CN102151265B - Lansoprazole composition for injection - Google Patents
Lansoprazole composition for injection Download PDFInfo
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- CN102151265B CN102151265B CN201110119367A CN201110119367A CN102151265B CN 102151265 B CN102151265 B CN 102151265B CN 201110119367 A CN201110119367 A CN 201110119367A CN 201110119367 A CN201110119367 A CN 201110119367A CN 102151265 B CN102151265 B CN 102151265B
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- lansoprazole
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Abstract
The invention provides a lansoprazole composition for injection, containing lansoprazole and disodium ethylenediaminetetraacetate, wherein the weight ratio of the lansoprazole to the disodium ethylenediaminetetraacetate is 1:(0.02-0.1). The composition is prepared by the following steps: (1) medical liquid preparation: putting the lansoprazole and the disodium ethylenediaminetetraacetate into a preparation tank, adding water for injection, stirring to mix uniformly, adding sodium hydroxide to dissolve the lansoprazole and the disodium ethylenediaminetetraacetate, and adjusting the pH value to11.5-12.0; (2) rubber plug processing; (3) aseptic filtration and subpackage; and (4) vacuum freezing and drying. For lansoprazole medicaments which are very easy to react with effusion from the rubber plug, the lansoprazole composition for injection, provided by the invention, can simultaneously and effectively ensure that visible foreign matters and insoluble particles of products conform to the requirement of an injection. The invention remarkably improves the quality of products, avoids hidden dangers brought to the clinical medication safety of patients due to the unqualified visible foreign matters and insoluble particles, and achieves a better curative effect and a lower clinical adverse reaction rate.
Description
Technical field
The present invention relates to a kind of Lansoprazole composition of injection, belong to medical preparing technical field.
Background technology
Lansoprazole is that lansoprazole belongs to proton pump inhibitor.After this medicine is distributed in the sour environment of gastric mucosa parietal cell, change activated metabolite into.This metabolite and the H that is present in acid generation position
+, K
+The sulfydryl combination of-ATP enzyme is by suppressing H
+, K
+The activity of-ATP enzyme and suppress acid secretion.
Lansoprazole gastric acid inhibitory secretory action is dose dependent, in 24 hours basis and the gastric acid secretion that stimulation causes is all had inhibitory action behind the medicine.1 30mg of health adult, 2 times on the one intravenously administrables, the visible gastric acid secretion inhibitory action that continues.
Be reported under the acid condition, blood coagulation and platelet aggregation are subjected to very big infringement.The formed fibrin of blood coagulation can be dissolved by pepsin under acid condition.This medicine improves blood coagulation and platelet aggregation by the rising stomach inner pH value, suppresses pepsic activity and brings into play the effect that suppresses hemorrhage.In addition, under acid condition, the damage mucosa reparation of stomach is suppressed, and this medicine rises stomach inner pH value by suppressing the acid secretion, promotes the reparation of damage mucosa.
Lansoprazole 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 lansoprazole 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 lansoprazole itself just very easily with plug in exudate react, higher pH has just been aggravated this process, simultaneously, because the lyophilized formulations of lansoprazole 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 lansoprazole, 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 200710201149.6 discloses a kind of treatment digestive ulcer medicament compositions, does not solve above-mentioned technological deficiency.Chinese patent CN 200810001185.2 discloses a kind of Lansoprazole freeze-dried powder for injection and preparation method thereof, does not solve above-mentioned technological deficiency.Chinese patent CN 200410036486.0 discloses a kind of blue drag-line azoles and can not solve above-mentioned technological deficiency for freeze-dried composition of injecting and preparation method thereof.Chinese patent CN 200410065853.X discloses a kind of injection preparation of sodium lansoprazole and preparation method thereof, does not solve above-mentioned technological deficiency.It is simple that Chinese patent CN 200610045935.7 discloses a kind of production technology, easy operating, and freeze dried Lansoprazole sodium powder pin that product quality is easy to control and preparation method thereof does not solve above-mentioned technological deficiency.Chinese patent CN 200510200782.4 discloses a kind of treatment digestive ulcer medicament compositions, does not solve above-mentioned technological deficiency.Chinese patent CN 200510040368.1 discloses a kind of Lansoprazole freeze-dried injection and preparation method thereof, does not solve above-mentioned technological deficiency.Chinese patent CN 200610025754.8 discloses a kind of Lansoprazole for injecting preparation, does not solve above-mentioned technological deficiency.Chinese patent CN 200710147351.5 discloses freeze-dried powder of a kind of lansoprazole and preparation method thereof, does not solve above-mentioned technological deficiency.Chinese patent CN 200810122761.9 discloses a kind of Lansoprazole freeze-dried injection and preparation method thereof, does not solve above-mentioned technological deficiency.Chinese patent CN 200710122134.0 discloses a kind of Lansoprazole medicine composition, its contain be no less than 10% weight alkaline matter as stabilizing agent, be used for the treatment of peptic ulcer, do not solve above-mentioned technological deficiency.Chinese patent CN 200910064447.4 discloses a kind of preparation method of lansoprazole freeze-dried injection for injection, does not solve above-mentioned technological deficiency.Chinese patent CN 201010221999.4 discloses freeze-dried powder of a kind of lansoprazole and preparation method thereof, does not solve above-mentioned technological deficiency.Chinese patent CN 201010125552.7 discloses a kind of Lansoprazole medicine composition, does not solve above-mentioned technological deficiency.Chinese patent CN 201010152664.1 discloses a kind of Lansoprazole for injecting preparation and preparation method thereof, does not solve above-mentioned technological deficiency.Chinese patent CN 201010198253.6 discloses a kind of Lansoprazole composition freeze-dried powder for injection, 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, does not solve above-mentioned technological deficiency.
