclusion: six months by a definite date accelerated test and long-term stable experiment explanation this product preliminarily stabilised is better, steady quality in this product room temperature 18 months.
The specific embodiment
Example 1: preparation tween 80 concentrated wiring liquid
Get tween 80 200g, add injection water 20000ml, stirring and dissolving adds the 45g active carbon and boiled 30 minutes, through sand filtration rod filtering decarbonization, gets concentrated wiring liquid.
Example 2: preparation adenosine triphosphate disodium salt concentrated wiring liquid
It is an amount of to get water for injection, adds adenosine triphosphate disodium salt 20g, stirs and makes dissolving, gets the adenosine triphosphate disodium salt concentrated wiring liquid.
Example 3: preparation carbonate buffer solution
It is an amount of to get water for injection, adds sodium carbonate 250g, sodium bicarbonate 150g, and EDTA-disodium 50g stirs and makes dissolving, gets carbonate buffer solution.
Example 4: preparation sodium chloride injection
It is an amount of to get water for injection, adds sodium chloride 900g, stirs to make dissolving, gets sodium chloride injection.
Example 5: adenosine triphosphate disodium salt sodium chloride injection
Treating excess syndrome example 1 tween 80 concentrated wiring liquid and example 2 adenosine triphosphate disodium salt concentrated wiring liquids merge, and add example 3 carbonate buffer solutions, example 4 sodium chloride injections more successively, add the injection water to 100000ml, add the 20g active carbon, stir evenly, insulation was placed 30 minutes, filtered, measure intermediate content, qualified after 0.45 μ m filtering with microporous membrane, fill are in infusion bottle or transfusion bag, through 100 ℃ of pressure sterilizings 30 minutes, cooling back lamp inspection promptly gets the adenosine triphosphate disodium salt sodium chloride injection after the product inspection.
Example 6: prepare phosphatic tribiofosfor injection
Press the method for example 1-5, substitute carbonate with phosphate and make.
Example 7: preparation contains the tribiofosfor injection of acetate
Press the method for example 1-5, replace carbonate to make with acetate.
Claims (5)
1, a kind of adenosine triphosphate disodium salt sodium chloride injection, it is characterized in that this medicine adenosine triphosphate disodium salt sodium chloride injection by tween as stabilizing agent, it can be formed with arbitrary proportion by the tween that contains 0.01-50.0% and other pharmaceutical carrier.
2, adenosine triphosphate disodium salt sodium chloride injection according to claim 1 is characterized in that wherein said pharmaceutical carrier has buffer agent and water for injection.
3,, it is characterized in that wherein used buffer agent can be phosphate, carbonate, acetate, citrate according to claim 1 and 2 described adenosine triphosphate disodium salt sodium chloride injections.
4,, it is characterized in that not contain or to contain simultaneously numerous buffers in this injection according to claim 1 and 2 described adenosine triphosphate disodium salt sodium chloride injections.
5, a kind of preparation method as claim 1 and described adenosine triphosphate disodium salt sodium chloride injection is characterized in that this preparation method comprises the following steps:
(1) preparation stabilizing agent concentrated wiring liquid
Get the water for injection that stabilizing agent adds 10% times of amount of full dose, stirring and dissolving adds 0.3% active carbon and boiled 30 minutes, through sand filtration rod filtering decarbonization, gets concentrated wiring liquid;
(2) preparation adenosine triphosphate disodium salt concentrated wiring liquid
Get the stabilizing agent concentrated wiring liquid, add adenosine triphosphate disodium salt, stir and make dissolving, get the adenosine triphosphate disodium salt concentrated wiring liquid;
(3) preparation buffer agent concentrated wiring liquid
Get the water for injection that buffer agent adds 20% times of amount of full dose, stirring and dissolving gets the buffer agent concentrated wiring liquid;
(4) preparation adenosine triphosphate disodium salt sodium chloride injection
Getting above-mentioned buffer agent concentrated wiring liquid and adenosine triphosphate disodium salt concentrated wiring liquid merges, add to the full amount of water for injection again, add 0.02% active carbon, stir evenly, insulation was placed 30 minutes, filter, measure intermediate content, pH value, through 0.45 μ m filtering with microporous membrane, fill is in infusion bottle or transfusion bag, through the routine sterilization, lamp inspection makes the adenosine triphosphate disodium salt sodium chloride injection after the quality inspection;
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| CN 03142254 CN1200715C (en) | 2003-08-11 | 2003-08-11 | Adetphos sodium chloride injection and its preparation method |
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| CN 03142254 CN1200715C (en) | 2003-08-11 | 2003-08-11 | Adetphos sodium chloride injection and its preparation method |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101596169B (en) * | 2009-07-06 | 2011-05-04 | 浙江大学 | Chitosan nanoparticle for encapsulating adenosine triphosphate and preparation method thereof |
| CN101455631B (en) * | 2009-01-06 | 2011-06-15 | 湖北德康药业有限公司 | Meglumine cyclic adenosine injection and preparation technique thereof |
| CN102512668A (en) * | 2011-12-21 | 2012-06-27 | 蚌埠丰原涂山制药有限公司 | Lyophilized powder of adenosine disodium triphosphate, coenzyme A and insulin for injection and preparation method thereof |
| CN102552950A (en) * | 2011-12-16 | 2012-07-11 | 刘小清 | Production process of unstable chemical injection |
-
2003
- 2003-08-11 CN CN 03142254 patent/CN1200715C/en not_active Expired - Fee Related
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101455631B (en) * | 2009-01-06 | 2011-06-15 | 湖北德康药业有限公司 | Meglumine cyclic adenosine injection and preparation technique thereof |
| CN101596169B (en) * | 2009-07-06 | 2011-05-04 | 浙江大学 | Chitosan nanoparticle for encapsulating adenosine triphosphate and preparation method thereof |
| CN102552950A (en) * | 2011-12-16 | 2012-07-11 | 刘小清 | Production process of unstable chemical injection |
| CN102552950B (en) * | 2011-12-16 | 2013-11-06 | 刘小清 | Production process of unstable chemical injection |
| CN102512668A (en) * | 2011-12-21 | 2012-06-27 | 蚌埠丰原涂山制药有限公司 | Lyophilized powder of adenosine disodium triphosphate, coenzyme A and insulin for injection and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN1200715C (en) | 2005-05-11 |
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