CN102406543A - Ceftazidime injection solution packaged by double-cavity bag and preparation method thereof - Google Patents
Ceftazidime injection solution packaged by double-cavity bag and preparation method thereof Download PDFInfo
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- CN102406543A CN102406543A CN201110386236XA CN201110386236A CN102406543A CN 102406543 A CN102406543 A CN 102406543A CN 201110386236X A CN201110386236X A CN 201110386236XA CN 201110386236 A CN201110386236 A CN 201110386236A CN 102406543 A CN102406543 A CN 102406543A
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Abstract
The invention discloses a ceftazidime injection solution packaged by a double-cavity bag. The medicinal composition of the injection solution comprises the following raw materials: 0.5-3 parts by weight of ceftazidime in a powder cavity, and 4-11 parts by weight of glucose injection solution with 100 parts by volume of glucose or 0.8-1 part by weight of sodium chloride injection solution with 100 parts by volume of sodium chloride in a solution cavity. The ceftazidime injection solution is packaged by the double-cavity bag; the sterilized ceftazidime powder and the solvent (sodium chloride injection solution or glucose injection solution) are filled in two cavities separated by pseudo soldering separations respectively; and when the ceftazidime injection solution is used, pseudo soldering isolating bars can be connected by extruding a medicine bag only, and the sterilized ceftazidime powder and the solvent are quickly solved and mixed under the sealed and sterilized condition to form a total medicine treatment mixed solution which can be directly applied to the patient.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, ceftazidime injection of particularly a kind of two-chamber bag packing and preparation method thereof.
Background technology
Ceftazidime chemistry (6R by name; 7R)-and 7-[[(2-amino-4-thiazolyl)-[(1-carboxyl-1-methyl ethoxy) imino group] acetyl group] amino]-2-carboxyl-8-oxo-5-thia-1-azabicyclo [4.2.0] oct-2-ene-3-picoline inner salt pentahydrate, be third generation cephalosporin class antibiotic.Has a broad antifungal spectrum, effective to most gram positive bacterias and negative bacterium.Enterobacteriaceae lactobacteriaceae such as escherichia coli, pneumobacillus and hemophilus influenza, Pseudomonas aeruginosa etc. there is the height antibacterial activity.Nitrate-negative bacillus, Bacillus alcaligenes etc. also there is good antibacterial action.Highly stable for bacteriogenic most of beta lactamases, so it still can have an antibacterial activity to multiple antibiotic resistant strain in above-mentioned most gram negative bacillis.GPC such as streptococcus pneumoniae, Hemolytic streptococcus is extremely sensitive to these article, but these article are only had a moderate activity to staphylococcus, and enterococcus and methicillin-resistant staphylococcus are then often to these article drug resistance.These article are to certain antibacterial activities of anaerobe tool such as dyspepsiacoccus and peptostreptococcuses, but poor to the bacteroides fragilis antibacterial action.These article are bactericide, mechanism of action be with bacterial cell membrane on penicillin-binding protein (PBPs) combine, make the transpeptidase acidylate; The intersection that influences the cell wall mucopeptide composition links; Suppress the synthetic of bacteria cell wall, cell division and growth are suppressed, dissolving at last and dead.Be used for septicemia, lower respiratory infection, abdominal cavity and biliary tract infection, complexity urinary tract infection and serious skin soft-tissue infection etc. due to the responsive gram negative bacilli.
The main at home and abroad dosage form of this product is at present: freeze-dried powder, aseptic subpackaged powder pin, small-volume injection etc.; Above-mentioned preparation in being infused to the patient body before; Must use appropriate solvent (sodium chloride injection as 0.9% or 5% glucose injection) that its dissolving or dilution are become the solution that concentration is lower than 2mg/ml; Just can carry out intravenous drip, and the process of dissolving and dilution is consuming time relatively, under specific conditions such as war or emergency aid and treatment; Often because the process of making up a prescription is loaded down with trivial details, intravenously administrable fast; The on-the-spot area of rescue equipment is narrow, advances and jolts, and is difficult for carrying out malpraxis or accidents such as the dispensing operation or the mistake of making up a prescription; Give first aid to on-the-spot air and particle contamination, be prone to cause secondary pollution; Medicine is a glass bottle packaging, is prone to broken and can't drops; There is the existence of problems such as medicine and carrier transfusion quantity, effect phase coupling in the war storage, causes the environment at the scene of giving treatment to and time all not to reach conventional transfusion preparation necessary requirement.
