CN102225063A - Pantoprazole sodium composition for injection - Google Patents
Pantoprazole sodium composition for injection Download PDFInfo
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- CN102225063A CN102225063A CN2011101193544A CN201110119354A CN102225063A CN 102225063 A CN102225063 A CN 102225063A CN 2011101193544 A CN2011101193544 A CN 2011101193544A CN 201110119354 A CN201110119354 A CN 201110119354A CN 102225063 A CN102225063 A CN 102225063A
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- injection
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- plug
- pantoprazole
- composition
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Abstract
The invention provides a pantoprazole sodium composition for injection. The composition contains pantoprazole sodium and disodium ethylene diamine tetraacetate that are in a proportion of 1:0.02-0.1 by weight. And the composition is prepared by the steps of: 1) liquid medicine preparation: placing pantoprazole sodium and disodium ethylene diamine tetraacetate in a preparation pot, adding water for injection and stirring to make the above agents dissolved and mixed well with the water, adjusting the pH value of the mixture to 10.5-12.5; 2) rubber stopper treatment; 3) aseptic filtration and separate packing; 4) vacuum freeze drying, thus obtaining the composition. For pantoprazole sodium medicaments extremely easy to react with exudates from a rubber stopper, the pantoprazole sodium composition for injection in the invention can simultaneously guarantee the visible foreign matters and insoluble particles in products meeting the requirement of an injection. According to the invention, quality level of the composition product is improved, and the hidden trouble that unqualified visible foreign matters and insoluble particles threat patient clinical medication safety can be avoided. Additionally, the composition of the invention has better curative effects and less clinical side effects.
Description
Technical field
The present invention relates to a kind of pantoprazole composition of sodium of injection, belong to medical preparing technical field.
Background technology
Pantoprazole Sodium (pantoprazole sodium) chemistry 5-difluoro-methoxy-2-[(3 by name, 4-dimethoxy-2-pyridine radicals) methyl] sulfinyl-1H-benzimidazole sodium, structural formula is
Pantoprazole Sodium is the proton pump inhibitor of new generation (PPI) after omeprazole, lansoprazole, is the first-line treatment medicine of peptic ulcer disease.After the listing of the whole world,, become the specific medicament of the treatment digestive system function disorder disease relevant at once with acid because of it presses down the significant advantage that the acid effect is lasting by force, ulcer healing rate is high, untoward reaction is few and drug interaction is few.
Pantoprazole Sodium is unstable under sour environment, in process for preparation, has all adopted higher pH (usually more than 9.5), to improve the physics and the chemical stability of Pantoprazole Sodium obtain solution.Rising along with pH value, the compatibility of content and inner packaging material (particularly plug) has been subjected to great challenge, in addition this class proton pump inhibitor of Pantoprazole Sodium itself just very easily with plug in exudate react, higher pH has just been aggravated this process, simultaneously, because the lyophilized formulations of Pantoprazole Sodium injection all is in negative pressure state in preparation and storage and transport process, even if content seldom contacts with plug, exudate in the plug also can be to the one side migration of negative pressure, thereby react with Pantoprazole Sodium, cause visible foreign matters and particulate matter defective, these microgranules enter human body, cause capillary embolism and granuloma, increase the clinical application risk greatly.
Use plated film (overlay film) plug, the obstruct of the film by relative inertness, can on certain depth, improve above defective, but often cause the significantly increase of cost, the exudate that the subtend negative pressure is simultaneously moved in the while plug, the inert coating barriering effect is unsatisfactory, thereby long-term back preparation visible foreign matters and the underproof phenomenon of particulate matter of placing occur.
And existing other technologies are all less than the suggestion that above defective is proposed improve: Chinese patent CN201010045827.6 discloses pantoprazole sodium combined drug and preparation method thereof.Form by Pantoprazole Sodium, tiopronin, calcium glutamate and disodium edetate, as anti-Pantoprazole Sodium to the detrimental effect of liver and the safe drugs of other untoward reaction, do not solve above-mentioned technological deficiency.Chinese patent CN99112872.9 discloses a kind of freeze-dried powder injection of pantoprazole sodium, does not solve above-mentioned technological deficiency.Chinese patent CN01819379.X discloses a kind of freeze-dried pantoprazole preparation, by with pantoprazole, ethylenediaminetetraacetic acid and/or its suitable salt, and the aqueous solution lyophilization of sodium hydroxide and/or sodium carbonate and getting, do not solve above-mentioned technological deficiency.Chinese patent CN200510023469.8 discloses a kind of freeze-dried powder injection of pantoprazole sodium, does not solve above-mentioned technological deficiency.Chinese patent CN200610156621.4 discloses a kind of Pantoprazole Sodium Freezing Injectable Powder And Its Preparation Method, does not solve above-mentioned technological deficiency.Chinese patent CN200810001189.0 discloses a kind of freeze-dried powder injection of pantoprazole sodium, comprises Pantoprazole Sodium and mannitol, has taked advanced freeze drying process, does not solve above-mentioned technological deficiency.
