CN102151264B - Omeprazole sodium composition for injection - Google Patents
Omeprazole sodium composition for injection Download PDFInfo
- Publication number
- CN102151264B CN102151264B CN201110119352A CN201110119352A CN102151264B CN 102151264 B CN102151264 B CN 102151264B CN 201110119352 A CN201110119352 A CN 201110119352A CN 201110119352 A CN201110119352 A CN 201110119352A CN 102151264 B CN102151264 B CN 102151264B
- Authority
- CN
- China
- Prior art keywords
- injection
- sodium
- omeprazole
- plug
- omeprazole sodium
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Abstract
The invention provides an omeprazole sodium composition for injection. The omeprazole sodium composition for injection contains omeprazole sodium and ethylene diamine tetraacetic acid; and the weight ratio of the omeprazole sodium to the ethylene diamine tetraacetic acid is 1: (0.02-0.1). The composition is prepared by the following method: 1) preparing a liquid medicine: placing the omeprazole sodium and the ethylene diamine tetraacetic acid into a mixing pot, adding water for injection, stirring to dissolve the omeprazole sodium and the ethylene diamine tetraacetic acid and mixing uniformly, and adjusting the pH value to 11.0 to 12.0 by using sodium hydroxide; 2) processing by a rubber stopper; 3) performing aseptic filtering and packing; and 4) freezing and drying in vacuum so as to obtain the omeprazole sodium composition for injection. For medicaments, such as the omeprazole sodium which is easily reacted with an effusion from a capsule, the omeprazole sodium composition for injection can effectively guarantee that visible foreign matters and insoluble particles of the product meet the requirement of injection at the same time. By the omeprazole sodium composition for injection, the quality level is enhanced obviously, and potential hazards in clinical safe medication use of patients due to unqualified visible foreign matters and insoluble particles can be avoided; and the omeprazole sodium composition for injection has better curative effect and lower clinical side reaction.
Description
Technical field
The present invention relates to a kind of omeprazole composition of sodium of injection, belong to medical preparing technical field.
Background technology
Omeprazole Sodium (Omeprazole Sodium) chemistry 5-methoxyl group-2-([(4-methoxyl group-4,5-dimethyl-2-arsenic pyridine base)-methyl]-sulfinyl) by name-lH-benzimidazole sodium-hydrate, structural formula is
Omeprazole Sodium is H
+, K
+---atpase inhibitor has obvious inhibitory action to gastric acid secretion.After the intravenous drip, this product onset is rapid, is administered once and can secretes by the reversibility gastric acid inhibitory in one day.The clinical duodenal ulcer that is mainly used in, gastric ulcer, acutes hemorrhage of upper gastrointestinal tract such as AGML plyability ulcer.
Omeprazole Sodium is unstable under sour environment, in process for preparation, has all adopted higher pH (usually more than 10.5), to improve the physics and the chemical stability of Omeprazole 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 Omeprazole Sodium itself just very easily with plug in exudate react, higher pH has just been aggravated this process, simultaneously, because the lyophilized formulations of Omeprazole 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 Omeprazole 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 CN 00816583.1 discloses the oral formulations that a kind of novel pharmaceutical compositions, especially every day are administered once, and the novel solid that wherein mixes described novel pharmaceutical compositions dosage unit is provided.Described solid dosage unit becomes to discharge medicine mutually, so that targeted produces drug effect or prolong drug effect.Described compositions is particularly suitable for heterogeneous transmission proton pump inhibitor, and for example lansoprazole, pantoprazole, omeprazole, perprazole etc. do not solve above-mentioned technological deficiency.Chinese patent CN 96197132.0 discloses a kind of composition and method of making the same that contains omeprazole, and said composition is particularly suited for oral.Said composition does not contain the alkaline reaction chemical compound, and comprises an inner core of being made up of kernel and described benzimidazole, and wherein kernel and benzimidazole are pressed together, and an intermediate layer and an enteric layer, does not solve above-mentioned technological deficiency.Chinese patent CN 99811908.3 discloses a kind of synthetic, separation of antiulcer reagent omeprazole and improving one's methods of purification, does not solve above-mentioned technological deficiency.Chinese patent CN 200810001181.4 discloses a kind of omeprazole freeze-dried powder injection, does not solve above-mentioned technological deficiency.Chinese patent CN 