The freeze-dried powder of market sale, aseptic subpackaged powder pin all adopt the cillin bottle packing; Seal with butyl rubber plug; In the medicine storage and transport process, when medicated powder with after plug contacts, the additive composition possibly separated out or with medicine part physics or chemical reaction taken place in the plug; It is defective to cause clarity of solution to investigate the result, influences the safety that product uses.
Summary of the invention
The object of the invention has been to provide a kind of ceftazidime injection that adopts two-chamber bag packing and preparation method thereof.
The present invention seeks to realize through following technical scheme:
The crude drug of injection pharmaceutical composition of the present invention consists of:
Powder chamber: ceftazidime 0.5～3 weight portion
Sap cavity: glucose injection: 100 parts by volume contain glucose 4～11 weight portions or sodium chloride injection: 100 parts by volume sodium chloride-containing, 0.8～1 weight portion
Above-mentioned raw materials medicine preferred weight proportioning is following:
Powder chamber: ceftazidime 0.5 weight portion
Sap cavity: glucose injection: 100 parts by volume contain glucose 5 weight portions
Above-mentioned raw materials medicine preferred weight proportioning is following:
Powder chamber: ceftazidime 2 weight portions
Sap cavity: glucose injection: 250 parts by volume contain glucose 12.5 weight portions
Above-mentioned raw materials medicine preferred weight proportioning is following:
Powder chamber: ceftazidime 3 weight portions
Sap cavity: sodium chloride injection: 100 parts by volume sodium chloride-containing, 0.9 weight portion
Above-mentioned raw materials medicine preferred weight proportioning is following:
Powder chamber: ceftazidime 1 weight portion
Sap cavity: sodium chloride injection: 250 parts by volume sodium chloride-containing, 2.25 weight portions
The concrete production technology of the present invention is following:
Bag forming: use the film for transfusion of double-layer seal to process bag, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers of exerting pressure and can open with weak welding rod in the middle of the bag.
The medicinal liquid preparation
The preparation of glucose injection: take by weighing glucose by formula ratio and add an amount of water for injection to process concentration be 4%～11% solution.
The preparation of sodium chloride injection: take by weighing sodium chloride by formula ratio and add an amount of water for injection to process concentration be 0.8%～1% solution.
Liquid medicine filling, seal: the medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and seal.
Sterilization: packaged sample is placed sterilizing installation, in 115 ℃～125 ℃ sterilizations 8～30 minutes.
Dry: the sample after will sterilizing descended dry 60-150 minute in 70-100 ℃.
The fill of aseptic powder: sample is fixed on the powder dispensing apparatus, under gnotobasis, cuts real welding rod on one side, the ceftazidime aseptic powder is quantitatively poured into the powder chamber after, firm slit edge edge is carried out real sealing mouth.
The welding of aluminium foil outside the powder chamber: aluminum film and powder chamber are welded all around, thereby form a kind of special protection structure, make it can block oxygen, water vapour and illumination in outside, powder chamber.
Ceftazidime injection of the present invention adopts two-chamber bag packing; Through ceftazidime aseptic powder and solvent (sodium chloride injection or glucose injection) being distinguished fill in cutting off with rosin joint in two chambers that separate; Only need push medicated bag during use; Can open the rosin joint isolating bar, make ceftazidime aseptic powder and solvent under airtight aseptic condition, accomplish rapidly dissolving mixed process, form full Drug therapy mixed liquor and directly be used for the patient.
The present invention can avoid with ceftazidime process directly that the related substance that very easily occurs behind the bulk capacity injection increases and active constituent content under the degradation problem and also since the ceftazidime medicated powder in the powder chamber only contact with the film material; The packaging material composition is compared simple relatively with the used cillin bottle plug of conventional powder; Avoided in the packaging material complicated additive composition to separate out or react with medicated powder; Prolonged keeping life greatly; Significantly strengthen the environmental suitability of medicine, kept bulk capacity injection to need not the less relatively advantage of dissolved dilution, secondary pollution, can effectively improve the actual effect and the safety of ceftazidime intravenously administrable under emergency rating.
Description of drawings
Accompanying drawing 1: two-chamber bag plane graph;
Indicate among the figure: 1-powder chamber, the weak welding rod of 2-, 3-sap cavity, 4-composite cover
Accompanying drawing 2: process chart.