Therefore, to this class preparating liquid of Pantoprazole Sodium pH higher and very easily with plug in the injection of exudate reaction, pressing for a kind ofly can significantly not increase manufacturing cost, again can permanently effective assurance preparation visible foreign matters and particulate matter meet the technology of injection requirement.
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art part, providing a kind of can significantly not increase manufacturing cost, again can permanently effective assurance preparation visible foreign matters and particulate matter meet the pantoprazole composition of sodium of injection requirement.
The pantoprazole composition of sodium of injection of the present invention contains Pantoprazole Sodium and disodiumedetate, and wherein, the part by weight of Pantoprazole Sodium and disodiumedetate is 1:0.02～0.1, and said compositions is prepared from by the following method:
1) medicinal liquid preparation: take by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, the regulator solution pH value is 10.5～12.5;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 6.0～7.0 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 41～47 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
Preferably,
In the pantoprazole composition of sodium of described injection, the part by weight of said Pantoprazole Sodium and disodiumedetate is 1:0.02～0.05.
In the pantoprazole composition of sodium of described injection, the material of said adjusting pH value is sodium hydroxide, sodium carbonate, sodium bicarbonate or sodium citrate.
More preferably,
In the pantoprazole composition of sodium of described injection, raw material also comprises mannitol, lactose, dextran or the glucose as excipient.
The principle of technical solution of the present invention is: by plug is handled, on the basis of not destroying the plug internal structure, easy exudate is removed from plug in advance, prevent the reaction of content and exudate, thereby guarantee that effectively product visible foreign matters and particulate matter meet the injection requirement.
At first, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulate pH value to 6.0～7.0 with sodium hydroxide after the stirring and dissolving, the Treatment Solution that this process obtains can guarantee that the commute exudate has enough removing abilities, is unlikely to destroy the plug internal structure again and causes more oozing out.
Secondly; get plug; the part by weight of pressing plug and Treatment Solution 1:10 adds Treatment Solution; be heated to 41～47 ℃ and be incubated 30 minutes; suitable removing temperature and time is to continue and the assurance of gentle cleaning process; the inventor finds that based on the color and the microgranule monitoring of cleanout fluid exudate substantially at the uniform velocity is cleaned in the research, and this just illustrates that this process internal structure has obtained good protection.
At last, the learn from else's experience plug of above-mentioned processing, with through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, put 121 ℃ of oven dry in the rubber plug cleaning machine, thoroughly removed the exudate that remains in the plug surface on the one hand, make also that on the other hand plug is in the state of aseptic cleaning, make things convenient for next step sterile filling to use.
The plug of handling by said method is in that to be used for this class preparating liquid of Pantoprazole Sodium pH higher and during very easily with the medicine of exudate reaction, further exudate release hardly, and it also is like this being included under the negative pressure state.
The pantoprazole composition of sodium of injection of the present invention, to this class preparating liquid of Pantoprazole Sodium pH higher and very easily with plug in the injection of exudate reaction, can significantly not increase under the prerequisite of manufacturing cost, can permanently effective assurance preparation visible foreign matters and particulate matter meet the technology of injection requirement.The present invention is by handling plug, on the basis of not destroying the plug internal structure, easy exudate is removed from plug in advance, prevent the reaction of content and exudate, fabulous elimination the influence of plug exudate to product quality, thereby guarantee that effectively product visible foreign matters and particulate matter meet the injection requirement, avoided scrapping of product to greatest extent, do not have because of a large amount of rejecting lamp inspection workload and lamp inspection human costs that waste product increased yet, yield rate significantly improves in addition, production cost is reduced, and has good economic implications.The present invention has significantly improved the quality level of product, has avoided having better therapeutic and lower clinical side reaction because of visible foreign matters and the defective hidden danger of bringing for patient's data for clinical drug use of particulate matter.
The specific embodiment
Further specify the present invention below by embodiment.Should correct understanding be: embodiments of the invention are only used for the present invention is described and provide, rather than limitation of the present invention, so, under method prerequisite of the present invention, simple modifications of the present invention is all belonged to the scope of protection of present invention.