200610042004.1 discloses a kind of stable new recipe and preparation technology thereof of injection omeprazole sodium lyophilized formulations, does not solve above-mentioned technological deficiency.Chinese patent CN 200710072855.5 discloses a kind of composite preparation that contains omeprazole, does not solve above-mentioned technological deficiency.Chinese patent CN 200710141577.4 discloses the compositions of a kind of omeprazole and sodium bicarbonate, the capsule that the sodium bicarbonate that the some enteric-coated pellets be made up of omeprazole, sodium bicarbonate and arbitrary form exist is formed does not solve above-mentioned technological deficiency.Chinese patent CN 200810062160.3 discloses a kind of omeprazole freeze-dried powder injection, does not solve above-mentioned technological deficiency.Chinese patent CN discloses a kind of injection omeprazole sodium lyophilized formulations, does not solve above-mentioned technological deficiency.Chinese patent CN 200910019998.9 discloses freeze-dried lipidosome preparation of a kind of Omeprazole Sodium and preparation method thereof, does not solve above-mentioned technological deficiency.Chinese patent CN 200910244378.5 discloses a kind of omeprazole freeze-dried powder injection and preparation method and method of quality control, does not solve above-mentioned technological deficiency.Chinese patent CN 201010123742.5 discloses lyophilized injectable powder of a kind of Omeprazole Sodium and preparation method thereof, does not solve above-mentioned technological deficiency.Chinese patent CN 201010045826.1 discloses a kind of composite medicament of omeprazole sodium and preparation method thereof, does not solve above-mentioned technological deficiency.Chinese patent CN 201010000490.7 discloses a kind of composite medicament of omeprazole sodium and preparation method thereof, does not solve above-mentioned technological deficiency.Chinese patent CN 200910226008.9 discloses a kind of omeprazole sodium freeze-dried powder pin and preparation method thereof, does not solve above-mentioned technological deficiency.Chinese patent CN 200910115570.4 discloses a kind of omeprazole sodium medicinal composition for injection and preparation method thereof, does not solve above-mentioned technological deficiency.Chinese patent CN 201010278647.2 discloses a kind of composite medicament of omeprazole sodium and preparation method thereof, does not solve above-mentioned technological deficiency.Chinese patent CN 200980110944.1 discloses a kind of pharmaceutical composition that comprises omeprazole, lansoprazole and sodium bicarbonate, also provides to use described method for compositions, does not solve above-mentioned technological deficiency.Chinese patent CN 200910056113.2 discloses a kind of omeprazol sodium preparation for injection and preparation method thereof, does not solve above-mentioned technological deficiency.
Therefore, to this class preparating liquid of Omeprazole 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 omeprazole composition of sodium of injection requirement.
The omeprazole composition of sodium of injection of the present invention contains Omeprazole Sodium and disodiumedetate, and wherein, the part by weight of Omeprazole Sodium and disodiumedetate is 1:0.02～0.1, and said compositions is prepared from by the following method:
1) medicinal liquid preparation: taking by weighing Omeprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 11.0～12.0 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 6.0～7.0 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 omeprazole composition of sodium of injection.
Preferably,
In the omeprazole composition of sodium of described injection, the part by weight of said Omeprazole Sodium and disodiumedetate is 1:0.02～0.05.
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 Omeprazole 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 omeprazole composition of sodium of injection of the present invention, to this class preparating liquid of Omeprazole 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 omeprazole composition of sodium of injection.
The omeprazole composition of sodium of reference examples 1 preparation injection
Prescription:
Omeprazole Sodium 426g
Ethylenediaminetetraacetic acid 8.52g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Omeprazole 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) 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 omeprazole composition of sodium of injection.
The omeprazole composition of sodium of reference examples 2 preparation injections
Prescription:
Omeprazole Sodium 426g
Ethylenediaminetetraacetic acid 21.3g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Omeprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 11.0 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 omeprazole composition of sodium of injection.