Experimental example 1
Adopt the sample of embodiment 1 preparation to be respectively charged in glass infusion bottle and the two-chamber bag; The laggard line stabilization property investigation of sterilizing; Can find; Sample is after the sterilization, after 40 ℃ of accelerated tests investigate and June, 25 ℃ of long term tests investigate December, and each item index of the sample of two-chamber bag packing has no significant change, and stability obviously is superior to glass infusion bottle packing sample.(as shown in table 1)
Table 1 product stability is investigated comparing result
Experimental example 2
(XiLin is bottled to get 10 ceftazidime powder pins respectively; Specification: 3g) with 10 bottles of glucose injections (glass transfusion bottle, specification: 100ml:0.5g), according to the clinical manipulation method of routine; Change the ceftazidime aseptic powder over to glucose injection, and it is dissolved fully; Other gets 10 bags of two-chamber bag samples that adopt embodiment 1 preparation, opens weak welding rod, and jolting is dissolved the ceftazidime aseptic powder fully, and operating process is compared investigation.(as shown in table 2, test data is the meansigma methods of 10 tests.)
Table 2
Can know by comparing result; Adopt the ceftazidime preparation of existing ordinary packing, operation relative complex, environmental requirement higher (the general requirement of large hospital operated at the clean operating board that the laminar flow protection is arranged at present); And be easy to generate particulate matter, cause potential hazards such as thrombosis and granuloma; And the ceftazidime injection that adopts two chambers bag to pack is more convenient to operate, quick, because medicinal liquid is enclosed among the bag all the time, environmental requirement is low, is convenient to special occasions and implements first aid; Owing to need not solution transfer, the particulate matter of generation is far below the product that adopts ordinary packing, and is littler to patient's potential hazard, uses safer simultaneously.
Experimental example 3
(XiLin is bottled to get the ceftazidime powder pin of two producers respectively; Specification: 3g) each 50 and 50 bags in two-chamber bag sample adopting embodiment 1 preparation, place simultaneously under 40 ℃ of accelerated test conditions and investigate June, all samples all adopts the mode of putting upside down; Take out respectively acceleration 0,1,2,3, June by 10 (bags); The ceftazidime aseptic powder is mixed with the solubility of 0.1g/ml with purified water, observes the clarity of solution, result such as table 3:
Table 3
Investigation data by last table can be known, adopt two chambers bag packaged products, and the clarity of ceftazidime aseptic powder is investigated the cillin bottle packaging product that the result obviously is superior to present list marketing, therefore adopt two chamber bag packaged products safeties higher.
Analyzing its reason, possibly be because the plug composition is more complicated than film for transfusion, with process that medicated powder for a long time contacts in, in the plug additive composition possibly separate out or with medicine part generation physics or chemical reaction, cause clarity of solution investigation result defective.
Powder chamber: ceftazidime 3g
Sap cavity: glucose injection: 100 parts by volume: 5g
Use the film for transfusion of double-layer seal, process bag through the multicell bag making, filling and sealing machine, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers (can exert pressure and open) with weak welding rod in the middle of the bag.Taking by weighing glucose 5g adds the injection water and is settled to 100 parts by volume to process concentration be 5% solution.The medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and the suitable accessory of welding composite cover or other seals.Packaged sample is placed steam autoclave, in 121 ℃ of sterilizations 12 minutes.Sample after the sterilization is following dry 80 minutes in 80 ℃.Sample is fixed on the full-automatic powder racking machine, under gnotobasis, cuts real welding rod on one side, the ceftazidime aseptic powder is poured into the powder chamber after, firm slit edge edge is carried out real sealing mouth.Adopt full-automatic laminating machine that aluminum film and powder chamber are welded all around, thereby form a kind of special protection structure, make it can block certain oxygen, water vapour and illumination, avoid powder intracavity drug powder is impacted in outside, powder chamber.
Powder chamber: ceftazidime 0.5g
Sap cavity: glucose injection: 250 parts by volume: 12.5g
Use the film for transfusion of double-layer seal, process bag through the multicell bag making, filling and sealing machine, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers (can exert pressure and open) with weak welding rod in the middle of the bag.Taking by weighing glucose 12.5g adds 250 parts by volume waters for injection to process concentration is 5% solution.The medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and the suitable accessory of welding composite cover or other seals.Packaged sample is placed steam autoclave, in 115 ℃～125 ℃ sterilizations 8～30 minutes.Sample after the sterilization was descended dry 60-150 minute in 70-100 ℃.Sample is fixed on the full-automatic powder racking machine, under gnotobasis, cuts real welding rod on one side, the ceftazidime aseptic powder is poured into the powder chamber after, firm slit edge edge is carried out real sealing mouth.Adopt full-automatic laminating machine that aluminum film and powder chamber are welded all around, thereby form a kind of special protection structure, make it can block certain oxygen, water vapour and illumination, avoid powder intracavity drug powder is impacted in outside, powder chamber.