Be guarantee test result's concordance, the embodiment of the invention has been used identical raw material, adjuvant, cillin bottle and plug, and has adopted consistent vacuum freeze-drying technique to prepare the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of reference examples 1 preparation injection
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 8.46g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 12.5 with the sodium hydrate regulator solution pH value;
2) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation to sterilizing room, is sub-packed in the cillin bottle false add plug with 0.22 μ m filter aseptic filtration;
3) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of reference examples 2 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 21.15g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 11.8 with the sodium hydrate regulator solution pH value;
2) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation to sterilizing room, is sub-packed in the cillin bottle false add plug with 0.22 μ m filter aseptic filtration;
3) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of reference examples 3 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 42.3g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 10.9 with the sodium hydrate regulator solution pH value;
2) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation to sterilizing room, is sub-packed in the cillin bottle false add plug with 0.22 μ m filter aseptic filtration;
3) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of reference examples 4 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 8.46g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 12.4 with the sodium hydrate regulator solution pH value;
2) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation to sterilizing room, is sub-packed in the cillin bottle false add plug with 0.22 μ m filter aseptic filtration;
3) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of reference examples 5 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 8.46g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 12.5 with the sodium hydrate regulator solution pH value;
2) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation to sterilizing room, is sub-packed in the cillin bottle false add plug with 0.22 μ m filter aseptic filtration;
3) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of reference examples 6 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 16.92g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 12.1 with the sodium hydrate regulator solution pH value;
2) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation to sterilizing room, is sub-packed in the cillin bottle false add plug with 0.22 μ m filter aseptic filtration;
3) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of reference examples 7 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 8.46g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 11.4 with sodium hydroxide and sodium carbonate regulating solution pH value;
2) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation to sterilizing room, is sub-packed in the cillin bottle false add plug with 0.22 μ m filter aseptic filtration;
3) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 1 preparation injection
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 8.46g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 12.5 with the sodium hydrate regulator solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 6.0 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 47 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 2 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 21.15g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 11.8 with the sodium hydrate regulator solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 6.5 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 47 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 3 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 42.3g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 10.9 with the sodium hydrate regulator solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 7.0 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 41 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 4 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 8.46g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 12.4 with the sodium hydrate regulator solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 6.8 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 45 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 5 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 8.46g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 12.5 with the sodium hydrate regulator solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 6.4 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 42 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 6 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 16.92g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 12.1 with the sodium hydrate regulator solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 6.0 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 41 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 7 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 8.46g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 11.4 with sodium hydroxide and sodium carbonate regulating solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 7.0 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 45 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 8 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 12.69g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 10.5 with the sodium carbonate regulating solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 6.5 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 45 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 9 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 21.15g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 12.0 with the sodium hydrate regulator solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 6.6 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 43 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 10 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 21.15g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 10.6 with the manganese hydrogen sodium regulating solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 6.8 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 46 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 11 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 8.46g
Mannitol 500g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium, mannitol and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 10.5 with the sodium hydrate regulator solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 6.2 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 42 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 12 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 42.3g
Lactose 500g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium, lactose and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 10.8 with the sodium hydrate regulator solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 6.0 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 44 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 13 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 29.61g
Lactose 800g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium, lactose and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 10.5 with the sodium hydrate regulator solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 7.0 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 44 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 14 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 21.15g
Dextran 500g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium, dextran and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 12.4 with the sodium hydrate regulator solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 7.0 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 43 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 15 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 16.92g
Glucose 500g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium, glucose and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 11.5 with the sodium hydrate regulator solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 6.0 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 46 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 16 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 16.92g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 12.5 with sodium citrate regulator solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 6.5 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 47 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
The pantoprazole composition of sodium of embodiment 17 preparation injections
Prescription:
Pantoprazole Sodium 423g
Ethylenediaminetetraacetic acid 8.46g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 12.3 with the sodium hydrate regulator solution pH value;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 6.5 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 41 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
Foreign body and particulate matter contrast in embodiment 18 reference examples 1～7 and embodiment 1～17 compositions
Each prepares the pantoprazole composition of sodium of injection respectively by reference examples 1～7 and embodiment 1～17, checks visible foreign matters, particulate matter, content and related substance more respectively, and it the results are shown in Table 1.
As can be seen from Table 1, technical scheme of the present invention (embodiment 1～17) is more secure than prior art (reference examples 1～7) visible foreign matters and particulate matter, and content and related substance do not have significant change.
Foreign body and particulate matter stabilizing effect contrast among embodiment 19 reference examples 1～7 and the embodiment 1～17
Each prepares the pantoprazole composition of sodium of injection respectively by reference examples 1～7 and embodiment 1～17, puts under the room temperature lucifuge condition and carries out study on the stability, checks visible foreign matters and particulate matter more respectively, and it the results are shown in Table 2, table 3.
Annotate: two regulations of Chinese Pharmacopoeia version in 2005, to injection, must not be more than the capacitive microgranule 10 μ m above 6000, must not be more than the 25 μ m above 600, because this index pharmacopeia regulation head and shoulders above in the reference examples study on the stability, so do not reexamine in the follow-up study on the stability, with "-" expression.