The omeprazole composition of sodium of reference examples 3 preparation injections
Prescription:
Omeprazole Sodium 426g
Ethylenediaminetetraacetic acid 42.6g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Omeprazole Sodium 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) 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 omeprazole composition of sodium of injection.
The omeprazole composition of sodium of reference examples 4 preparation injections
Prescription:
Omeprazole Sodium 426g
Ethylenediaminetetraacetic acid 8.52g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Omeprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 11.3 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 omeprazole composition of sodium of injection.
The omeprazole composition of sodium of reference examples 5 preparation injections
Prescription:
Omeprazole Sodium 426g
Ethylenediaminetetraacetic acid 21.3g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Omeprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 11.7 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 omeprazole composition of sodium of injection.
The omeprazole composition of sodium of embodiment 1 preparation injection
Prescription:
Omeprazole Sodium 426g
Ethylenediaminetetraacetic acid 8.52g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Omeprazole 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 6.5 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 omeprazole composition of sodium of injection.
The omeprazole composition of sodium of embodiment 2 preparation injections
Prescription:
Omeprazole Sodium 426g
Ethylenediaminetetraacetic acid 21.3g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Omeprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 11.0 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 6.0 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 omeprazole composition of sodium of injection.
The omeprazole composition of sodium of embodiment 3 preparation injections
Prescription:
Omeprazole Sodium 426g
Ethylenediaminetetraacetic acid 42.6g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Omeprazole Sodium 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 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 omeprazole composition of sodium of injection.
The omeprazole composition of sodium of embodiment 4 preparation injections
Prescription:
Omeprazole Sodium 426g
Ethylenediaminetetraacetic acid 8.52g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Omeprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 11.3 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 6.8 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 omeprazole composition of sodium of injection.
The omeprazole composition of sodium of embodiment 5 preparation injections
Prescription:
Omeprazole Sodium 426g
Ethylenediaminetetraacetic acid 21.3g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Omeprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 11.7 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 omeprazole composition of sodium of injection.
The omeprazole composition of sodium of embodiment 6 preparation injections
Prescription:
Omeprazole Sodium 426g
Ethylenediaminetetraacetic acid 21.3g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Omeprazole 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 6.1 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 omeprazole composition of sodium of injection.
The omeprazole composition of sodium of embodiment 7 preparation injections
Prescription:
Omeprazole Sodium 426g
Ethylenediaminetetraacetic acid 12.78g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Omeprazole 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 omeprazole composition of sodium of injection.
The omeprazole composition of sodium of embodiment 8 preparation injections
Prescription:
Omeprazole Sodium 426g
Ethylenediaminetetraacetic acid 17.04g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Omeprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 11.2 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 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 omeprazole composition of sodium of injection.
The omeprazole composition of sodium of embodiment 9 preparation injections
Prescription:
Omeprazole Sodium 426g
Ethylenediaminetetraacetic acid 8.52g
Water for injection adds to 20Kg
1) medicinal liquid preparation: taking by weighing Omeprazole Sodium 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 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 omeprazole composition of sodium of injection.
Foreign body and particulate matter contrast in embodiment 10 reference examples 1～5 and embodiment 1～9 compositions
Each prepares the omeprazole composition of sodium of injection respectively by reference examples 1～5 and embodiment 1～9, 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 1～9) is more secure than prior art (reference examples 1～5) 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 11 reference examples 1～5 and the embodiment 1～9
Each prepares the omeprazole composition of sodium of injection respectively by reference examples 1～5 and embodiment 1～9, 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 1～9) is better than prior art (reference examples 1～5) visible foreign matters and particulate matter stability, has clear superiority.
Claims (2)
1. the omeprazole composition of sodium of an injection, it is characterized in that, contain Omeprazole Sodium and disodiumedetate, wherein, the part by weight of Omeprazole Sodium and disodiumedetate is 1:0.02～0.1, and said compositions is prepared from by the following method:
1) medicinal liquid preparation: taking by weighing Omeprazole Sodium and disodiumedetate and put in the preparing tank, add water for injection, stir and make dissolving and mix homogeneously, is 11.0～12.0 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 6.0～7.0 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 omeprazole composition of sodium of injection.