Powder chamber: ceftazidime 1g
Sap cavity: sodium chloride injection: 100 parts by volume: 0.9g
Use the film for transfusion of double-layer seal, process bag through the multicell bag making, filling and sealing machine, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers (can exert pressure and open) with weak welding rod in the middle of the bag.Taking by weighing sodium chloride 0.9g by formula ratio adds 100 parts by volume waters for injection to process concentration is 0.9% solution.The medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and the suitable accessory of welding composite cover or other seals.Packaged sample is placed steam autoclave, in 115 ℃～125 ℃ sterilizations 8～30 minutes.Sample after the sterilization was descended dry 60-150 minute in 70-100 ℃.Sample is fixed on the full-automatic powder racking machine, under gnotobasis, cuts real welding rod on one side, the ceftazidime aseptic powder is poured into the powder chamber after, firm slit edge edge is carried out real sealing mouth.Adopt full-automatic laminating machine that aluminum film and powder chamber are welded all around, thereby form a kind of special protection structure, make it can block certain oxygen, water vapour and illumination, avoid powder intracavity drug powder is impacted in outside, powder chamber.
Embodiment 4
Powder chamber: ceftazidime 2g
Sap cavity: sodium chloride injection: 250 parts by volume: 2.25g
Use the film for transfusion of double-layer seal, process bag through the multicell bag making, filling and sealing machine, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers (can exert pressure and open) with weak welding rod in the middle of the bag.Taking by weighing sodium chloride 2.25g adds 250 parts by volume waters for injection to process concentration is 0.9% solution.The medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and the suitable accessory of welding composite cover or other seals.Packaged sample is placed steam autoclave, in 115 ℃～125 ℃ sterilizations 8～30 minutes.Sample after the sterilization was descended dry 60-150 minute in 70-100 ℃.Sample is fixed on the full-automatic powder racking machine, under gnotobasis, cuts real welding rod on one side, the ceftazidime aseptic powder is poured into the powder chamber after, firm slit edge edge is carried out real sealing mouth.Adopt full-automatic laminating machine that aluminum film and powder chamber are welded all around, thereby form a kind of special protection structure, make it can block certain oxygen, water vapour and illumination, avoid powder intracavity drug powder is impacted in outside, powder chamber.
Claims (8)
1. the ceftazidime injection of two-chamber bag packing is characterized in that the crude drug of this injection pharmaceutical composition consists of:
Powder chamber: ceftazidime 0.5～2 weight portion;
Sap cavity: glucose injection: 100 parts by volume contain glucose 4～11 weight portions or sodium chloride injection: 100 parts by volume contain 0.8～1 weight portion;
Use the film for transfusion of double-layer seal to process bag, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers of exerting pressure and can open with weak welding rod in the middle of the bag; Liquid medicine filling, seal: the medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and seal; Sterilization: packaged sample is placed sterilizing installation, in 115 ℃～125 ℃ sterilizations 8～30 minutes; Dry: the sample after will sterilizing descended dry 60-150 minute in 70-100 ℃; The relation of said weight portion and parts by volume is the relation of g/ml.
2. the ceftazidime injection of two-chamber bag packing as claimed in claim 1 is characterized in that the crude drug of this injection pharmaceutical composition consists of:
Powder chamber: ceftazidime 1 weight portion;
Sap cavity: glucose injection: 100 parts by volume contain glucose 5 weight portions.
3. the ceftazidime injection of two-chamber bag packing as claimed in claim 1 is characterized in that the crude drug of this injection pharmaceutical composition consists of:
Powder chamber: ceftazidime 0.5 weight portion
Sap cavity: glucose injection: 250 parts by volume contain glucose 12.5 weight portions.
4. the ceftazidime injection of two-chamber bag packing as claimed in claim 1 is characterized in that the crude drug of this injection pharmaceutical composition consists of:
Powder chamber: ceftazidime 3 weight portions
Sap cavity: sodium chloride injection: 100 parts by volume sodium chloride-containing, 0.9 weight portion.