From table 2 and table 3 as can be seen, technical scheme of the present invention (embodiment 1～17) is better than prior art (reference examples 1～7) visible foreign matters and particulate matter stability, has clear superiority.
Claims (4)
1. the pantoprazole composition of sodium of an injection, it is characterized in that, contain Pantoprazole Sodium and disodiumedetate, wherein, the part by weight of Pantoprazole Sodium and disodiumedetate is 1:0.02～0.1, and said compositions is prepared from by the following method:
1) medicinal liquid preparation: take by weighing Pantoprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, the regulator solution pH value is 10.5～12.5;
2) plug is handled:
A, get disodiumedetate, the part by weight of pressing disodiumedetate and water for injection 1:1000 adds water for injection, regulates pH value to 6.0～7.0 with sodium hydroxide after the stirring and dissolving;
B, get plug, the part by weight of pressing plug and a solution 1:10 adds a solution, is heated to 41～47 ℃ and be incubated 30 minutes;
The plug that c, the b process of learning from else's experience are handled is used through the filtering water for injection rinsing of 0.22 μ m filter 15 minutes, puts 121 ℃ of oven dry in the rubber plug cleaning machine, and is standby;
3) aseptic filtration, packing: will go on foot poly-1) medicinal liquid of preparation, is sub-packed in the cillin bottle to sterilizing room with 0.22 μ m filter aseptic filtration, false add is through going on foot poly-2) plug of processing;
4) vacuum lyophilization promptly gets the pantoprazole composition of sodium of injection.
2. the pantoprazole composition of sodium of injection according to claim 1 is characterized in that, the part by weight of said Pantoprazole Sodium and disodiumedetate is 1:0.02～0.05.
3. the pantoprazole composition of sodium of injection according to claim 1 is characterized in that, the material of said adjusting pH value is sodium hydroxide, sodium carbonate, sodium bicarbonate or sodium citrate.
4. according to the pantoprazole composition of sodium of any one described injection in the claim 1 to 3, it is characterized in that, also comprise mannitol, lactose, dextran or glucose in the said composition material as excipient.
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| CN 201110119354 CN102225063B (en) | 2011-05-10 | 2011-05-10 | Pantoprazole sodium composition for injection |
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| CN102670524A (en) * | 2012-05-04 | 2012-09-19 | 南京正大天晴制药有限公司 | Pantoprazole sodium freeze-dried preparation for injection and preparation method thereof |
| CN103058999A (en) * | 2013-01-29 | 2013-04-24 | 黄明芳 | Novel pantoprazole sodium compound and pharmaceutical composition thereof |
| CN103202816A (en) * | 2013-05-09 | 2013-07-17 | 成都天台山制药有限公司 | Pantoprazole sodium freeze-dried powder injection |
| CN104188924A (en) * | 2014-09-01 | 2014-12-10 | 山东绿叶制药有限公司 | Pantoprazole sodium medicine composition for injection |
| CN106474076A (en) * | 2015-11-30 | 2017-03-08 | 湖南恒生制药股份有限公司 | The preparation method of Pantoprazole sodium for injection |
| CN106619541A (en) * | 2016-10-27 | 2017-05-10 | 南京师范大学 | Isavuconazonium sulfate freeze-dried powder injection and preparation method |
| CN107982221A (en) * | 2016-10-27 | 2018-05-04 | 江苏正大丰海制药有限公司 | Injection sulfuric acid Chinese mugwort Saperconazole freeze drying powder injection and preparation method |
| CN112274481A (en) * | 2020-10-27 | 2021-01-29 | 海南卫康制药(潜山)有限公司 | Pantoprazole sodium composition for injection and preparation method thereof |
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| CN106474076A (en) * | 2015-11-30 | 2017-03-08 | 湖南恒生制药股份有限公司 | The preparation method of Pantoprazole sodium for injection |
| CN106619541A (en) * | 2016-10-27 | 2017-05-10 | 南京师范大学 | Isavuconazonium sulfate freeze-dried powder injection and preparation method |
| CN107982221A (en) * | 2016-10-27 | 2018-05-04 | 江苏正大丰海制药有限公司 | Injection sulfuric acid Chinese mugwort Saperconazole freeze drying powder injection and preparation method |
| CN112274481A (en) * | 2020-10-27 | 2021-01-29 | 海南卫康制药(潜山)有限公司 | Pantoprazole sodium composition for injection and preparation method thereof |
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|---|---|
| CN102225063B (en) | 2012-10-10 |
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Address after: 211112 Jiangsu Province, Nanjing City, Jiangning Science Park Road No. 699 Patentee after: Jiangsu Aosaikang Pharmaceutical Co., Ltd. Address before: 211112 Jiangsu Province, Nanjing City, Jiangning Science Park Road No. 699 Patentee before: Jiangsu Aosaikang Pharmaceutical Co., Ltd. |