2. the omeprazole composition of sodium of injection according to claim 1 is characterized in that, the part by weight of said Omeprazole Sodium and disodiumedetate is 1:0.02～0.05.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110119352A CN102151264B (en) | 2011-05-10 | 2011-05-10 | Omeprazole sodium composition for injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110119352A CN102151264B (en) | 2011-05-10 | 2011-05-10 | Omeprazole sodium composition for injection |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102151264A CN102151264A (en) | 2011-08-17 |
| CN102151264B true CN102151264B (en) | 2011-12-28 |
Family
ID=44433156
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201110119352A Active CN102151264B (en) | 2011-05-10 | 2011-05-10 | Omeprazole sodium composition for injection |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102151264B (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102512380B (en) * | 2011-12-20 | 2013-04-17 | 海南锦瑞制药股份有限公司 | Freeze-dried powder injection with omeprazole sodium as active component and preparation method thereof |
| CN104840433A (en) * | 2014-12-23 | 2015-08-19 | 贵州景峰注射剂有限公司 | Freeze drying method of omeprazole sodium for injection and omeprazole sodium for injection |
| CN110946860A (en) * | 2019-12-30 | 2020-04-03 | 丽珠集团丽珠制药厂 | Composition containing omeprazole sodium and preparation method thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101987099A (en) * | 2009-08-07 | 2011-03-23 | 上海秀新臣邦医药科技有限公司 | Omeprazole sodium for injection and preparation method thereof |
-
2011
- 2011-05-10 CN CN201110119352A patent/CN102151264B/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| CN102151264A (en) | 2011-08-17 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN102225063B (en) | Pantoprazole sodium composition for injection | |
| CN102552159B (en) | Rabeprazole sodium enteric-coated micro-pellet and preparation method thereof | |
| WO2018086498A1 (en) | Pharmaceutical composition and application thereof | |
| CN105030725B (en) | Vonoprazan fumarate enteric-coated composition and preparation method thereof | |
| CN102151264B (en) | Omeprazole sodium composition for injection | |
| JP2007522086A (en) | Solid composition containing a proton pump inhibitor | |
| CN113679680B (en) | Lansoprazole freeze-dried powder for injection and preparation method thereof | |
| CN103054863B (en) | Pharmaceutical composition of omeprazole sodium, and preparation method of pharmaceutical composition | |
| CN101804035B (en) | Lansoprazole preparation for injection and preparation method thereof | |
| CN102973524A (en) | Esomeprazole sodium lyophilized powder injection and preparation method thereof | |
| CN103301077A (en) | Esomeprazole sodium composition for injection and preparation method thereof | |
| CN102228459B (en) | Sodium rabeprazole composition used for injection | |
| CN101249078A (en) | Sodium rebeprazole freeze-dried injection | |
| CN108371657A (en) | A kind of preparation method of esomeprazole enteric capsules | |
| CN102631327B (en) | Enteric coated omeprazole pellet and preparation method thereof | |
| CN109925287A (en) | A kind of Pyrochep and preparation method thereof | |
| CN103768028A (en) | Esomeprazole sodium sterile lyophilized powder for injection and preparation process of lyophilized powder | |
| CN102151265B (en) | Lansoprazole composition for injection | |
| CN102600088A (en) | Injection lansoprazole medicine composition and preparation method thereof | |
| CN102641286A (en) | Compound omeprazole dry suspension and preparation method thereof | |
| CN103550170A (en) | Lafutidine composition freeze-dried powder injection for injection | |
| CN102670524A (en) | Pantoprazole sodium freeze-dried preparation for injection and preparation method thereof | |
| CN104739779A (en) | Lansoprazole injection and preparation technology thereof | |
| CN105726509A (en) | Pantozol medicine capsule | |
| CN104856993A (en) | Medical pantoprazole sodium freeze-dried powder injection composition for treating digestive system diseases |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CP01 | Change in the name or title of a patent holder |
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. |
|
| CP01 | Change in the name or title of a patent holder |