5. the ceftazidime injection of two-chamber bag packing as claimed in claim 1 is characterized in that the crude drug of this injection pharmaceutical composition consists of:
Powder chamber: ceftazidime 2 weight portions
Sap cavity: sodium chloride injection: 100 parts by volume sodium chloride-containing, 0.9 weight portion.
6. method for preparing like the ceftazidime injection of the arbitrary described two-chamber bag packing of claim 1-5 is characterized in that this method is:
Bag forming: use the film for transfusion of double-layer seal to process bag, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers of exerting pressure and can open with weak welding rod in the middle of the bag;
Medicinal liquid preparation: the preparation of glucose injection: take by weighing glucose by formula ratio and add an amount of water for injection to process concentration be 4%～11% solution;
The preparation of sodium chloride injection: take by weighing sodium chloride by formula ratio and add an amount of water for injection to process concentration be 0.8%～1% solution;
Liquid medicine filling, seal: the medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and seal;
Sterilization: packaged sample is placed sterilizing installation, in 115 ℃～125 ℃ sterilizations 8～30 minutes.
Dry: the sample after will sterilizing descended dry 60-150 minute in 70-100 ℃.
The fill of aseptic powder: sample is fixed on the powder dispensing apparatus, under gnotobasis, cuts real welding rod on one side, the ceftazidime aseptic powder is quantitatively poured into the powder chamber after, firm slit edge edge is carried out real sealing mouth;
The welding of aluminium foil outside the powder chamber: with welding around aluminum film and the powder chamber.
7. the method for preparing of the ceftazidime injection of two-chamber bag packing as claimed in claim 6 is characterized in that this method is:
Use the film for transfusion of double-layer seal, process bag through the multicell bag making, filling and sealing machine, the bag edge adopts real weldering sealing, and reserves the interface that is used for fill, is divided into two chambers with weak welding rod in the middle of the bag; Taking by weighing glucose 5g adds the injection water and is settled to 100ml to process concentration be 5% solution; The medicinal liquid for preparing is poured into the transfusion bag sap cavity through interface, and the suitable accessory of welding composite cover or other seals; Packaged sample is placed steam autoclave, in 121 ℃ of sterilizations 12 minutes; Sample after the sterilization is following dry 100 minutes in 80 ℃.Sample is fixed on the full-automatic powder racking machine, under gnotobasis, cuts real welding rod on one side, the ceftazidime aseptic powder is poured into the powder chamber after, firm slit edge edge is carried out real sealing mouth; Adopt full-automatic laminating machine with welding around aluminum film and the powder chamber.
8. the method for preparing of the Azithromycin injection of two-chamber bag packing as claimed in claim 6 is characterized in that:
The concentration of said glucose injection is 5%;
In the said sealing process with composite cover or other and the corresponding accessory heat sealing of interface;
Sterilising temp in the said sterilization process is 121 ℃, and sterilization time is 12 minutes;
In the said drying process, baking temperature is 80 ℃, and be 100 minutes drying time;
The equipment that adopts in the welding sequence of aluminium foil outside the said powder chamber is full-automatic laminating machine.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106265491A (en) * | 2015-06-01 | 2017-01-04 | 徐亮 | A kind of clindamycin phosphate injection of Double-cavity bag packaging and preparation method thereof |
| CN112229947A (en) * | 2020-08-27 | 2021-01-15 | 四川科伦药业股份有限公司 | Method for measuring residual oxygen amount of gas in ampoule bottle |
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| CN102232906A (en) * | 2011-06-13 | 2011-11-09 | 湖南科伦制药有限公司 | Production process for powder-liquid double-chamber transfusion bag products |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102232906A (en) * | 2011-06-13 | 2011-11-09 | 湖南科伦制药有限公司 | Production process for powder-liquid double-chamber transfusion bag products |
Non-Patent Citations (1)
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| 陆瑶华: "头孢他啶在输液中的稳定性", 《华西药学杂志》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106265491A (en) * | 2015-06-01 | 2017-01-04 | 徐亮 | A kind of clindamycin phosphate injection of Double-cavity bag packaging and preparation method thereof |
| CN112229947A (en) * | 2020-08-27 | 2021-01-15 | 四川科伦药业股份有限公司 | Method for measuring residual oxygen amount of gas in ampoule bottle |
| CN112229947B (en) * | 2020-08-27 | 2023-03-17 | 四川科伦药业股份有限公司 | Method for measuring residual oxygen amount of gas in ampoule bottle |
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Application publication date: 20120411 |