CN102429861A - Double-cavity bag packaged cefradine injection and preparation method thereof - Google Patents

Double-cavity bag packaged cefradine injection and preparation method thereof Download PDF

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Publication number
CN102429861A
CN102429861A CN2011103864026A CN201110386402A CN102429861A CN 102429861 A CN102429861 A CN 102429861A CN 2011103864026 A CN2011103864026 A CN 2011103864026A CN 201110386402 A CN201110386402 A CN 201110386402A CN 102429861 A CN102429861 A CN 102429861A
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Prior art keywords
injection
cefradine
bag
powder
chamber
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佘佑廷
冉良骥
田洪伍
邹瑰丽
万一龙
梁隆
王利春
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Hunan Kelun Pharmaceutical Co Ltd
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Hunan Kelun Pharmaceutical Co Ltd
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Abstract

The invention discloses a cefradine injection packed by a double-cavity bag, which comprises the following raw material medicaments: powder cavity: 0.1-2 parts by weight of cefradine; liquid cavity: glucose injection: 100 volume parts of glucose-containing 4-11 weight parts or sodium chloride injection: 100 parts by volume of sodium chloride, 0.8-1 part by weight of sodium chloride; the cefradine injection is packaged by adopting a double-cavity bag, and the cefradine sterile powder and the solvent (sodium chloride injection or glucose injection) are respectively filled in two cavities separated by a rosin joint partition, so that the rosin joint isolating strip can be opened by only extruding the medicine bag when the cefradine sterile powder injection is used, the cefradine sterile powder and the solvent can quickly complete the dissolving and mixing process under the closed sterile condition, and the full-medicament treatment mixed liquid is formed and directly used for a patient.

Description

Cefradine injection of a kind of two-chamber bag packing and preparation method thereof
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, cefradine injection of particularly a kind of two-chamber bag packing and preparation method thereof.
Background technology
The cefradine chemical name is: (6R; 7R)-7 [(R)-2-amino-2-(1; The 4-cyclohexenyl group) acetylamino]-3-methyl-8-oxo-5-thia-1-azabicyclo [4,2,0] oct-2-ene-2-carboxylic acid; Be first generation cephalosporin, to not producing penicillinase and the good antibacterial action of part bacterial strain tool that produces penicillinase gold Portugal bacterium, CN-S, GPCs such as A group Hemolytic streptococcus, streptococcus pneumoniae and Streptococcus viridans.How responsive the anaerobism gram positive bacteria is to these article, and bacteroides fragilis presents drug resistance to these article.Methicillin-resistant staphylococcus, Enterococcus are to this article drug resistance.Cefradine is similar with cefalexin with the effect of gram-negative bacteria to gram positive bacteria.These article have certain effect to gonococcus, and also tool is active to producing the enzyme gonococcus; Active relatively poor to hemophilus influenza.Be applicable to respiratory tract infection such as acute pharyngitis, tonsillitis, otitis media, bronchitis and pneumonia, urogenital infections and skin soft-tissue infection etc. due to the sensitive organism.
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, in the plug additive composition possibly separate out or with medicated powder generation physics or chemical reaction; 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 cefradine 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: cefradine 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
Above-mentioned raw materials medicine preferred weight proportioning is following:
Powder chamber: cefradine 1 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: cefradine 0.5 weight portion
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: cefradine 2 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: cefradine 0.5 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 cefradine 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.
Cefradine injection of the present invention adopts two-chamber bag packing; Through cefradine 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 cefradine 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 cefradine 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 cefradine 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 cefradine 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
Figure BDA0000113611190000031
Figure BDA0000113611190000041
Experimental example 2
(XiLin is bottled to get 10 cefradine powder pins respectively; Specification: 0.5g) with 10 bottles of glucose injections (glass transfusion bottle, specification: 100ml:0.5g), according to the clinical manipulation method of routine; Change the cefradine 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 cefradine 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
Figure BDA0000113611190000042
Can know by comparing result; Adopt the cefradine 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 cefradine 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 cefradine powder pin of two producers respectively; Specification: 0.5g) 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 cefradine 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
Figure BDA0000113611190000051
Investigation data by last table can be known, adopt two chambers bag packaged products, and the clarity of cefradine 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.
Embodiment 1
Powder chamber: cefradine 0.5g
Sap cavity: glucose injection: 100ml: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 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 80 minutes in 80 ℃.Sample is fixed on the full-automatic powder racking machine, under gnotobasis, cuts real welding rod on one side, the cefradine 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 2
Powder chamber: cefradine 0.5g
Sap cavity: glucose injection: 250ml: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 250ml water 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 cefradine 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 3
Powder chamber: cefradine 1g
Sap cavity: sodium chloride injection: 100ml: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 100ml water 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 cefradine 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: cefradine 2g
Sap cavity: sodium chloride injection: 250ml: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 250ml water 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 cefradine 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 cefradine injection of two-chamber bag packing is characterized in that the crude drug of this injection pharmaceutical composition consists of:
Powder chamber: cefradine 0.1~2 weight portion
Sap cavity: glucose injection: 100 parts by volume contain glucose 4~11 weight portions or
Sodium chloride injection: 100 parts by volume sodium chloride-containing, 0.8~1 weight portion sodium chloride;
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 cefradine 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: cefradine 0.125 weight portion
Sap cavity: glucose injection: 100 parts by volume contain glucose 5 weight portions.
3. the cefradine 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: cefradine 0.25 weight portion
Sap cavity: glucose injection: 250 parts by volume contain glucose 12.5 weight portions.
4. the cefradine 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: cefradine 2 weight portions
Sap cavity: sodium chloride injection: 100 parts by volume sodium chloride-containing, 0.9 weight portion.
5. the cefradine 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: cefradine 0.5 weight portion
Sap cavity: sodium chloride injection: 250 parts by volume sodium chloride-containing, 2.25 weight portions.
6. method for preparing like the cefradine 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 cefradine 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 cefradine 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 cefradine 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.
CN2011103864026A 2011-11-29 2011-11-29 Double-cavity bag packaged cefradine injection and preparation method thereof Pending CN102429861A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1408336A (en) * 2001-10-03 2003-04-09 尼普洛株式会社 Complex room container preparation
CN1751751A (en) * 2005-09-07 2006-03-29 华北制药集团有限责任公司 Immediate dispensing infusion
CN201784917U (en) * 2010-09-17 2011-04-06 四川科伦药物研究有限公司 Combined package for cefradine for injection

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1408336A (en) * 2001-10-03 2003-04-09 尼普洛株式会社 Complex room container preparation
CN1751751A (en) * 2005-09-07 2006-03-29 华北制药集团有限责任公司 Immediate dispensing infusion
CN201784917U (en) * 2010-09-17 2011-04-06 四川科伦药物研究有限公司 Combined package for cefradine for injection

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Application publication date: 20120502