Therefore, to this class preparating liquid of lansoprazole 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 Lansoprazole composition of injection requirement.
The Lansoprazole composition of injection of the present invention contains lansoprazole and disodiumedetate, and wherein, the part by weight of lansoprazole 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 lansoprazole and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 11.5～12.0 that the adding sodium hydroxide makes dissolving and 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 Lansoprazole composition of injection.
Preferably,
In the Lansoprazole composition of described injection, the part by weight of said lansoprazole and disodiumedetate is 1:0.02～0.05.
In the Lansoprazole composition 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 lansoprazole 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.
Lansoprazole composition of injection of the present invention and preparation method thereof, to this class preparating liquid of lansoprazole 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 Lansoprazole composition of injection.
The Lansoprazole composition of reference examples 1 preparation injection
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 6g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 11.5 that the adding sodium hydroxide makes dissolving and 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 Lansoprazole composition of injection.
The Lansoprazole composition of reference examples 2 preparation injections
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 9g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 11.7 that the adding sodium hydroxide makes dissolving and 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 Lansoprazole composition of injection.
The Lansoprazole composition of reference examples 3 preparation injections
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 12g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 11.9 that the adding sodium hydroxide makes dissolving and 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 Lansoprazole composition of injection.
The Lansoprazole composition of reference examples 4 preparation injections
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 15g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 12.0 that the adding sodium hydroxide makes dissolving and 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 Lansoprazole composition of injection.
The Lansoprazole composition of reference examples 5 preparation injections
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 30g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 11.6 that the adding sodium hydroxide makes dissolving and 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 Lansoprazole composition of injection.
The Lansoprazole composition of embodiment 1 preparation injection
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 6g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 11.5 that the adding sodium hydroxide makes dissolving and 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 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 Lansoprazole composition of injection.
The Lansoprazole composition of embodiment 2 preparation injections
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 9g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 11.7 that the adding sodium hydroxide makes dissolving and 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 Lansoprazole composition of injection.
The Lansoprazole composition of embodiment 3 preparation injections
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 12g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 11.9 that the adding sodium hydroxide makes dissolving and 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 Lansoprazole composition of injection.
The Lansoprazole composition of embodiment 4 preparation injections
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 15g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 12.0 that the adding sodium hydroxide makes dissolving and 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 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 Lansoprazole composition of injection.
The Lansoprazole composition of embodiment 5 preparation injections
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 30g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 11.6 that the adding sodium hydroxide makes dissolving and 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 6.3 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 Lansoprazole composition of injection.
The Lansoprazole composition of embodiment 6 preparation injections
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 15g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 11.8 that the adding sodium hydroxide makes dissolving and 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 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 Lansoprazole composition of injection.
The Lansoprazole composition of embodiment 7 preparation injections
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 15g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 11.5 that the adding sodium hydroxide makes dissolving and 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 6.9 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 Lansoprazole composition of injection.
The Lansoprazole composition of embodiment 8 preparation injections
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 6g
Mannitol 300g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole, mannitol and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 12.0 that the adding sodium hydroxide makes dissolving and 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 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 Lansoprazole composition of injection.
The Lansoprazole composition of embodiment 9 preparation injections
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 6g
Lactose 500g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole, lactose and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 11.7 that the adding sodium hydroxide makes dissolving and 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 Lansoprazole composition of injection.
The Lansoprazole composition of embodiment 10 preparation injections
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 9g
Glucose 300g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole, glucose and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 11.8 that the adding sodium hydroxide makes dissolving and 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 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 Lansoprazole composition of injection.
The Lansoprazole composition of embodiment 11 preparation injections
Prescription:
Lansoprazole 300g
Ethylenediaminetetraacetic acid 30g
Dextran 200g
Water for injection adds to 20Kg
1) medicinal liquid preparation: take by weighing lansoprazole and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 11.9 that the adding sodium hydroxide makes dissolving and 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 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 Lansoprazole composition of injection.
Foreign body and particulate matter contrast in embodiment 12 reference examples 1～5 and embodiment 1～11 compositions
Each prepares the Lansoprazole composition of injection respectively by reference examples 1～5 and embodiment 1～11, 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 1～11) 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 13 reference examples 1～5 and the embodiment 1～11
Each prepares the Lansoprazole composition of injection respectively by reference examples 1～1 and embodiment 1～11, 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 1～11) is better than prior art (reference examples 1～5) visible foreign matters and particulate matter stability, has clear superiority.
Claims (3)
1. the Lansoprazole composition of an injection, it is characterized in that, contain lansoprazole and disodiumedetate, wherein, the part by weight of lansoprazole 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 lansoprazole and disodiumedetate and put in the preparing tank, add water for injection, stir and make mix homogeneously, it is 11.5～12.0 that the adding sodium hydroxide makes dissolving and 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 Lansoprazole composition of injection.
2. the Lansoprazole composition of injection according to claim 1 is characterized in that, the part by weight of said lansoprazole and disodiumedetate is 1:0.02～0.05.
3. the Lansoprazole composition of injection according to claim 1 and 2 is characterized in that, also comprises mannitol, lactose, dextran or glucose as excipient in the said composition material.
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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. |